In the past the FDA has on occasion waded into the territory of medical device service, refurbishment, repair, reconditioning, and modification. This has included, at various times, interest in potentially regulating service entities who are not the device manufacturer.
The big two in this regard are hospitals working on their own equipment, and third parties (ISOs) that are engaged by device owners to work on those devices. Contract “in-house” departments may fall somewhere in between.
Questions in this arena have included the availability of adequate service instructions, tools, and parts, and personnel training and skills such that someone other than the manufacturer can provide competent service. The latter concerns seem to assume that manufacturer personnel are inherently competent although the basis for this assumption is unknown. Personnel qualifications are also an issue for The Joint Commission and the Centers for Medicare and Medicaid Services (CMS), and in some states.
The FDA’s new foray into this arena comes in the form of an open-ended request for comments with the succinct title “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices performed by Third-party entities and Original Equipment Manufacturers.” 1 The introduction notes that various stakeholders have expressed concerns that some third-party entities who refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices may use unqualified personnel and that the work performed may not be adequately documented.
The document also cites possible public health issues arising from these activities that include ineffective recalls, disabled device safety features, and improper or unexpected device operation. OEMs have also requested clarification of their responsibilities when their devices have been altered by a third-party entity. Federal agencies other than the FDA address service and maintenance activities as well. Note that the words some, may, and possible constitute undocumented assertions and/or speculation.
The questions that the FDA would like addressed include, in brief:
- What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities?
- What potential risks and failure modes are introduced?
- Are the risks different depending on who performs the activities?
- Are some devices riskier than others with respect to such activities?
- What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device?
Information collected through this request will be processed by the FDA and may result in a public workshop late in 2016.
Potential outcomes could include no changes in the current service situation from the FDA perspective, greater regulation of third-party entities, and/or requirements for more useful and complete information from manufacturers to ISOs. While in-house activities are not being focused on here, they may be next to receive further scrutiny, and the comments obtained by the FDA could spill over into this arena.
Moreover, it may not be logical to differentiate between true in-house departments, resident contractors, and periodic or specialty ISOs. It may also be determined that no problem actually exists. This instance might remind us of CMS’s tightening of maintenance requirements, even though there was no evidence that the old requirements were creating any added or correctable risk.
As the FDA wades into these waters, you might also want to get some boots or stock up on sand bags. More importantly, you may want to comment either individually or through appropriate professional organizations.
William A Hyman, ScD, is professor emeritus, Biomedical Engineering, at Texas A&M University, College Station, Tex, and adjunct professor of Biomedical Engineering at The Cooper Union, New York.
References
1. FDA, Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices performed by Third-party entities and Original Equipment Manufacturers, Federal Register, 81 FR 11477, March 4, 2016, https://www.federalregister.gov/articles/2016/03/04/2016-04700/refurbishing-reconditioning-rebuilding-remarketing-remanufacturing-and-servicing-of-medical-devices?source=govdelivery&utm_medium=email&utm_source=govdelivery
Mr. Hyman unfortunately missed an important “detail” when he stated that “While in-house activities are not being focused on here…”
The Summary of the FDA document states clearly that “FDA is taking this action, in part,
because various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have
been subject to one or more of these activities that are performed by both original equipment manufacturers (OEM) and third parties,
including health care establishments.” The same erroneous assumption was made in 1997 when FDA published an intent to regulate non-OEMs. FDA officers later clarified that hospitals are definitely included and actually became regulated for reprocessing of single-use devices.
Your active and vigorous response is critical to avoid another unnecessary and costly mandate that does not enhance patient safety.
As a Biomed who, who has been in the biz for 35 years and on a daily basis supports caregivers and their technology, in real time, at the point of care, in the O.R., in a 1000 bed academic medical center, I can tell both HTM leaders and FDA investigators that the current industry model is negatively biased against workers like me who use tools and support technology in real life at the point of care.
A root cause of this problem is that too many OEMs either do not, cannot or will not, write and distribute with their device, as NFPA-99 requires, a comprehensive well written and illustrated, repair and maintenance manual.
