FDA update 29th July 2011

FDA to seek public comment on factors affecting the reprocessing of reusable medical devices

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

  • 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.

To assist interested parties, FDA is 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 clean ability 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)?

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?

PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FDA-2011-N-0294.

Or you can send your comments before September 26 2011 at info@mdiconsultants.com and REF: factors affecting the reprocessing of reusable medical devices.

For more information on this guidance you can go to the following linkhttp://www.gpo.gov/fdsys/pkg/FR-2011-07-28/html/2011-19098.htm.