[UPDATED on April 17]
DENVER — For years, manufacturers of ventilators and other medical equipment have kept a tight grip on the ability of hospitals to service and repair those products, prompting lawsuits and under-the-table sharing of repair manuals and software passwords.
Now, in the midst of the COVID-19 pandemic, the need for product information to keep ventilators up and running is at an all-time high.
Modern ventilators are typically serviced either every six months or 2,000 hours of use and can last for 10 years if maintained properly. But now nearly every ventilator is being called into near-constant service in hot spots, with some pulled out of storage after eight years on the shelf. When any ventilator breaks down amid the surge of cases, waiting two weeks for a repair can mean patients die.
While some manufacturers have made limited concessions to help hospitals and third-party service providers maintain equipment during the crisis, many biomedical equipment technicians, known in the field as “biomeds,” are facing roadblocks in evaluating and servicing ventilators desperately needed for patient care.
“Manufacturers have been in more of a protective mode, making sure they’re protecting their market share and the quality of their services,” said Ken Ottenberg, vice president of medical equipment management for Denver-based service provider HSS. “Saving lives and taking care of patients is what we’re trying to do. Are we not going to meet the demand at this time because of a business decision, instead of a quality-of-care decision?”
AdvaMed, a trade group for medical device manufacturers, has argued against allowing third-party servicers to work on complex equipment without proper training and oversight, and maintains that even during the current crisis, there is no evidence of a shortage of qualified manufacturer-trained technicians.
“The bottom line is that medical technology companies or their designated representatives are best equipped to service their products and keep patients who use them safe,” said AdvaMed spokesperson Jim Jeffries. “They are effectively serving the needs of patients and health care providers to respond both to the COVID-19 pandemic and other ongoing health care needs.”
Part of the equation is economic. Many manufacturers add to their revenues by controlling the servicing and repair of the equipment they sell. They restrict access to equipment information to only those technicians who complete a manufacturer’s training course. And as machines have become more computerized, companies use software locks to prevent repairs without permission.
“If you can’t get the access to the software, then all you have is a bunch of metal there,” said Bill Bassuk, president and CEO of the College of Biomedical Equipment Technology in San Antonio. “If they sold the equipment and it belongs to the hospital, then whomever that hospital wants to work on that equipment should be allowed to work on it.”
Right To Repair
That’s prompted a “right to repair” movement for medical technology, seeking to break up the manufacturers’ monopoly on service and repair. Similar battles have been fought over cars, farming equipment and cellphones.
“When the only company to fix it is the company that made it, that’s another incentive for them to get you to buy a new one instead,” said Nathan Proctor, director of the Right to Repair campaign for the public interest advocacy group U.S. PIRG.
So far, at least 20 states have considered right-to-repair legislation. Colorado was scheduled to vote on a bill this year, but the legislature was shut down early because of the pandemic.
Proctor argues that manufacturers should allow access to service information at least during the current crisis. Once the pandemic abates and lives are no longer at stake, the industry could have a more measured discussion about the right to repair.
Some manufacturers have made allowances during the past month as demand for ventilators and servicing spiked. Medtronic, for example, released the schematic designs for an older ventilator model so that new manufacturers can refer to a proven design.
But technicians said they are still having trouble accessing service manuals for Medtronic’s top-of-the-line ventilators.
“They need to move from a service model to an information-sharing model,” Proctor said. “There needs to be training, and there needs to be access to service information and passwords.”
In a statement emailed to Kaiser Health News, Medtronic spokesperson John Jordan said the company provides service manuals to hospital biomeds to help them with basic troubleshooting and testing when requested but, to date, had received fewer than 10 requests.
“Currently, our hospital customers are more concerned about having or receiving a ventilator than servicing one,” Jordan said. “Publishing service manuals broadly would not help increase the number of available ventilators.”
In Colorado, Ottenberg said, one ventilator manufacturer, which he declined to name, has just two service technicians for the state.
