Twist Ties & Tape: MITA Highlights the Need for Third-Party Servicer FDA Registration
The alliance is calling for all third-party medical equipment servicers to be required to register with – and abide by regulations from – the FDA.
Worries over equipment maintenance provided by third-party servicers has been a long-standing concern for radiology leaders. In its latest push for greater safety, the Medical Imaging & Technology Alliance (MITA) released a white paper this week, calling for third-party servicers to register with the U.S. Food & Drug Administration (FDA).
Related Content: MITA Calls for FDA Registration for Third-Party Medical Device Servicers
Currently, third-party groups are not subject to the same requirements and regulations that govern original equipment manufacturers and healthcare facilities. Instead, they abide by voluntary standards. This situation has resulted in multiple scenarios that put both patients and providers at significant risk, including instances of equipment that have been repaired with tape or twist ties, as well as improper ventilation.
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Diagnostic Imaging spoke this week with Peter Weems, MITA senior director of strategic operations and policy, about the pervasiveness of this issue and the threats it presents. He also shared details on the ongoing efforts to require FDA registration for these services and what individual radiologists and rad techs can do to participate, directing providers and other interested parties to Protect Safe Servicing, a website that can provide more information about the risks of third-party servicing, how to address the problem, and case studies of unsafe incidents.
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