by
John R. Fischer, Senior Reporter | February 02, 2022
From the January/February 2022 issue of HealthCare Business News magazine
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.
Back to HCB News
