[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Page 12067]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03993]



[[Page 12067]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0118]


Extreme Weather Effects on Medical Device Safety and Quality

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is studying the 
potential effects of extreme weather and natural disasters on medical 
device safety and quality. FDA is announcing at this time its request 
for comments on the topic of extreme weather effects on medical device 
safety and quality.

DATES: Submit either electronic or written comments by May 10, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jennifer Kelly, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 3429, Silver Spring, MD 20993-0002, 
Jennifer.Kelly@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Extreme Weather (EW) events and natural disasters can interfere 
with the manufacturing, shipping, storage, or use of marketed devices, 
which may lead to concerns with their safety or effectiveness. Examples 
of such events include hurricanes, floods, lightning storms, 
earthquakes, and fires.
    FDA is holding a meeting of its Device Good Manufacturing Practice 
Advisory Committee on April 11, 2013, to discuss how to optimize the 
use of FDA's current regulatory framework to address risks and 
vulnerabilities to the manufacturing chain resulting from EW 
conditions. Future steps may be identified to help industry mitigate or 
better tolerate challenges to the manufacturing chain as a result of EW 
conditions. FDA is opening this docket to gather additional information 
to support FDA's efforts to minimize the impact of EW events on the 
safety, effectiveness, and availability of medical devices. FDA is 
requesting comments on three scenarios related to medical devices and 
EW. FDA will use this information to help industry anticipate and 
prepare for potential challenges from EW situations in the future.

Scenario A. Marketed Devices Already in Use for Patient Care

    Medical devices in use for ongoing patient care may be damaged or 
prevented from functioning by EW conditions. In particular, those 
medical devices that are essential to ongoing patient safety, 
treatment, or comfort need to continue functioning even under less than 
optimal conditions such as electric power or network outages or lack of 
clean water. Examples include ventilators in hospitals, infusion pumps 
providing essential medicines at home, and dialysis machines in 
outpatient centers. The specific risks to patients and the best options 
for device optimization will depend on the type of product, the 
expected uses, and the locations of treatment.

Scenario B. New/Unused Devices, Components, or Accessories

    Medical devices, components, or accessories may be damaged by EW 
conditions before use, while in storage, or during shipping. Examples 
include surgical gloves being held for shipment in a warehouse when it 
floods or weather interrupting transportation of temperature-sensitive 
devices.

Scenario C. Damage to Medical Device Manufacturing Sites

    Medical device manufacturing facilities or equipment may be damaged 
during EW, limiting the number or quality of devices that can be 
produced until repairs are made. EW may also interrupt access to 
electric power, filtered water, or other necessary materials and 
utilities, thereby limiting production. Examples include a 
manufacturing plant damaged by fire, flooding in a storage warehouse, 
or power interruptions in clean rooms and other controlled environments 
during the manufacturing process.
    FDA is seeking information particularly on the following questions; 
however, you may respond to any, all, or none of these questions, or 
you may submit comments on any topic relating to the purposes of this 
document, regardless of whether a topic is addressed by these 
questions:
    1. Have you experienced any of the scenarios or any other effects 
of EW on the safety and effectiveness of medical devices?
    2. How did you respond to extended periods of electrical or network 
outages or other events related to EW?
    3. In past EW situations, how was communication handled between the 
manufacturer facility and patients/users about the safe use of products 
during EW events? How did you provide/receive information about device 
failures? Do you have any suggestions for complaint handling during 
these situations?
    4. How should industry optimize the design, production, and use of 
medical devices during and after EW events?
    5. How could products be monitored during transport and storage in 
light of potential interruptions and environmental extremes from EW 
events?
    6. How can manufacturers best prevent or minimize temporary 
shortages of medical devices when EW may damage existing inventory or 
impact just-in-time production of critical components?
    7. In what ways have EW events impacted your manufacturing site? 
What were the lessons learned during the recovery process as you 
returned to production? What changes were made as a result of the EW 
event?
    8. Are there additional steps FDA can take to help industry 
anticipate, mitigate, or better tolerate the effects of EW?
    9. Are there steps that standards development or other professional 
organizations can take to support industry to optimally prepare for EW 
events?

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03993 Filed 2-20-13; 8:45 am]
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