In market economics, a popular theme is the concept of competition and its positive impact on the prices consumers pay. When airlines merge, it is not beyond the pale to anticipate higher prices as competitive pressures ease and the whim of a few major players dictates the fares and fees in that industry. It’s not a good day for the paying public when a few major players dictate the market’s pricing.
There was a time when the backyard mechanic could easily figure out an auto repair. The lack of onboard computers and the straight-forward nature of the internal combustion engine of past years made narrowing down a problem the result of a few diagnostic steps. That ended with the introduction of more sophisticated electronics systems and monitoring systems in automobiles. This gave the dealership a decided advantage, along with the $130/hour labor rate.
The macroeconomic principle of market choice and competition has not skipped over the HTM profession and the ability of individual HTM professionals to control costs by simply doing their job. We can fix it; let us fix it, is the mantra of many who are frustrated by having their hands tied. This fight has become so contentious that it has even landed in the courtroom. The information and access to accomplish a repair should be unfettered; but that’s not always the case.
Manufacturers argue that right to repair laws would weaken intellectual property protections. The argument is countered by those often affected, like ISOs, who argue that downtime impacts patients.
Some manufacturers limit access to diagnostics as well. Legal actions are nothing new in the right to repair debate. Litigation in 1990 awarded some ISOs the right to use a manufacturer’s software in repairs.
In 1998, the Justice Department settled an antitrust lawsuit with GE allowing 500 hospitals to service MRIs and CT scanners and lifting restrictions on software licenses.
“In regards to servicing anesthesia systems, there have been two major lawsuits by independent service organizations protecting their rights to service the OEM equipment,” says Thomas G. Green, president of Paragon Service in Saline, Michigan.
“The first was Red Lion versus Ohmeda (now GE Healthcare) which settled in 1999. The other lawsuit was Metropolitan Medical Services versus Drager Medical which settled in 2005. Both cases settled on an amicable basis as agreed to by all parties.”
Green is a party to a current litigation as an ISO.
As with so many other issues, that are major concerns in the HTM community. The flexibility of hospital budgets plays a pivotal role as well. The cost of parts and training may be higher than a service contract. Which will the person making the purchasing decision decide on? That can work to the advantage of the manufacturer, but it can also work during negotiations and before finalizing capital equipment sales for the customer. Holding tight to the purse strings, before approving a purchase that must include training and/or documentation is a bargaining tool.
Manufacturers who offer different levels of contract coverage help to assuage some of the resistance to the high costs of cutting the HTM department out of their ability to tackle more projects. Shared service models, with the HTM department handling the PMs and front-line support, while the OEM provides a break on parts or labor can offer a compromise.
There is also the question of true competence to repair. As one manager observed, “You don’t ever cross a line with equipment. You only go as far as your comfort zone, which includes your skill set and knowledge base. There are too many who will cross that line.” With that caveat in mind, we look at the experience of some in the HTM community when it comes to this topic. We also hear from an advocacy group that has given the topic extensive consideration.
“If I buy a car, I can still do my own diagnostics with help of aftermarket tools or even go to what we would call third-party vendors,” says Jeffrey Ruiz, biomedical engineering manager at Holland Hospital in Holland, Michigan.
“I have the right to troubleshoot or fix my car. I can get parts, service manuals or even go look up YouTube and see how to replace my wipers or headlights. I know that cars and medical equipment are different animals, but if I could go to YouTube to do a PM on a device, could you imagine the impact that would have?”
Addressing Right to Repair
“There is the possibility, when you purchase, [that] you demand the required documentation and information,” says Matt Du Vall, a biomedical technician at Treasure Valley Hospital in Boise, Idaho. “That only works as long as the purchasing agent does not bargain it away and if it’s not a substantial purchase.”
“Your administration can also help if they are backing you,” Du Vall adds. “In the past, my department held up the authorization of paying on items until manuals were supplied. We have held the equipment in a store room and put it on the floor but it needed our manager’s signature for the payment to be made.”
But these measures should not even be at issue in the first place according to Gay Gordon-Byrne, executive director of the Digital Right to Repair Coalition and author of the book “Buying, Supporting, Maintaining Software and Equipment: An IT Managers Guide to Controlling the Product Lifecycle.”
She says that often the negotiation is limited by the controlling position the OEM happens to be in.
“Medical equipment repair is suffering from the same monopolization policies as other industries for the same simple profit motive. Repair can be very profitable, and much more profitable when there is no competition,” she says.
“Monopolization of repair is very easy when digital products are involved – all an OEM has to do is claim ‘proprietary’ software and ‘complicated’ equipment and voila – very few organizations attempt to negotiate better terms,” Gordon-Byrne says. “Medical equipment buyers are also fearful of making patient care errors – so the OEMs have an extremely powerful marketing message. It is only marketing – not technological.”
“The reason we are confident we can change laws to protect repair is that the claims supporting monopolization of repair are actually weak, if not bogus,” Gordon-Byrne adds.
“Repair is restoration of products to function. It is not how IP or patents are stolen. The same objections were raised by auto manufacturers in opposition to Automotive Right to Repair – and then accepted when faced with legislation. Cars and MRI machines are very similar when it comes to their electronic components,” she adds. “Chips are chips regardless of the covers.”
Gordon-Byrne says that patents are not at risk because patents are already public. She points out that it takes manufacturing without the permission of the patent holder to violate patents. She also makes the point that software (IP) is legal to backup and restore for purposes of repair. She says that “anyone intent upon copyright infringement can do so when products are working, and not wait for a hardware failure to make an illegal copy.”
She also points out that those tasked with repair have no need for access to trade secrets. She says that many people assume that service documentation is a trade secret when it is not.
