The Truth About Medical Equipment Repair and Patient Safety

Medical equipment repair is a complex and often misunderstood field. There are many misconceptions about the safety and efficacy of third-party repairs, especially when it comes to life-saving medical devices. To get to the truth, I spoke with several experts in biomedical equipment technology (BMET) to understand the realities of medical device repair and maintenance.

The Importance of Right to Repair in Healthcare

One of the key issues in medical equipment repair is the right to repair. Many original equipment manufacturers (OEMs) try to restrict who can repair their devices, claiming this is necessary for patient safety. However, the experts I spoke with strongly disagreed with this stance.

As Bill Bastic, founder of the College of Biomedical Equipment Technology, explained:

"The right to repair enables all of us to work on whether it's medical devices, cars, phones...If you bought a car and someone told you you couldn't work on your brakes or something and that's not allowed, it's your car, you should be able to do that. Well that's what's happening in the medical field, but they're trying to use the - when I say they, the OEM is trying to use life safety in regards to saying there's more jeopardy when an independent service organization works on medical equipment than them, but there's no data to prove that."

In fact, a FDA study found no evidence that third-party repairs pose any increased safety risk compared to OEM repairs. The study concluded that "the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system."

Restricting repairs to only OEMs can lead to increased costs and longer equipment downtime, which ultimately impacts patient care. As Chase, a biomedical technician, noted:

"If you consider that bulb too, they're putting a mandate on when the bulb is going to go bad even though it can go far longer. Not to mention when you consider the cost of the bulb, these bulbs are ridiculously $500 and there's nothing in those bulbs that dictate that price to begin with."

Debunking Myths About Third-Party Repairs

A common argument against third-party repairs is that they put patients at risk. However, the experts emphasized that this is simply not true when repairs are done by properly trained technicians.

Bill Bastic explained:

"As long as we do the PMs [preventative maintenance] to the manufacturer standards, there's no difference as who works on it as long as they're trained properly...We never do it on the case of patient safety. If it passes the calibration checks and the preventive maintenance checks, it'll go back in use."

In fact, the biomedical technicians I spoke with said that user error and malpractice are far more common causes of patient harm than equipment malfunctions. They emphasized that their work is heavily regulated and follows strict quality control processes.

As Chase noted:

"We are trained on this, we go through a high level of training, not to mention every BMET in the field continues their education even after that, going through manufacturer-provided training, go to get further degrees."

The Reality of Medical Equipment "End of Life"

Another contentious issue is when medical equipment reaches "end of life" as determined by the manufacturer. The experts explained that this is often more about selling new equipment than actual safety concerns.

Bill Bastic said:

"End of life means that they no longer want to support it and they're not going to make any more parts for it, and therefore they want to sell a new medical device...We never do it on the case of patient safety. If it passes the calibration checks and the preventive maintenance checks, it'll go back in use and it's not end of life until we say it's end of life."

He emphasized that rural hospitals and clinics often can't afford to constantly replace equipment just because the manufacturer deems it "end of life." Third-party repair allows this equipment to be safely maintained and used for longer periods.

The Importance of Proper Training

While the experts strongly supported the right to repair, they also emphasized the critical importance of proper training and certification for anyone working on medical equipment.

As Bill explained:

"A good ISO [independent service organization] will not work on equipment that they're not really qualified to work on...In my hospital, we do not work on anesthesia equipment. I give that to the OEM, and that's because that's my choice as a business owner and the reason why I do that, it reduces my risk on liability insurance."

The biomedical technicians undergo extensive training and continuing education to stay up-to-date on the latest equipment. Many have specialized expertise that may even exceed that of OEM technicians in some cases.

Challenges and Opportunities in the Field

The experts highlighted both exciting developments and ongoing challenges in medical equipment technology and repair:

Positive trends:

• Increasing sophistication of medical devices, like robotic surgical systems, that improve patient outcomes
• Growing awareness of the importance of right to repair
• Efforts to improve collaboration between OEMs, ISOs, and in-house biomedical departments

Ongoing challenges:

• Shortage of trained biomedical technicians
• Extremely high costs for some OEM training programs
• Continued pushback from some OEMs against right to repair

Bill Bastic is working to address some of these challenges through his online biomedical equipment technology school. The program aims to train more technicians and is implementing virtual reality to provide hands-on experience.

Conclusion

Medical equipment repair and maintenance is a complex field that plays a critical role in our healthcare system. While patient safety must always be the top priority, the evidence shows that properly trained third-party technicians can safely repair and maintain medical devices.

Right to repair is essential for controlling healthcare costs and ensuring hospitals and clinics have access to working equipment. As the experts emphasized, the key is proper training, rigorous quality control processes, and collaboration between OEMs, ISOs, and in-house biomedical departments.

For those interested in entering this rewarding field, there are growing opportunities to train as a biomedical equipment technician. With the ongoing shortage of qualified technicians, it's a career path with strong job prospects and the chance to make a real difference in healthcare.

Article created from: https://www.youtube.com/watch?v=Ow7XZbyLklA