[Federal Register Volume 62, Number 90 (Friday, May 9, 1997)]
[Rules and Regulations]
[Pages 25477-25498]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 97-11967]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 898

[Docket No. 94N-0078]


Medical Devices; Establishment of a Performance Standard for 
Electrode Lead Wires and Patient Cables

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
establishing a performance standard for electrode lead wires and 
patient cables. The agency is taking this action because it has 
determined that a performance standard is needed to prevent electrical 
connections between patients and electrical power sources. The final 
rule will substantially reduce the risk of electrocution from 
unprotected electrode lead wires and patient cables.

DATES: This regulation is effective August 7, 1997, except that 
Sec. 898.14 (21 CFR 898.14) is stayed pending Office of Management and 
Budget (OMB) clearance for information collection. FDA will announce 
the effective date of Sec. 898.14 in the Federal Register. Submit 
written comments on the information collection provisions of this final 
rule by July 8, 1997.

[[Page 25478]]

For information on the compliance dates, see 21 CFR 898.13(a) and (b).

ADDRESSES: Submit written comments on the information collection 
provisions of this final rule to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Ave., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 19, 1994 (59 FR 26352), FDA 
published an advance notice of proposed rulemaking (ANPRM) and 
announced the need for further FDA action to address the risk of 
patient exposure to macro shock or electrocution due to the 
inappropriate connection of a patient-connected cable or electrode lead 
wire to an alternating current (AC) power source. In that ANPRM, FDA 
described various regulatory actions it had taken since the first 
reported incidents in 1985 of exposed male connector pins of electrode 
lead wires being inserted into either AC power cords or a wall outlet, 
rather than into the patient cable that connects to the device monitor. 
The ANPRM also described actions that various organizations, such as, 
the Emergency Care Research Institute (ECRI) and outside standard 
setting bodies have taken to prevent electrode lead wires from being 
connected to electrical power sources. A summary of these actions is 
provided in section VII. of this document. In the ANPRM, FDA stated 
that ``despite efforts to eliminate the risk, unprotected electrode 
lead wires and patient cabling systems are still distributed by some 
manufacturers as replacements for existing equipment, and may also be 
interchangeable among various medical devices.'' (See 59 FR 26352 at 
26353.) In the ANPRM, FDA further announced that it, in conjunction 
with the Health Industry Manufacturers Association and the American 
Hospital Association (AHA), was sponsoring a public conference entitled 
``Unprotected Patient Cables and Electrode Lead Wires.'' The conference 
was held on July 15, 1994, and provided a forum for device users, 
manufacturers, and other health care professionals to offer and to hear 
comments for FDA's consideration during the rulemaking process.
    The need for FDA action to resolve the hazard of the use of 
unprotected electrode lead wires and patient cables with medical 
devices was further emphasized in a letter dated August 2, 1994, to FDA 
Commissioner David A. Kessler, from the Honorable Ron Wyden, then 
Chairman, U.S. House of Representatives, Committee on Small Business, 
Subcommittee on Regulation, Business Opportunities, and Technology 
(Ref. 1). In that letter, Mr. Wyden stated that ``shocks, burns, and 
electrocutions occur despite warnings issued by the FDA to hospitals, 
manufacturers, and others.''
    Specifically, Mr. Wyden wrote that:
    Hospitals have been told to purchase and use only protected 
wires and cables. They have also been told to remove unprotected 
equipment and to alert staff members of possible hazards to 
patients.
    Manufacturers have been encouraged to modify their designs to 
prevent lead wires from being inserted into electrical outlets.
    Despite warnings and other communications, some manufacturers 
still distribute to hospitals unprotected [patient cables and] lead 
wires as replacements for deteriorated equipment.
    It is clear that regulatory action, as well as additional 
education and training, is needed to stop the slow but steady flow 
of children (and adults) who are burned or electrocuted.
    FDA's records of incidents with unprotected electrode lead wires 
and patient cables reveal the following:
    Between 1985 and 1994, 24 infants or children received ``macro-
shock'' (large externally applied currents) from electrode lead wires 
or cables, including five children who died by electrocution (Ref. 2). 
The most recent death (1993), of a 12-day old infant, occurred in a 
hospital. The apnea monitor involved in the incident had been sold to 
the hospital with a protected electrode lead wire and patient cable. 
However, when the infant was electrocuted, an unprotected patient cable 
from a second manufacturer and unprotected prewired electrodes from a 
third manufacturer were being used instead of the protected 
configuration.
    There are reports of injuries associated with unsafe electrode lead 
wires and patient cables involving medical devices other than apnea 
monitors (Ref. 3). In 1986, for example, a death occurred when the 
electrocardiogram (ECG) lead wires were inserted into a pulse oximeter 
power cord. FDA has received additional reports of similar events that 
resulted in electrical shocks, burns, and possible brain damage to 
patients.
    In response to the death and electrical burns that occurred in 
1985, FDA issued an alert to home-use apnea monitor manufacturers, home 
user support organizations, and apnea monitor users, announcing, among 
other things, the agency's intent to embark on a cooperative effort 
with industry and the medical profession to resolve the problem of 
users making a hazardous electrical connection between the patient and 
an electrical power source. FDA also requested each home-use apnea 
monitor manufacturer to assess its device for potential electrode lead 
wire and patient cable connection hazards and, when necessary, to 
consider design changes to preclude insertion of electrode lead wire 
connectors into AC power cords and outlets. In addition to issuing the 
alert, FDA's Center for Devices and Radiological Health's (CDRH's) July 
1985 ``Medical Devices Bulletin'' was devoted primarily to publicizing 
the unprotected electrode lead wire and patient cable connection 
hazard.
    Since 1985, FDA has not cleared for marketing any home-use apnea 
monitor that features an unprotected electrode lead wire and patient 
cable configuration. For all apnea monitors cleared for marketing since 
1989, FDA has required a protected electrode lead wire and patient 
cable design, whether or not the device was intended for home use. 
Despite these efforts, some hospitals continue to use older units, or 
electrode lead wires and patient cables from other devices, which do 
not have the protected cable and electrode lead wire design. Even with 
the new protected models, as evidenced by the 1993 incident, it may be 
possible to switch to use of an unprotected electrode lead wire and 
patient cable configuration, thereby recreating the hazard.
    On September 3, 1993, FDA issued a safety alert to hospital 
administrators, risk managers, and pediatric department directors, 
warning them that the use of unprotected electrode lead wires and 
patient cables with an apnea monitor may be dangerous to the patient, 
and may be in violation of section 518(a) of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 360h(a)) (Ref. 4). FDA included 
in the alert a number of recommendations to help prevent these 
accidents. FDA also sent all apnea monitor manufacturers a notification 
letter under section 518(a) of the act (Ref. 5).
    Section 518(a) of the act authorizes the agency to issue an order 
to ensure that adequate notification is provided in an appropriate 
form, by the means best suited under the circumstances involved, to all 
health care professionals who prescribe or use a particular device and 
to any other person who should properly receive such notification, in

[[Page 25479]]

order to eliminate an unreasonable and substantial harm to the public 
health when no other practicable means is available under the act to 
eliminate such risk. FDA stated that, for these devices, notification 
should include replacement of unprotected apnea monitor electrode lead 
wires and patient cables, and that a warning label should be 
permanently affixed to all apnea monitors stating that unprotected 
electrode lead wires and patient cables should not be used with the 
device because inappropriate electrical connections may pose an 
unreasonable risk of adverse health consequences or death. FDA also 
requested manufacturers of all apnea monitors to cease further 
distribution of unprotected electrode lead wires and patient cables. On 
September 20, 1993, FDA issued a similar letter to all known third-
party manufacturers of electrode lead wires and patient cables (Ref. 
6).
    On December 28, 1993, FDA issued a Public Health Advisory to 
hospital nursing directors, risk managers, and biomedical/clinical 
engineering departments for distribution to all units in their 
hospitals and outpatient clinics, as well as to home health care 
providers and suppliers affiliated with those facilities, advising them 
of the hazards associated with use of electrode lead wires with 
unprotected male connector pins (Ref. 7). In the Public Health 
Advisory, FDA expanded the scope of its September 3, 1993, apnea 
monitor safety alert to include all devices using unprotected electrode 
lead wires and patient cables. FDA noted that, even though many 
manufacturers have changed the design of their devices to minimize the 
potential hazard, some facilities are still using older models that 
make it possible for staff to switch to unprotected patient cables and 
lead wires, thus recreating the hazard. FDA recommended various 
precautions be taken to prevent the use of unprotected electrode lead 
wires and patient cables.
    Manufacturers of devices other than apnea monitors that utilize 
patient-connected electrode lead wires, e.g., ECG monitors, have been 
encouraged by various organizations to modify their electrode lead 
wires and patient cables so that they cannot be inserted into AC power 
cords or outlets. For example, in February 1987 and May 1993, ECRI 
issued hazard reports concerning electrical shock hazards from 
unprotected electrode lead wires and patient cables. Further, 
standards-setting bodies have developed various standards, both in 
draft and final form, that have the same goal in mind--safety 
requirements for electrode lead wires and patient cables.
    In March 1995, the International Electrotechnical Commission (IEC) 
published a second amendment to IEC 601-1 (1988), the safety standard 
for electromedical equipment, which includes a requirement that 
electrode lead wires be unable to make contact with hazardous voltages.
    The Underwriters Laboratories (UL) adopted a modified version of 
IEC 601-1 by issuing its standard 2601-1, which became effective on 
August 31, 1994. This standard superseded UL 544 (referenced in the 
ANPRM). In adopting the IEC standard, UL included a deviation requiring 
that patient-connected electrodes be designed to avoid connection to 
electrical power sources. (See UL 2601-1, Medical Electrical Equipment 
Part 1: General Requirements for Safety.) The UL standard states in the 
rationale section that ``this is a basic safety concern prompted by 
recent accidents involving patient injury, including infant deaths. 
Patients were being accidently connected to hazardous circuits while 
being connected to applied parts of medical equipment, such as an apnea 
monitor.'' FDA has been advised that it is possible that UL will modify 
its requirement to be equivalent to the one included in the second 
amendment to IEC 601-1 (1988).
    There is also a German DIN standard for touch proof connectors for 
electromedical applications. This design standard was also referenced 
in the ANPRM and states that it was developed because of the accidents 
that occurred with infants in 1985 and 1986.
    The National Fire Protection Agency (NFPA) is also proposing a 
standard for patient electrode lead wire connectors. FDA has received 
information that, even though it is voluntary, this NFPA standard will 
be adopted by many States and municipalities as a mandatory standard 
for health care facilities. Further, this standard is referenced by the 
hospital accrediting body, the Joint Commission on Accreditation of 
Health Care Organizations.
    Finally, the Association for the Advancement of Medical 
Instrumentation (AAMI) has developed a standard that covers electrode 
lead wires and patient cables for surface electrocardiographic 
monitoring in cardiac monitor applications (ECG cables and lead wires, 
ANSI/AAMI EC53-1995). This design standard addresses safety and 
performance of electrode lead wires and patient cables with the added 
purpose of discouraging the availability of unprotected patient cable 
and lead wire configurations for ECG monitoring applications. The 
standard defines a safe (no exposed metal pins) common interface at the 
cable yoke and electrode lead wire connector. The standard was approved 
by ANSI on December 7, 1995.
    FDA believes that industry also recognizes the importance of 
addressing this hazard. In response to FDA's alert letter in June 1985, 
manufacturers voluntarily began to redesign their electrode lead wires 
and patient cables for home apnea monitors. More recently, many firms 
have taken voluntary action to recall electrode lead wires and patient 
cables with unprotected exposed metal pins. Apnea monitor firms are 
replacing their male pin lead wires and associated cables with safety 
cable systems, usually free of charge, while other device manufacturers 
are making adapters and warning labels available. Some device 
manufacturers have ceased supplying unprotected electrode lead wires 
and patient cables altogether.

