In an atmosphere of cutting costs within health care, it would seem that every opportunity to do so, that preserves patient safety, would be considered and endorsed. Yet, that produces a conundrum of sorts in regards to the ability for an in-house biomed department to repair all equipment at a reasonable cost to their employer. This is one of the costs, after all, that a health care system must bear and pass along to its customers.
Automobile dealers know that there is good reason to have salespeople direct the customer to the “finance guy” after they have made a purchase. Between the service department, and the add-ons that the finance department can sell the customer, there is more profit than in the actual sales department. Getting so much more profit, after the sale, does not seem to benefit the customer, who was only interested in buying transportation and already had their budget stretched in many cases.
The analogy seems to hold true in the medical equipment marketplace as well. At least, this is the perception of many people who are closely involved in maintaining medical equipment. Very often, the biomed department, or an imaging engineer in that department, will want to help ensure that a patient gets a needed diagnostic imaging procedure when a piece of equipment goes down. In many cases, their good intentions are met with frustration because only the OEM can make the repair, and at an increased cost.
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The frustration for the HTM profession for several years has been the general inaccessibility of service manuals, passwords, replacement parts and/or access to training that fits into their employer’s budget.
As of this writing, the issue of new federal standards, that relate to the servicing of medical devices by trained service technicians or ISOs, is in flux. It is the fluid nature of the topic that dictates that we revisit it at a time when state and federal lawmakers are reviewing language for new laws.
At the federal level, a bill that was passed by the House on July 12, and the Senate on August 3, 2017, which is titled H.R.2430; the ‘‘FDA Reauthorization Act of 2017,’’ has been signed by the president.
In March of 2016, the FDA had requested comments from all stakeholders for any future proposed rules, which could be found in a docket titled: “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers.” The request was met with 176 comments from OEMs, ISOs, biomeds, The Joint Commission and other interested parties. The biomeds who responded pointed out that there was a crucial time element involved in waiting on an OEM, that injuries at their facilities resulting from repairs or maintenance were negligible or non-existent and that there are other levels of oversight related to HTM department procedures.
The Making of Local Laws
It’s often said that the best decision making, from a legislative perspective, is when it is closer to the people that it impacts. While Congress and the FDA wrestle with the issue of servicing medical devices, and who has the right to all the information needed to do so, the debate has been addressed in state legislatures as well. In those cases, there is more action taking place that moves the ball forward.
There is proposed legislation in a dozen states. In Nebraska, where a large percentage of the population works in the agriculture business, the ability to repair farm equipment is a concern very similar to medical equipment. If a piece of farm equipment is down at a time of year when a farmer needs it, the need to repair it in a timely manner or wait for a technician, is not a practical solution. The bill in Nebraska, (LB67), recognizes that the issue is also like repairing automobiles. With on-board computers in both, the ability to read a fault-code could lead to an expedited repair.
Frustration at the Point of Repair
The arguments on both sides of the right to repair debate haven’t changed much since day one. The OEMs maintain that they, or their designated representatives, are the most qualified to repair their devices. They, and their advocacy groups, also argue that if anyone else makes certain repairs, it can put a patient’s well-being at risk. There are other arguments centered on the OEMs rights regarding proprietary information and intellectual property.
Within the HTM ranks, the arguments for right to repair include the urgency created by inoperative equipment, that is so often a reality, cost and budget considerations, and the time consumed when shipping and packaging is required. Biomeds also cite the fact that restrictions by OEMs tie the hands of those tasked with repairing and maintaining equipment in their own facilities or restricting local ISOs from attending to quicker, or most cost-efficient, repairs.
Biomeds also cite the reluctance of OEMs to share service manuals or make a replacement part available.
The obstacles, according to Curtis Ange, manager of biomedical engineering at Kennestone Hospital in Marietta, Georgia, include “tooling, training and certification.”
“The typical manufacturer warranty period, with any new purchase or installation, is 12 months. So, during this warranty period, I’ll need to plan then [to] purchase any necessary or required test equipment or tooling in order to perform any scheduled or unscheduled service interventions once that new manufacturer warranty has expired,” Ange says.
