FTC needs to enforce pandemic moratorium on denying access to medical device service information

April 29, 2020

These trade associations are, of course, free to lobby the Congress and others. I am not a mathematician but when I totaled the expenses related to lobbying by AdvaMed and NEMA and various firms and business consultants, the total for the first quarter appeared to be $2,800,000. Could their energies have also been used to come up with solutions for, among other things, the elephants in the room? Many manufacturers have multi-vendor contracts and face some of the same challenges as ISOs when servicing equipment that they did not manufacturer. IAMERS has been informed that some administering multi-vendor contracts would welcome cooperation when servicing other manufacturers’ equipment.

Rumors abound about the efforts of some to renew their interest in further regulating ISOs. One rumor suggests that around the time of discussions on the upcoming user fee funding package reportedly beginning later this year, some will call again for the further regulating of ISOs. Meanwhile, there is the pandemic and it appears that a responsible referee is what is needed to ensure that smaller healthcare institutions and independent servicers are provided necessary information in order to safely service devices.

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While the FDA has led the way and continues to lead the way worldwide in patient safety, its goals are rightly to focus on patient safety and not on sorting out de facto competition issues with some of the largest companies in the world or in determining what device equipment information is/is not a protected "trade secret". Accordingly, IAMERS calls for a moratorium during this pandemic on limiting access to medical equipment servicing information. IAMERS recommends the assignment by the Federal Trade Commission of one or more liaisons to address these concerns. Though this particular liaison role is new to the FTC on this matter, memorandums of understanding have been previously reached by the FDA and FTC on matters of importance.

Robert J. Kerwin

At this challenging time, it is a matter of great importance to ensure a safe and competitive servicing market for medical devices and equipment. If patients’ safety and hospital choices are to be truly observed, this will be the right choice.

About the author: Robert J. Kerwin is the general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.

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(28) (1) Wayne Webster Great Article May 01, 2020 10:47 We need for information and discussion as presented here. We don't need the endless OEM tries at eliminating competition by either deny access to training, information and software keys. It's time they recognized that their actions are not only pushing up the cost of health care but, they are also putting patient safety at risk. Log inor Register to rate and post a comment (3) (1) Mark Shina re: Great Article May 05, 2020 05:44 Rob great article , the right to repair is so critical to not only the ISO world but helping hospitals control health care cost. Log inor Register to rate and post a comment (2) (8) Tim Martin Imaging Service Access needs to be made available May 01, 2020 10:47 Rob very nice article. Right to Repair is very much needed. Customers need to be able to have a choice and not forced to only have the OEM as an option. Log inor Register to rate and post a comment (132) (6) (42) Don Bogutski FTC needs to enforce pandemic moratorium on denying access med May 05, 2020 10:07 An important article incorporating truths which needed to be stated. Now it is incumbent for the O E Ms to respond with a plan to address this urgent need for service support. O E Ms have cut way back on service personnel and need to acknowledge and work with the I S Os in order to bridge the service gap which their cutbacks have created. Log inor Register to rate and post a comment (1) (135) Mads Vittrup Right To Repair is crucial May 05, 2020 10:07 Thank you, Kerwin, for a great article on a tremendously important topic. Though most people outside the US still haven't spend much time on this subject, nothing is more important for the future of the third party industry than the right to repair. This is the cornerstone of an actual alternative to an otherwise monopolistic OEM behavior. If the right to repair is denied in the USA it will for sure spread across the globe and as such deny millions of people the access to affordable healthcare solution. I wish more companies would join IAMERS and contribute to this struggle. Otherwise there will in the future be no alternatives to the OEMs. Log inor Register to rate and post a comment
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