I'm definitely curious about the inevitable scenario when an authorized service agent outside the manufacturer, with the best intentions, repairs the system inadequately and down the road results in patient harm. I'm usually not one to bring up what-ifs...and am usually an advocate for right-to-repair fights, but this seems over the top. Especially when it comes to the topic of this being extended post pandemic.
In its response to Congress on this matter within the last two-years, the FDA concluded third parties “provide high-quality, safe and effective servicing of medical devices”. This outcome was as a result of a year-long study about safety of service performed by third parties. But, the larger point is that by withholding key information from commercial third parties and hospital biomedical engineers, the OEM's bring on the very safety concerns they grouse about. Therefore, one can only make a single conclusion...it's not about safety it's about eliminating the independents from the market and thus controlling all the revenue from the medical marketplace. It's time to stop monopolistic practices that result in less competition and higher costs.
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It's a good start
August 10, 2020 10:02
The OEM's are working hard to eliminate the ISO and the medical center biomedical engineers. This Bill is the first large Congressional step in the right direction. Let's get this approved and then let's see if we can make it permanent.
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