By Keri Forsythe-Stephens
On Tuesday, April 25, Congressmen Ryan Costello (R-Pa.) and Scott Peters (D-Calif.) introduced H.R. 2118, “Ensuring Patient Safety through Accountable Medical Device Servicing”—legislation that has garnered mixed reviews from members of the HTM community. While some entities have praised the bill for better regulating medical device servicers, others fear that it will negatively affect independent service organizations.
International Association of Medical Equipment Resellers and Servicers (IAMERS) Counsel Robert Kerwin, who holds the latter view, is slated to appear before the U.S. House of Representatives Committee on Energy and Commerce on the Legislation on Tuesday, May 2, to share his reservations about H.R. 2118.
In a statement posted on the association’s website, IAMERS executives laid out their problems with the legislation. A big issue, they said, was that H.R. 2118 requires companies that service medical devices to register with the U.S. FDA. “The FDA will [then] be required to specify the timing, format, and information to be submitted by any person required to register.”
“Independent servicers will likely need to either absorb the cost of compliance (if they can afford to do so) or pass along the cost in terms of higher fees and expenses,” IAMERS officials added. “In this age of controlling healthcare costs and encouraging competition, this legislation seems at odds with these goals.”
It’s a vastly different view than that held by Medical Imaging & Technology Alliance (MITA) personnel. MITA officials have overwhelmingly supported increased regulation in the medical device service sector—with MITA’s executive director Patrick Hope applauding Congressmen Costello and Peters for their “reasonable, commonsense solution that will not be costly or burdensome to third-party organizations, but will protect patients who rely on the safety, effectiveness, and reliability of our technologies.”
Joe Robinson, chairman of MITA’s board of directors and senior vice president of health systems solutions at Philips Healthcare, echoed Hope’s statements. “We appreciate the strong bipartisan leadership of Congressmen Costello and Peters and applaud their commitment to patients through their support of medical device servicing requirements for both OEMs and third-party vendors,” Robinson said.
IAMERS officials, however, beg to differ. “It seems, if adopted, that some independent servicers may well have to employ a compliance officer to address satisfaction of the requirements imposed by the legislation, though they may in fact be duplicative of the scope of responsibilities of the owner, manufacturer, or importer,” IAMERS members said in a statement.
Robert Kerwin will raise these concerns to members of Congress when he presents IAMERS’ position on May 2. It remains to be seen, however, how legislators will respond to IAMERS’ qualms about H.R. 2118.
Binseng Wang, ScD, CCE, fAIMBE, fACCE, director of quality and regulatory affairs with WRP32 Management, Inc., shares Kerwin’s concerns about H.R. 2118. “What worries me is not this ‘innocent’ bill,” he says, “but the beginning of the proverbial slippery road ahead.” Wang’s particularly concerned that the FDA will extend full quality system (QS) regulations to all service entities as advocated by MITA and other OEMs during last year’s FDA debate.
“This bill exempts “contractors” because the user facilities and doctors’ offices are already covered by [the Safe Medical Devices Act of 1990]. When the FDA extends QS, it’s likely that the ‘contractors’ will not be exempted anymore since the user facilities are not under QS,” Wang adds. “It will also be very tempting for the FDA to also include user facilities, once it realizes that these servicers are just as likely to make mistakes and harm patients.” After all, he says, prior studies have shown that no servicer segment is safer than another.
So, where do you fall in the divisive H.R. 2118 debate? Please share your personal opinions below.
Keri Forsythe-Stephens is chief editor of 24×7 Magazine. Questions and comments can be sent to email@example.com.
My understanding is that FAA regulates both producers of airplanes and its “user: community (airlines and airports). I believe NRC does likewise for its industry. For whatever reason, medical devices seem to be more like cars, where the regulation is mostly on the production side (although roads, bridges, etc, do have to meet state-mandated safety codes and inspected by the state). It would be interesting to know whether other user communities are regulated the same way as their corresponding manufacturing community. It does seem odd to me that providers might have to meet the same QSRs as manufacturers do. One has little interaction with the users and environment of use, the other lives it every day. One way of expressing the impact of the difference is imagining the assurance case each community would make that what they provide safety and effectively meets the needs of their users. I assure you they’d be different. And what is the purpose of regulation other than assurance?
Other than money, I mean.
