By Alan Moretti
Recently I sat in as a “listener” to a conversation that had a round able of HTM industry representatives chatting as to their “ongoing challenges and hurdles” in being able to reasonably acquire service keys, codes and what some may say is “proprietary information.”
This discussion is not a new topic and for those “outside of original equipment service contracting relationships” can be a continued source of heartburn and frustration in many equipment support circles.
There is a “buzz” within the HTM medical equipment service industry around the topic of “intellectual property” infringement and it is rumored that some original equipment manufacturers (OEMs) may begin to pursue legal channels after those perceived to be in violation. It sounds threatening but this posturing and pursuit of perceived “intellectual property” violators is not a new subject or action within the HTM service industry.
Many HTM service professionals remember the 1980s and 1990s and the Independent Service Organization (ISO) battles with the OEMs over the acquiring of ionizing radiation medical equipment service documentation and the deciphering of just what the “Code of Federal Regulations – Title 21” really meant. The real ability for enforcement of “21 CFR” is still considered a series of never ending hurdles with limited tangible results. Perhaps this most recent March 4 Food and Drug Administration (FDA) call to the “HTM community for comments” can enable these “hurdles” to finally be overcome. Hopefully, all advanced equipment service tools will be made available for transactional reasonable purchase to the betterment of the healthcare equipment servicing community and the mutual customer being served (that customer would be the medical equipment owner that is enhancing the delivery of patient care to the patients we all serve)!
Many of today’s medical equipment technologies have become a “locked box” unless the HTM service technician has what is considered “intellectual service property” such as the service dongle, password string, or access through a service agreement to the OEM’s propriety service documentation in some cases. Though “Title 21” provides “rights” to necessary service documentation at a reasonable cost, this generally means not much more than the standard service and operator manual of a medical device. It’s these advanced “intellectual service tools and documentation” which provide a “deeper service access” capability that may still require the medical device owner to purchase some level of OEM service agreement in order to acquire needed resources and at a hefty price!
So what is the message and take-away from this article you may ask? Good question – a change in ability to access and reasonably acquire through purchase these “intellectual property” tools is a crossroad that maybe the FDA can finally pave for all who support the medical equipment service support mission!
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