The FDA recently requested comments from the public on Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers. The period for comment closed on June 3 and I have had an opportunity to read and contemplate all 73 submissions.
The stated reason for the request was that “various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities that are performed by both original equipment manufacturers (OEM) and third parties, including health care establishments.” The request targets either users or providers of this equipment and/or related services.
Where this is going is not predictable, but one of the secondary effects is that health care providers are beginning to question the quality and qualifications of parts and service providers like never before. Up until recently, the focus of many providers has been centered on initial price rather than long-term cost, quality and safety. Now, we are getting questions about repair processes and methodologies, quality assurance, safety testing, quality manuals, test equipment calibrations, ISO certifications, warranty/DOA statistics and repair personnel credentials. This is information all health care providers should be asking any vendors they use. These questions are also imperative for any secondary vendors. Many organizations within our industry will source parts, probes, assembly components and subcontract services. As an ISO-certified organization, we not only are held to high standards but are also bound to ensure any providers we use for products and/or services are properly vetted as well.
A couple of years ago, we began placing ducks in the boxes of every ultrasound part and probe we sell as a symbol of a genuine Conquest Imaging part and the fact that our ducks are in a row. As the industry continues to evolve, please make certain the vendors you use have their ducks in a row as well.
As someone who has been in the industry for over 30 years (16 with OEMs and 14 with Conquest Imaging), I welcome these questions and applaud the FDA for trying to ensure the care someone’s loved one receives retains OEM equivalent specifications for performance and safety. After all, at the end of the day, it is patient care and safety we are all focused on.
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