The Medical Imaging & Technology Alliance (MITA) announced that it is expanding the scope of the NEMA American National Standard for Servicing of Medical Imaging Devices to cover all medical devices, not just medical imaging technologies. MITA officials say this decision—which is likely to be met with criticism from many in the medical device sector—“comes after the consideration of extensive stakeholder feedback indicating a desire for one, universal standard for the medical device industry.”
The voluntary NEMA Standard will outline the minimum quality management system requirements for medical device servicing, MITA officials say. “When followed, the standard will ensure servicers consider operational, performance, and safety factors to ensure safe and effective device operation,” they add.
Patrick Hope, MITA’s executive director, explained the decision in greater detail, commenting: “With an expanded scope, MITA will now leverage its existing consensus across various stakeholder groups to codify what quality management of medical device servicing should look like for the industry. Given the many perspectives on this issue, MITA is committed to an open and balanced development process.”
Interested stakeholders, including manufacturers, independent servicing organizations, clinical engineers, healthcare providers, regulators, accreditors, and others are welcome to apply by May 11, according to MITA.
In May 2017, Jim Spearman, president of Consensys Imaging Service, Inc. (which is now a Merry X-Ray company) discussed the MITA-backed “Medical Device Servicing Safety and Accountability Act” in a Viewpoint article. It’s a controversial topic, indeed, and one that has many differing opinions.
24×7 Magazine editorial board member and The LynchPin columnist Patrick Lynch, CBET, CCE, CHTM, CPHIMS, FACCE, for one, is not a fan of MITA’s move. “MITA is doing exactly what most biomeds thought they would—taking a simple, limited standard and expanding it to over-reach the necessary scope,” Lynch tells 24×7 Magazine exclusively. “I predict that this will not be the last time that MITA uses ‘extensive stakeholder feedback’ to justify expanding the scope to create further barriers to entry for medical device repairers.”
To Lynch, it’s simply a bid to reduce the number of players in the marketplace. “I challenge MITA to disclose exactly where this ‘extensive stakeholder feedback’ came from,” Lynch adds. “I will wager that it is primarily from MITA members, which translates to the equipment manufacturers who want to exclude others from repairing medical devices.”
So, do you agree with this assessment? Why or why not? Please comment below and share your thoughts and opinions about MITA’s latest decision.
I totally agree with Mr. Lynch’s assessment of the situation. This is nothing but an attempt to further limit the already struggling healthcare providers’ ability to repair the equipment they own to keep the equipment working safely as cost effectively as possible.
What if you were banned from changing the brakes on your own car but were instead forced to take it to the OEM controlled dealer? You hold the title to the vehicle but you are not allowed to decide how to best service it. Vehicles hurt and kill many orders of magnitude more people every year than medical equipment yet anyone who can get to the parts store or an online store can order virtually any part on the car and install the parts if they like. How is this okay but suddenly I am not qualified to repair my own IV Pump?
From my experience, in-house service is very often of a higher quality than what the OEM’s service personnel provide because those of us who are part of an in-house program view the patients as our patients and treat each repair or PM as if our own family member is going to be the next person hooked up to that device.
MITA is “fixing” a “problem” that does not exist!
This action clearly is based on and supports MITA’s self interest on behalf of its members. It has little if anything to with safety or the needs of the user community. And how is it a consensus standard if MITA can unilaterally change it? Oh wait, its a consensus at MITA.
Exactly! I couldn’t agree more.. This seems like a valiant attempt to serve MITAS interests and nothing more. They’re are simply use Safety as a side note to serve as a justification ..
MITA does not speak for groups who do not sell equipment and specifically hospitals who service equipment. At best they can be “Associate Members.” A search of the NEMA standards for Servicing of Medical Imaging Devices comes up with “nothing found” but they do have many technical standards. They need to become an ANSI consensus standard otherwise this statement applies – “Standards are like toothbrushes – everyone wants to use their own”
It would seem MITA is fixing the problem of competition.
Exactly! I couldn’t agree more.. This seems like a valiant attempt to serve MITAS interests and nothing more. They’re are simply use Safety as a side note to serve as a justification .thanks for sharing such informative and educative post