[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