In the past the FDA has on occasion waded into the territory of medical device service, refurbishment, repair, reconditioning, and modification. This has included, at various times, interest in potentially regulating service entities who are not the device manufacturer.
The big two in this regard are hospitals working on their own equipment, and third parties (ISOs) that are engaged by device owners to work on those devices. Contract “in-house” departments may fall somewhere in between.
Questions in this arena have included the availability of adequate service instructions, tools, and parts, and personnel training and skills such that someone other than the manufacturer can provide competent service. The latter concerns seem to assume that manufacturer personnel are inherently competent although the basis for this assumption is unknown. Personnel qualifications are also an issue for The Joint Commission and the Centers for Medicare and Medicaid Services (CMS), and in some states.
The FDA’s new foray into this arena comes in the form of an open-ended request for comments with the succinct title “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices performed by Third-party entities and Original Equipment Manufacturers.” 1 The introduction notes that various stakeholders have expressed concerns that some third-party entities who refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices may use unqualified personnel and that the work performed may not be adequately documented.
The document also cites possible public health issues arising from these activities that include ineffective recalls, disabled device safety features, and improper or unexpected device operation. OEMs have also requested clarification of their responsibilities when their devices have been altered by a third-party entity. Federal agencies other than the FDA address service and maintenance activities as well. Note that the words some, may, and possible constitute undocumented assertions and/or speculation.
The questions that the FDA would like addressed include, in brief:
- What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities?
- What potential risks and failure modes are introduced?
- Are the risks different depending on who performs the activities?
- Are some devices riskier than others with respect to such activities?
- What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device?
Information collected through this request will be processed by the FDA and may result in a public workshop late in 2016.
Potential outcomes could include no changes in the current service situation from the FDA perspective, greater regulation of third-party entities, and/or requirements for more useful and complete information from manufacturers to ISOs. While in-house activities are not being focused on here, they may be next to receive further scrutiny, and the comments obtained by the FDA could spill over into this arena.
Moreover, it may not be logical to differentiate between true in-house departments, resident contractors, and periodic or specialty ISOs. It may also be determined that no problem actually exists. This instance might remind us of CMS’s tightening of maintenance requirements, even though there was no evidence that the old requirements were creating any added or correctable risk.
As the FDA wades into these waters, you might also want to get some boots or stock up on sand bags. More importantly, you may want to comment either individually or through appropriate professional organizations.
William A Hyman, ScD, is professor emeritus, Biomedical Engineering, at Texas A&M University, College Station, Tex, and adjunct professor of Biomedical Engineering at The Cooper Union, New York.
1. FDA, Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices performed by Third-party entities and Original Equipment Manufacturers, Federal Register, 81 FR 11477, March 4, 2016, https://www.federalregister.gov/articles/2016/03/04/2016-04700/refurbishing-reconditioning-rebuilding-remarketing-remanufacturing-and-servicing-of-medical-devices?source=govdelivery&utm_medium=email&utm_source=govdelivery