[Federal Register Volume 78, Number 70 (Thursday, April 11, 2013)]
[Notices]
[Pages 21607-21608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08461]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health Partnership
Opportunity on a Research Project To Evaluate the Performance of
Isolation Gowns
AGENCY: National Institute for Occupational Safety and Health (NIOSH)
of the Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of opportunity to support research.
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SUMMARY: The NIOSH National Personal Protective Technology Laboratory
is initiating a research study in support of American Society for
Testing and Materials (ASTM) International standards development to
establish minimum performance requirements for isolation gowns for
health care workers. NIOSH is seeking to identify currently marketed
isolation gown products. All manufacturers are requested to submit
samples to NIOSH free of charge for testing. There will be no cost to
the manufacturers for testing. Not all submitted products may be
tested, depending on the response to this announcement and the results
of screening tests. Each manufacturer that submits gowns that are
tested will receive the test results from their gowns. Through
submission of the gown samples, manufacturers will be making an
important contribution to ASTM, International's process to establish an
important standard for evaluating the protection provided for health
care workers by isolation gowns. Participating manufacturers will be
recognized as contributing to the establishment of the performance
standard. Manufacturers whose products are tested will also receive the
results of all gowns tested in a blinded format.
Gown Criteria: Candidate gowns for inclusion in the research
program must meet the following criteria: (1) The gowns must be
identified (labeled) as ``isolation gowns'' and have full coverage in
the back to provide protection for the health care worker and the
patient; (2) A minimum of 100 units for each code (model) of disposable
(single use) gown submitted; (3) A minimum of 200 ``new'' (unprocessed,
unused, unwashed) reusable gowns for each model submitted. Reusable
gown submissions must include a labeling recommendation for the maximum
number of laundering cycles to be included in this study. Half of the
gown samples will be tested after one laundering and drying cycle and
half of the gown samples will be tested as laundered for the maximum
number of cycles claimed by the manufacturer; and, (4) Samples should
be provided in finished package format, with any claims that may not be
noted on the packaging or labels provided by the manufacturer. NIOSH
will not return any gowns submitted for this testing.
DATES: Submit letters of interest to provide gowns and participate in
this research program prior to May 13, 2013.
ADDRESSES: Interested manufacturers should submit a letter of interest
with information about their isolation gowns' capabilities to: NIOSH,
National Personal Protective Technology Laboratory, Attn: Selcen
Kilinc, PO Box 18070, Pittsburgh, PA 15236, Email address: [email protected]
Background: It has been reported by user groups (e.g. Association
of Perioperative Registered Nurses and Association for Professionals in
Infection Control and Epidemiology) as well as U.S. Food and Drug
Administration (FDA), that performance properties and levels of
protection for isolation gowns are poorly understood and defined. NIOSH
and FDA are currently working with the ASTM International Committee on
Personal Protective Clothing and Equipment--Biological Subcommittee, to
establish a standard that defines criteria for measurement and minimum
levels of performance for isolation gowns. Development of a standard is
expected
[[Page 21608]]
to improve users' understanding of levels of protection to be provided.
Product testing results will be provided to the ASTM Committee on
Personal Protective Clothing and Equipment--Biological Subcommittee
(a.k.a. ASTM Task Force), which will utilize the data as the scientific
basis to develop a standard establishing minimum performance criteria
for single-use and reusable isolation gowns. The research objective is
to evaluate performance properties, such as strength and barrier
properties, of isolation gowns to be provided to the ASTM Task Force as
scientific input for establishing minimum performances for conformance
to this standard.
In this study, all testing will be conducted blind. Results will be
shared with the ASTM Task Force only in a blinded format. Results will
be shared with the individual manufacturers for their gowns only. The
final summary of the testing will be shared in a blinded format only
with all manufacturers that participated.
Randomized samples will be tested by both NIOSH and Nelson Labs.
The ASTM Task Force will review and analyze all test results.
Establishment of the minimum requirement for each property will be the
responsibility of the ASTM Task Force. NIOSH plans to conduct testing
to measure the following properties: Fabric weight, breaking strength,
tear strength, seam strength, water resistance (impact penetration and
hydrostatic pressure), microbial/viral penetration resistance, air
permeability, evaporative resistance, and thermal insulation.
Neither this announcement, nor product submittals in response to
this announcement, obligates NIOSH to enter into a contractual
agreement with any respondent. Inquiries should be sent to Selcen
Kilinc at [email protected]. NIOSH reserves the right to establish a
partnership based on scientific analysis and capabilities found by way
of this announcement or other searches, if determined to be in the best
interest of the government.
Dated: April 5, 2013.
John Howard,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2013-08461 Filed 4-10-13; 8:45 am]
BILLING CODE 4163-19-P