II. The Proposed Rule

    Despite repeated efforts to reduce the risk associated with the use 
of unprotected electrode lead wires and patient cables, these products 
are still available and in use in homes and in various health care 
settings.
    In the Federal Register of June 21, 1995 (60 FR 32406), FDA issued 
a proposed rule designed to allow the orderly removal of unprotected 
electrode lead wires and patient cables from the marketplace. The 
proposal set forth a phased-in approach for removing unprotected lead 
wires and patient cables while seeking to minimize the economic impact 
to manufacturers and user facilities during the transition to a 
protected cabling configuration.
    Under FDA's proposed phased-in approach, unprotected lead wires and 
patient cables would be subject to a proposed performance standard, 
developed by FDA. The effective date for any final regulation based on 
the proposal was to be phased-in over 1 or 3 years, depending on the 
device type. Under the proposed rule, any devices that did not meet the 
standard on its effective date would be banned.
    Devices that were to be subject to the 1-year effective date were 
those devices believed to present the greatest potential risk of harm 
as demonstrated by use in environments where accidental inappropriate 
connections could reasonably be anticipated, and by frequent use of the 
devices and frequent connections of electrode lead wires. Devices 
subject to the 1-year effective date included all devices that had been 
the subject of reported adverse events, as well as other devices 
believed to present the greatest potential risk of

[[Page 25480]]

harm. Devices that were proposed to be subject to the 3-year effective 
date were those devices that did not satisfy the criteria for the 1-
year effective date but also utilized unprotected electrode lead wires. 
As stated earlier, the agency proposed to ban those devices that did 
not meet the standard on its effective date.
    FDA received comments on various aspects of the proposed rule, 
including: (1) The cost of conversion for manufacturers and user 
facilities; (2) the placement of a given device on the 1-year or the 3-
year list; (3) the appropriate list for devices that were not 
specifically mentioned on either list, as well as for future devices; 
and (4) whether the agency might adopt one of the consensus performance 
standards mentioned in the proposed rule instead of issuing a new one. 
This final rule addresses these concerns and others in providing a cost 
effective remedy to eliminate an inappropriate, but preventable 
occurrence of macro shock or electrocution due to the accidental 
connection of an electrode lead wire or patient cable to an AC power 
source.

III. Highlights of the Final Rule

    In response to comments, the agency has revised and clarified 
certain provisions of the final regulation. The final rule establishes 
a performance standard that FDA believes will eliminate the risk, to 
the extent possible, of unprotected electrode lead wires and patient 
cables being inadvertently inserted or manipulated so as to make 
contact with live parts of an AC power cord or electrical outlet. This 
standard applies to all electrode lead wires and patient cables. The 
revisions in the final rule are based on focusing the regulation on the 
most cost-effective mechanism of accomplishing its important public 
health goal. The most significant changes from the proposed rule 
follow:
    1. The performance standard being established applies directly to 
electrode lead wires and patient cables, rather than to the medical 
equipment to which they are attached. This revision focuses the 
standard on the actual products that could create a patient hazard.
    2. In issuing this standard, the agency is adopting the relevant 
portion of a recently updated international standard (IEC 601-1). This 
standard contains all the necessary provisions for patient protection. 
Moreover, by adopting an existing and widely followed international 
standard, the cost to industry in complying with this standard is 
minimized.
    3. The agency is revising the effective date so that only the 
electrode lead wires and patient cables used with those devices 
presenting the greatest potential risk will be required to conform to 
the standard within 1 year. Specifically, the 1-year category has been 
limited to 10 devices that, if unprotected, present the greatest 
potential risk of harm as demonstrated by past incidents, their use in 
environments where accidental inappropriate connections could most 
likely be anticipated, or by the frequency with which the devices are 
used and the frequency of connections of the patient-connected 
electrode lead wires. Electrode lead wires and patient cables that are 
intended for use with those 10 devices will be required to conform to 
the standard within 1 year. FDA has placed all remaining devices in the 
3-year category. Electrode lead wires and patient cables that are 
subject to the 3-year effective date are those used with, or intended 
for use with devices that are not subject to the 1-year effective date.
    4. The agency has deleted the provision banning devices that do not 
meet the standard because such a provision is unnecessary. Under 
section 501(e) of the act (21 U.S.C. 351(e)) electrode lead wires and 
patient cables not meeting the performance standard on or following the 
effective date are adulterated.
    5. This rule constitutes the first mandatory performance standard 
established by FDA under section 514 of the act (21 U.S.C. 360d).

IV. The Framework

    In order to eliminate the risk of macro shock and electrocution in 
the future, the agency is establishing a performance standard for all 
electrode lead wires and patient cables. In reaching this decision, the 
agency reviewed several standards that are in various stages of 
development before deciding to adopt a provision of the international 
performance standard of IEC 601-1 on lead wires for medical devices.
    Firms whose electrode lead wire and patient cable systems are 
subject to this performance standard should begin to adapt existing 
products to meet the standard, if they have not already done so, before 
the effective date of the standard. These efforts are consistent with 
Congress' admonition that ``stockpiling of nonconforming devices is 
discouraged, since standards will apply to all devices in commercial 
channels on their effective date.'' (See H. Rept. 853, 94th Cong., 2d 
sess. 30; see also 45 FR 7474, February 1, 1980, final standards 
regulation.)
    Later in this document, FDA is publishing a list of the 10 devices 
at highest risk of a user inadvertently connecting the device's 
electrode lead wire(s) or patient cable to an AC power source. One year 
from the publication date of this rule, unprotected electrode lead 
wires and patient cables intended for use with, or used with, any of 
these 10 devices will be subject to FDA's performance standard. Three 
years after the publication date of this rule, unprotected patient 
cable and lead wire systems intended for use with any other medical 
device, absent an FDA waiver or exemption, will be subject to FDA's 
performance standard. FDA reserves the right, upon proper notification 
to interested parties, to amend the list of devices in the future. FDA 
believes the effective dates are reasonable and consistent with the 
congressional intent in enacting section 514 of the act, as well as 
with comments received at the public conference and written comments on 
the proposed rule.
    The agency anticipates a smooth, but rapid, transition for the vast 
majority of existing devices to a protected electrode lead wire and 
patient cable configuration following publication of the final rule.

V. Performance Standard

    The Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629) 
prescribes changes to the act (21 U.S.C. 321-394), as amended, that 
improve the regulation of medical devices and strengthen the Medical 
Device Amendments of 1976, which established a comprehensive framework 
for the regulation of medical devices.
    The SMDA amended section 513 of the act (21 U.S.C. 360c) to 
redefine class II as the class of devices that is or will be subject to 
special controls, and amended section 514 of the act to simplify the 
requirements for establishing performance standards. Section 513 of the 
act states that the ``special controls * * * shall include performance 
standards for a class II device if the Secretary determines that a 
performance standard is necessary to provide reasonable assurance of 
the safety and effectiveness of the device.'' The legislative history 
of the SMDA states that:
by simplifying the process for establishing performance standards, 
and by allowing the Secretary discretion to employ such standards as 
one of a variety of additional controls to assure the safety and 
effectiveness of Class II devices, performance standards will become 
valuable tools to regulate those devices for which they are most 
needed.
(S. Rept. 513, 101st Cong., 2d sess. 19 (1990))
    Under this rule, the mandatory performance standard applies to all 
electrode lead wires and patient cables intended for use with medical 
devices and is phased-in over a period of 1 or

[[Page 25481]]

3 years. New Sec. 898.12(a) and (b) identifies the devices that are 
subject to the performance standard, with the applicable effective 
dates of the standard.

A. The Standard

    FDA is issuing the following standard for electrode lead wires or 
patient cables:
Electrode lead wires and patient cables shall comply with the 
International Electrotechnical Commission (IEC) standard 601-1 
subclause 56.3, paragraph c (1995).
    Compliance with this standard shall be determined by inspection 
and by applying the test requirements also found in IEC 601-1, 
subclause 56.3(c). This standard is available from the American 
National Standards Institute (ANSI), 11 West 42nd Street, New York, 
NY 10036.

B. The Effective Date for Compliance

    21 CFR 861.36 states that:
A regulation establishing * * * a performance standard will set 
forth the date upon which it will take effect. To the extent 
practical, consistent with the public health and safety, such 
effective date will be established so as to minimize economic loss 
to, and disruption or dislocation of, domestic and international 
trade.
(See also section 514(b)(3)(B) of the act)
    FDA has determined that the cost of converting or adapting unsafe 
electrode lead wire configurations in order to comply with the 
performance standard being established minimizes economic loss to, and 
disruption or dislocation of, domestic and international trade because 
the standard is to be phased in over a 1- or 3-year period, depending 
on the device(s) with which the electrode lead wire or patient cable is 
intended to be used, and the vast majority of devices fall under the 3-
year rule. Furthermore, FDA believes that this cost is justifiable 
given the severity of the adverse events that have occurred and the 
fact that such adverse events are entirely preventable.

VI. The Banning Action

    FDA proposed to ban devices under section 516 of the act (21 U.S.C. 
360f) that did not meet the standard on the applicable effective date. 
Upon reconsideration, FDA has determined that a ban is unnecessary. 
Under section 501(e) of the act, devices not meeting the performance 
standard on its effective date are adulterated. Furthermore, original 
equipment manufacturers (OEM's) and third-party suppliers will not be 
permitted to supply replacement cables and lead systems that fail to 
meet the standard, absent an FDA waiver or exemption.

VII. Summary and Analysis of Comments and FDA's Response

    The agency received 27 written comments from manufacturers, 
distributors, user facilities, and trade associations in response to 
the proposed rule. A summary of the written comments is provided below.
    1. In general, several comments supported FDA's efforts to resolve 
the problem of macro shock or electrocution due to an improper 
connection of a patient-connected electrode lead wire to an AC power 
source. However, a few comments expressed concern that the proposed 
banning action would apply to the devices that utilize unprotected 
electrode lead wires and patient cables instead of the lead wire 
systems themselves.
    FDA has shifted the applicability of the performance standard from 
the device utilizing the electrode lead wires and patient cables onto 
the electrode lead wires and patient cables themselves. Moreover, FDA 
has withdrawn the banning action from the final rule, because it was 
determined not to be necessary.
    2. FDA received several comments questioning which devices should 
be subject to the 1-year effective date and which should be subject to 
the 3-year effective date. One comment suggested that the two lists of 
devices in the proposed rule be eliminated from the final rule and that 
the ban simply be made effective for all devices 1 year from the 
publication date of the final rule. Other comments questioned whether 
particular devices should be placed on the 1-year list and, thus, 
subjected to the ban and performance standard after 1 year or whether 
the devices should properly be included in the 3-year list and thus be 
given additional time to meet the standard.
    In response to the comments, FDA has limited the devices on the 1-
year list to the 10-device types that the agency believes to be most 
likely to expose persons to macro shock or electrocution based on the 
reported adverse events and the environments in which the devices are 
used. Electrode lead wires or patient cables intended for use with any 
other device will be subject to the performance standard 3 years from 
the date of publication.
    3. One comment suggested replacing the word ``protected'' in the 
proposed performance standard (Sec. 898.11) with the word ``designed'' 
to allow greater flexibility for electrode lead wire designers.
    FDA advises that, although the standard that the agency is issuing 
in this final rule has been modified from the proposed standard, the 
word ``protected'' in the proposed rule was intended to encompass 
creative design changes to devices as well as the development of 
adapters for use with existing devices in order to achieve a safe 
electrode lead wire and patient cable configuration. The agency 
believes that the mandatory performance standard being established in 
this final rule accomplishes the goal of providing manufacturers 
flexibility in achieving the desired protected configuration. It is 
anticipated that the marketplace will determine one or more suitable 
design standards for the manufacture of new equipment and adapters 
which will provide safe and effective protected electrode lead wire and 
patient cable configurations.
    4. One comment suggested that, instead of instituting a ban on 
unprotected electrode lead wires and patient cables and establishing a 
mandatory performance standard, it would be easier to simply fire the 
hospital employee who plugs a patient into a receptacle.
    FDA disagrees with this comment. The agency believes that proactive 
measures are appropriate to address the risk of harm presented by 
unprotected electrode lead wires and patient cables, particularly when 
it is reasonably foreseeable that risk of misuse of a device will 
result in serious adverse health consequences or death. Imposing 
sanctions after adverse incidents would not necessarily reduce the risk 
presented by those devices, nor would it address the risks presented by 
them when used in a home environment. The agency has determined that a 
change in the design of electrode lead wires and patient cables to a 
protected configuration is both technologically and economically 
feasible, if given a reasonable time for implementation.
    5. One comment questioned whether devices that utilize unprotected 
patient cables and/or electrode lead wires which simply contact the 
patient during operation, as opposed to being directly attached to him 
or her, are included in this rule.
    FDA has determined that, because the electrical contact between a 
patient and an unprotected cable or electrode lead wire that is plugged 
into an AC power source need only be momentary to produce disastrous 
results, devices that simply contact the patient during operation are 
also hazardous and, consequently, are included within the scope of the 
performance standard.
    6. One comment suggested that a company should be allowed to label 
its conforming product as registered and approved by FDA so that 
physicians

