If you're reprocessing single-use devices (SUDs), take note. The FDA has revised the guidelines covering procedures and timeframes for reviewing the validation data submitted to the FDA for certain SUDs. The "Validation Data in Premarket Notification Submissions (5109(k)s) for Reprocessed Single-Use Medical Devices," which supersedes last year's document of the same name, is available at www.fda.gov/cdrh/ode/guidance/1216.html. The 23-page guidance is a bit much to wade through, so here's what you need to know.
Addendum to the MDUFMA
First, you have to understand that the updated guidance is an addendum to the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which set new requirements for reprocessing SUDs, and made hospitals subject to this regulatory process.
For the purposes of the MDUFMA, hospitals that reprocess SUDs are considered manufacturers; the FDA has deemed that reprocessing a device essentially makes it new, and hospitals must therefore be able to back up the safety and efficacy of these "new" devices. The MDUFMA seeks to ensure that reprocessed SUDs are what it calls "substantially equivalent" to the originals, and sets a timetable for hospitals to submit validation data and defines validation data - such as cleaning and sterilization data and functional performance data showing the reprocessed SUDs' equivalence and the maximum number of times they can be reprocessed.
The implementation of these regulations was to be phased in, with validation data for the most critical devices being due first, for semi-critical second and for non-critical last. These designations are separate from the low- (Class I), medium- (Class II) and high-risk (Class III) labels. The MDUFMA requirements right now apply only to critical reprocessed SUDs, which contact normally sterile tissue or body space, and to semi-critical SUDs, which contact intact mucous membranes without penetrating normally sterile areas of the body. For a complete list of SUDs you need to submit validation data for, see www.fda.gov/ ohrms/dockets/98fr/03-16109.html.
The new guidance
The FDA issued the revised "Validation Data" document June 1 to clarify new procedures and timeframes for submitting validation data regarding certain SUDs (those on the aforementioned list) to the FDA. Here are the highlights:
- Validation data for critical reprocessed SUDs on the list printed in the April 30, 2003, Federal Register had to be submitted by July 30.
- Validation data for semi-critical reprocessed SUDs on the list printed in the April 13 Federal Register must be submitted by July 13, 2005.
- After the FDA reviews your validation submissions, it will send you a letter to let you know the SUD in question is substantially equivalent or it will request more information.
- In the latter case, you will have 30 days to submit further data; the FDA will make a final decision - clearing or denying the SUD's reprocessing - within 60 days.
- If the FDA finds the SUD is "not substantially equivalent" to the original after this second review, you won't be allowed to reprocess the device in your facility. You will either have to hire an approved company to do it or convert solely to single use.
What this means to you
The MDUFMA and subsequent updates are intended to better regulate the practice of reprocessing devices intended for single use, therefore making it more uniform and safer. Complying with the regulations - and keeping up with the updates - is time-consuming and involves a lot of paperwork.
If you're a stand-alone outpatient surgery center, take heart. You're not (at this time) subject to the requirements of the act. However, you might be if your outpatient facility is attached to a hospital or if your freestanding ambulatory surgery center is owned and operated by a hospital, and you use the hospital's resources for your sterile processing needs, which would include reprocessing.
My recommendation is that you acquaint yourself with the devices currently listed as critical or semi-critical and decide if you want to potentially become subject to FDA regulations by reprocessing any of those devices. The FDA Web site (www.fda.gov/oc/mdufma) is the best resource for all the information you need. If you do reprocess, be sure to get written instructions from the manufacturer on how to safely clean, wrap and re-sterilize the device - and follow those instructions to the letter. If the manufacturer is not forthcoming with this information - many SUD manufacturers won't be - develop a process for handling each device and validate that your process results in a product that is safe and effective. If this isn't practical for your facility, then you should consider a third-party reprocessor that meets the MDUFMA's regulations.