ISOs vs. OEMs in Medical Maintenance: Part 2

August 01, 2017

The following blog post is in response to an article written by AAMI, which can be found here.

In our previous blog, we highlighted Technation's response to the ongoing debate regarding whether or not HTM professionals are better off utilizing third-party Independent Service Organizations (ISOs) in healthcare, or continuint to use OEMs for their medical device maintenance needs. This debate was sparked by a FDA docket released in March 4th, 2016.

Rockwell Kriger, Sales Manager at Cadex Electronics Inc., attended this years AAMI Conference, held in Houston TX, where similar discussions were raised. At the conference, Michael Capuano, manager of biomedical technology at Hamilton Health Sciences, and Binseng Wang, director of quality and regulatory affairs at WRP32 Management, Inc. and Greenwood Marketing LLC, ran a seminar in which they analyzed data from the 171 comments submitted in response to the FDA’s call for comments back in March 2016.

The goal of the FDA docket was to collect responses regarding the "refurbishing, reconditioning, rebuilding, remarketing and remanufacturing" of medical devices. This call to action was sparked after stakeholder concerns arose about "the quality, safety, and continued effectiveness of medical devices... that are performed by both original equipment manufacturers (OEM) and third parties, including health care establishments".

Wang argues that there is "a lack of clear data to support the claim that service by third parties poses a greater risk" and that most responses made by OEMs were "subjective [and] anecdotal" with none of the data suggesting that medical devices maintained by ISO's were directly affiliated with patient injury or death.

When an informal poll of the audience was taken at the beginning of the session, "35 out of 53 respondents (67.27%) did not think third parties, including in-house HTM teams, should be required to register with and be regulated by the FDA". Wang's analysis concludes that the FDA's push for further regulations towards in-house HTM teams and ISO's would not make any significant impacts on patient safety when it comes to medical devices.

With data being inconsistent and incomplete, it is difficult to judge whether or not there is a need for third parties to require FDA regulation.

To learn how Cadex battery analyzers help ISOs maintain medical equipment to higher standards, contact Rocky Kriger at [email protected] or 1-800-565-5228.


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