“In any given normal month, those technicians can service all the equipment as needed for scheduled maintenance,” he said. “Now we get into COVID, there’s no way.”
Marty Fulkerson, director of operations for clinical engineering at the Centura Health system, which includes 17 hospitals in Colorado and Kansas, said that when one manufacturer’s service technician in Colorado was quarantined for two weeks after a COVID-19 exposure, the company pulled senior officials with repair experience out from behind their desks to meet the demand.
Third-party service providers say manufacturers may have no choice but to loosen their restrictions, as they cannot handle the increased need for service.
Ottenberg said the industry has had a shortage of technicians for the past two years at least, and with the pandemic, many of the technical schools have stopped training new biomeds. Now, biomeds say, service calls are scheduled out at least one to two weeks, leaving some equipment offline.
“It’s insane. It’s unacceptable if they can’t get out there for one to two weeks,” Bassuk said. “They’re trying to recruit enough to have a proper workforce, but they’re pretty much going to be overworked now.”
While in-house and third-party biomeds are willing to take on the extra work, they have not been able to attend in-person training sessions because of restrictions on travel. Some manufacturers are holding online training to help biomeds trained on one model of ventilator troubleshoot other equipment from the same company.
Burning The Midnight Oil
Jean Roberts, a biomed with the University of Vermont Medical Center, has been working six to seven days a week to maximize the availability of his facility’s ventilators.
“Thankfully, we biomeds are pack rats by nature,” he said. “Anything not in use, but not defective either, we scurried away to a warehouse for times like this.”
During the crisis, he has pulled 14 older ventilators out of storage and worked to replace the batteries and perform required maintenance. He then had to find the disposable components for those ventilators and train staffers who had never used those old-school machines before.
“They’re used to a touchscreen,” he said.
The University of Vermont hospital had more than 100 ventilators scheduled for preventive maintenance in April. Roberts and another senior biomed put other tasks aside in early March to work solely on ventilator maintenance, knowing a surge in demand was likely coming.
But finding replacement parts has been a challenge.
“We’re getting a lot of partial orders where we get all but one part we need,” he said.
The arrival of new ventilators from other hospitals or from a stockpile can mean biomeds need to get up to speed quickly on unfamiliar equipment. Roberts said that when Vermont ordered new ventilators, three of the four models available were ones the University of Vermont hospital had never used.
Some of the stockpiled ventilators haven’t been used for six to eight years and require immediate maintenance before they can be pressed into service.
When manufacturers are unwilling to share maintenance procedures, biomeds sometimes turn to online forums, such as MedWrench or iFixit, for help. The forums are inundated with requests for service manuals or software passwords for ventilators from technicians all over the world.
Frank’s Hospital Workshop, a website run by a German biomed living in Tanzania, created a site with manuals for older medical equipment that finds its way to hospitals in developing regions. Those hospitals have little choice but to try to make repairs on their own and eke out additional years of life from the aging equipment. Still, manufacturers have prohibited the download of some service manuals on the site, arguing that the equipment can no longer be safely repaired.
“For a premature child, the downside of it not working is a lot bigger than the repair quality,” Proctor said. “It’s not that complicated a device.”
Roberts has tried to help other biomeds posting on forums by directing them to manufacturer websites, but he said he won’t go so far as to share service manuals or passcodes, even during the current crisis.
“If you weren’t doing the maintenance to begin with,” Roberts said, “now’s not the time to learn.”
These unprecedented conditions, however, may be biomeds’ time to shine.
“The work that biomeds do has been historically largely confined to the dark corners of the basement or the lower recesses of the hospitals,” said Richard Gonzales, director of the College of Biomedical Equipment Technology. “But they do truly keep the lights on in the hospital.”
[Correction: This story was last revised at 10:15 a.m. ET on April 17 to correct the status of “right to repair” legislation. At least 20 states have considered such legislation.]