08.01.11
The U.S. Food and Drug Administration (FDA) s seeking public comment on factors affecting the reprocessing of resuable medical devices according to a July 28 notice published in the Federal Register. According to the notice, the agency is examining reprocessing quality, device design as it relates to reprocessing, reprocessing methodologies, validation methodologies and healthcare facility best practices.
There is a pubic comment period open until Sept. 26. It is the second chance for interested parties to weigh in, after the FDA accepted electronic comments in June following a two-day public workshop on the issue of reprocessing.
The notice indicated that many devices are designed for more than one use, and thousands of those devices are used daily to diagnose and treat patients. However, the “FDA has received a number of reports of patient exposure to inadequately reprocessed medical devices and subsequent healthcare associated infections."
Some evidence suggests that inadequate reprocessing may contribute to microbial transmission and subsequent infection, according to the agency.
“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 in reusable medical devices,” according to the agency's note.
There is a pubic comment period open until Sept. 26. It is the second chance for interested parties to weigh in, after the FDA accepted electronic comments in June following a two-day public workshop on the issue of reprocessing.
The notice indicated that many devices are designed for more than one use, and thousands of those devices are used daily to diagnose and treat patients. However, the “FDA has received a number of reports of patient exposure to inadequately reprocessed medical devices and subsequent healthcare associated infections."
Some evidence suggests that inadequate reprocessing may contribute to microbial transmission and subsequent infection, according to the agency.
“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 in reusable medical devices,” according to the agency's note.