[[Page 25482]]

could buy from an FDA approved manufacturer.
    The act specifically prohibits a manufacturer from representing its 
medical device as having been approved. (See section 301(l) of the act 
(21 U.S.C. 331(l)); and see also 21 CFR 807.97, regarding premarket 
notifications.) In addition, compliance with a mandatory performance 
standard is different from FDA approval of a device.
    7. Several comments expressed concern over the ability of their 
health care facilities to absorb the cost of either adapting old 
equipment to the protected configuration or purchasing new equipment to 
meet the performance standard in a 1-year timeframe. These comments 
requested that a particular device be moved from the proposed 1-year 
list to the 3-year list in order to have an adequate opportunity for 
compliance.
    It is not the intent of the agency to create undue economic 
hardship on facilities in its efforts to minimize the risk of injury or 
death from an improper connection of a patient cable or electrode lead 
wire to an AC power source. The agency is interested in balancing the 
cost of implementing this rule with the demonstrated risk. The agency 
has addressed the issue of cost to facilities in the following two 
ways. First, in the final rule, FDA has significantly reduced the 
number of devices subject to the performance standard in the 1-year 
timeframe. Due to the higher level of risk they present, unprotected 
electrode lead wires and patient cables cannot be used with the 10-
device types that remain in this category 1 year after the publication 
date of this rule. However, 3 years from the date of publication of 
this rule, unprotected electrode lead wires and patient cables cannot 
be manufactured, distributed, sold, resold, or used on patients unless 
they meet the performance standard. On the effective date of the 
performance standard, electrode lead wire and patient cable 
manufacturers can no longer produce or supply unprotected electrode 
lead wires and patient cables as replacements for use with these 
existing devices.
    FDA encourages the entrepreneurial development of suitable adapters 
that can be used with existing equipment to speed the creation of a 
safer environment for patients.
    8. Several comments have cited the professionalism of their health 
care staff as evidence of the improbability that an adverse event such 
as a macro shock or electrocution would occur in their facility. These 
comments believe that their devices should not be subject to the ban or 
performance standard.
    FDA disagrees with these statements. Since 1985, when the first 
incident occurred, various groups have made the argument that such 
events do not, have not, and would not happen at their facility. After 
the first death in 1985 in a patient's home, it was argued that these 
events could only happen outside of a health care facility, away from 
the watchful eye of a professional. However, since that time, at least 
23 additional cases of macro shock or electrocution have occurred, 
including 3 electrocutions by nurses. FDA believes that, while some 
areas of a health care setting are more stressful than others, human 
error can and does occur. A patient should not needlessly be exposed to 
a known and preventable risk simply because it has not happened yet in 
a particular area of a facility. However, in an effort to address the 
cost considerations for health care facilities, the agency has moved 
most devices to the 3-year effective date.
    9. One comment suggested that FDA simply encourage manufacturers to 
comply with one of the existing voluntary standards (e.g., IEC 601-1), 
rather than issuing its own mandatory standard. Other comments 
suggested that enforcement of a voluntary standard could be achieved 
through manufacturer ``self-certification'' of compliance with IEC 601-
1. It was further suggested that compliance with a voluntary standard 
could be monitored through the 510(k) review process.
    FDA disagrees with a voluntary approach. The agency has determined 
that a mandatory performance standard is necessary to address the 
significant risk of harm presented by unprotected electrode lead wires 
and patient cables. However, FDA has taken the suggestion that the 
agency adopt an existing consensus standard rather than develop its own 
and possibly conflicting standard.
    10. Two comments questioned the need for a protected electrode lead 
wire performance standard to apply to battery-powered devices, such as 
a transcutaneous electrical nerve stimulator (TENS) device. The 
comments indicated that TENS devices use a lead wire with a 2.5 
millimeters (mm) coaxial pin connection that is not universally 
interchangeable with apnea monitors and ECG lead systems.
    FDA disagrees with these comments. Two electrocutions occurred when 
one child plugged his own attached lead wire into a wall socket and 
when a second child plugged a sibling's attached lead wire into a power 
cord. These incidents happened with a 2.0 mm exposed pin, but could 
easily have happened with a 2.5 mm plug. The point that these devices 
are battery-powered is not relevant because it is the dangling patient-
connected cable or electrode lead wire that is dangerous, not the 
battery-powered device.
    11. Several comments suggested that each electrode lead wire or 
cable simply be labeled with specific warnings about exposed pins and 
the potential hazard of electrocution when connected to an AC power 
source.
    FDA is aware that, in response to the section 518(a) of the act 
letters that the agency issued in 1993 (Ref. 7), many firms conducted 
voluntary recalls of unprotected electrode lead wires to correct the 
labeling on these devices. However, FDA has determined that the 
continued marketing of unprotected electrode lead wires and patient 
cables, no matter how they are labeled, presents an unreasonable and 
substantial risk of illness or injury to individuals, and provides no 
benefit to the public health that is not provided by protected 
electrode lead wires and patient cables. Use of unprotected electrode 
lead wire and patient cable configurations have resulted in, and can be 
expected to continue to result in, serious adverse health consequences 
or death because these devices are inherently dangerous when used in a 
reasonably foreseeable, albeit inappropriate, manner. There are no 
labeling requirements that can reliably prevent inappropriate 
connections of unprotected electrode lead wires and patient cables and, 
thus, unprotected electrode lead wire configurations cannot be safely 
marketed for their intended purpose.
    Accordingly, FDA determined that a change in labeling will not 
suffice. Indeed, labeling warnings are meaningless when unprotected 
electrode lead wires and patient cables are available to preschool 
children or individuals with limitations such as vision problems or 
cognitive impairments. Further, labeling is often an inadequate 
solution in certain hospital settings when health care professionals 
find themselves in busy, stressful situations in which they may not be 
provided with, or could inadvertently overlook, instructions.
    12. Two comments questioned whether 2.5 mm coaxial pin electrode 
lead wires should be subject to the performance standard because these 
lead wires may not produce the same potentially damaging result. These 
comments cited a 1994 class II recall and labeling action by CDRH's 
Office of Compliance in which the agency did not call for user 
notification and labeling of

[[Page 25483]]

2.5 mm coaxial plugs. In addition, one comment stated that there is no 
reasonable possibility of substitution of a 2.5 mm coaxial plug for use 
with an apnea monitor patient cable designed to accept individually 
exposed 2.0 mm pins.
    FDA disagrees. The August 1993 incident in which a protected 2.0 mm 
electrode lead wire and patient cable system for an apnea monitor had 
been replaced by an unprotected 2.0 mm cable and lead wire 
configuration had disastrous results. In this incident, an infant was 
electrocuted when the replacement unprotected electrode lead wire was 
directly connected to an AC power cord. CDRH's Office of Compliance 
required contraindication labeling of exposed 2.0 mm pin lead wires 
which, in short, warned users not to use unprotected 2.0 mm pin lead 
wires with apnea monitors. Older apnea monitor designs use electrode 
lead wires with individual 2.0 mm pins and a patient cable with 2.0 mm 
sockets. Unprotected electrode lead wires having a 2.5 mm pin (such as 
those used with TENS devices) were exempted from the labeling 
requirement because it was believed to be physically impossible to fit 
a 2.5 mm plug into a 2.0 mm patient cable socket. FDA accepted the 
firm's argument against labeling an unprotected lead wire with a 2.5 mm 
pin to warn against its use with an apnea monitor.
    In view of the information available to the agency at the time, on 
March 8, 1994, the agency informed a contract leads manufacturer that, 
``It is our understanding from discussions with other manufacturers 
that a 2.5 mm pin plug is too large to fit into an electrical power 
cord or wall outlet, and therefore would not need to be labeled.'' 
However, that assessment was subsequently changed following test 
results submitted by two TENS/national medical equipment supplies 
manufacturers, both of whom confirmed that the 2.5 mm coaxial pin could 
be inserted into power cords and wall outlets. One manufacturer also 
showed the same results for flexible 2.75 mm ``banana'' plugs. One test 
showed no electrical current flow for the 2.5 mm pins, while a second 
test showed that an electrical connection was made.
    Because it is physically possible to insert a 2.5 mm pin into an AC 
power source, these devices are subject to the performance standard 
established in this rule.
    13. One comment sought clarification of FDA's assertion in the 
proposal that, ``if an adapter is used, it should prevent removal by 
the user.'' The comment suggested that ``like the patient cable, an 
adapter can trap blood and other contaminants during use. A reusable 
adapter must be easily and thoroughly cleaned and sterilized. The 
adapter should be submersible, capable of being abrasively scrubbed, 
and autoclavable.''
    FDA agrees that, in some applications, it may be necessary to have 
an adapter that is capable of being removed from the device for 
cleaning purposes. However, because reported adverse events have shown 
a propensity for individuals to simply remove a protected configuration 
from a device and replace it with an unprotected configuration for the 
sake of convenience, the agency recommends use of adapters that are not 
easily removed by the user (e.g., only detachable with the use of a 
tool). The agency believes that, for those applications where device 
contamination is of concern, the adapter should be disposable, if 
possible, and that the device should not be suited to accept and 
function with an unprotected electrode lead wire and patient cable 
configuration.
    14. One comment sought to clarify whether only electrodes with 
preattached lead wires were unprotected or whether the ``snap-on'' 
electrodes without the lead wires are also considered unprotected. 
Another comment questioned whether patient-connected electrodes with 
exposed wires were covered under the standard or only those having a 
pin attached at the end distal to the patient.
    FDA considers any patient cable or electrode lead wire having a 
distal end that is capable of making conductive contact with an AC 
power source (e.g., a power cord, or wall outlet) to be unprotected 
and, therefore, subject to the performance standard. The standard 
applies to the lead wires themselves, and not to detachable ``snap-on'' 
electrodes with which they may be used.
    15. One comment questioned who would be responsible for product 
inventory once the banning action becomes effective. Another comment 
expressed opposition to manufacturers having to recover product from 
the field. Yet another comment sought clarification of the 
responsibility of the manufacturer for a device that was introduced 
into the marketplace prior to the effective date of the standard but 
the user returns the device for repair or maintenance under a 
maintenance agreement and the device has not yet been modified in 
accordance with the standard.
    As mentioned in section VI. of this document, FDA has eliminated 
the proposed banning action in this final rule. FDA believes that the 
manufacturer, distributor, seller, and user should share in the 
responsibility for removing adulterated goods under their control from 
the marketplace. Because many of the devices that are affected by the 
performance standard may be retrofitted in the field, or perhaps 
equipped with a suitable adapter, the agency has not determined that a 
device recall is warranted at this time. The agency believes that each 
participant in the chain of commerce has a role to play in ensuring 
that the devices under their control meet the performance standard by 
the effective date. The responsibility for equipping a device that is 
returned to the manufacturer under a maintenance agreement such that it 
conforms to the standard would likely depend upon the specific terms of 
the agreement. As both users and manufacturers are equally concerned 
for the safety and welfare of the patients that they serve, FDA 
anticipates that they will work cooperatively to ensure that these 
devices are in compliance with the performance standard. FDA reiterates 
that the performance standard in the final rule applies to the lead 
wire and patient cable, not to the medical equipment to which they are 
attached.
    16. One comment suggested that the agency adopt the comparable IEC 
601-1 standard (i.e., IEC 601-1, subclause 56.3(c)) as the performance 
standard because it addresses test methods that were not included in 
FDA's proposed performance standard. The comment believed that adoption 
of this international standard would also promote global harmonization 
of standards.
    FDA agrees with this comment. Prior to drafting the proposed 
standard, FDA evaluated the voluntary standards that were then in 
existence to determine whether any of these standards might be adopted 
to address the concerns of the agency with unprotected electrode lead 
wires. At the time of publication of the proposed rule, IEC 601-1 was 
being amended and it could not be determined whether the amended 
standard would be adopted by the membership and, if so, when it would 
be published. However, in March 1995, IEC published the second 
amendment to IEC 601-1, including subclause 56.3(c), which prohibits 
electrode lead wires and patient cables from having the capacity to 
make conductive contact with hazardous voltages. After examination of 
this ratified amendment, the agency has determined that adherence to 
the IEC 601-1 as amended would provide acceptable protection of 
patients from connections to hazardous