“OEMs do not publish and distribute secrets to thousands of technicians,” Gordon-Byrne says. “Publication is the end of secrets.”
“We have seen instances where a technician is more that capable of handling a service event, but is locked out because the vendor has a service key,” Ruiz says.
“In the time to contact the vendor help desk, leave a message, wait for a call back and then schedule a time for the field service team to respond, we could have already had the device serviced, tested and parts identified for replacement. The down time during these events could be both costly and affect patient safety in the delay in servicing the equipment,” he adds.
“Also, the hospital is the owner of the equipment, not the manufacturer,” Ruiz points out. “Therefore if the hospital wants to have their own in-house, or third-party, or multi-vendor service their equipment, the hospital should have the right to own their software, service manuals and service keys available for such service. I totally understand the manufacturers have their regulatory agencies to fall under, but in today’s world, hospitals are under the microscope themselves and need to have the right to reduce costs and down time by having these tools available to them.”
Leverage used Wisely
As mentioned earlier, the point of purchase, or the period during negotiations, is the time to take advantage of leverage. When the HTM department is involved, obstacles to repair are more likely to be addressed.
“My facility has been great in the last few years about including the biomedical engineering department in the information gathering and decision making when purchasing new equipment,” says Dean Stephens, EET, CBET, supervisor of the Biomedical Engineering Department at Penn Highlands Elk hospital in St. Mary’s, Pennsylvania.
“This has allowed us to mandate that service and technical manuals be included with the equipment as part of the purchase contract. If the new equipment is high-risk, manufacturer’s service training is required as part of the purchase contract,” he adds.
Stephens says that if a manufacturer balks at providing the service and technical manuals, the sale won’t be made; there are other manufacturers out there.
“The only exception to this, that I can come up with easily, is the hydrogen peroxide plasma sterilizer. Since it is the only one available and the manufacturer is such a prig about documentation and training,” he says. He abstained from naming names.
Staffing an HTM department, with a diverse skill set of HTM professionals, can remove any obstacles to repair with available resources.
“The HTM departments are always eager to leverage the existing talent and take on medical equipment maintenance and related activities,” says Izabella Gieras, MS, MBA, CCE, director of Clinical Technology at Huntington Hospital in Pasadena, California. “In order to ensure seamless service, we need to consider the current resources we have [to] support the current and future opportunities, and thus people resources are often a challenge.”
“With so many new opportunities, such as medical device integrations, clinical alarms and numerous safety and process improvement initiatives, we need to continue to seek appropriate talent to support these initiatives,” she says. “People and service resources as well as time management are the key considerations.”
Even when the talent is on hand to do the repairs, a lack of access to needed information can occur when an OEM claims that the equipment is too complicated or that software is proprietary.
“We have experienced this with some of the vendors. With some, we have limitations to what we can work on even after the HTM training has been completed and with others, there is no HTM training available at all. In those cases, we work with the vendors to develop cost-effective maintenance models for the equipment,” Gieras says.
When the ability to fix the device is available through in-house talent, Gieras’ department has what they need from point of sale negotiations.
“We ask for the service documentation/manual as well as user manual as part of our purchasing agreements,” she says. “We often include this as part of our evaluation process to ensure we can compare ‘apples to apples’ when it comes to servicing the equipment after the warranty has expired. This also helps us develop the appropriate maintenance models to support the equipment during its useful life.”
In addition to the documentation, training brings the ability to repair in-house.
“Getting training in the purchase price of the equipment is the best way to get the information you need to support the equipment,” Du Vall says.
“My manager would always demand OEM training for at least two staff. He usually only got one trained. There are times where training was in the price and the purchasing agent dropped it to save money,” he says. “[Since] we need to be OEM trained to service and buy parts for the equipment, we had to pay a larger amount for the training. The easiest and least costly way is if it is negotiated at the time of purchase. Be sure to play one against the other ‘openly.’ If it’s above board, the chances are better to get a better price on it too.”
Du Vall points out that there are times when an OEM has set prices and won’t budge. He says that this coincidently is on the equipment you really want to get.
“Some things that also need to be negotiated are ‘fair price’ repair exchange programs,” he says. “This causes a problem with the inventory program, checking things in and out all the time. It cuts down time and having to stock parts, sending techs for training. It’s not my favorite thing to do, but it keeps the system running smooth.”
Gieras says it’s a good idea to voice your opinion with the manufacturer as part of the evaluation process.
“Sometimes this happens after the purchase is completed; however is included in the purchasing agreement,” Gieras says. “We have had opportunities to work with vendors who have customized HTM training for us as part of the negotiation process, which allowed us to be more flexible in the type of maintenance solutions we choose for the proposed equipment as well as leverage the in-house clinical technology talent.”
Beyond the macrocosm changes that come through negotiations at purchase, Gordon-Byrne says that more sweeping change in the right to repair debate can come through state legislatures.
“Since repair is neither a matter of copyright nor patent, limitations on repair fall squarely within the purview of states regarding unfair and deceptive business practices, contract law, consumer protection, environmental protection, and commerce,” she says.
Some changes have already happened on the automotive front.
“The auto Memorandum of Understanding (MOU) is an excellent template for Digital Right to Repair (DRTR) because it requires all OEMs to make service documentation, tools, diagnostics, and firmware with all applicable corrections, available to independent mechanics on fair and reasonable terms,” Gordon-Byrne says.
“These are exactly the problems facing BMETs and independent medical repair technicians with the exception of access to the OEM ‘parts desk,’ also on fair and reasonable terms,” she adds. “We added a parts requirement to DRTR to finish the puzzle.”
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