por John R. Fischer
, Senior Reporter | September 27, 2021
Since the publication of the FDA’s 2018 report on medical device servicing, improving technician training has become a priority for OEMs, ISOs, in-house healthcare delivery organizations (HDOs), HTM professionals and other service organizations.
To help meet that need, a coalition of volunteer organizations, known as the Medical Device Servicing Community, was formed in the wake of the report. Three years later, a working group appointed by the MDSC has drafted a white paper outlining best practices for training technicians and is seeking feedback from medical device servicers for finalization.
The white paper will be open for comments until 5 p.m. EST on October 13, with the aim being to ensure that such professionals are trained to service equipment safely, effectively and with the proper quality it requires, Dave Francoeur, co-chair to the steering committee and leader to the benchmark subgroup for MDSC, told HCB News. “We absolutely hope we can influence the industry to play a small role in helping to ultimately increase uptime, reduce response time, increase customer satisfaction and improve patient outcomes.”
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Commenting is open to any interested party with a connection to medical device servicing, including, but not limited to OEMs, ISOs, in-hospital biomeds, clinical engineers, HDOs/HTM departments, professional organizations and regulatory bodies. The Association of periOperative Registered Nurses (AORN), an active member of MDSC, will help to collect comments and work with the coalition and the Association for the Advancement of Medical Instrumentation (AAMI) to review and consider all comments for the final draft.
Recommendations in the paper are geared toward training across all service organization types and include general practices that can be applied to any training regardless of equipment type.
In addition to helping prevent adverse events, Francoeur says the draft is meant to help validate the findings of the 2018 FDA report, which found no evidence
to suggest that there was a widespread public health concern around the servicing of medical devices that justified the need to regulate third-party service providers. Despite this, manufacturer interest groups like the Medical Imaging and Technology Association have sought increased regulation of third-party servicers
“Over the past several years, since the inception of the MDSC, we have been attempting to work on and provide evidence that supports the FDA findings that say individuals providing ‘service’ on medical devices does not mean less safety or quality of maintaining medical devices,” however, "striving to continually work toward establishing baselines and implementing process that can be validated as improvements in safety and quality as it relates to maintain medical equipment, should be something everyone eagerly works together to achieve, driving measurable better outcomes," said Francoeur, who is also senior vice president of marketing and sales at Tech Knowledge Associates, a company providing HTM services to healthcare facilities.
When OEMs ISOs, HDOs and third-party servicers are not working together and sharing relevant information, it hampers equipment service. According to Francoeur, if there are "flags" suggesting the highest level of safe quality maintenance cannot be assured, steps must be taken to address it.