The American College of Clinical Engineering (ACCE) will host a complimentary webinar next week to discuss the FDA’s request for comments on medical device service, refurbishment, repair, reconditioning, and modification by OEMs, third parties, and healthcare organizations.
Binseng Wang and David Francoeur will present “The New FDA Proposed Rule on Medical Device Servicing: A Review of Past History and An Analysis of Current Status” on April 11, 12 to 1 pm EST. Registration will be limited to the first 500 participants. Priority will be given to American members due to the US-focused subject matter.
The event will provide background on similar steps the FDA took in 1997, when it announced its intention to regulate refurbishers, rebuilders, reconditioners, servicers, and ”as is” remarketers of medical devices due to safety concerns. At that time, feedback provided by ACCE and other representatives of the field indicated that there was little evidence of patient injuries and deaths caused by the parties in question, and the FDA abandoned its plan.
The session will review new evidence of maintenance-related risk collected since 1998 and discuss the potential impact of additional regulation on healthcare costs and patient safety. Wang and Francoeur will also provide guidelines for attendees to submit their own comments to the FDA and suggest steps for analyzing in-house data and communicating internally and externally with stakeholders.
To register, visit the ACCE website.