Registration fees are nominal, and we would support a small business exemption. Also, the legislation says nothing about staff requirements or compliance officers. That’s just not in the bill and the requirements would not necessitate such steps being taken.
Another argument Mr. Kerwin makes against legislation is the frequently-cited ECRI study indicating a low incidence of adverse events. The ECRI study is based on a severely limited database where participation by manufacturers is mandatory and only voluntary for third parties. Therefore, we have to ask ourselves, “How do we know what we don’t know?” Even Dr. Shuren testified that “the absence of evidence doesn’t mean the absence of a problem.”
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The ECRI study is flawed and doesn’t tell us the full story.
The point, though, is not to cast blame or wait for more adverse events to become public before we take action. Regulation, when done right, is preventive, not punitive, and builds the public’s trust in all of our businesses.
We all have a shared goal – to ensure the safety and efficacy of medical devices for patients regardless of who is servicing the equipment. H.R. 2118, if passed, would put patient safety first, without placing any undue burdens on third parties.
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Richard Geertson
H.R. 2118
May 19, 2017 07:34
Does any sentient being actually believe "this isnât about whether manufacturers service medical devices better than ISOs. This is about protecting patient safety..."
"We applaud the fact that many ISOs do a great job and provide high-quality service for their customers."
Really? Yes, the applause is deafening...
"The point...is not to cast blame or wait for more adverse events to become public before we take action."
And... what adverse events would those be? OH, that's right! You don't know because 'they haven't become public' which is why out of sheer magnanimity, the OEMs have only patient safety in mind by imposing burdensome regulations on the competition...
My cynicism meter is off the charts.
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