Ange says that in addition to the capital needed to obtain the required tools or test equipment, operational expenses will also be needed to train and/or certify the person or persons who will maintain the new device, devices or system.
“This tooling and training, if pricing or travel expenses have not been negotiated up front, can become costly, so it’s important to include these amounts and expenses as part of the planning and budgetary costs when considering a new product,” Ange adds.
Dean Stephens, EET, CBET, in the biomedical engineering department at Penn Highlands Healthcare, says that there are two camps when it comes to the OEMs approach.
“Refusal to provide service and repair documentation has always been a problem. Some manufacturers seem to realize that we the biomedical engineering departments can be [a] great asset when it comes to how their product appears to the end users. This type of OEM makes their documentation and parts breakdowns easily available and provides knowledgeable tech support technicians who aren’t lost as soon as your issue goes off of their script,” Stephens says.
Stephens points out, with some intentional sarcasm, that for other OEMs, the end game is all about loosening the purse strings.
“On the other end of the spectrum, there are the OEMs who feel that every item they have ever produced should be protected more closely than the U.S. nuclear arsenal. I have contacted one in particular attempting to purchase a service manual. Their reply was that they had never produced any service or technical manuals for the device in question, but if I was to send the broken one to them, with a small basket of shekels, they would be glad to tell me how many more shekels I would need to send in order for them to complete a repair,” Stephens adds.
He said that a recent experience illustrates the frustration with parts accessibility.
“There are now several OEMs who won’t sell parts, but insist that the only means to have a piece of equipment repaired is to send it in for depot repair. In one case, I needed a small plastic clip, that’s smaller than a dime, in order to repair a charger base for a handheld pulse oximeter. Not only did their tech support insist that I had to send the base in for a $250 flat-rate depot repair to have this replaced, the tech I was speaking with insisted that this piece was part of the plastic chassis and isn’t removable. I had the piece, which is removable with a small screw, in my hand as he was telling me this,” Stephens says.
Sometimes OEMs will claim that their equipment is too “complicated.” In many cases, HTM professionals have the basic knowledge to handle these repairs.
“Many times I’ve been told that ‘their’ equipment is too complicated to work on, but over my career, I’ve learned that whether it’s medical, aviation or audio-video, electronics is electronics, no matter what type of box you stuff them into,” Ange says.
“The only exception to this observation is that typically each manufacturer will have their own patented component or components within ‘their’ box, and it’s that component or application or software, you won’t understand or know how to repair or operate until trained,” he adds.
Stephens says that one solution can be leveraged at the point of purchase.
“When we have advance warning that a department is considering new equipment, we ask that department to make it a requirement of the contract that it includes service manuals,” he says.
“In the case of new ventilators, anesthesia machines, etcetera, make a bid requirement that it includes training for one or two techs. This has worked for me in the past, though I had never seen such grumpy salespeople as when some would try to weasel out of the training requirement, and be reminded that if their bid didn’t include the training, it would be summarily tossed,” Stephens adds.
He points out that the request isn’t for “free training,” but requests training for a certain number of technicians.
Representing Consumer Rights
While large corporate concerns have lobbyists representing their interests in Washington and in state legislatures, The Repair Association represents the purchasers, including medical device purchasers, to fight for repair rights and the passage of Fair Repair legislation.
“Right to Repair aka Fair Repair aka Digital Right to Repair legislation has been filed so far in 12 states. Most include medical equipment, along with everything else, from a cellphone to a tractor. Two bills were set up to cover only farm equipment,” says Gay Gordon-Byrne, executive director of the Repair Association in North River, New York.
“None of the bills has passed yet. This is normal for any significant piece of legislation it takes more than a few months to work through the issues sufficiently to get legislators comfortable with passage,” she says.
Gordon-Byrne says that Massachusetts is one of those locations where her group has invested enough time and education to be serious about passage this year.
“The legislature is still in session and has a public hearing set for September 26 (2017). We will have members of the medical community, such as Stephen Grimes, helping to testify in favor of legislation, but opposition will also be there in force to block passage,” Gordon-Byrne adds.
