MITA survey finds Americans want FDA to regulate third-party device servicers

MITA survey finds Americans want FDA to regulate third-party device servicers

por Thomas Dworetzky, Contributing Reporter | November 30, 2016
Business Affairs HTM Medical Devices Parts And Service RSNA
Most Americans say that those who service medical and radiation-producing electronic health care equipment should be “consistently regulated,” according to a recent survey by the Medical Imaging and Technology Alliance (MITA).

The feelings reportedly apply to both original equipment manufacturers and third-party servicers.

“Although many third-party service organizations perform quality work, the lack of consistent oversight and regulation is a direct threat to millions of patients who rely on medical devices for their health,” Nelson Mendes, MITA Board Chairman and CEO of Ziehm Imaging said in a statement.

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“It’s clear from this survey that Americans overwhelmingly agree with our view that FDA should extend regulatory oversight, including minimum quality, safety and regulatory requirements, to all entities servicing medical devices.”

While the FDA currently covers device servicing done by a manufacturer, third-party servicing is not currently regulated by the administration.

“Patient safety should be the top priority for all companies performing service on medical devices, and we believe the FDA should be consistent in its regulation across the space, including third-parties and original equipment manufacturers,” stated Dennis Durmis, vice president and head of commercial operations, Radiology Americas, at Bayer.

The survey looked at public assumptions about the way in which such servicing is regulated.

Among its findings:

  • 90 percent of Americans agree that all medical devices should be covered by regulations, regardless of who performs the service.

  • 74 percent of Americans think that, like OEMs, third-party servicers should be strictly regulated under FDA guidelines.

  • 85 percent of Americans agree the government should take action to resolve concerns around third-party servicing of medical devices.

  • 82 percent of Americans would think twice before seeking treatment at a facility that allows device maintenance by unregulated servicers.

The issue of third-party service and refurbishment has been an area of focus for the FDA all year, starting with a docket calling for input on the definition of these terms, and recently addressed in a Silver Spring, Maryland, workshop that drew hundreds of stakeholders together from each side of the discussion.

Two perspectives on present practices and the issues emerged at that meeting, as reported by HCB News:
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Chris Bowers

Of course the OEM's want more regulation

December 02, 2016 09:17

All this would do is prevent all but the biggest third party servicers form starting or staying in business. the more regulatory red tape the better for large organizations.

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Richard Johnson

Third Party Regulation

December 02, 2016 09:17

Lets start by looking at what is not in this article. The following is just fluff, “OEMs want ISOs and HTMs to be regulated in some way — not because they feel all third-parties are bad, but because the limited data that exists includes evidence that some third-parties are not providing safe service,” according to the news report." What news report?
ISO's have been fighting an uphill battle for decades to provide consistently safe and reliable service. The OEM's have refused to follow FDA regulations already in place ie: Providing full documentation to the owners and users of the equipment is just the biggest problem that exists. OEM's have pushed for requirements that ONLY the OEM provide service yet they form multi-vendor service departments within their own company!!!
I was recently in an outpatient surgery center to check a new demo Anesthesia machine, yet the field service engineer had never seen this machine and had received only a video inservice the night before. The machine failed during the setup and even after 3 hours of contact with his tech support it was decided that nothing could be done. Having never seen this machine myself but having 42 years of experience I was able to suggest a possible solution to the problem and it did show that the dedicated sodasorb canister was faulty. Of course there were none available and the machine was never properly demo'd and the Docs went a different direction. This was a major OEM!!
The needs of the hospital and surgery center's have been overlooked for too long. The OEM's quit supporting equipment just to sell new equipment yet the service life (if properly maintained) of equipment is longer than 5-7 years.
I believe consistent safe affordable medical equipment service and support options are available through third party ISO's with the proper training but do not need more government oversight.
The current government regulations have only worsened the problem to the point that surgery centers are not getting any planned maintenance done until equipment breaks to the point of safety issues.
I am also a firm believer that just doing an electrical safety is not a "PM".

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Luis Rodriguez

re: Third Party Regulation

December 02, 2016 02:24

Richards comments were excellent. ISOs offer a competitive alternative in industries. Margins are substantially lower than OEMs and in many cases provide "customer intimacy" and develop customized service delivery solutions that OEMs cannot or would not like to provide. No matter how negative an OEM's service experience is with customers, they get the benefit of the doubt. Equipment can be down for unacceptable times, and yet many customers "just deal with it" because they feel they have no other options. Happens across this Country everyday, yet an ISO is kept on a very "short leash" and a customer's expectations are at a completely different level. In many cases ISOs have to work twice as hard than an OEM to gain their confidence. Lastly I believe every experienced service professional will tell you that great service comes down to the actual engineer delivering the service not the OEM. That's why ISOs are created.

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Gus Iversen

re: Third Party Regulation

December 05, 2016 10:31

Thanks for the well-stated feedback, Richard.

