Analyzing FDA Guidance to Develop Adequate Reprocessing Instructions for Devices
1 Hour Video | Jeffrey K. Shapiro, Hyman, Phelps & McNamara, P.C.
The reprocessing of a medical device is a complex process that has evolved in recent years and increased significantly when multiple cases of the antibiotic resistant superbug carbapenem-resistant enterobacteriaceae (CRE) were linked to duodenoscopes, which had not been adequately sterilized. In response, the FDA released finalized guidance entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” which outlines expectations and recommendations for manufacturers to ensure the safe and effective use of reprocessed devices. Among the new expectations is a provision which stipulates that it is the responsibility of the manufacturer to validate and provide adequate reprocessing instructions that are comprehensive and user-friendly. While the guidance does contain various areas of ambiguity, such as the ideal size or design of a validation study, manufacturers must rigorously test and label new devices to clearly specify the appropriate reprocessing procedures.
- In-depth review of guidance expectations and six criteria for clear reprocessing instructions
- Developing labels with sufficient instructions on how to prepare device for next use
- Defining human factors considerations in reprocessing
- Incorporating effective reprocessing considerations throughout the product life cycle
- FDA initiatives to enhance reprocessing oversight of devices
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
Jeff Shapiro is a partner in the law firm of Hyman, Phelps & McNamara (Washington, DC). For 20 years, Mr. Shapiro has represented medical device companies before the Food and Drug Administration (FDA). He assists in both premarket and postmarket compliance matters. Mr. Shapiro also has expertise in combination products and FDA’s regulation of human tissue based products (361 HCT/Ps). Mr. Shapiro is on the Editorial Advisory Board of MDDI and Update magazines. He is also a frequent speaker at medical device and diagnostic seminars and conferences. Mr. Shapiro is a graduate of Brown University (magna cum laude) and the Harvard Law School (cum laude).
His areas of medical device expertise include: Developing premarket regulatory strategy for products, assistance with IDE, 510(k), and PMA submissions, advice in MDR, recall (field action) and QSR compliance matters, review of labeling and advertising for compliance, regulatory due diligence and post-acquisition risk mitigation, reviewing contracts and security disclosure documents and responding to 483s and warning letters.