On June 8th and 9th, the FDA will be hosting a public workshop entitled “Reprocessing of Reusable Medical Devices Workshop.” This workshop is part of an ongoing FDA effort to address patient exposure to inadequately reprocessed reusable medical devices with the overall goal to reduce the risk of infection. Among the topics to be discussed include:
- Factors affecting reprocessing quality;
- Device design as it relates to reprocessing reusable medical devices;
- Reprocessing methodologies;
- Validation Methodologies; and
- Healthcare facility best practices.
Although the FDA has specifically indicated this workshop will focus on medical devices that are “intended for reuse after reprocessing, rather than third-party reprocessing of single-use-only medical devices,” our industry will be carefully monitoring the activities throughout these meetings to see how this issue is addressed, what solutions are proposed, and how their decisions could potentially influence all reprocessing practices in the future.
Persons interested in attending the workshop, either in-person or via the Web cast, must register online at http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/default.htm. The deadline to register is June 1 at 5 P.M.
Please visit www.amdr.org and ‘follow us’ on Twitter for all the latest updates on medical device reprocessing!