FDA seeks input on reprocessing reusable medical devices
The FDA is seeking public comment on factors affecting the reprocessing of reusable medical devices, according to a July 28 notice published in the Federal Register. According to the article, the administration is considering reprocessing quality, device design as it relates to reprocessing, reprocessing methodologies, validation methodologies and healthcare facility best practices.
The public comment period—open until Sept. 26—is the second opportunity for interested parties to weigh in, after the FDA accepted electronic comments in June following a two-day public workshop focused on the reprocessing of reusable medical devices.
The notice indicated that multiple devices—from surgical suction tips to complex endoscopes—are designed for more than one use, and thousands of those devices are utilized 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.”
It is difficult to establish a causal relationship between healthcare associated infections and inadequate reprocessing, because reprocessing is not often investigated, the article noted. However, 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,” the authors wrote.
The public comment period—open until Sept. 26—is the second opportunity for interested parties to weigh in, after the FDA accepted electronic comments in June following a two-day public workshop focused on the reprocessing of reusable medical devices.
The notice indicated that multiple devices—from surgical suction tips to complex endoscopes—are designed for more than one use, and thousands of those devices are utilized 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.”
It is difficult to establish a causal relationship between healthcare associated infections and inadequate reprocessing, because reprocessing is not often investigated, the article noted. However, 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,” the authors wrote.