[[Page 25484]]

voltages. In addition, FDA's adoption of this requirement of the IEC 
standard demonstrates the agency's continued interest in promoting the 
adoption of international voluntary standards, where feasible, to 
satisfy safety and effectiveness requirements for medical devices.
    17. One comment asked whether, for a preamendment device, FDA would 
accept a letter of notification of a change to a protected 
configuration. The comment believed that it would be unreasonable to 
subject a preamendment device, that has been modified to incorporate a 
protected configuration, to additional regulatory requirements while 
those devices under a 510(k) require only an addendum.
    FDA is establishing the following procedures for notifying the 
agency of device modifications in compliance with the following 
performance standard:
    For a device reviewed through the premarket notification (510(k)) 
process or for a preamendment device, information regarding 
modification of the device from an unprotected electrode lead wire and 
patient cable configuration to a protected configuration, and 
information demonstrating compliance with the performance standard, 
should be documented in the manufacturer's device master records in 
accordance with the current good manufacturing practice regulation. FDA 
recognizes that a change from the unprotected to the protected 
configuration is a change that under 21 CFR 807.81(a)(3) could affect 
safety and effectiveness. However, in the interest of public health, 
and due to the straightforward nature of the device modification and 
demonstration of compliance with the performance standard, the agency 
is not requiring prior clearance for this specific device modification. 
FDA recognizes that this procedure differs from the agency's previous 
recommendation that manufacturers who were voluntarily making changes 
from the unprotected to the protected configuration submit 
documentation of the changes as an addendum to their existing premarket 
notification (510(k)) files. Because compliance with the performance 
standard will no longer be voluntary, but will be mandatory, placement 
of documentation of the device modification from an unprotected 
configuration to a protected configuration and of documentation 
demonstrating compliance with the performance standard into the device 
master records will be sufficient.
    For devices reviewed through the premarket approval process, 
modifications from an unprotected electrode lead wire and patient cable 
configuration to a protected configuration also may be implemented 
without prior approval by FDA. FDA has determined under 21 CFR 
814.39(e) that an alternate submission, a periodic report, is 
appropriate. Thus, in the interest of public health, and due to the 
straightforward nature of the device modification, information 
regarding modifications to the protected configuration and information 
demonstrating compliance with the performance standard should be 
provided in the next annual report to the applicable premarket approval 
application (PMA). The modification can be made prior to submission of 
the annual report.
    The information provided in the manufacturer's device master record 
or the PMA annual report should include engineering drawings and a 
description of the change(s), an explanation of how the change(s) 
prevents connection to a power source, and documentation demonstrating 
compliance with the performance standard. If an adapter design is 
implemented, an explanation of how the signal acquisition and 
processing is not compromised by the addition of the adapter, and how 
the design of the adapter prevents removal by the user, should also be 
provided.
    18. One comment sought clarification of the manner in which the 
agency would identify those devices that would be subject to this rule, 
but have not yet been classified (e.g., electrode lead wires and 
patient cables intended for use with dental TENS units).
    All devices that meet the applicability section of the standard 
(Sec. 898.11) are subject to the requirements under the rule, whether 
or not they have been formally classified.
    19. One comment wrote that implementation of the ban and 
performance standard in 1 year might not provide the time needed for 
design changes, validation, and manufacturing, and for production of a 
device inventory sufficient to meet global demand. The comment believed 
that difficulties in meeting the 1-year timeline may cause some 
manufacturers to abandon businesses associated with the affected 
devices, which potentially could affect supply.
    The agency believes that changes made to the final rule adequately 
balance public health concerns with the economic impact of making this 
transition. Under the final rule, the devices for which the performance 
standard will become effective in 1 year are only those electrode lead 
wires and patient cables associated with the 10 devices presenting the 
highest risk of a user inappropriately connecting the electrode lead 
wire or patient cable to an AC power source. Of these 10 devices, 
electrode lead wires and patient cables intended for use with apnea 
monitors are largely in compliance with the standard. Because of their 
early involvement with electrocution and macro shock incidents, new 
apnea monitor devices without a protected electrode lead wire 
configuration have not received agency clearance for marketing since 
1989. ECG manufacturers have also been encouraged by the agency to 
provide protected electrode lead wire and patient cable systems with 
their devices. In addition, the agency published the ANPRM in the 
Federal Register of May 19, 1994, held a public conference on the issue 
in July 1994, and advised the manufacturing and medical user community 
of efforts to address this problem through wide dissemination of public 
health advisories, direct mailings to the users and the manufacturing 
communities, and published its proposal to establish a performance 
standard and a ban in the June 21, 1995, proposed rule. The agency 
believes that both manufacturers and the medical user community have 
had ample time to begin modifying these 10-device types, and electrode 
lead wires and patient cables intended for use with them, to avoid this 
potential problem. The agency is establishing the effective date of the 
performance standard for electrode lead wire and patient cables for use 
with these 10 devices at 1 year from the date of publication of the 
final rule to provide further time for a steady transition to a safe 
electrode lead wire and patient cable configuration. Finally, for 
exceptional circumstances that are not adequately addressed in the 1-
year timeframe, the agency has established a variance procedure in 
which affected parties may request an exemption or additional time in 
which to meet the standard.
    20. One comment stated that the marginal replacement costs 
mentioned in section IX. of the proposed rule (60 FR 32406 at 32414) 
assume an appropriate replacement accessory is available through the 
manufacturer at costs comparable to the original lead system. According 
to the comment, because lead wire manufacturers do not have to produce 
replacement leads, but rather must cease producing unprotected patient 
cables and leads, the costs of unplanned replacement of even a small 
fraction of expensive diagnostic devices as a result of the 
unavailability of the protected style

[[Page 25485]]

accessories is exponentially greater than the lead-for-lead replacement 
costs alluded to section IX. of the proposed rule.
    FDA disagrees with this statement. Several lead wire manufacturers 
have already informed the agency that they are now, or soon will be, 
producing protected electrode lead wire and patient cable 
configurations. The agency does not have any evidence to show that 
manufacturers will simply cease manufacturing unprotected electrode 
lead wires and patient cables and fail to produce a protected electrode 
lead wire configuration as a replacement.
    21. One comment suggested that in cases where the electrode lead 
wires are permanently attached to incontinence electrodes, the leads 
could not migrate to other uses or environments and, therefore, the 
lead wire cannot be detached from the uniquely shaped electrodes.
    Sections 898.11 and 898.13 specify the applicability of the 
performance standard. If a device meets the applicability requirements 
under Sec. 898.11 and an interested party believes, due to the unique 
circumstances of the device, its intended use, or its reasonably 
foreseeable misuse, that no electrical hazard is presented to a 
patient, the party may petition the agency under the variance procedure 
for review of these unique circumstances.
    22. One comment expressed concern about not having a sufficient 
manufacturing staff to retrofit its devices. Concern was also expressed 
that hospital staffs lack qualifications to perform and validate 
changes to installed medical devices. The comment contended that making 
these changes increases the risk of device failure due to unapproved or 
improperly tested device adaptations, and increases legal liability for 
the institution.
    FDA disagrees with this comment. It is imperative that the 
manufacturer of a device that utilizes electrode lead wires and patient 
cables provide a connection arrangement from the patient to the 
monitoring or treatment device which cannot be conductively connected 
to a hazardous voltage. The manufacturer has a choice of modifying the 
design of the equipment to accept only a protected cable and electrode 
lead wire, of providing an adapter for the equipment interface to 
receive only a protected electrode lead wire configuration, or of 
directing the user of its medical device to a third-party manufacturer 
of protected electrode lead wires and patient cables or suitable 
adapters. Hospital staff with ability to make an unprotected patient 
cable and lead wire connection from the patient to the device are 
equally capable of making a protected connection. It is up to the 
manufacturer to ensure that the device change is in conformity with its 
specifications and labeling.
    23. One comment noted that lead wires are not always class II 
devices and, therefore, it is not clear that FDA has the authority to 
regulate all electrode lead wires with a mandatory standard.
    FDA agrees that a few unprotected cable and electrode lead wire 
systems are class I devices, and, as such, are not subject to a 
mandatory performance standard. Specifically, these devices include:

                                                    Table 1.                                                    
----------------------------------------------------------------------------------------------------------------
                                     Product                                                                    
              Phase                    code     21 CFR section    Class                 Device name             
----------------------------------------------------------------------------------------------------------------
2................................  89 IKD           890.1175    I          Cable, Electrode (for Use With       
                                                                            Diagnostic Physical Medicine        
                                                                            Devices).                           
2................................  74 KARI          870.4200    I          Accessory Equipment, Cardiopulmonary 
                                                                            Bypass.                             
2................................  87 KQX           888.1500    I          Goniometer, AC-Powered.              
----------------------------------------------------------------------------------------------------------------

Because of the degree of the health risk, the agency plans to initiate 
procedures to reclassify these devices into class II so that all 
electrode lead wires and patient cables will be subject to the 
mandatory performance standard.
    24. Another comment questioned whether a manufacturer would be in 
violation of the banning action for repairing a user's banned device.
    As stated above, FDA is not banning these devices. Therefore, this 
comment is now moot.
    25. One comment suggested that there may be cases where the OEM is 
out of business and protected replacement cables and electrode lead 
wires cannot be obtained.
    FDA has no evidence to suggest that the absence of the OEM would 
pose a significant obstacle to obtaining suitable lead wire 
replacements. Replacement cables and electrode lead wires may often be 
obtained from third-party manufacturers, or an adapter set may be used 
to convert the unprotected pin configuration to a protected one. In 
rare cases, where a user finds that the OEM is unwilling or unable to 
supply a protected electrode lead wire and patient cable system, and 
that there exists no thirdparty equivalent, the user has the option of 
petitioning the agency under the variance procedure by documenting the 
special circumstances that warrant an exception to the standard.

VIII. Enforcement

    FDA's statutory authority to issue performance standards is derived 
from section 514 of the act. Section 701(a) of the act (21 U.S.C. 
371(a)) authorizes FDA to issue binding regulations for the efficient 
enforcement of the act. (Weinberger v. Hynson, Westcott & Dunning, 
Inc., 412 U.S. 609 (1973); see also Weinberger v. Bentex 
Pharmaceuticals Inc., 412 U.S. 645, 653 (1973); National Assn. of 
Pharmaceutical Manufacturer v. FDA, 637 F.2d 877 (2d Cir.), cert. 
denied, 423 U.S. 827 (1975).) Section 519(a) of the act (21 U.S.C. 
360i(a)) also authorizes the agency to issue regulations requiring 
manufacturers of devices to maintain and provide records to ensure that 
devices are not adulterated, misbranded, unsafe, or ineffective. FDA's 
performance standards for medical devices are substantive regulations 
with the force and effect of law. (See United States v. Undetermined 
Quantities of Various Articles of Device * * * Proplast II, 800 F. 
Supp. 499, 502 (S.D. Tex. 1992); United States v. 789 Cases * * * Latex 
Surgeons' Gloves, 799 F. Supp. 1275, 1287 (D.P.R. 1982).)
    Section 501(e) of the act deems a device to be adulterated, and 
thus prohibited from commerce, if it is a device subject to a 
performance standard established under section 514 of the act, unless 
such device is in all respects in conformity with such standard. 
Introduction into interstate commerce of a device that fails to comply 
with the requirements established by section 514 of the act is a 
prohibited act under section 301(a) of the act (21 U.S.C. 331(a)), and 
the agency will use its enforcement powers to deter noncompliance. 
Persons who violate section 301 of the act may be subject to injunction 
under section 302(a) of the act (21 U.S.C. 332(a)). In addition, any 
person responsible for

[[Page 25486]]

violating section 301 of the act may be subject to civil penalties 
under section 303(f) of the act (21 U.S.C. 333(f)) and criminal 
prosecution under section 303(a).

IX. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(3) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

X. Unfunded Mandates Reform Act of 1995

    Under the Unfunded Mandates Reform Act, FDA concludes that the 
substantial benefits of this regulation will greatly exceed the 
compliance costs that it imposes on the U.S. economy. In addition, the 
agency has considered other alternatives and determined that the final 
rule is the least burdensome and the most cost effective alternative 
that would meet the objectives of this rule. Because FDA anticipates no 
significant additional costs to State, local, or tribal governments, 
this regulatory action does not require an assessment under the 
Unfunded Mandates Reform Act.

XI. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this rule is consistent with the regulatory philosophy and principles 
identified in the Executive Order. The Regulatory Flexibility Act 
requires agencies to analyze regulatory options that would minimize any 
significant impact on small entities. As a result of its analysis, FDA 
has determined that this final rule is not a significant regulatory 
action as defined by Executive Order 12866. In addition, the 
Commissioner of Food and Drugs certifies that the rule will not have a 
significant economic impact on a substantial number of small entities.

