[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45268-45269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19098]
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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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is considering factors
affecting the reprocessing of reusable medical devices, including
reprocessing quality, device design as it relates to the reprocessing
of reusable medical devices, reprocessing methodologies, validation
methodologies, and health care facility best practices. This is part of
an ongoing effort to address patient exposure to inadequately
reprocessed reusable medical devices. FDA would like to provide another
opportunity for public comment by establishing a docket to receive
information and comments from the public on factors affecting the
reprocessing of reusable medical devices.
DATES: Submit either electronic or written comments by September 26,
2011.
ADDRESSES: You may submit comments, identified with the FDA docket
number found in brackets in the heading of this document, by any of the
following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and
[[Page 45269]]
docket number for this notice. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Carol Krueger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5437, Silver Spring, MD 20993, 301-796-3241,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA has launched an effort focused on the reprocessing of reusable
medical devices, including reprocessing quality, device design as it
relates to the reprocessing of reusable medical devices, reprocessing
methodologies, validation methodologies, and health care facility best
practices. As part of this effort, FDA held a 2-day public workshop on
June 8 and 9, 2011, at FDA's White Oak Conference Center in Silver
Spring, MD. In the Federal Register of May 2, 2011 (76 FR 24495), FDA
announced the workshop and provided background information. The
workshop focused on medical devices that are intended for reuse after
reprocessing, rather than third-party reprocessing of single-use-only
medical devices. FDA has a Web cast of the workshop available for
viewing at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm252205.htm. The workshop included a public
comment session.
On the workshop Web site (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm252205.htm), FDA stated that
electronic comments regarding the public workshop could be submitted to
http://www.regulations.gov until June 29, 2011. FDA inadvertently
failed to state this in the May 2, 2011, workshop notice. Hence, http://www.regulations.gov was not open for submission of electronic
comments. FDA is publishing this notice to provide another opportunity
for public comment on reprocessing of reusable medical devices issues.
Various types of medical devices used in health care settings, from
surgical suction tips to complex endoscopes, are designed and labeled
for use on multiple patients. 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 health care-
associated infections (HAIs).
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. Several reports, however, contained evidence
suggesting that inadequate reprocessing may have been a contributing
factor in microbial transmission and subsequent infection. 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, health care facilities, health care
professionals, and FDA all have a role in reducing the risk of
inadequately reprocessed medical devices. To help address these issues,
FDA has engaged partners at the Centers for Disease Control and
Prevention, the Centers for Medicaid and Medicare Services, the
Veterans Health Administration, and The Joint Commission, who bring
valuable expertise in disease control and health care practices to this
effort.
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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/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/default.htm.
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II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
To assist interested parties, we are asking for public comment on
the following issues:
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 health care 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,'' available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/default.htm?
4. What factors or criteria should be considered by a health care
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?
Dated: July 25, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-19098 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P