In the debate within Massachusetts, Gordon-Byrne’s group has told the legislature that they believe health care safety is improved if biomeds “can have access to the essential information and materials necessary for complete, safe and effective repairs.”
Consumers in Massachusetts tend to agree that they have a right to repair. In 2012, 86 percent voted in favor of the Automobile Owners’ Right to Repair Law. In principle, the ability for the purchaser to have the capability to repair what they have purchased, is a widely-held belief. This kind of freedom for consumers also extended to cellphones, prompting a change in the law that now allows cellphones to be “unlocked.” The issue includes medical devices but is a topic of dispute for vehicle owners, cellphone owners, in farming and consumer electronics, to name a few.
“Manufacturers, in opposition to repair, have taken to conflating their requirement to provide safe products – with or without regulatory oversight – with use of the products. Such claims are made to confuse and frighten legislators – very few of whom know that the FDA requires reporting on adverse events so that unsafe designs can be corrected. Only the OEM can make this kind of adjustment or improvement,” Gordon-Byrne says.
“Users, meaning doctors, patients, HTM or others, cannot re-design products to make them safer; they can only use them safely. According to the FDA and CMS, the hospital administrator, supervising physician, or HTM/BMET/clinical engineer is responsible for safe use and also responsible for assuring that repaired equipment is returned to service in full working order,” Gordon-Byrne adds.
She points out that purchase documentation includes much more than just purchase price and warranty terms. Contracts always include disclaimers and indemnifications of use, such as this very common sentence:
“In no event shall [company] be liable for any direct, indirect, punitive, incidental, special consequential damages, to property or life, whatsoever arising out of or connected with the use or misuse of its products.”
Making the Case
Echoing many in the HTM community, Stephen L. Grimes, FACCE, FHIMSS, FAIMBE, managing partner and principal consultant with Strategic Healthcare Technology Associates LLC in Swampscott, Massachusetts says “manufacturers should provide service materials (i.e., troubleshooting advice, manuals, parts lists, software codes, etcetera) to medical equipment owner/operators and third-party services at a reasonable cost.”
“For much of this decade, some major manufacturers and their trade and lobby groups q have taken steps attempting to force through new regulations that require in-house and third-party servicers to follow the maintenance procedures as recommended by the manufacturer and to register with the FDA and implement the same quality management system and reporting requirements as the FDA requires of manufacturers,” Grimes says.
Along with a lobbyist from the Repair Association, J. Scot Mackeil, CBET, a senior BMET at an academic medical center in Boston, as well as a colleague from ACCE, attended a series of meetings at the Massachusetts State House, which included leaders of key legislative committees working in support of pending bills S.96 and H.143.
As a result of that experience, Mackeil says that “the device manufacturers’ lobbyists are trying to neuter our pending right to repair legislation by getting an exemption for Class III medical devices — quite a bit of what biomeds work on falls in this category; defibs for example. I would assume MITA and MDMA have this request going on in other states that [the Repair Association] has similar bills in process,” Mackeil says.
The Joint Commission’s new element of performance EP 3, that is slated to go into effect in January, provides: “The organization has a library of information regarding inspection, testing, and maintenance of its equipment and systems. Note: This library includes manuals, procedures provided by manufacturers, technical bulletins and other information.”
The new EP gives the HTM community another arrow in its quiver in attempts to obtain information from OEMs.
In addition to Gordon-Byrne’s organization, which attempts to aid consumers in many sectors, the establishment of a national HTM organization would provide a strong lobbying voice for the HTM community.
“Biomeds, regional biomed societies and ISO groups should become politically active and partner with [the Repair Association] (www.repair.org) and support right to repair legislative initiatives in their states,” Mackeil says. “Our adversaries are well entrenched in the regulatory front. But, Right to Repair laws may be able to trump the OEM lobbyists, and if we can start to get these laws on the books in multiple states, HTM could win its own ‘Battle of Midway.’ The recent EP released by TJC, regarding service manuals and information, will prove to be a powerful new tool,” Mackeil adds.
More will be known in the near future as the right to repair issue is considered by lawmakers in several states.
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