By Frank Nickells, CBET
In the November 2021 issue of 24×7, chief editor Keri Forsythe-Stephens asked our opinion on the Right to Repair and whether we agree with Dr. Binseng Wang, who said, “It’s time to make decisions based on evidence (data) and not emotions.” To Wang, the Medical Imaging & Technology Association’s (MITA’s) argument that expanding access to medical device data “undermines patient safety” stems from “FUD”—or fear, uncertainty, and doubt.] I can answer Forsythe-Stephens’ question with an unequivocal “yes!”
As a retired biomedical technician and BMET manager, I no longer have a dog in this fight from a professional standpoint, but I still have an opinion based on my 47 years in the medical equipment industry. Throughout my career, I have worked as a hospital-based BMET and as an ISO employee. During this time, I spent a lot of time fighting with manufacturers over service information, parts, and device training. And I beg to differ with the OEM’s opinion that only their technicians can repair their devices.
I, along with many of my coworkers, successfully maintained “their” devices for years—with cost-containment thrown in as a bonus. My colleagues and I have been able to bring the cost of maintaining medical devices into a manageable budget, all while providing excellent service, keeping equipment records, and maintaining safety.
Is the Right to Repair About Money?
In my opinion, OEMs couldn’t care less about cost-containment—and the only thing that has kept them in line as to costs has been the in-house and ISO competition. For one thing, in-house and in-house ISO technicians are onsite. This has always been a bonus for healthcare facilities as medical devices often cannot wait for the OEM to arrive. (OEMs are notoriously understaffed and their response time can be days, not minutes).
I have always had patient safety in mind, as do most all the BMETs I’ve known and worked with throughout the years. I cannot think of a time when a patient has been harmed by work performed by non-OEM personnel. This is the “fear” in FUD that OEMs have put forth. As to the “U”—uncertainty—BMETs are trained to go as far as they can, but then “know when to say when” and call the manufacturer for help to repair a device correctly and safely.
Most problems can be resolved without the OEM’s expertise if local techs can be trained and have materials to accomplish normal repairs and scheduled maintenance. So, if there is any doubt, the local techs handle the situation using the OEM techs. Plus, a high percentage of in-house techs are certified in medical device service by AAMI and hold CBET and CRES credentials. The same cannot be said of the OEMs.
To me, medical equipment OEMs want to have their cake and eat it too. They have set up two business models: sales and repair. (Oh, we won’t forget the Gillette razor blade theory of sales from the past—make a device that requires the manufacturer’s disposables and parts as well. But that’s another fight.)
OEMs serve the company and their investors first. ISOs and especially in-house departments serve the end buyers (hospitals) and, therefore, the patient. Without the Right to Repair, the cost of maintaining medical devices could put many U.S. hospitals out of business, thereby stifling patients’ access to local healthcare facilities.
I like to say, “Why is it that medical device company executives don’t take their car to the manufacturer for an oil change or tires?” Instead, they use an independent service organization who services all car models and all different problems due to cost and availability. The same should be said and done for medical devices. If you look at MITA, you will notice that its membership is all manufacturers who have everything to gain by stifling competition. They even have government lobbyists.
Let’s keep providing for the patients and keep our BMETs maintaining equipment.
Frank Nickells, CBET, is a retired biomedical technician and BMET manager. Questions and comments can be directed to 24×7 Magazine chief editor Keri Forsythe-Stephens at email@example.com.