Third Party Repairs of Medical Devices – Why All the Fuss?
G. Wayne Moore
The United States Food and Drug Administration announced on March 4th 2016; “…the establishment of a docket to receive information and comments on the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service and repair medical devices (known as “third-party entity or entities”). One may rightfully ask what the genesis of this document is; after all aren’t those entities performing the above activities already regulated by the FDA? The short answer is no, no they’re not. There is the rub, and the fuss over this issue. The FDA does currently regulate Original Equipment Manufacturers (OEMs) of medical devices and part of the Quality System Regulations (QSR) includes device repair activities (including product recalls), but seemingly gives 3rd Party repair entities a pass. What OEMs, and others, would like to see happen is for the creation of a clearly articulated FDA recognized definition of what constitutes the term “service”. The FDA does have one such clearly defined definition as it pertains to remanufacturers; “Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished medical device that significantly changes the finished device’s performance or safety specifications, or intended use.” Remanufacturers must, by law, register, list, and pay fees to the FDA. As registered facilities they can and often are inspected and audited by the FDA. 3rd Party repair facilities are not currently required to register with the FDA and are not, generally, inspected. I say generally not inspected in the sense that the FDA can conduct a “for cause” inspection of any facility engaged in medical device repair if there is a patient event that is tied to the repair.
In my world of diagnostic ultrasound I am aware of several so-called 3rd Party repair entities that have crossed the line from repair into remanufacturing and have not registered with FDA as such. Let me focus on just one aspect of this topic; ultrasound probe repair. I am surprised that many in the field of diagnostic ultrasound do not realize that the FDA regards an ultrasound probe as a finished medical device, and because of that requires a 510(k) clearance from the FDA to be legally sold in the United States. Therefore any service performed on a probe must be viewed in the context of the above definition of remanufacturer. Specifically, does the repair “significantly change the finished device’s performance or safety specification, or intended use?”
Physicians and sonographers rely on the optimal performance of the probe to obtain a high quality diagnostic image. To that end, ultrasound OEMs take great care during the design process to insure the maximum possible transmit and receive sensitivity of the array inside the probe. The probe design is carefully matched to the ultrasound system design to further insure the highest quality ultrasound image and Doppler signal can be produced. Many clinical applications of ultrasound are highly quantitative in nature, allowing the physician to use the ultrasound examination results to make a differential diagnosis. Thus, using an ultrasound device that may be performance compromised could lead to either a misdiagnosis, or under-diagnosis, thereby putting the patient at risk. For example, a “repair” that includes replacing the OEM array inside the probe with a “knock-off” array manufactured by an entity other than the OEM may significantly compromise the clinical performance of the probe. OEMs are required to perform not only extensive testing of the acoustic output power of the probe, but also other important safety testing such as thermal (i.e., lens operating temperature may not exceed 43˚C) and biocompatibility. If a 3rd Party repair compromises any of these three key safety issues it puts the patient and user at risk. OEMs perform extensive testing on their finished probes to validate what sterilization and disinfection protocols (and chemicals) should be used to insure mitigation of cross-contamination risks. Lastly probes are designed and tested by the OEMs to insure electrical leakage safety performance. There are “repair” companies in the United States currently performing one or more repairs that could impact the performance of the safety issues outlined above. They should register with the FDA as remanufacturers and operate on the same playing field as the OEMs are currently required to do. This is not about restraint of trade, it is about patient safety.
About the Author, G. Wayne Moore:
A 30-year veteran of the diagnostic ultrasound market Wayne has held senior level positions with several major medical equipment manufacturers, including Honeywell Medical Systems and Siemens Medical Solutions. Wayne has been directly involved in the development and commercialization of more than 15 technologically intensive ultrasound systems. He is widely published in diagnostic ultrasound literature, a sought after speaker at medical imaging conferences, has served as an expert witness in multiple ultrasound litigations, and holds more than 16 United States ultrasound related patents. Wayne obtained his MBA from the University of Denver – Daniels College of Business.
He was elected as a Fellow of the American Society of Echocardiography (FASE) in 2009.