Conspicuously absent from the recently published FDA 2018 priorities list are QMS Servicing matters of the scope similar to which MITA has been addressing. FDA did note that it intends to prioritize principles and procedures for recognizing voluntary consensus standards. Perhaps this priority will offer guidance on the best manner to pursue a consensus standard and avoid the adoption of standards whose development process has been dominated by a single interest, category or organization.
Perhaps it is also time for independent servicers to contact their congressional representatives to remind them that the FDA will be providing a report in a few short months and that there are other recognized comprehensive medical device standards which exist or are in the process of revision. It is further important to note that competition in the health care ecosystem is essential, and that medical device standards should not, by their terms, be drafted to exclude valuable contributors such as the independent service organizations or in-house service groups.
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ABOUT THE AUTHOR: Robert J. Kerwin has served as general counsel to the International Association of Medical Equipment Remarketers and Servicers Inc. for over twenty years.Back to HCB News
Wayne Webster
Vigilence is key
December 21, 2017 09:19
A well written article that once again demonstrates vigilance in the face of OEM strategies to monopolize the service marketplace is key to independent service providers survival. The medical equipment marketplace is ill served by these sorts of tactics mounted by the OEM's for the purpose of expanding their reach and revenue with no commensurate return to those paying the bill, medical providers and ultimately the U.S. consumer of health care services. If patient safety is the actual basis for all this activity by MITA, an OEM only club, then show the community your genuine concern and make available to those who service medical equipment the AITA information so patient safety can be assured. Without the release of the manuals, training and service keys, let's call this so call standard what it is, a means to the removal of the independent service organization and the establishment of an OEM monopoly on the service of medical devices.
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Steve Arey
re: Vigilence is key
December 22, 2017 07:57
I don't know who you are Wayne and your qualifications, but if I were a manufacturer I would have a problem with you trying to make me provide you with patented information on my product under the guise of patient safety when the history of AAMI, MITA, et.al. has been complete neglect of requiring service individuals to be credentialed or "Certified" to maintain devices used in the healthcare setting, like Japan does.
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Wayne Webster
re: re: Vigilence is key
December 23, 2017 04:39
You are correct. You don't know who I am. I have over 40-years in the business with consumables and equipment. And to address your issues, AIAT information is not something you patent. Manufacturers can claim that ISO's are not performing to certain standards and therefore putting patients at risk, but when they withhold the very information that is in fact what may put patients at risk, they, the OEM's, are the creators of the problem. You can't have it both ways, create the problem and then complain that there's a problem. If you missed any of the facts presented at the many forums held on this issue you may wish to familiarize yourself with the statistics reported by ECRI. According to ECRI the incidence of adverse events reported as a result of service of equipment is below 0.0005%. The statistic speaks for itself.
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Steve Arey
re: re: re: Vigilence is key
January 05, 2018 12:25
I expect that service individuals, as I am, don't even know what ECRI is, much less report to them that there was an "incident" with their servicing of a manufacturers equipment. I started working for the Federal Government in 1978 and yes, we used ECRI information in purchasing and maintenance of medical devices. VA biomedical engineering was the first in creating preventative maintenance criteria for all medical devices in the hospital. Today, 30 years later, the "public sector" is just now catching up with the program and crying about it. AAMI has had 30 years to drive certification as a requirement in the industry and it failed. Again, if I were a manufacturer you wouldn't be turning a wrench on my equipment without some credentials behind your name, 40 years or not.
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Wayne Webster
re: re: re: re: Vigilence is key
January 05, 2018 02:21
Manufacturers don't own the equipment. They have nothing to say about who services it. That's the responsibility of the owner of the equipment. As I stated in my earlier response, ECRI analyzed and reported on FDA data, not their own. They stated that 0.0005% of all reported events were a result of service failure that resulted in a patient safety issue. MITA is attempting to solve a problem that doesn't exist. The only reason to do this is to restrict the service of equipment to OEM's only.
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