A service manual for a medical device software, electrical, mechanical or combination of all 3, should in fact be exactly that, a service manual, nothing redacted, all parts drawn and diagramed, all facts explained, all troubleshooting procedures laid out in plain English, with simple access codes to enter diagnostic modes.
A well written manual and necessary specialized tools and fixtures should be all a good Biomed needs to repair almost any device short of large scale imaging systems.
IF a service manual is written too poorly to enable a Biomed to understand and service the device then, the device maker’s technical writer has failed and needs to go back to the word processor.
What I would want the FDA to regulate more is a “GMP” for device’s service manuals and service procedures. procedures need to be written to a professional industry standard with an intent to make it possible to completely understand the device and its theory of operation and the key knowledge check points one needs to expedite repair and maintenance of the device.
We all know that OEMs withhold vital knowledge as a method to create profit and revenue for their internal service providers. obscuring vital knowledge from hospital based Biomeds is NOT the way to do this. They could do it by providing a high quality service product at a highly attractive price instead of by unilaterally enforcing a monopoly on service business by failing to comply with the service manuals requirements in NFPA-99
Far too many so called “service manuals” one gets today are highly redacted and fail to meet the NFPA-99 spec we are all familiar with.
and lets not forget parts, for the sake of taxpayers and insurance payers, the FDA should regulate the OEM repair parts sales and availability models. A Biomed should be able to buy all the common repair parts for a device at fair market value. Especially PM kits and those parts most likely to fail from use wear or damage.
I will also, I agree with and support comments made above. I will not deny there may be a bad apple or two who have done a bad repair or two, but I vehemently deny the OEMs the use of the “bad apple excuse” to ice out all the good biomeds in the biz no matter who they work for.
So FDA – please invite us to the table..
and HTM leaders – lets pull out all the stops on his one, right to repair, and service manuals and repair parts are the foundation of our industry all the other parts topple if these bricks get pulled out of the bottom…
your thoughts???
I was 1/2 owner in a distributorship/dealership that both sold and serviced medical equipment. In our organization, there was a vast difference in the operation of our service department, vs. the competing ISO’s that said that they could do the same thing. We documentated ever part that was installed and every bit of repair work that was done. When the ISO would come in with a lower price,they got the contract and never furnished the documentation and traceability that our company did. If a part was rebuilt, it was engraved with a unique serial number and its history was entered into a database which allowed tracking throughout its life. All is for naught when the administrative bean counters are really in control.
Whether or not the FDA is including in-house, hospital employee departments needs clarification from the FDA. “Third-party” implies that there are two others. These two might be understood to be the OEM and the device owner and their personnel. A hospital employee department cant be a “third-party”. On the other hand it probably isn’t rational to distinguish between hospital employee departments and contractor resident departments.
But neither Binseng or I can decide what the FDA meant, the FDA has to tell us.
The real issue is not whether a MFR rep, in house service personal or a Third party rep is doing the work, it is weather they have the training< knowledge and experience necessary. Years ago while I was working as a MFR rep I was asked to do things I was not trained to do and sometimes more problems resulted. Now years later, as an in house Biomed Tech, several times I have had to show MFR service reps how do repair or test equipment that they were supposed to know how to test and repair. I have also worked with many 3rd party service persons. some have been excellent, some not so excellent.
So while in general the MFR Rep. may know best, it is not always the case.
Having in house personal who know their limits and know when to ask for help and know how to evaluate that help is always best.
“Clarification” (?) from the FDA
According to an email from the FDA:
“If an individual is not the manufacturer of the device, but refurbish, recondition, rebuild, remarket, remanufacture, service, and repair a medical device you would be considered a third party as stated in the FRN. We would like to receive information from the outside contractor and your department as it relates to the activities associated with refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, servicing and repairing.”
But if everyone except the OEM is a third-party, who is a second-party?
I would like to see the stats on OEM Vs. 3rd party and in-house Biomed as far as repeat failures. I have worked for an OEM as a Biomed and am now am in-house. The thing that really bothers me is how long hospitals use equipment (especially Life support and high risk) after it is deemed “end of life” by the manufacturer. Personally I think this issue should be addressed before the OEM Vs. 3rd party/ in-house Biomed issue.
