FDA Service Docket – ISO9001:2015 Clause 7.4.1, Supplier Selection
G. Wayne Moore
June 14, 2016
As I have watched and actively participated in the progression of the FDA Docket on so-called Third Party servicing I am struck by the seeming lack of attention being paid by so many service organizations, both in-house (HTMs) and independent 3rd parties to the actual quality of their respective suppliers; whether those suppliers provide parts, components, sub-systems, or perform the actual repairs on a finished medical device. To me this is a key component in the overall discussion about the safety and efficacy of third-party repair. Not knowing the source (provenance) of replacement parts, not knowing the actual (and measurable) capabilities of a repair entity, and not having the means to test and validate repair of a device coming back from a repair entity is inexcusable. There is already a vehicle for objectively determining these items without FDA involvement; ISO Supplier Selection. The core of ISO Supplier Selection is stated very clearly and succinctly in Clause 7 of the standard; “criteria for selection, evaluation, and re-evaluation shall be established,” and that records shall be maintained. I underlined evaluation as too often I have seen evaluation defined as; “he’s a friend of mine” or “we have been working with them for years”, or “they are the cheapest”. These are not the criteria that should be used in selecting a supplier that will be repairing finished medical devices, or supplying non-validated non-OEM parts. If you are selecting a 3rd party service or parts supplier the very first question, and the one that gates all other questions is; “Do you employ a Quality Management Systems (QMS) that is certified to the correct ISO Standard, and who’s Scope matches the service or products/parts you are providing.”* If they do not have a relevant QMS in place why in heaven’s name would you even consider them as a supplier?
Yet many hospitals not only consider them, but sign them on. Thus the genesis of the FDA Docket; they see a substantial percentage of the post-warranty service market as unaccountable to an appropriate standard and to regulatory oversight. The HTM also has obligations to objectively test repaired products being returned to the hospital from an outside repair entity to ensure it actually has been repaired and is safe for use – AAMI’s Supportability Task Force Replacement Parts Checklist, Bullet 9: “If you send a device out for repair, how do you verify the quality of the repair when it comes back?” As a developer and manufacturer of test devices designed to objectively evaluate the performance of diagnostic ultrasound probes, Acertara, and the company I previously founded, Sonora Medical Systems, has been at the forefront of providing HTM’s with the test devices, tools and training they need to ensure they can meet Bullet 9 since 1996. Yet there are still far too many facilities that do not have a process in place to test and validate the performance of returned devices.
The FDA Docket has created a wonderful opportunity for the post-warranty repair market players to come together and have these frank and open discussions on regulations and standards. If you currently are using a supplier who is arguing against standards, quality management systems, accountability, traceability, and regulatory oversight I have two words for you: dump them.
* An Overview of ISO Standards – A Blue Paper available from Acertara Labs.
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.