XII. Introduction to Economic Analysis

    FDA believes that the presence of unprotected lead wires in a home, 
hospital, or other user facility creates an unreasonable risk to 
patients of hazardous electrical connections from electrical power 
sources. In the proposed rule of June 21, 1995, FDA proposed to create 
a performance standard for electrode lead wires, and to ban the use of 
unprotected leads. Many comments supported the intent of the proposal, 
and agreed with the phased approach toward eliminating the problem. 
Other comments, however, expressed the view that the benefits would be 
outweighed by the costs associated with converting the large number of 
device types listed in the proposed rule. For example, AHA wrote that 
``[when] all costs from all devices are considered, the total cost 
impact to a facility would be at least $45 per licensed bed * * *. For 
the over one million hospital beds in the United States, the impact 
would be greater than $45 million.'' AHA called this a conservative 
estimate, and requested that a comprehensive impact analysis be 
performed by FDA, which would include logistical costs, stocking costs, 
cost for ongoing surveillance, and the capital cost to replace 
equipment for which protected style lead systems are not available. In 
this economic analysis, FDA considers those costs and benefits that 
would be incurred as a direct result of this final regulation.
    Due to liability concerns, many of today's manufacturers are 
already moving toward protected lead and cable pin configurations for 
select devices. In order to prevent future adverse incidents, however, 
FDA is issuing a new regulation that will ensure the movement toward 
protected electrode lead wires and patient cables. Phase I of the 
regulation applies to unprotected lead wires used with the 10 devices 
for which there is the highest risk of accidental connection to 
hazardous voltages. In 1 year from the publication date of this rule, 
electrode lead wires and patient cables used with or intended for use 
with the following devices will be subject to a performance standard: 
Patient cable, apnea/breathing frequency monitor, ECG monitor, cardiac 
monitor, multi-parameter/vital signs monitor, ECG electrode with 
attached lead wire, arrhythmia monitor, transmitters and receivers/
physiological signal/radiofrequency, recorder/magnetic tape/medical, 
and transmitters and receivers, electrocardiograph/telephone. Phase II 
applies to electrode lead wires and patient cables used with or 
intended for use with all other medical devices. Three years from the 
effective date of this rule, lead wires and patient cables that do not 
meet the performance standard may no longer be used or sold. The rule 
also states that exemptions may be requested for devices that 
justifiably cannot meet the standard on the date it goes into effect.

A. Regulatory Benefits

    Since 1985, there have been at least 24 reported incidents 
involving the use of unprotected electrode lead wires and patient 
cables. These incidents occurred with both infants and children who 
received ``macro-shock'' due to the improper use of these leads and 
cables. Such occurrences have caused burns to the skin under the 
electrodes, cardiorespiratory arrest, comas, neurological damage, or 
other serious injuries. In five of these incidents, children died by 
electrocution. Less significant incidents are probably underreported as 
FDA typically receives reports on only a fraction of all events.\1\
---------------------------------------------------------------------------

    \1\ ``Medical Devices: Early Warning of Problems is Hampered by 
Severe Underreporting,'' United States General Accounting Office 
Report to the Chairman, Committee on Governmental Affairs, U.S. 
Senate, p. 61, December 1986.
---------------------------------------------------------------------------

    FDA believes that this regulation will eliminate, to the extent 
possible, the hazard associated with unprotected lead wires and patient 
cables. While most comments acknowledged the unacceptable risk 
attributable to the unprotected Phase I devices, many denied the need 
to extend the scope of the rule to the Phase II devices. FDA, however, 
finds that the interchangeability of electrode lead wires and patient 
cables among medical equipment establishes the need to encompass such a 
large number of devices. Regardless of where or what device they are 
used with, unprotected electrode lead wires themselves can be plugged 
into a receptacle and become hazardous. Through the implementation of 
this regulation, FDA expects to prevent another incident of ``macro-
shock'' or death.

B. Regulatory Costs

    In order to comply with this final rule, unprotected devices will 
either be replaced or modified to accept only protected leads, and all 
new devices under development will need to be designed to accept only 
protected leads. The agency received no comments indicating that 
incremental cost to manufacturers for the redesign of new devices would 
be substantial, if adequate time was allowed. Moreover, few existing 
devices will need to be prematurely replaced because virtually all 
devices can be made safe through the use of protected lead wires and 
either adaptors or other modifications of the connecting equipment. 
Where adaptors or modifications are not feasible, FDA

[[Page 25487]]

will consider individual variance requests. A number of manufacturers 
have indicated that adaptors are inexpensive and easy to install, and 
provide no loss of signal integrity. Adaptors are not presently 
available for all existing devices, because there is inadequate current 
demand. The regulation, however, will create strong incentives for 
device manufacturers or other suppliers to develop adequate adaptors, 
and the extended phase-in periods will provide sufficient time for such 
conversions to be made. Thus, FDA expects that there will be minimal 
costs for redesigning the new devices currently under development, and 
most existing devices will comply by obtaining appropriate adaptors. As 
derived below, FDA estimates the total cost of bringing all of these 
devices into compliance to be about $21 million.
1. Phase I
    a. Devices. For the purpose of this analysis, the lead wires and 
patient cables used with or intended for use with the 10 previously 
mentioned Phase I devices have been grouped into two categories. The 
first category consists solely of the lead wires and patient cables 
used with the apnea/breathing frequency monitor. In the early 1990's, a 
Federal performance standard was proposed to phase out the use of 
unprotected lead wires with apnea monitors. Encouraged by the intense 
liability concerns among industry, almost all of the lead wires for 
these monitors are now protected. Therefore, FDA assumes no costs 
associated with bringing this first category of lead wires into 
compliance.
    The second category consists of the lead wires used with the 
remaining nine devices (hereinafter referred to as ECG-type devices). 
The useful life for these devices reportedly ranges from 7 to 10 years. 
Using an average useful life of 8 years 6 months, the 1-year phase-in 
period implies that about 88 percent of these devices will have to be 
converted. According to a survey by AHA conducted in early 1994,\2\ 
approximately 78 percent of their responding members indicated that 
steps have already been taken to replace the unprotected lead wires on 
their ECG devices. In this cost analysis, therefore, FDA only counts 
the costs associated with bringing into compliance the lead wires on 
the remaining 22 percent of those devices that would still have some 
remaining useful life by the conclusion of the 1-year timeframe 
following publication of this rule.
---------------------------------------------------------------------------

    \2\ ``Electrode Leadwire Survey,'' distributed by the American 
Society for Hospital Engineering of AHA, early 1994.
---------------------------------------------------------------------------

    b. Lead wires. All of the ECG-type devices have three lead wires 
except for the arrhythmia monitors and the Holter monitors (classified 
under transmitters and receivers/physiological signal/radiofrequency, 
recorder/magnetic tape/medical, and transmitters and receivers, 
electrocardiograph/telephone). The number of lead wires on an 
arrhythmia monitor could range from 5 to 12. For analysis, FDA 
estimates the mean number of lead wires on an arrhythmia monitor to be 
8.5. The number of lead wires on a Holter monitor generally ranges from 
three to five. Thus, FDA estimates the mean number of lead wires on a 
Holter monitor to be four.
    Lead wires are generally sold in pairs, sets, or bulk quantities. 
For this analysis, FDA uses an average price of $7 for a set of three 
lead wires, or $2.33 per unit. This estimate may be too high as some 
user facilities may purchase lead wires in bulk at less expensive per 
unit prices.
    There is only an incidental price difference between the protected 
lead wires and those that are not protected. Therefore, no incremental 
costs have been added for the purchase of the protected leads as 
compared to the unprotected leads. As costs are counted only for leads 
that need to be replaced while they still have some useful life, FDA 
charges only half the cost of the purchase of these lead wires to the 
regulation. Because the lead wires for ECG-type devices have a useful 
life of approximately 2 years, 50 percent of these lead wires will be 
replaced on average within the 1-year timeframe after the publication 
date of this final rule.
    c. Adaptors. For all ECG-type devices, FDA assumes that adaptors 
will be available to connect the cables and lead wires. Only one cable 
is used per ECG-type device, with the exception of the Holter monitor. 
These cables cost between $50 to $100 to be replaced. Because it is 
less costly to purchase adaptors than to purchase new cables to fit the 
protected lead wires, FDA assumes that user facilities would purchase 
adaptors to use for the remaining useful life of the cables. For Holter 
monitors, FDA assumes that adaptors will be used between the lead wires 
and the device itself. The costs of purchasing adaptors is 
approximately $5 each. One adaptor is needed for each lead wire used 
with or intended for use with the device. Therefore, most ECG-type 
devices would require three adaptors, the arrhythmia monitor would use 
8.5 adaptors, and the Holter monitor would use four adaptors on 
average. A block of adaptors may be purchased, however, FDA assumes the 
unit price will remain unchanged. After discussions with various 
manufacturers, FDA finds that the distal ends of most cables are either 
already protected or too large to be forced into contact with a 
hazardous voltage. Thus, no costs were assigned for attaching adaptors 
to the distal end of the cables.
    Because the useful life of cables for ECG-type devices is 
approximately from 2 to 3 years, FDA estimates that 40 percent of these 
original cables will need to be replaced with cables that accept the 
protected lead wires within 1 year after the publication date of this 
final rule. As redesigned cables are sold at about the same price as 
the older cables, no added cost is attributable to these cables. 
Therefore, only about 60 percent of these devices will require an 
adaptor due to the regulation. Some facilities whose cables have little 
remaining useful life may opt to replace their cables earlier, even 
though the price of new cables are significantly higher than that of 
adaptors. Nevertheless, this analysis assumes that users would purchase 
new cables only if they were a less costly option.
    d. Adaptor installation. FDA uses the 1995 median weekly earnings 
of $598\3\ for engineering and related technologists and technicians as 
the base for the costs associated with affixing the adaptors onto the 
unprotected cables. Adding 40 percent for benefits, total hourly 
earnings are estimated at $20.93. The following tables show a per 
minute salary rate of $0.35. Based on discussions with industry 
representatives, FDA estimates that it will take a total of about 5 
minutes to thoroughly clean the connector area on the cable or device 
itself, and then to affix the adaptor to the cable or device. For those 
instances where the adaptor is to be affixed onto a cable, FDA allots 5 
minutes per device, regardless of the number of lead wires utilized by 
the device. This time should be adequate because one block of adaptors 
could be used to convert the entire device. For those instances where 
the adaptors are to be affixed onto the device itself, FDA allots 5 
minutes per lead wire. FDA also added a one-time cost for each facility 
to capture the amount of time they would need to familiarize themselves 
with the conversion process and to locate the affected devices.
---------------------------------------------------------------------------

    \3\ Employment and Earnings, U.S. Department of Labor Bureau of 
Labor Statistics, Table 39, p. 206, January 1996.
---------------------------------------------------------------------------

    e. User facilities. The user facilities examined are hospitals, 
nursing homes,

[[Page 25488]]

ambulances, and doctor's offices, and clinics. It is in these 
facilities that the majority of ECG-type devices are found. ECG-type 
devices found in Free-Standing Ambulatory Care Centers and in Cardiac 
Labs of Hospital Outpatient Centers are accounted for under costs to 
doctor's offices and clinics.
    (i). Cost to hospitals. In 1993, 6,467 hospitals were accepted for 
registration by AHA, with an average number of 179 beds in each of 
these hospitals.\4\ According to several clinical engineers and 
bioengineering directors at various hospitals, one ECG-type device is 
found at approximately 30 percent of these beds. Therefore, FDA 
calculates that approximately 347,278 ECG-type devices are used in 
hospitals across the United States. Because the arrhythmia monitors 
were estimated to make up about 10 to 20 percent of the ECG-type 
devices used in the average hospital, FDA assumes that 15 percent of 
ECG-type devices in all hospitals are arrhythmia monitors. Holter 
monitors were estimated to make up another 15 percent of the ECG-type 
devices used in the average hospital. In addition, assuming that it 
might take roughly 1 minute to scan the devices in each room, FDA adds 
3 hours per facility to account for the time it will take an average 
hospital to locate the appropriate devices. As shown in the table 
below, the total cost of this rule to hospitals comes to about $1.6 
million.
---------------------------------------------------------------------------

    \4\ The Statistical Abstract of the United States, U.S. 
Department of Commerce Economics and Statistics Administration, 
Bureau of Census, No. 183, p. 125, 1995.

