Yes, this is about OEM’s vs. ISO’s and in-house biomed service groups.
As you recall, the FDA just issued their report on the latest challenge by OEM’s attempting to restrict the ability of third parties to perform service work on the equipment the OEM’s produce and sell. A number of concerns were voiced by the OEM’s, including patient safety and fact that these ISO’s were not being held to the same regulatory standards as the OEM’s.
The over-simplified answer from the FDA was that there was no data to support any change to the system now in place and that more regulation of service groups was not indicated.
…but this fight is far from over….read on…
Having lost in front of the FDA, the OEM’s (as represented by their lobbying group, MITA, and others) have taken the fight to Congress. They seem to be saying that the FDA has failed to understand the most important aspect of their case, patient safety, and therefore Congress needs to legislate a solution. They have sponsored H.R. 2118 – the Medical Device Servicing Safety and Accountability Act – to try to win their case in this third round.
If this issue is of importance to you, you may want to read these three articles from the most recent copy of DotMed’s HealthCare Business News (August 2018).
- OEM Perspective – Basic third-party regulations are not about business, but patient safety – a discussion with Dennis Burmis, Senior Vice presISO and Biomend Perspective – OEM’s must meet their-party stakeholders halfway dotmed.com/news/43764
- ISO and Biomend Perspective – OEM’s must meet their-party stakeholders halfway dotmed.com/news/43765
- OEM Viewpoint Piece – Let’s stop the dangerous waiting game – Patrick Hope, executive director of theMedical Imaging and Technology Alliance (MITA) – dotmed.com/news/43763
We all need to keep an eye on this issue. Some of your livelihoods are completely dependent on service and support, and if this bill goes forward, how it is written may be of vital importance to you.
Love to hear your comments.
Great information Dan. We falsely assumed the issue was decided and over. It is about the money to the OEMs and masking it under patient safely Concerns us all they have to push on Congress. It’s simply not true as we all know. Third party service groups often are more effective than the OEM regarding price, responsiveness and solutions.
Having worked for small, medium, and large OEMs; Brokers; and ISOs – I have seen my fair share of systems in all modalities. And in the end, it does not matter the type of organization doing the service and support…it is that organization’s culture that matters.