“fear”, “reservations”, “concerns”, “worries”, and “slippery road”? Come on folks the FDA is not the boogie-man. If you are running a quality-centric service organization then why use such language? I do not find the argument that adopting parts of the QSR is going to cost ISOs a bit more to run their business, and thereby cause many of them to go out of business, very persuasive.
Wayne, I think a valid concern for the industry is that the OEM’s lost the battle before (to wrap up service) so this time they are taking a more subtle, multi-staged approach.
I have already experienced several OEM’s ‘no longer offering’ service schools, then in the next breath tell me how I need a contract to be compliant with state and federal regulations for equipment maintenance. Such agreements are two to five times my normal T&M support run rate.
We need to ensure quality in our programs, I agree there. I just think we need to make sure no one side drives the process….
I see this legislation in the same context as the story about putting a frog in a pot of water and slowly bringing it to a boil — if you tried to put the frog in already hot water, it jumps out. If you bring up the temp slowly, it will not notice the rise in temp, and eventually die….
Mark, I had no idea you were boiling frogs, I have reported your activities to PETA.
I used to ask if FDA regulations were good practices, regulatory burden, neither or both. Assuming they are good practices then as was noted a quality organization shouldn’t have trouble meeting a service oriented QSR (which is not the current QSR). But I also used to ask if having a Quality System results in a quality system which in turns results in quality services (in this case). There is actually very little evidence that regulations improve things.
PS. I still don’t understand the language on contractors, or Binseng’s explanation. You should read the bill for yourself at:
As a underprivileged (but legal) immigrant from Asia and Latin America, I fully admit that my English is not as good as native speakers, so my interpretation of the proposed Bill and explanation are definitely subject to corrections. Hopefully someone much smarter can shed more light after reading the Bill and the testimonies provided by MITA and IAMERS today.
I believe that I have a unique perspective in this particular matter. Myself and my partner (who was also my brother) ran a medical device sales and service company for 44 years employing over 11 people. We started as an independent service organization and later grew into equipment sales and service. When we first started out my father, then President of the company, had many years under his belt working directly for the OEM manufacturers whose equipment we later serviced, after he formed his own company. This was back in the 1960’s and 70’s before the FDA even started regulating sterilizers and autoclave manufacturers. Back then, when we approached a potiential customer, we were always ask a barrage of questions regarding our qualifications. At that time, anyone working on sterilizers, autoclaves, surgical table and surgical lights other than the OEM was an anomaly. As time progressed and other ISO’s came into the business, in competition with us, it seems that most of those qualifying questions were no longer ask by the hospital, they were simply concerned with price. Price was king and qualifications were out the window. Before it was ever required, we kept and provided documentation on every service performed and part installed, all tied into the individual equipment by serial number. Our competition was allowed to skate by without providing documentation. We had QC and tracibilty before it was ever even thought of. To make a long story short, as much as I abhor regulation, all medical device service organizations need to be on the same page and not allowed to exist at the expense of quality or the patient safety. Even though you do not hear much about sterilizers, surgical lights, surgical tables in these discussions they are one of the most integral parts of medicine. Without a sterilizer producing a sterile product, hospitals would grind to a halt!
Now I am retired but I still try to keep up with the industry.
God Bless America and our fighting men and women!
Who in their right mind can utilize some wording in their explanation the way they have? For many years, I disallowed sales of any equipment unserviceable by an inhouse service team. This is another ploy for equipment manufacturers to take the servicing away from 3rd party or inhouse service teams. I am against any of these rediculous corporate money making schemes that try to monopolize the service industry. How many stories or sequestered device reports are out there where ISO’s were the cause of equipment failure vs. the same occurrence from the OEM? I don’t think we will see much difference if not, more issues with these OEMs. It is not the ISO’s that have raised this issue, but I can guess 100% where the responsibility lays for BS such as this legislation!Rediculous!!
Andrew, the bill specifically excludes in-house hospital service. Below is from the hearing yesterday.
Ranking Member Green: We know certain types of medical devices and technology often require servicing and maintenance and repair. Hospitals and health systems have a right to rely on the original or a third party service entity to fulfil that maintenance decision. The bill that we’re considering today would require third party service entities to register and report certain adverse events and malfunctions to the FDA. In your understanding, is that all this bill does?
Robinson: Yes, that’s all this bill does. It excludes hospital-owned in-house service from that.
Ranking Member Green: So if you’re an employee of the hospital, you know where the responsibility is.