                                                   Table 2.--Cost of Protected Lead Wires to Hospitals                                                  
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                 Percent (%) of    Percent (%) of    Percent (%) of                                        Percent (%) of               
  Hospitals    Number of ECG's      ECG's not        leads to be       ECG's with       Cost per lead    Number of leads  useful lead life   Total cost 
                per hospital        protected         replaced         useful life                                            remaining                 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                        
                                         ECG-Type Devices Except the Arrhythmia Monitor and the Holter Monitor                                          
                                                                                                                                                        
6,467.......          38               22%               50%               88%                $2.33              3               50%            $82,581 
                                                                                                                                                        
                                                                 The Arrhythmia Monitor                                                                 
                                                                                                                                                        
6,467.......           8               22%               50%               88%                $2.33              8.5             50%            $50,138 
                                                                                                                                                        
                                                                   The Holter Monitor                                                                   
                                                                                                                                                        
6,467.......           8               22%               50%               88%                $2.33              4               50%            $23,594 
--------------------------------------------------------------------------------------------------------------------------------------------------------



                                     Table 3.--Cost of Adaptors to Hospitals                                    
----------------------------------------------------------------------------------------------------------------
               Number of    Percent (%) of   Percent (%)    Percent (%)                                         
 Hospitals     ECG's per       ECG's not     of cables to  of ECG's with     Cost per      Number of      Total 
               hospital        protected     be converted   useful life      adaptor        adaptors      cost  
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                      ECG-Type Devices Except the Arrhythmia Monitor and the Holter Monitor                     
                                                                                                                
6,467.....         38             22%            60%            88%             $5.00           3       $424,700
                                                                                                                
                                             The Arrhythmia Monitor                                             
                                                                                                                
6,467.....          8             22%            60%            88%             $5.00           8.5     $257,854
                                                                                                                
                                               The Holter Monitor                                               
                                                                                                                
6,467.....          8             22%            N/A            88%             $5.00           4       $202,238
----------------------------------------------------------------------------------------------------------------



[[Page 25489]]


                                                     Table 4.--Cost to Install Adaptors to Hospitals                                                    
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                Percent (%) of   Percent (%) of   Percent (%) of                     Installation                                       
  Hospitals   Number of ECG's     ECG's not       cables to be      ECG's with       Salary per        time (in      Learning cost        Total cost    
                per hospital      protected        converted       useful life         minute          minutes)       per hospital                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                        
                                                       ECG-Type Devices Except the Holter Monitor                                                       
                                                                                                                                                        
6,467.......         46              22%              60%              88%               $0.35             5              N/A                   $59,965 
                                                                                                                                                        
                                                                   The Holter Monitor                                                                   
                                                                                                                                                        
6,467.......          8              22%              N/A              88%               $0.35            20              N/A                   $70,547 
                                                                                                                                                        
                                                                      Learning Time                                                                     
                                                                                                                                                        
6,467.......        N/A              N/A              N/A              N/A              N/A              N/A              $62.79               $406,063 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Cost to Hospitals (Tables 1 through 3) =                                                                                               $1,577,680 
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 25490]]

    (ii). Cost to nursing homes. In 1993, there were approximately 
11,309 skilled nursing facilities\5\ in the United States. FDA 
estimates that there are approximately one to two ECG-type devices per 
nursing home (assuming no arrhythmia monitors or Holter monitors). FDA 
adds one-half hour to account for the time it would take each 
individual facility to learn how to convert their devices. As shown 
below, the total cost of this rule to the nursing homes amounts to 
about $157,000.
---------------------------------------------------------------------------

    \5\ The Statistical Abstract of the United States, U.S. 
Department of Commerce Economics and Statistics Administration, 
Bureau of Census, No. 200, p. 134, 1995.

                                                 Table 5.--Cost of Protected Lead Wires to Nursing Homes                                                
--------------------------------------------------------------------------------------------------------------------------------------------------------
   Skilled                        Percent (%) of    Percent (%) of    Percent (%) of                                        Percent (%) of              
   nursing      Number of ECG's      ECG's not        leads to be       ECG's with       Cost per lead    Number of leads  useful lead life   Total cost
  facilities   per nursing home      protected         replaced         useful life                         per device         remaining                
--------------------------------------------------------------------------------------------------------------------------------------------------------
11,309.......           1.5             22%               50%               88%                $2.33              3               50%            $5,763 
--------------------------------------------------------------------------------------------------------------------------------------------------------



                                   Table 6.--Cost of Adaptors to Nursing Homes                                  
----------------------------------------------------------------------------------------------------------------
  Skilled       Number of     Percent (%)    Percent (%)    Percent (%)                                         
  nursing       ECG's per     of ECG's not   of cables to  of ECG's with     Cost per      Number of      Total 
 facilities   nursing home     protected     be converted   useful life      adaptor        adaptors      cost  
----------------------------------------------------------------------------------------------------------------
11,309.....          1.5          22%            60%            88%             $5.00           3        $29,636
----------------------------------------------------------------------------------------------------------------



                                                   Table 7.--Cost to Install Adaptors to Nursing Homes                                                  
--------------------------------------------------------------------------------------------------------------------------------------------------------
   Skilled                        Percent (%) of    Percent (%) of    Percent (%) of                       Installation                                 
   nursing      Number of ECG's      ECG's not       cables to be       ECG's with        Salary per         time (in        Learning cost    Total cost
  facilities   per nursing home      protected         converted        useful life         minute           minutes)        per facility               
--------------------------------------------------------------------------------------------------------------------------------------------------------
11,309.......           1.5             22%               60%               88%                $0.35              5               N/A            $3,446 
                                                                                                                                                        
                                                                      Learning Time                                                                     
                                                                                                                                                        
11,309.......         N/A               N/A               N/A               N/A               N/A               N/A               $10.47       $118,349 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Cost to Nursing Homes (Tables 4 through 6) =                                                                                             $157,194 
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (iii). Cost to ambulances and other ground transport vehicles. In 
1995, the United States was reported to have 59,640 active and reserve 
ground transport vehicles for emergency purposes.\6\ This figure does 
not include emergency vehicles designed to extinguish fires. Of this 
total number of vehicles, some are classified with advanced life 
support (ALS) services. These vehicles carry a manual defibrillator 
with an ECG monitor. These ECG-type devices have three lead wires and a 
screen with the ability to print a tape. The other vehicles have basic 
life support (BLS) services. Of these BLS transport vehicles, some have 
an automated external defibrillator (AED) which fires shocks 
automatically. These ECG-type devices have two lead wires, but do not 
have a screen or the capability to print a tape.
---------------------------------------------------------------------------

    \6\ ``The United States Emergency Medical Services Market 
Report,'' based on data gathered from EMS Census 1995, prepared by 
Emergency Care Information Center and JEMS Communications, p. 40.
---------------------------------------------------------------------------

    According to a survey completed by the National Association of 
State Emergency Medical Services (EMS) Directors in 1992, 59 percent of 
all emergency transport vehicles have ALS transport services.\7\ 
Therefore, FDA estimates that 35,188 vehicles are ALS transport 
systems. Of the reporting organizations in 1995, 48 percent are 
classified as BLS with AED.\8\ To determine the number of BLS vehicles 
with AED, FDA assumes that all 30,000 organizations with emergency 
transport vehicles identified in the 1995 survey\9\ have two vehicles 
per organization. If all organizations reporting BLS with AED services 
have at least one vehicle offering this service, 14,314 BLS transport 
vehicles have AED. FDA adds one-half hour to account for the time it 
would take each individual organization to learn to convert its 
devices. Because FDA assumed two vehicles per organization, the costs 
associated with one-quarter hour per vehicle are shown in the table 
below. The total cost of this regulation amounts to approximately 
$362,000 for ambulances and other ground transport vehicles.
                              ___________


\7\ ``Transportation Systems, 1994,'' produced by the National 
Association of State EMS Directors, p. 2, 1994.
\8\ ``The United States Emergency Medical Services Market Report,'' 
based on data gathered from EMS Census 1995, prepared by Emergency 
Care Information Center and JEMS Communications, p. 17.
\9\ ``The United States Emergency Medical Services Market Report,'' 
based on data gathered from EMS Census 1995, prepared by Emergency 
Care Information Center and JEMS Communications.

[[Page 25491]]



                                                  Table 8.--Cost of Protected Lead Wires to Ambulances                                                  
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Ground                        Percent (%) of    Percent (%) of    Percent (%) of                                        Percent (%) of              
  transport     Number of ECG's      ECG's not        leads to be       ECG's with       Cost per lead    Number of leads  useful lead life   Total cost
   vehicles       per vehicle        protected         replaced         useful life                         per device         remaining                
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                        
                                                       ECG-Type Devices on ALS Transport Vehicles                                                       
                                                                                                                                                        
35,188.......           1               22%               50%               88%                $2.33              3               50%           $11,954 
                                                                                                                                                        
                                                       ECG-Type Devices on BLS Transport Vehicles                                                       
                                                                                                                                                        
14,314.......           1               22%               50%               88%                $2.33              2               50%            $3,242 
--------------------------------------------------------------------------------------------------------------------------------------------------------



                                    Table 9.--Cost of Adaptors to Ambulances                                    
----------------------------------------------------------------------------------------------------------------
  Ground       Number of    Percent (%) of   Percent (%)    Percent (%)                                         
 transport     ECG's per       ECG's not     of cables to  of ECG's with     Cost per      Number of      Total 
 vehicles       vehicle        protected     be converted   useful life      adaptor        adaptors      cost  
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                                   ECG-Type Devices on ALS Transport Vehicles                                   
                                                                                                                
35,188....          1             22%            60%            88%             $5.00           3        $61,476
                                                                                                                
                                   ECG-Type Devices on BLS Transport Vehicles                                   
                                                                                                                
14,314....          1             22%            60%            88%             $5.00           2        $16,671
----------------------------------------------------------------------------------------------------------------



                                                    Table 10.--Cost to Install Adaptors to Ambulances                                                   
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Ground                        Percent (%) of    Percent (%) of    Percent (%) of                       Installation                                 
  transport     Number of ECG's      ECG's not       cables to be       ECG's with        Salary per         time (in        Learning cost    Total cost
   vehicles       per vehicle        protected         converted        useful life         minute           minutes)      per organization             
--------------------------------------------------------------------------------------------------------------------------------------------------------
49,502.......           1               22%               60%               88%                $0.35              5               N/A           $10,056 
                                                                                                                                                        
                                                                      Learning Time                                                                     
                                                                                                                                                        
49,502.......         N/A               N/A               N/A               N/A               N/A               N/A                $5.23       $259,019 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Cost to Ambulances and Other Ground Transport Vehicles (Tables 7 through 9) =                                                            $362,418 
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (iv). Cost to doctor's offices and clinics. In 1992, there were 
approximately 199,500 offices and clinics of medical doctors\10\ in the 
United States. FDA estimates that, on average, there is at most one 
Holter monitor and/or ECG-type device per office, and one to two ECG-
type devices per clinic. For analysis, FDA assumes 1.25 ECG-type 
devices per doctor's office and clinic. FDA further assumes an equal 
proportion of Holter monitors and other ECG-type devices would be found 
in both doctor's offices and clinics. FDA adds one-half hour to account 
for the time it would take each individual facility to learn how to 
convert their devices. The total cost of this rule to the doctor's 
offices and clinics comes to about $3 million.
                              ___________


\10\ The Statistical Abstract of the United States, U.S. Department 
of Commerce Economics and Statistics Administration, Bureau of 
Census, No. 1316, p. 795, 1995.

