“It’s definitely life and death,” Nader Hammoud explained about his job as a biomedical engineer (or biomed), “especially during the COVID-19 crisis.”
Hammoud is with the California Medical Instrumentation Association and manages a biomedical engineering team at a California hospital. During a CALPIRG event earlier this week, he recalled multiple times in his career when he had to go into the hospital in the middle of night to fix a device. Doctors were waiting to use these devices, and if “you don’t get that device up and running in an hour or two hours, that patient will die.”
You can’t “wait to see if the manufacturer is going to respond to us,” Hammoud explained, because sometimes the answer is “you need a contract” or “no you can’t buy this part.“
Frustrated by manufacturers' restrictions on repair and maintenance, which biomeds like Hammoud argue interfere with life-saving fixes, hospital repairers are speaking up and taking action. The goal: win a Right to Repair for medical devices.
“It is always life or death in this domain,” Hammoud said. “I don’t see how a manufacturer can say, ‘No, I’m not going to let you do this.’”
Hundreds of biomeds call for reform
This week, U.S. PIRG delivered a letter signed by 326 biomedical professionals (clinical engineers, biomedical technicians and health technology managers) to members of Congress, calling for access to service information including manuals. Meanwhile, PIRG’s state affiliates across the country delivered the letter to their state lawmakers. It’s part of U.S. PIRG's larger Right to Repair Campaign, which aims to remove unnecessary barriers to repair that drive up costs for product owners, increase electronic waste, and in May 2020, can have life or death implications.
As the COVID-19 crisis scaled up, stories emerged about restrictions to fixing ventilators and other critical medical devices. When we raised these concerns to state and federal officials, it became clear that our leaders wanted to hear more from frontline medical repairers before taking any action to resolve these issues.
Our Right to Repair team started reaching out to biomeds across the country, and through the course of our outreach, we grew more concerned about the scale of the problem.
For example: One biomedical professional told us that their hospital was almost unable to repair one model of their ventilators at the height of the crisis. A manufacturer was attempting to cut off access to repair for their technicians -- because they were due for the refresher training. Not only did these technicians have no need to be “retrained” on a device they were fixing around the clock, the manufacturer had cancelled all the in-person trainings, recalled the hospital biomed (whose anonymity I am protecting, since the person was not given permission to tell this story publicly). If the hospital hadn’t fought for an exemption, “I would have been down ventilators in the midst of a crisis. That’s just crazy,” the biomed told us.
Stories like this are why, in just one week, 326 biomeds signed our petition calling for manufacturers to share repair information, including service manuals, with hospitals and independent medical device technicians. We hope this is just the beginning of our work with our allies in the Repair.org coalition to highlight and fix unnecessary restrictions to medical repair.
iFixit, Biomeds share information to keep devices going
In addition to pressing for regulatory relief, biomeds are also sharing the manuals they can access with other technicians. When a technician doesn’t have a manual, they often go to online forums and ask for help -- but might be stuck waiting for a response. Justin Barbour, a Houston-area biomed, told Reason, “I can honestly tell you that we don’t have service manuals for a lot of stuff … we rely on forums.”
But today, biomeds and iFixit have created a new solution to this issue. iFixit is unveiling an incredibly helpful new resource today:
Biomedical technicians in our hospitals are on the front line, keeping critical hospital equipment functional. But medical device manufacturers have made their jobs increasingly difficult by restricting access to repair information.
That changes today. Our team of librarians, archivists, and biomedical technicians have released a central, multi-manufacturer library of user manuals and repair documentation for hospital equipment. We have organized 13,000 manuals for products from hundreds of manufacturers on iFixit.com. These manuals are freely available and ready for use immediately: https://www.ifixit.com/Device/Medical_Device
No repair technician should have to waste time searching online forums for what they need for an urgent, middle-of-the-night repair. iFixit’s project helps make it easier to find materials. Now, we’re calling on manufacturers to cooperate, stop restricting access to qualified service personnel, and give hospitals what they need.
As Hammoud said, “We need cooperation. We need to work together for the sake of the patient.”
And if manufacturers won’t, our elected officials should step in and compel them to.