Manufacturers are working with stakeholders on myriad standards and best practices ranging from cyber security to "good refurbishment practices" to "post market vigilance". Their representatives speak openly and sincerely about possible national and international adoption of these standards and best practices for risk management and safety. They have spent countless hours devoted to collaborative endeavors aimed at advancing the industry and meeting patient safety needs, but there are still very big elephants in the room.

Absent from many of the standards and white papers for device purchase, repair and refurbishment, are sections addressing concretely how to: (i) participate in manufacturer training on device repair; (ii) obtain manuals and technical information; (iii) product alerts/updates; and (iv) service access information including service keys. The reasons for the omission of this information range variously from claims of trade secrets to cyber security.


With all this good work, failing to address these key concerns and for all practical purposes locking ISOs out does not seem to meet the American National Standards Institute or other standards organizations requirements for openness, lack of dominance and coordination and harmonization of standards. The standards should not cause one critical party within the healthcare ecosystem to be unable to do its job.

One might expect during a pandemic that a moratorium would be reached with regard to service access information. However, no industry-wide moratorium has been voluntarily reached. Some larger hospitals may have successfully negotiated, pre-pandemic, for access to service information, but we are hearing that, even at this time in our history, there has been little cooperation afforded smaller healthcare institutions with their financial challenges and ISOs.

And yet, some medical device trade associations, their lawyers and lobbying firms, business and governmental affairs consultants have reported in their first quarter 2020 Lobbying Reports (filed with the clerk of the U.S. House of Representatives) significant expenses related to lobbying activities for their manufacturer members. AdvaMed reports expenses related to lobbying activities in the first quarter were $1,400,000. Separately, it appears several other firms filed reports for this quarter advising that they were lobbying on behalf of AdvaMed. NEMA, of which MITA is a division, reported expenses related to lobbying activities for the first quarter were $670,000. Some of the specific lobbying issues for both trade associations are reported as related to third-party servicing of medical devices.

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