[[Page 25492]]


                                             Table 11.--Cost of Protected Lead Wires to Offices and Clinics                                             
--------------------------------------------------------------------------------------------------------------------------------------------------------
   Doctor's     Number of ECG's   Percent (%) of    Percent (%) of    Percent (%) of                                        Percent (%) of              
 offices and    per office and       ECG's not        leads to be       ECG's with       Cost per lead    Number of leads  useful lead life   Total cost
   clinics          clinic           protected         replaced         useful life                                            remaining                
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                        
                                          ECG-Type Devices Except the Arrhythmia Monitor and the Holter Monitor                                         
                                                                                                                                                        
199,500......           0.6             22%               50%               88%                $2.33              3               50%           $40,605 
                                                                                                                                                        
                                                                   The Holter Monitor                                                                   
                                                                                                                                                        
199,500......           0.6             22%               50%               88%                $2.33              4               50%           $54,140 
--------------------------------------------------------------------------------------------------------------------------------------------------------



                               Table 12.--Cost of Adaptors to Offices and Clinics                               
----------------------------------------------------------------------------------------------------------------
 Doctor's      Number of                                                                                        
  offices      ECG's per     Percent (%)    Percent (%)    Percent (%)      Cost per      Number of      Total  
    and       office and     of ECG's not   of cables to  of ECG's with     adaptor        adaptors       cost  
  clinics       clinic        protected     be converted   useful life                                          
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                     ECG-Type Devices Except the Arrhythmia Monitor and the Holter Monitor:                     
                                                                                                                
199,500...          0.6          22%            60%            88%             $5.00           3        $209,123
                                                                                                                
                                               The Holter Monitor                                               
                                                                                                                
                  190.600...     22%            N/A            88%             $5.00           4        $464,718
----------------------------------------------------------------------------------------------------------------



[[Page 25493]]


                                               Table 13.--Cost to Install Adaptors to Offices and Clinics                                               
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Doctor's    Number of ECG's   Percent (%) of   Percent (%) of   Percent (%) of                     Installation                                       
 offices and   per office and     ECG's not       cables to be      ECG's with       Salary per        time (in      Learning cost        Total cost    
   clinics         clinic         protected         replaced       useful life         minute          minutes)       per facility                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                        
                                                       ECG-Type Devices Except the Holter Monitor                                                       
                                                                                                                                                        
199,500.....          0.6            22%              60%              88%               $0.35             5              N/A                   $24,316 
                                                                                                                                                        
                                                                   The Holter Monitor                                                                   
                                                                                                                                                        
199,500.....          0.6            22%              N/A              88%               $0.35            20              N/A                  $162,109 
                                                                                                                                                        
                                                                      Learning Time                                                                     
                                                                                                                                                        
199,500.....        N/A              N/A              N/A              N/A              N/A              N/A              $10.47              2,087,768 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Cost to Doctor's Offices and Clinics (Tables 10 through 12) =                                                                          $3,042,779 
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 25494]]

2. Phase II
    This section examines the cost to user facilities for Phase II of 
this regulation. Although FDA believes that the use of adaptors will be 
an effective and available conversion method for most affected devices, 
facilities are permitted to request a variance for those devices that 
cannot be modified to accept protected leads. Therefore, the agency has 
not counted the cost of conversion methods other than adaptors.
    For analysis, FDA has grouped most of the devices into the 
following general categories: Electrosurgery appliances, telemetry 
transmitters, external pacemakers, supervised diagnostic equipment, 
stimulators, and patient monitoring devices. While FDA recognizes that 
a small number of devices may not be represented in these categories, 
these device categories are based on the categories used in a survey 
distributed by AHA in 1995.\11\ FDA assumes that at the end of 3 years, 
adaptors will be available for all devices. Therefore, the only costs 
identified as a direct result of the regulation are the cost of the 
adaptors, and the costs associated with their installation. FDA 
continues to assume that the distal ends of these cables have either 
previously been protected or are too large to be forced into a 
connection with a hazardous voltage, and therefore, no adaptor will be 
needed to attach the distal ends of these cables to the face plates of 
the devices. FDA has not included the costs of purchasing new cables or 
new lead wires because the 3-year phase-in period allows adequate time 
for protected models to be purchased through general attrition. The 
percentage of devices that utilize patient cables are estimated for 
each category. For example, all machines in the category of patient 
monitoring devices, typically have cables. As these devices move toward 
protected lead wire and patient cable designs, they will incur no extra 
costs as a direct result of this regulation.
                              ___________


\11\ ``Electrode Leadwire Survey II,'' distributed by the American 
Society for Hospital Engineering of AHA, fall 1995.

    Because specific data on the number of all affected devices are 
unavailable, FDA examines the cost to hospitals for Phase II of the 
rule by again estimating the device quantities as a percentage of 
hospital beds. As in Phase I, FDA's estimates are based upon the 6,467 
hospitals in the United States and the reported average number of 179 
beds in each hospital.\12\ To determine the total number of devices in 
each category, FDA relied on estimates from clinical and biomedical 
engineering directors for the percentage of beds that would have these 
devices. The estimates are: Six percent for electrosurgery appliances, 
15 percent for telemetry transmitters, 5 percent for external 
pacemakers, 13 percent for supervised diagnostic equipment, and 6 
percent for stimulators. FDA assumed that between 90 percent to 100 
percent of the devices have not already been converted to protected 
styles, and that a general useful life ranges from 7 to 10 years. Also, 
only devices without cables would need modification. These percentages 
were estimated to be approximately 75 percent for electrosurgery 
appliances, 100 percent for telemetry transmitters, 60 percent for 
external pacemakers, 50 percent for supervised diagnostic equipment, 
and 100 percent for stimulators. As previously noted, FDA uses a $20.93 
hourly compensation figure to estimate incremental labor costs, or a 
per minute salary rate of $0.35.
---------------------------------------------------------------------------

    \12\ The Statistical Abstract of the United States, U.S. 
Department of Commerce Economics and Statistics Administration, 
Bureau of Census, No. 183, p. 125, 1995.
---------------------------------------------------------------------------

    The agency once more estimates it will take a total of 5 minutes 
per lead wire to both thoroughly clean the connector area on the device 
itself and to affix the adaptor to the device. The number of adaptors 
needed for each of the device categories is based on estimates of the 
average number of lead wires found on all devices in each category. FDA 
estimates that the adaptors cost $5 apiece and that it will take each 
hospital twice as long as for the Phase I devices, or 6 additional 
hours, to locate all of the Phase II devices. This adds $812,126 to the 
total cost of Phase II of this regulation. Using an average useful life 
of 8 years 6 months, the 3-year phase-in period implies that about 65 
percent of these devices would have to be converted. The total costs to 
hospitals are illustrated in the following tables.

                                                      Table 14.--Cost of Adaptors to Hospitals Only                                                     
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Electrosurgery                                                     Supervised diagnostic                          
                                        appliances        Telemetry transmitters   External pacemakers         equipment               Stimulators      
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of hospitals.............              6,467                   6,467                   6,467                  6,467                        6,467 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of beds..................                179                     179                     179                    179                          179 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent (%) of beds.............                 6%                     15%                      5%                    13%                           6% 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent (%) not protected.......        90% to 100%             90% to 100%             90% to 100%            90% to 100%                  90% to 100% 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent (%) without cables......         70% to 80%                    100%              55% to 65%                    50%                         100% 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent (%) to be converted.....                65%                     65%                     65%                    65%                          65% 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost per adaptor................                 $5                      $5                      $5                     $5                           $5 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of adaptors (average)....                  1.5                    10.5                     3.5                   10                            3 
--------------------------------------------------------------------------------------------------------------------------------------------------------
TOTAL COST......................  $213,315-$270,877       $5,332,886-$5,925,429   $325,899-$427,948      $2,200,874-$2,445,415        $609,473-$677,192 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Cost of Adaptors =........  $8,682,447-$9,746,861                                                                                                 
--------------------------------------------------------------------------------------------------------------------------------------------------------



[[Page 25495]]


                                                  Table 15.--Cost of Install Adaptors to Hospitals Only                                                 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Electrosurgery                                                     Supervised diagnostic                          
                                        appliances        Telemetry transmitters   External pacemakers         equipment               Stimulators      
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of hospitals.............              6,467                   6,467                   6,467                  6,467                        6,467 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of beds..................                179                     179                     179                    179                          179 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent (%) of beds.............                 6%                     15%                      5%                    13%                           6% 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent (%) not protected.......        90% to 100%             90% to 100%             90% to 100%            90% to 100%                  90% to 100% 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent (%) without cables......         70% to 80%                    100%              55% to 65%                    50%                         100% 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent (%) with useful life....                65%                     65%                     65%                    65%                          65% 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Salary per minute...............                 $0.35                   $0.35                   $0.35                  $0.35                     $0.35 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Installation time per adaptor...          5 minutes               5 minutes               5 minutes              5 minutes                    5 minutes 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of adaptors..............                  1.5                    10.5                     3.5                   10                            3 
--------------------------------------------------------------------------------------------------------------------------------------------------------
TOTAL COST......................    $14,882-$18,898       $372,058-$413,397         $22,737-$29,856      $153,548-$170,608              $42,520-$47,245 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Cost to Install Adaptors =                                                                                                                        
 ...............................  $605,745-$680,008                                                                                                     
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Because these numbers account for the cost to hospitals only, FDA 
uses quantity of shipment data from the 1994 Current Industrial Report 
for Electromedical and Irradiation Equipment\13\ to establish a 
proportion between the number of the devices found in a hospital 
setting versus all other user facilities. To make the Current 
Industrial Report data more applicable, FDA derived some quantity 
estimates from the value of shipment data, made categorical 
adjustments, corrected for exports, and consulted additional sources to 
customize the categorical adjustments, corrected for exports, and 
consulted additional sources to customize the estimates. In instances 
where no quantity data was given, FDA used the average price of 
equipment in the particular device category and the value of shipments 
data to derive a quantity of shipments. The average prices used are as 
follows: Electrosurgery appliances, $10,000; telemetry transmitters, 
$4,000; external pacemakers, $5,000; supervised diagnostic equipment, 
$35,000; and stimulators, $3,500. To account for the telemetry 
transmitters, which were not specifically mentioned in the Current 
Industrial Reports, FDA used worldwide sales data for total cardiac 
diagnostic equipment and the telemetry monitoring markets.\14\ This 
figure includes sales data on electrocardiographs, long-term 
electrocardiographs, and cardiac telemetry systems. The agency 
multiplied this figure by 55 percent to account for U.S. sales in this 
market.\15\ To break out the sales data for the telemetry products, FDA 
subtracted the U.S. sales data for electrocardiographs in 1994 as given 
by the Current Industrial Report. To break out data for the external 
pacemakers covered by this rule, FDA used the sales data for all 
pacemakers in the Current Industrial Report, and subtracted out the 
sales for implantable cardiac pacemakers.\16\ Since this 1990 sales 
data for cardiac pacemakers is worldwide, FDA multiplied this data by 
43 percent, which represents the percentage of the world medical device 
market held by the United States in 1990.\17\ The following categories 
were counted under the Supervised Diagnostic Equipment category: 
Magnetic resonance imaging equipment, electroencephalograph, 
electromyograph, and respiratory analysis equipment. The value of 
shipment data for all other medical therapy equipment was used to 
derive FDA's stimulator estimate. Total quantity data estimates by FDA 
for 1994 are as follows: Electrosurgery appliances, 24,447; telemetry 
transmitters, 6,432; external pacemakers, 5,813; supervised diagnostic 
equipment, 9,325; and stimulators, 132,340. To adjust for exports, FDA 
multiplied these numbers by 57 percent in accordance with the U.S. 
Industrial Outlook forecast that 43 percent of U.S. electromedical 
equipment production would be exported in 1994.\18\ The estimated total 
number of devices sold in the United States per year were then 
multiplied by the average useful life to make the data comparable to 
the number of devices found in a hospital setting. An analysis of both 
data sources indicates that 60 percent of all of the above devices are 
located in hospitals. Therefore, the hospital cost estimates are 
assumed to be 60 percent of the total costs of Phase II of this rule, 
and the total costs are increased to account for the 40 percent of 
devices found in other user facilities.
---------------------------------------------------------------------------

    \13\ ``Current Industrial Reports--Electromedical Equipment and 
Irradiation Equipment (including x-ray)--MA38R,'' U.S. Department of 
Commerce News, Bureau of the Census, issued September 1995.
    \14\ ``Forecasts of the Total World Cardiac Diagnostic Equipment 
and Telemetry Monitoring Market,'' Frost and Sullivan, 1992, April 
1995.
    \15\  Medical and Healthcare Marketplace Guide, MLR Biomedical 
Information Services, 8th ed., p. 92, 1992.
    \16\  Medical and Healthcare Marketplace Guide, MLR Biomedical 
Information Services, 8th ed., p. 75, 1992.
    \17\  Medical and Healthcare Marketplace Guide, MLR Biomedical 
Information Services, 8th ed., p. 69, 1992.
    \18\  U.S. Industrial Outlook, U.S. Department of Commerce, 
International Trade Administration, pp. 44-113, 1994.
---------------------------------------------------------------------------

    The analysis assumes that Phase II costs will be incurred in equal 
increments for the first 3 years after the regulation is issued. 
Therefore, annual costs of $6 million will be incurred for 3 years. 
Using a 7 percent discount rate, the present value of the total costs 
for Phase II is approximately $16 million.

