Maintenance-related incidents for medical devices are being reported more worldwide

An international review of maintenance-related device incidents

February 02, 2022
by John R. Fischer, Senior Reporter
While regulations for reporting and handling maintenance-related incidents in medical equipment can help mitigate their impact, not all countries are on the same level when it comes to adverse event protocols. Four countries with relatively thorough and accessible data are the U.S., Germany, Scotland and Canada. In a session last summer at the 2021 AAMI eXchange, three experts looked at the numbers to see how the four countries stacked up.

Incidents related to servicing in the U.S. are tricky to quantify due to discrepancies between what the FDA reports and what the Joint Commission reports, according to Binseng Wang, VP of program management for Sodexo CTM – USA. However, the number of device maintenance related incidents reported lands somewhere between 18 and 172 per year between 1977 and 2018, or between .0004% and 3.14% of total incident reports.

Underreporting may also represent a challenge among doctors in the U.S. due to fear of litigation. FDA reports were found to contain bias from manufacturers who deny anything wrong with their equipment and blame issues on user errors. “So-called user errors are not exactly errors made by the users, but issues related to the human-machine interface,” said Wang.

Despite these issues, quality of service in the U.S. for medical equipment, however, is recognized as “very high” and in the “in the neighborhood” of 7 SIGMA (a measurement of manufacturing quality), said Wang, adding that one of the biggest issues is the “right to repair” debate around whether or not manufacturers should be obliged to share service information about their technologies with independent servicers.

A total of 603 incidents relating medical equipment servicing were reported between 2005 and 2016 in Germany, three of which resulted in death, due to poor maintenance (two by OEMs and one by an ISO).

Unlike in the U.S., manufacturers in Germany are required to share information with non-OEMs. Issues, however, still exist. “In many cases OEMs try to limit access to the information, proprietary parts, and technical training to keep their service monopoly,” said Frank Rothe, head of service management Europe at Vamed Management und Service GmbH, Deutschland – Germany. He argued that a more appropriate strategy would be to implement a remote service where manufacturers aid BMETs and technicians working in hospitals to solve issues that arise in devices for the safety of patients.

In Scotland, no medical device-related deaths were identified between 2014 and 2019, with the country documenting 18 reports involving medical equipment servicing. Jean Ngoie, head of instrumentation and clinical engineering for NHS Tayside in Scotland, attributes this to rigorous maintenance in biomedical engineering programs and continuous improvement of medical device regulatory processes.

Any data for research on medical device incidents and maintenance and service-related adverse events in Scotland must be requested under the Freedom of Information Act. This presents a challenge, said Ngoie. “The data we received were very limited and only tailored to the request made, to the question we asked, and the information we obtained for it. Healthcare in Scotland could benefit from making incident events available to the public.”

Also an expert on maintenance-related incidents for medical devices in Canada, Ngoie said underreporting was an issue there until 2015 with the introduction of the Canadian Medical Sentinel Network. While the country recorded 355,972 total health incidents between 2011 and 2020, the percentage of incidents related to maintenance and services of devices was minimal at 0.004% and only two led to death.

As with Scotland, he chalked this up to rigorous maintenance programs in biomedical engineering departments and continued regulatory improvements, and called on those in charge of clinical engineering not lose sight of their responsibility. “They should protect at all costs the gain shown here through a rigorous incident reporting process and the investment in service and repair of medical equipment, devices and systems.”

All told, preliminary results from a study conducted by health technology professionals across the globe show that less than 1.5% of all medical device related issues reported each year can be attributed to medical device maintenance or service.

The presenters concluded by reminding servicers to recognize the difference between servicing and remanufacturing, and report anyone performing improper services that pose harm to patients. They also made the case that additional regulations on service would not increase patient safety. But rather stifle competition, as manufacturers seek to withhold service information, proprietary parts and tools.

“We want to have access to this information at a reasonable cost in a reasonable manner so we can protect the patients ultimately,” said Wang.