Three weeks into the Biden administration, we’re already seeing a much more robust coronavirus response than we experienced over the first 11 months of the pandemic. However, one thing is notably absent: a plan to repair broken medical equipment. It’s hard to believe that nearly a year after the United States reported its first COVID-19 death, hospital repair technicians, also known as biomeds, still face barriers to fixing medical devices critical to treating coronavirus patients.
At the outset of the pandemic, the status of our country’s medical devices -- particularly ventilators -- was of utmost concern. And for good reason. When biomeds can’t fix broken equipment, patient care suffers. Nader Hammoud, a biomedical engineering manager and member of the California Medical Instrumentation Association, told us with certain broken equipment, “if you don’t get that device up and running in an hour or two hours, that patient will die.”
While fatigued Americans are naturally shifting their attention to vaccines, more than 80,000 Americans remain hospitalized with COVID-19, some of them in makeshift rooms because ICU beds are full. As we trudge through this dark winter of spiking cases and deaths, U.S. PIRG’s new survey of 129 biomeds shows why we must renew our focus on our equipment, particularly how we fix it.
Biomeds are the frontline workers charged with maintaining medical equipment to keep it running. And yet, device manufacturers restrict their access to necessary repair materials. These groups need to work together, but our survey shows that biomeds get too little help from manufacturers.
More than three out of four of biomeds who responded to our survey have been denied access to parts or service manuals for critical medical equipment over the past three months. A striking eight in 10 report having equipment on-site that they cannot service because of restricted access to service keys, parts or other materials. And 97 percent of biomeds agree that removing barriers to manufacturer parts and service manuals is important to their repair work right now.
This problem is exacerbated for rural hospitals. Biomeds in more remote parts of Colorado and Minnesota have told U.S. PIRG that they have had to wait hours, weeks, or even a month for a manufacturer representative to travel to their hospital and service their broken equipment. Ultimately, it’s the patient who bears the brunt of those delays -- a ventilator waiting for a repair is a ventilator that can’t be used to treat a patient who needs help breathing.
By preventing fully capable, on-site biomeds from fixing medical equipment as soon as it breaks, manufacturers are doing a disservice to a wide variety of patients. A 2018 FDA report even found that, “availability of third party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.”
This urgent moment requires urgent action to make sure that biomeds have the repair materials they need to keep our hospitals running. That’s why more than 500 biomeds have called for Right to Repair reforms, which would guarantee access to replacement parts, repair manuals, service passwords, and other essential repair materials.
There are some rays of hope. After U.S. PIRG delivered more than 43,000 petitions to medical device manufacturers, three major companies -- GE Healthcare, Fisher & Paykal and Medtronic -- made more service materials available. And it appears that helped improve the situation for many biomeds -- 59 percent of those who responded to our recent survey indicated that manufacturers have become more cooperative with their repair operations over the course of the pandemic.
Legislators and decision makers have also taken notice. Led by Treasurer Joe Torsella of Pennsylvania, numerous state treasurers called for the removal of medical device repair restrictions. In August, Sen. Ron Wyden (OR) and Rep. Yvette Clarke (NY) introduced the Critical Medical Infrastructure Right-to-Repair Act of 2020, which, if it had passed, would have provided biomeds with access to the repair materials they need for the duration of the pandemic.
But this problem is far from solved. Nine out of 10 biomeds surveyed said that the recent uptick in COVID-19 cases has increased their need for medical Right to Repair.
We at U.S. PIRG will continue to advocate for solutions until we get parts, tools, and repair information into the hands of hospital biomeds so that they can effectively play their essential role in combating the pandemic. Congress should do its part by investigating the ways that manufacturers restrict repair and passing an updated version of the Critical Medical Infrastructure Right-to-Repair Act. States considering Right to Repair legislation that includes medical devices should do the same.
One year on, it’s due time that we take the lessons that we have learned throughout the course of this devastating pandemic and apply them to prevent further loss of life. We have much to fix, and that starts with the way that we repair medical equipment.
This survey was taken by 129 biomedical repair professionals and was conducted online beginning in December 2020. A link to the survey form was sent by biomedical associations and hospital networks to their members across the country, as well as to biomedical repair professionals who had previously engaged with U.S. PIRG. Participation was voluntary, and all data was self-reported by respondents. The survey collected additional information about the respondents beyond what is covered in this report.