[[Page 25496]]

C. Small Business Impact

    FDA certifies that the rule will not have a significant economic 
impact on a substantial number of small entities. To illustrate this 
result, the agency examined the potential impact of the rule on small 
entities by using the highest cost scenario for analysis. Hospitals 
will absorb an approximate total of $11 million over both phases of 
this regulation. The cost for an average-sized 179 bed hospital would 
be about $1,723, or less than $10 per bed. According to the Small 
Business Administration, profit-making hospitals with revenue at $5 
million or less per year are considered a small business. Using this 
criteria and 1993 data from AHA\19\, FDA finds that most hospitals with 
6 to 24 beds are small businesses. Because the individual cost to 
hospitals with 6, 24, 50, or 100 beds would be approximately $230, 
$394, $629, and $1,084 respectively, it would be less than 1 percent of 
the total net revenue for any of these bed size categories, and far 
less than 1 percent of gross revenue. Nursing homes would absorb 
approximately $157,000 of the total costs, or about $14 per nursing 
home. Ambulances and other ground transport vehicles would incur 
approximately $362,000 or about $7 per vehicle, and approximately $15 
per organization. If doctor's offices and clinics incur the remainder 
of the costs, they absorb approximately $3 million under Phase I of the 
rule and approximately $6 million under Phase II. These estimates 
amount to about $47 per office and clinic. While some user facilities 
will incur a greater share of these costs than others, all of the above 
cost figures represent far less than 1 percent of total gross revenue 
per facility. As a result, FDA finds that the magnitude of the 
individual costs determined above would not represent a significant 
impact for a substantial number of small user facilities.
---------------------------------------------------------------------------

    \19\ ``Hospital Statistics,'' The American Hospital Association 
Profile of U.S. Hospitals, Table 11, p. 206, 1994.
---------------------------------------------------------------------------

D. Conclusion

    FDA estimates the total costs for Phase I of the regulation to be 
$5 million. The Phase II costs are approximately $6 million per year 
for 3 years, or a total present value cost of $16 million. All cost 
estimates are based upon the use of adaptors as a viable conversion 
method. Adding costs for Phase I and Phase II, total costs for this 
rule are $21 million.
    As shown in section XIII. of this document, the reporting and 
recordkeeping burden is minimal for user facilities. Using the 
previously mentioned $20.93 hourly compensation figure, FDA calculates 
the recordkeeping burden to user facilities and manufacturers for 
filing an exemption or variance. FDA estimates these reporting costs 
under Sec. 10.30 to be $10,465 per year. Such a minimal amount does not 
significantly add to the final costs of this regulation.

XIII. Paperwork Reduction Act 1995

    This final rule contains information collection provisions that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520). The title, description, and respondent description 
of the information collection provisions are shown below with an 
estimate of the annual reporting burden. Included in the estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    Title: Exemptions and Variances from the Performance Standard for 
Electrode Lead Wires and Patient Cables
    Description: Section 898.14 provides that any person subject to the 
standard may submit a petition under Sec. 10.30 (21 CFR 10.30) 
requesting an exemption or variance from the standard. The petition 
must demonstrate why compliance with the standard is unnecessary or 
unfeasible and what alternate means will be used to protect the public 
health. FDA will use this information to determine whether granting an 
exemption is in the best interests of the public health. Allowing for 
exemptions and variances will provide for flexibility while assuring 
public health protection.
    Description of Respondents: Manufacturers, distributors, health 
care facilities.

                             Table 16--Estimated Additional Annual Reporting Burden                             
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
10.30                                  50               1              50              10            500        
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs expected as a result of this rule.                

    The proposed rule did not include a Paperwork Reduction Act burden 
estimate because it contained no information collection provisions. In 
the final rule, a new regulation, providing that requests for 
exemptions and variances from the performance standard may be submitted 
under Sec. 10.30, has been added. Because of the resulting anticipated 
additional reporting burden under Sec. 10.30, FDA is providing a burden 
estimate and an opportunity for public comment, as required by the 
Paperwork Reduction Act of 1995. Therefore, FDA now invites comments 
on: (1) Whether the proposed collection of information is necessary for 
the proper performance of FDA's functions, including whether the 
information will have practical utility; (2) the accuracy of FDA's 
estimate of the burden of the proposed collection of information, 
including the validity of the methodology and assumptions used; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) ways to minimize the burden of the collection of 
information on respondents, including through the use of automated 
collection techniques, when appropriate, and other forms of information 
technology. Individuals and organizations may submit comments on the 
information collection provisions of this final rule by July 8, 1997. 
Comments should be directed to the Dockets Management Branch (address 
above).
    At the close of the 60-day comment period, FDA will review the 
comments received, revise the information collection provision as 
necessary, and submit these provisions to OMB for review. FDA will 
publish a notice in the Federal Register when the information 
collection provisions are submitted to OMB, and an opportunity for 
public

[[Page 25497]]

comment to OMB will be provided at that time. After receiving OMB's 
decision, FDA will publish a notice in the Federal Register of OMB's 
decision to approve, modify, or disapprove the information collection 
provisions. The effective date of Sec. 898.14 will be announced in the 
Federal Register after OMB approval has been received. An agency may 
not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number.

XIV. References

    The following references have been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Letter to FDA Commissioner David A. Kessler from Ron Wyden, 
then Chairman, U.S. House of Representatives, Committee on Small 
Business, Subcommittee on Regulation, Business Opportunities, and 
Technology, dated August 2, 1994.
    2. Information from FDA's medical device reporting (MDR) data 
base, Rockville, MD.
    3. Information from FDA's MDR data base, Rockville, MD.
    4. ``FDA Safety Alert: Unsafe Patient Lead Wires and Cables,'' 
FDA's September 3, 1993, Safety Alert.
    5. Section 518(a) notification letter to apnea monitor 
manufacturers, September 3, 1993.
    6. Section 518(a) notification letter to patient cable and lead 
wire manufacturers, September 20, 1993.
    7. FDA Public Health Advisory: Unsafe Electrode Lead Wires and 
Patient Cables Used With Medical Devices, December 28, 1993.
    8. Proceedings, Unprotected Patient Cables and Electrode Lead 
Wires Conference, July 15, 1994.
    9. ``Medical Devices: Early Warning of Problems is Hampered by 
Severe Underreporting,'' United States General Accounting Office 
Report to the Chairman, Committee on Governmental Affairs, U.S. 
Senate, p. 61, December 1986.
    10. Fran Hos ``Electrode Leadwire Survey,'' distributed by the 
American Society for Hospital Engineering of AHA, early 1994.
    11. Employment and Earnings, U.S. Department of Labor Bureau of 
Labor Statistics, Table 39, p. 206, January 1996.
    12. The Statistical Abstract of the United States, U.S. 
Department of Commerce Economics and Statistics Administration, 
Bureau of Census, No. 183, p. 125, 1995.
    13. The Statistical Abstract of the United States, U.S. 
Department of Commerce Economics and Statistics Administration, 
Bureau of Census, No. 200, p. 134, 1995.
    14. ``The United States Emergency Medical Services Market 
Report,'' based on data gathered from EMS Census 1995, prepared by 
Emergency Care Information Center and JEMS Communications, p. 40.
    15. ``Transportation Systems, 1994,'' produced by the National 
Association of State EMS Directors, p. 2, 1994.
    16. ``The United States Emergency Medical Services Market 
Report,'' based on data gathered from EMS Census 1995, prepared by 
Emergency Care Information Center and JEMS Communications, p. 17.
    17. ``The United States Emergency Medical Services Market 
Report,'' based on data gathered from EMS Census 1995, prepared by 
Emergency Care Information Center and JEMS Communications.
    18. ``The Statistical Abstract of the United States,'' U.S. 
Department of Commerce Economics and Statistics Administration, 
Bureau of Census, No. 1316. p. 795, 1995.
    19. The Statistical Abstract of the United States, U.S. 
Department of Commerce Economics and Statistics Administration, 
Bureau of Census, No. 183. p. 125, 1995.
    20. ``Electrode Leadwire Survey II,'' distributed by the 
American Society for Hospital Engineering of AHA, fall 1995.
    21. The Statistical Abstract of the United States, U.S. 
Department of Commerce Economics and Statistics Administration, 
Bureau of Census, No. 183, p. 125, 1995.
    22. ``Current Industrial Reports--Electromedical Equipment and 
Irradiation Equipment (including x-ray)--MA38R,'' U.S. Department of 
Commerce News, Bureau of the Census, issued September 1995.
    23. ``Forecasts of the Total World Cardiac Diagnostic Equipment 
and Telemetry Monitoring Market,'' Frost and Sullivan, April 1995.
    24. Medical and Healthcare Marketplace Guide, MLR Biomedical 
Information Services, 8th edition, p. 92, 1992.
    25. Medical and Healthcare Marketplace Guide, MLR Biomedical 
Information Services, 8th edition, p. 75, 1992.
    26. Medical and Healthcare Marketplace Guide, MLR Biomedical 
Information Services, 8th edition, p. 69, 1992.
    27. U.S. Industrial Outlook, U.S. Department of Commerce, 
International Trade Administration, pp. 44-113, 1994.

List of Subjects in 21 CFR Part 898

    Administrative practice and procedure, Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, Chapter I of Title 21 of the Code of 
Federal Regulations is amended as follows:
    1. Part 898 is added to read as follows:

PART 898-PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT 
CABLES

Sec.
898.11  Applicability.
898.12  Performance standard.
898.13  Compliance dates.
898.14  Exemptions and variances.

    Authority: Secs. 501, 502, 513, 514, 530-542, 701, 704 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360c, 
360d, 360gg-360ss, 371, 374); secs. 351, 361 of the Public Health 
Service Act (42 U.S.C. 262, 264).

Sec. 898.11  Applicability.

    Electrode lead wires and patient cables intended for use with a 
medical device shall be subject to the performance standard set forth 
in Sec. 898.12.


Sec. 898.12  Performance standard.

    (a) Any connector in a cable or electrode lead wire having a 
conductive connection to a patient shall be constructed in such a 
manner as to comply with subclause 56.3(c) of the following standard:
    International Electrotechnical Commission (IEC)
    601-1: Medical Electrical Equipment
    601-1 (1988) Part 1: General requirements for safety
    Amendment No. 1 (1991)
    Amendment No. 2 (1995).
    (b) Compliance with the standard shall be determined by inspection 
and by applying the test requirements and test methods of subclause 
56.3(c) of the standard set forth in paragraph (a) of this section.


Sec. 898.13  Compliance dates.

     The dates for compliance with the standard set forth in 
Sec. 898.12(a) shall be as follows:
    (a) For electrode lead wires and patient cables used with, or 
intended for use with, the following devices, the date for which 
compliance is required is May 11, 1998:

                          Listing of Devices for Which Compliance is Required Effective                         
                                                  May 11, 1998                                                  
----------------------------------------------------------------------------------------------------------------
                                                             21 CFR                                             
                Phase                    Product code       section          Class             Device name      
----------------------------------------------------------------------------------------------------------------
1....................................  73 BZQ                868.2375   II              Monitor, Breathing      
                                                                                         Frequency.             
1....................................  73 FLS                868.2375   II              Monitor (Apnea          
                                                                                         Detector), Ventilatory 
                                                                                         Effort.                

[[Page 25498]]

                                                                                                                
1....................................  74 DPS                870.2340   II              Electrocardiograph.     
1....................................  74 DRG                870.2910   II              Transmitters and        
                                                                                         Receivers,             
                                                                                         Physiological Signal,  
                                                                                         Radio Frequency.       
1....................................  74 DRT                870.2300   II              Monitor, Cardiac        
                                                                                         (including             
                                                                                         Cardiotachometer and   
                                                                                         Rate Alarm).           
1....................................  74 DRX                870.2360   II              Electrode,              
                                                                                         Electrocardiograph.    
1....................................  74 DSA                870.2900   II              Cable, Transducer and   
                                                                                         Electrode, Patient     
                                                                                         (including Connector). 
1....................................  74 DSH                870.2800   II              Recorder, Magnetic Tape,
                                                                                         Medical.               
1....................................  74 DSI                870.1025   III             Detector and Alarm,     
                                                                                         Arrhythmia.            
1....................................  74 DXH                870.2920   II              Transmitters and        
                                                                                         Receivers,             
                                                                                         Electrocardiograph,    
                                                                                         Telephone.             
----------------------------------------------------------------------------------------------------------------

    (b) For electrode lead wires and patient cables used with, or 
intended for use with, any other device, the date for which compliance 
is required is May 9, 2000.


Sec. 898.14  Exemptions and variances.

    (a) A request for an exemption or variance shall be submitted in 
the form of a petition under Sec. 10.30 of this chapter and shall 
comply with the requirements set out therein. The petition shall also 
contain the following:
    (1) The name of the device, the class in which the device has been 
classified, and representative labeling showing the intended uses(s) of 
the device;
    (2) The reasons why compliance with the performance standard is 
unnecessary or unfeasible;
    (3) A complete description of alternative steps that are available, 
or that the petitioner has already taken, to ensure that a patient will 
not be inadvertently connected to hazardous voltages via an unprotected 
patient cable or electrode lead wire for intended use with the device; 
and
    (4) Other information justifying the exemption or variance.
    (b) An exemption or variance is not effective until the agency 
approves the request under Sec. 10.30(e)(2)(i) of this chapter.

    Dated: April 28, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-11967 Filed 5-7-97; 8:45 am]
BILLING CODE 4160-01-F