I spent 4 hours reading and rereading the bill. I downloaded the pertinent sections of the FDA Act. I made every change to the Act that the Bill calls for. (I have posted this marked-up part of the FDA Act on the HTMA-SC website – http://www.HTMA-SC.org) I could see little to disagree with. It mandates a Complaint Tracking System. This system requires all complaints be tracked, investigated, and dealt with. It also requires that they are periodically summarized and send to the FDA. I see nothing with this. Somebody will develop a cheap, off-the-shelf product to track this. And generate the required reports. And if you have to spend an inordinate amount of time tracking complaints, maybe you shouldn’t be repairing medical equipment. I can’t fault this step because of what the next step might be. This seems very logical a worthwhile effort.
This makes sense to an extent; however, does it need its own legislation? Could the FDA add to their SMDA MedWatch form 3500A in section D “equipment owner” and/or “group maintainer” onto this form? Wouldn’t this essentially involve an ISO at that point if the ISO owned/maintained the equipment?
Recent recommendations places responsibility onto the medical facility treating the patient regardless of actual equipment owner (EQ 56:2013 (5.3)). If a rental, contractor owned, provider owned, patient owned or demo piece of equipment comes into a facility and harms a patient, the in-house (or contracted HTM group representing the facility) has the responsibility/duty to investigate the occurrence and forward it to risk management to report via a SMDA Med Watch form.
If the medical facility reports the incident and follows proper protocol with the proposed addition I mentioned above, what’s the point of reporting the complaint to the FDA a second time through the ISO and having to mate one report with another? Seems rather redundant. By having inclusion onto the 3500A form, high reporting occurrences involving specific ISOs can then be investigated further and have direct accountability.
The FDA deferred this to legislation for a reason. I strongly suspect they failed to see reason for new rules during the NPRM.
Robert, you are correct that the FDA does not need new rules to regulate 3rd party service providers, they only need to enforce the authority they already have as explained by Dr.Shuren at yesterday’s hearing:
Ranking Member Green: Can you discuss the rules and requirements that currently apply to third party service providers? For example, are they required to register with the FDA, label products they have repaired or remanufactured, or submit adverse event reports associated with their work?
Shuren: In our regulation on quality systems, we have made clear that third party servicers are manufacturers, but they have been subject to enforcement discretion and we have not enforced those requirements.
After reading through the Bill, as well as the article and comments above there seems to be a significant gap in what was presented at the FDA conference back in October 2016 and what H.R 2118 presents.
While the Bill as written is probably a positive step, back in October the two day conference covered not only the concerns of MITA to address reporting safety incidents but also questioned who is qualified to perform maintenance and repairs, as well as refurbishment of medical technology.
There was an OEM assertion back then that there should not only be oversight by the FDA on registration and reporting but also oversight of qualifications.
Additionally at the conference, Definitions of Independent Service organizations (ISO) grouped in Hospital based departments and hospital employees.
So again while this as currently written is a logical and needed step, a few amendments to it and or reinterpretation could as Binseng Wang noted be “a slippery slope”. Paranoia is not warranted but a watchful eye in my opinion is needed.
The onus on the purchase of any and all medical devices and their upkeep falls upon the owner. Whether the owner is a private practice or large government facility, regulations to insure patient safety by enforcing proper ongoing service, maintenance, quality control, history tracking, and record keeping just makes sense. It keeps owners accountable and provides patients with the reassurance big brother is looking out for them. What should also happen is that FDA steps in to stop medical devices from being used beyond “end of life”. Too many third party companies are just “repainting” some piece of garbage that should have been retired years ago only to surface and create some of the reasons why this bill has been brought in in the first place. Owners of medical devices are who this bill should address.
Anyone who installs assemble remanufacturers any medical device is an installer and a manufacturer.
Any initial import distributor is a manufacturer
Anyone who remanufacturers under 1020.33 is a manufacturer.
Anyone installing any of the certified X-ray components is an assembler and is a manufacturer.
There is more but at this. point any of the above is required to have a compliance program and register at the FDA.
ISO, inhouse resellers etc may need to have these requirements.
Those who don’t believe in the “slippery slope” that I mentioned in the story above should read the Viewpoint written by Jim Spearman (https://24x7mag.com/2017/05/viewpoint-medical-device-servicing-safety-accountability-act/?ref=cl-title). He stated “As I listened closely, there was a subtle hint that this would be an “important first step,” like Joe Robinson mentioned.”