The news report you mentioned was written by me while attending the workshop (https://www.dotmed.com/news/story/33723). I've modified the link to that article so the connection should be clearer.

HealthCare Business News is very aware of situations like the one you describe, in which OEMs are not cooperating with ISOs and limiting their ability to service equipment.

What's interesting to me about this survey is that it was geared toward people who are not at all involved with the industry. Personally, I don't find it very surprising that the 'average Joe' may want more oversight on hospital equipment service. Afterall, the 'average Joe' also wants the post office to be open seven days a week, more paid vacation days and lower gas prices.

People acquainted with the issues understand that achieving these goals without creating more harm than good is an infinitely more complicated matter, therefore it might be interesting to see a similar survey directed toward health care facilities and the care providers who actually use the equipment.

HCB News has reported somewhat extensively on this ongoing discussion and we will continue to. I hope you will continue to share your insider opinion with us.

Gus Iversen
Daily News Editor
giversen@dotmed.com

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Stephen Grimes

Apply some critical thinking to what's being said

December 02, 2016 02:24

The article’s title is “MITA survey finds Americans want FDA to regulate third party servicers” and then article goes on to quote Mr. Mendes (MITA Board Chair) as saying “Although many third-party service organizations perform quality work, the lack of consistent oversight and regulation is a direct threat to millions of patients who rely on medical devices for their health.”
Trade groups like MITA representing manufacturers have made it clear they would like to see additional regulations placed on third party servicers of medical devices (including hospital in-house clinical engineering services). A cynical observer of their efforts might conclude that placing additional regulations on these third-party servicers will have the effect of discouraging competitors of the manufacturers’ service businesses.

I am always concerned when information is presented in such an unbalanced manner. First, the “survey” was not done by an unbiased organization and survey results can be and often are affected by how questions are framed. That may not altogether discount its “findings” but it suggests those findings be viewed critically. Second, the fact that FDA may not regulate third-party servicers does not mean (as a uniformed reader might otherwise assume) that medical device service performed by non-manufacturers is unregulated. The fact is that CMS and states regulate medical device maintenance in healthcare organizations (whether maintenance is by manufacturers, independent service organizations or the organization’s own in-house staff). CMS and accrediting organizations (like Joint Commission) reference AAMI’s EQ 56 equipment management and EQ89 equipment maintenance standards. Third, the data the FDA has been collecting for 20 years on reported medical device problems does not show service quality by third-parties to be an issue. The independent and high respected ECRI Institute recently reported that an analysis of over 2.1 million device problem reports made to the FDA over the latest 10 year period and only 0.005% were due to maintenance related issues (whether the fault of manufacturer or third party service).

Let’s agree that we all want medical devices safely and effectively produced, used and maintained. Let’s also recognize that it’s not practical or economically feasible for healthcare organizations (each with medical devices produced by hundreds of manufacturers scattered around the country) to have their medical devices serviced only by the manufacturer. There are high quality alternatives to choose from. Let’s not force regulatory and jurisdictional changes unless there is real evidence suggests a change is justified. Changes not fully justified or contemplated invariably have unintended consequences.

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Gus Iversen

re: Apply some critical thinking to what's being said

December 05, 2016 10:31

Thanks for the thoughtful comment, Stephen.

We chose to cover this survey in our news because we know that our readers -- who are mostly health care professionals familiar with the various stakeholders and interests at play with the FDA's ongoing investigation -- would want to know about it.

You're correct that this MITA survey does not paint a complete picture of this complex issue. It is one small piece of a large puzzle that is far from finished.

The FDA's refurb docket is an issue that we have covered closely all year. If you have time and interest, please take a look at some of our reports on the topic:

"An in-depth look at the FDA's refurb docket"
https://www.dotmed.com/news/story/32062

"Five things you missed at the FDA refurb workshop"
https://www.dotmed.com/news/story/33723

"FDA refurb docket workshop day one: no easy answers"
https://www.dotmed.com/news/story/33688

"FDA third-party docket elicits old fears, new hopes for transparency"
https://www.dotmed.com/news/story/30088

We sincerely appreciate your feedback.

Gus Iversen
Daily News Editor
giversen@dotmed.com

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Wayne Moore

Third Party Regulations

December 22, 2016 04:54

The core issue for the FDA right now is; "can you have only half of the repair industry regulated and the other half not?" If the bogus 0.005% number from the ECRI "study" is to be believed then it would imply that OEMs are over-regulated. My company, Acertara, is a member of MITA and I am on the MITA service committee. I am amazed at how many folks say that the OEMs are just trying to push people out of business. I am throwing the BS flag on that notion. This is about patient safety. Again you cannot have only half of the industry regulated and claim that is in the best interest of the patient. So go one way or the other; either (a) there is no issue therefore no one is regulated, or (b) there is a potential issue and everyone participating should be regulated.

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