By Jason Pope, Study Director, Healthcare Sterilization Section, BS, ASQ CQA
It has been a challenge for the industry to stay current on the regulatory landscape as it relates to reusable device sterilization validation. FDA expectations tend to change so frequently, it can be difficult to keep up, but it is critical to stay on top of the regulatory landscape as it evolves as the FDA and other regulatory bodies continue to require more and more detail in the instructions for use that medical device manufacturers provide for reusable device sterilization.
Nelson Laboratories is heavily involved with AAMI working groups in order to maintain a continued and timely understanding of what regulatory agencies are requiring. As part of its participation with the AAMI working groups, Nelson Laboratories is involved with writing and revising the industry standards and guidance documents.
Nelson Laboratories also works closely with the FDA. Before the FDA’s most recent draft guidance document was released in May of 2011, Nelson Laboratories was able to implement changes for reusable device sterilization validations with its clients. Upon publication of the FDA draft guidance document, Nelson Laboratories attended the two summit meetings held by the FDA to better understand FDA expectations and industry interpretations of the document.
In addition to its work with AAMI and FDA, the company continually participates in regulatory and industry webinars and conferences – all so the company stays ahead of the regulatory environment to best serve its clients.
The regulatory landscape has changed since 2011 in regards to reusable device sterilization. One of the key updates in the FDA guideline resulted in a move to require the validation of standard sterilization cycles, where before it was more common for FDA to approve the listing of extended sterilization cycles in reprocessing instructions. Another key development is the expectation that manufacturers perform drying validations in conjunction with the demonstration of appropriate sterility assurance for their devices.
As the regulatory environment continually changes, Nelson Laboratories will continue to work with the FDA, AAMI, our customers, and others in the industry in order to provide as much industry knowledge as possible regarding requirements that will need to be met by our clients.
We encourage our clients to solicit FDA feedback on their test procedures to ensure FDA “buy in” before testing begins and to let us know if they receive any FDA follow up questions after submission review. This ensures Nelson Laboratories and its clients are always ahead of FDA expectations in order to provide up-to-date and thorough validations for reusable device sterilization.