[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Notices]
[Pages 24495-24496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10532]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0294]
Reprocessing of Reusable Medical Devices; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled: ``Reprocessing of Reusable Medical Devices
Workshop.'' The purpose of the workshop is to discuss factors affecting
the reprocessing of reusable medical devices and FDA's plans to address
the identified issues. This workshop is part of an ongoing FDA effort
to address patient exposure to inadequately reprocessed reusable
medical devices with the overall goal to reduce the risk of infection.
The topics to be discussed are: Factors affecting reprocessing quality,
device design as it relates to reprocessing reusable medical devices,
reprocessing methodologies, validation methodologies, and healthcare
facility best practices.
Date and Time: The public workshop will be held on June 8, 2011,
from 8:30 a.m. to 5:30 p.m. and June 9, 2011, from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held in the Great Room at the
FDA White Oak Conference Center, Bldg. 31, Rm. 1503, 10903 New
Hampshire Ave., Silver Spring, MD 20993.
Contact Person: Carol Krueger, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5437, Silver Spring, MD 20993, 301-
796-3241, FAX: 301-847-8510, or e-mail: [email protected].
Registration and Requests for Oral Presentations: Registration is
free and on a first-come, first-served basis. Persons interested in
attending this workshop must register online by 5 p.m. on June 1, 2011.
Early registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permit, on-site registration on the day
of the public workshop will be provided beginning at 7:30 a.m. Non-U.S.
citizens are subject to additional security screening, and they should
register as soon as possible. If you need special accommodations due to
a disability, please contact Susan Monahan (e-mail:
[email protected] or phone: 301-796-5661) no later than June 1,
2011.
This workshop will also be Web cast. Persons interested in
participating by Web cast must register online by 5 p.m. on June 1,
2011. Early registration is recommended because Web cast connections
are limited. Organizations are requested to register all participants,
but view using one connection per location. Web cast participants will
be sent connection requirements.
To register for the public workshop, please visit the following Web
site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to the FDA Medical Devices News
& Events--Workshops & Conferences calendar and select this public
workshop from the posted events list). Please provide complete contact
information for each attendee, including: Name, title, affiliation,
address, email, telephone and FAX number. For those without Internet
access, please call the contact person to register. Registrants will
receive confirmation once they have been accepted. You will be notified
if you are on a waitlist.
This workshop includes a public comment session. During online
registration you may indicate if you wish to make an oral presentation
during a public comment session at the public workshop, and which topic
you wish to address in your presentation. FDA has included general
topics for comment in this document. FDA will do its best to
accommodate requests to speak. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation. FDA will
determine the amount of time allotted to each presenter and the
approximate time each oral presentation is to begin. All requests to
make oral presentations, as well as presentation materials, must be
sent to the contact person by June 1, 2011.
SUPPLEMENTARY INFORMATION:
[[Page 24496]]
I. Background
Various types of medical devices used in healthcare settings, from
surgical suction tips to complex endoscopes, are designed and labeled
for use on multiple patients. The workshop will focus on medical
devices that are intended for reuse after reprocessing, rather than
third-party reprocessing of single-use-only medical devices.
Thousands of reusable medical devices requiring reprocessing are
used every day in diagnosing and treating patients. FDA has received a
number of reports of patient exposure to inadequately reprocessed
medical devices and subsequent healthcare-associated infections (HAIs).
Several reports contained evidence suggesting that inadequate
reprocessing may have been a contributing factor in microbial
transmission and subsequent infection. A definitive causal relationship
between reusable device reprocessing and any patient infection is
difficult to establish, because inadequate reprocessing is not often
investigated as a cause when an HAI is diagnosed. Ensuring adequate
reprocessing of reusable medical devices could reduce the incidence of
HAIs associated with the use of a reprocessed medical device. This will
decrease the public health burden of HAIs in terms of morbidity,
mortality and cost.
The adequate reprocessing of reusable medical devices is a
critically important factor in protecting patient safety. Inadequate
reprocessing between patients can result in the retention of blood,
tissue, and other biological debris (soil) in reusable medical devices.
This soil can allow microbes to survive the high level disinfection or
sterilization process, potentially resulting in HAIs or other adverse
patient outcomes. FDA receives reports of problems in all steps of
medical device reprocessing \1\, including cleaning, disinfecting and
sterilizing. Manufacturers, healthcare facilities, healthcare
professionals, and the FDA all have a role in reducing the risk of
inadequately reprocessed medical devices.
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\1\ A more comprehensive description of reprocessing steps is
available in FDA's draft guidance ``Processing/Reprocessing Medical
Devices in Health Care Settings: Validation Methods and Labeling''
at http://www.fda.gov/reprocessingreusabledevices.
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Because of the critical importance of adequate reprocessing of
medical devices, the FDA has launched an initiative to focus on
improvements in device design, reprocessing procedures and validation
methodologies, and healthcare facility quality assurance practices. To
help address these issues, the FDA has engaged partners at the Centers
for Disease Control and Prevention (CDC), the Centers for Medicaid and
Medicare Services (CMS), the Veterans Health Administration (VHA), and
The Joint Commission (JC), who bring valuable expertise in disease
control and healthcare practices to this initiative.
II. Topics for Discussion at the Public Workshop
The public workshop will be organized to discuss the following
topic areas:
1. What are the nature, scope, and impact of reusable medical
device reprocessing problems that have been observed? What are the
causes of these problems?
2. What factors or criteria to facilitate reprocessing should be
considered when designing reusable medical devices? How can the design
process be improved to better incorporate cleanability as a design
endpoint?
3. What factors or criteria should be considered when developing
reprocessing instructions and validation protocols for devices to be
used in various healthcare environments (e.g., hospital, ambulatory
surgical center, physician's office), based on the draft guidance
document ``Processing/Reprocessing Medical Devices in Health Care
Settings: Validation Methods and Labeling'' at http://www.fda.gov/reprocessingreusabledevices.
4. What factors or criteria should be considered by a healthcare
facility when developing reusable device reprocessing procedures and
quality assurance processes?
5. How should problems with reusable medical device reprocessing be
identified, reported, and acted upon by industry and users?
III. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857. A link to the transcripts will
also be available on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this public
workshop from the posted events list), approximately 45 days after the
public workshop.
Dated April 26, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-10532 Filed 4-29-11; 8:45 am]
BILLING CODE 4160-01-P