As I take some time to review industry periodicals, in almost every issue is an article presenting pros and cons of the right to repair movement. Well, here’s one more, but with a potential solution. As a consumer as well as a former HTM in-house service engineer, I personally view the conversation as very well-needed. Formerly working for Medrad and Bayer Healthcare, and now Innovatus (an FDA-registered manufacturer of ultrasound probes) I also understand the concerns that OEMs may have.
The third-party market fills a huge void and provides a much-needed, very valuable service. How many of us take our vehicles to the dealership for service, even for an oil change? Not many, right? Why, because it’s over-the-top expensive. Many of us take our vehicles to a local mechanic, or maybe to Manny, Moe and Jack. In fact, given the right parts and correct tools, many of us could perform certain auto maintenance ourselves. After all, “It’s all ball bearings these days.” (1985 “Fletch” movie reference) Third parties enable us to pay a reduced cost for, what we believe is, a product or service equivalent to that of the OEM.
Currently, our government provides us the liberty of choosing how we service medical devices. That being said, it’s not a two-way street. OEMs are not required to share very much information at all. Highly qualified, very talented technicians could perform quality service on medical devices if allowed access to documentation, parts and proper tools. Truth! We have 50 years of HTM history to prove it.
A few questions. Are you an advocate for regulation and government oversight of the third-party market or are you an advocate for the right to repair? Careful what you wish for, as the results might have more significant consequences than you think. Believe it or not, there may just be a solution that is not either-or.
A reasonable solution might just be requiring any organization, involved in the sales or servicing of medical devices, to be governed by an ISO 13485:2016 certified quality management system. Does this mean that every HTM department should be ISO certified? I think not, but that’s a discussion for another time. Let’s keep this discussion focused on external third-party organizations. Whether selling or supporting a medical device or an automobile, the questions for any third-party should include:
What, exactly, is your organization qualified to do?
Why is your organization qualified to sell this device or perform this service?
What does your organization do to mitigate risk, improve and ensure quality, and address customer concerns?
All of these concerns, and many more, would be addressed through maintaining ISO 13485:2016 certification. Let’s take a look at one of Innovatus’ certificates. A few items to point out.
Near the top, note that the certification is valid for our Tulsa facility. It does not include our design and manufacturing facility in Denver nor the MRI coil repair facility in Pittsburgh. Those facilities hold their own certificates relative to how the QMS is used in those locations. In these days of mergers and acquisitions, one organization may have acquired another, may operate several facilities or have separate divisions. Just because one facility or division is governed by an ISO certified QMS, does not mean that the others are covered by that same certificate. They could be totally separate legal entities, responsible for different services, providing varying degrees of quality.
In the section titled “Scope of Registration”, Innovatus’ Quality Management System in Tulsa is certified for the “Repair of medical ultrasound transducers.” The certification would not include ultrasound system service or any other ultrasound-related services. This may seem like a minor detail but is actually very important. From above, it shows, EXACTLY, what the organization, operating at the specific location, is qualified to do.
It’s also important to note the dates listed on the certificate. Certifications expire. Organizations must periodically undergo formal audits to re-certify their quality management systems. This is a very rigorous process, usually spanning multiple days, in which several quality experts assess the effectiveness of the QMS. Proudly, in May Innovatus’ QMS in Tulsa was recertified, and the certificate is valid until June 2025.
So, why is all of this important to you? You have the liberty to select your service provider. Your patients, and our loved ones, rely upon accurate diagnoses from well-maintained medical devices. Your goal is to provide quality service at an acceptable cost. Price IS important, but it should not be a main driver. Insist on your service partners maintaining active ISO 13485:2016 certificates at a minimum for the specific services you require. If your current repair providers claim to be “ISO certified,” request a copy of their certificate(s). For more information on ISO 13485:2016 certification or to request our certificates, please reach out to email@example.com.
For more information, email at TedL@innovatusimaging.com or visit www.innovatusimaging.com/ultrasound.
-Ted Lucidi, CBET, is a clinical, technical and commercial specialist at Innovatus Imaging.
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