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

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

April 29, 2020
Parts And Service
An editorial by Robert J. Kerwin

With a big tip of the hat to Captain Obvious, our hospitals and health delivery organizations are heroically dealing with a terrible pandemic the likes of which we have no real comparison for in our lifetime. As Healthcare Business News has reported, hospitals have incurred substantial financial losses during the pandemic. Two hospitals in West Virginia recently closed. Rural hospitals are particularly at risk, and hospitals were already spending $25.7 billion more than necessary on supply chains.

While there are plans afloat to resume outpatient and inpatient operations for many hospitals, there are no magic solutions to ensure hospitals will be able to manage their future operational costs. For many, buying new equipment will not be the optimal choice.

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Now, more than ever, hospitals and health delivery organizations need choices when it comes to safely servicing their medical equipment. For some, this means using their trained in-house teams to service medical equipment. For others, the right choice is perhaps to use the original equipment manufacturer, particularly if the OEM originally bundled the equipment purchase with services. For still others, the right choice is to use a trained independent service organization. ISOs can represent a savings of as much as 50% when compared to the OEM service charges. In its 2018 report on servicing, the FDA noted that the continued availability of ISOs was critical to the healthcare infrastructure.

But even in the midst of a pandemic, ISOs are being denied service information access. One highly regarded ISO recently reported to IAMERS that its requests to simply change an IP address were being denied. Another reported that equipment manuals issued by a leading manufacturer are being released on a per-request basis to its own employees and that no actual manuals are being physically delivered. Though we have learned that some providing ventilators have cooperated, by and large, ISOs who are maintaining some of the diagnostic equipment, are still not being provided service access information. Perhaps recognizing the seriousness of the situation, on April 20, 2020, a Right to Repair Bill for digital electronic equipment was filed in the General Assembly of Pennsylvania. See House Bill No. 2326. We will continue to encourage "right to repair" filings on a state and federal level. They are especially needed at this time.

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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.

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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.

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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.

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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.

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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.

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