The following are Medical Imaging & Technology Alliance (MITA) Senior Director Strategic Operations & Policy Peter Weems’s replies to submitted questions regarding the white paper “Understanding Accountability in Medical Device Servicing.”
TechNation: What prompted the creation of the “Understanding Accountability in Medical Device Servicing” white paper?
Weems: We want our devices to always perform safely and effectively for patient care. Increasing accountability and transparency of the third-party service industry is an important step to ensuring the safe and effective operation of all devices.
TechNation: What is the goal/purpose of the white paper?
Weems: The purpose of this white paper is to clarify how different entities are, or are not, held accountable for their medical device servicing activities.
TechNation: Who is the target audience for the white paper?
Weems: All interested or affected parties, including medical device manufacturers, health care providers, unregulated third-party servicing businesses, policymakers, patients and others.
TechNation: When was the white paper first posted and how many times has it been downloaded?
Weems: February 5, 2021. We have not received download figures yet.
TechNation: Can you explain the difference between third-party servicers and in-house hospital servicers? As non-OEM servicers aren’t they the same?
Weems: Third-party medical device service businesses compete with manufacturers and each other to win contracts to service medical devices. Third-party service businesses are currently not regulated by the FDA and are not required to meet any accreditation requirements.
Health care facilities often employ in-house staff charged with the management and maintenance of medical devices. To participate in the Medicare or Medicaid programs, health care organizations must meet certain Conditions of Participation (CoPs). Health care organizations can be accredited as meeting applicable CoPs by accrediting organizations such as The Joint Commission. Under the Joint Commission’s Standards, a health care facility must meet certain Environment of Care (EC) Elements of Performance (EP) requirements, including inspecting, testing, and maintaining imaging and radiologic equipment in accordance with the manufacturers’ recommendations.
TechNation: After reading the white paper, I understand that health care facilities/hospitals must report deaths and serious injuries. When they make these reports do they indicate who has serviced the device (OEM, in-house, third-party)?
Weems: FDA recently added a new question to Form FDA 3500A: “Was this device serviced by a third party?” followed by a checkbox for “Yes” and a checkbox for “No.”
MITA supported the addition of this question to the reporting form. Increasing accountability and transparency of the third-party service industry is an important step to ensuring the safe and effective operation of all devices. Very little is currently known about unregulated third-party medical device servicing businesses. Nonmanufacturer, third-party servicer businesses do not even have to register with the FDA, and they are not held to any quality, safety and regulatory requirements. In May 2018, the FDA estimated that “total number of firms performing medical device servicing in the U.S. is between 16,520 and 20,830,” but said the “precise number of entities that perform servicing of medical devices in the U.S. is not known.” Why do third-party medical device servicers refuse to make themselves known to the FDA?
TechNation: The white paper does not have a “conclusion” or “summary.” What is the call to action or desired action/outcome?
Weems: We support policy reforms that would protect patient safety by requiring third-party servicing businesses to also meet the basic requirements that OEMs are currently meeting, including:
TechNation: Is NEMA/MITA asking the FDA to require all medical device servicers to register with the organization?
Weems: Medical device servicing businesses should be required to register with the FDA.
TechNation: How can individuals provide comments regarding the white paper?
TechNation: Please share anything else you think the readers of TechNation magazine and/or ICE magazine would find helpful regarding the white paper and this topic.
Weems: For more information, please visit www.protectsafeservicing.org.
An article on the white paper with input from a variety of stakeholders is available here.
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