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.

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".

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.

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.