“Intellectual property (IP) refers to creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce.”
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 (OEM’s) may begin to pursue legal channels after those perceived to be in violation. Sounds threatening – may be but this posturing and pursuit of perceived “Intellectual Property” violators is not a new subject or action historically within the HTM service industry.
For those of our HTM service professionals that remember the 1980-90’s Independent Service Organization (ISO) battles with the OEM’s over the acquiring of 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” even up to today is still considered a series of never ending hurdles with limited tangible results.
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 possible access through a service agreement to the OEM’s proprietary 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 these sought after resources and at a hefty price!
So what is the message and take-away from this blog you may ask yourself? Good question – we know as an industry one pathway way that some service groups have taken is to acquire these so called “Intellectual Property” service tools in manners that may be considered questionable I’m not going to take it any further than that but I would recommend validating your “intellectual service tools” are properly possessed!
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