Given the uproar felt within the HTM community of a few years ago when the CMS / JC tried to limit the use of relocatable power taps (of all things), it should be going nearly ballistic now with the FDA’s recent call for comments on a Proposed Rule involving the “Refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing of medical devices performed by third-party entities and original equipment manufacturers”. ( See: https://www.federalregister.gov/articles/2016/03/04/2016-04700/refurbishing-reconditioning-rebuilding-remarketing-remanufacturing-and-servicing-of-medical-devices ).
As noted in their request for comments, “various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities” – which includes the hospital-based support and repair of medical devices; activities that have been the very essence and foundation of clinical engineering and the entire healthcare technology management community for close to the last half century!
The mere fact that such a challenge and questions are even being raised continues to speak to the community’s collective inability to have reached a consensus let alone some form of standardization on:
• equipment maintenance procedures, inspection schedules, documentation practices, or and in addition to, how to determine which devices even need to be inspected;
• program efficacy and performance metrics. While there is no one single metric that would fully describe the performance of any given HTM department or program, the cost-of-service ratio remains – conceptually – one of the best and most valid; especially for the comparison and benchmarking across service providers. The problem with its use, however, is not its validity – but its reliability. Simply, without standardized cost and labor accounting practices and the continuous and rigorous adherence to such practices by HTM staff, derived measures of COS will almost always be grossly underestimated. The questionable accuracy of such measures has often been cited as arguments against their use.
• definitions and measures of service quality – admittedly, an extremely subjective, fuzzy concept to define let alone measure.
• definitions and measures of device safety. Here, and of course, we need to be thinking way beyond ungrounded leakage currents.
While we have well over four decades worth of great anecdotal examples, case studies, and probably multiple petabytes of data – we still have very little knowledge regarding the true and meaningful cause and effect relationships associated with our efforts.
Despite the likely billions of dollars of cost savings and avoidances that we’ve given to healthcare, such savings rarely get partitioned and attributed to continuous and good HTM. As such, it’s no wonder that the community is again being questioned on its work.
Despite all of our procedural shortcomings, this current challenge may also be the result of us simply having been too good, too effective – to the point where we’re now almost invisible. Which for the patients and clinical equipment users that we serve – is precisely where we want to be; for those ‘stakeholders’ worried about our capabilities, it is our greatness and effectiveness, perhaps, that may be the real motivating threat behind this current action. . . ?
We are in the process of formulating our reply to the FDA and with this endeavor have gone as far as to contact our third-party service providers and requested their individual participation as well.
Additionally, this morning I sent an email to all of our OEM Service Provider asking them to specifically state their position on this PR. I indicated that we expect their support of our in-house clinical engineering department based on the high levels of quality and integrity that we have established throughout our program.
They know the work we do, and we know the work they do and I believe, for the most part, both are well run programs. What this boils down to a service revenue issue – we are taking big chunks out of their pie and they don’t like it.
I recommend that all of us engage as many third-party service provides as we have access too and solicit their support and participation, and do not hesitate to have a conversation with your OEM providers as well. Find out where they stand and use that information in your individual response to the FDA.
Good luck!
This dialog may be good for the industry as a whole.
The OEM’s have and will continue to impede 3rd party repair of their parts, the loss in revenue would be too great for them to tolerate.
I know the savings/cost avoidance provided by our meager repair operation is greater than $700,000/year for the company. Latest win was $18K cost avoidance for repair of 3 devices for $0.75 total in components. It’s easy to see the lost revenue for the OEM and why they are fighting so hard to restrict us from performing in house repairs.
This will be interesting, hopefully the OEM and their paid representatives in the government will be reined in and hopefully be required to provide full documentation and access to software to maintain the equipment we purchase from them for our use. If the FDA allows the OEM’s to further restrict 3rd party repair/service operations then expect costs to maintain your equipment to sky rocket and those $0.25 repairs will cost $6,000.00.