The Medical Imaging & Technology Alliance (MITA) has released a draft of a standard for the servicing of medical imaging equipment to a mixed early reaction from stakeholders. The proposed national standard would apply to any entity that services imaging equipment, including healthcare technology management (HTM) departments in hospitals, original equipment manufacturers (OEMs), and independent service organizations (ISOs).
Following a year in which the debate over the servicing of medical devices has made its way from hospital halls to Capitol Hill, some stakeholders fear the draft standard will ultimately open the door to more federal regulation and greater burdens on ISOs and HTM departments. Supporters, on the other hand, have long cast the effort as an attempt to bolster patient safety and level the regulatory playing field for all those who service medical devices.
The public comment period for the draft MITA standard is open until Dec. 18, and there is one thing that most observers seem to agree on: all stakeholders need to weigh in and share their perspectives and experiences.
The proposed standard – which is largely based on 21 CFR 820, a quality management system regulation developed for medical device manufacturers – outlines the minimum quality system requirements for servicers of medical imaging equipment, such as computed tomography, magnetic resonance imaging, ultrasound, and video equipment, as well as the software, hardware, and systems that make up imaging devices and any devices required to capture effective images.
In addition, the standard summarizes necessary purchasing controls, training, acceptance activities, and inspections, as well as requirements for service reports, managing customer feedback, corrective and preventive action, and cybersecurity considerations.
Voluntary Standard or New Requirement?
The servicing standard is being developed as a voluntary consensus standard in compliance with American National Standards Institute requirements. However, once the standard is finalized, it could be “easily adopted” by regulators, such as the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), as well as other “authorities having jurisdiction,” according to Steve Grimes, managing partner and principal consultant at Strategic Healthcare Technology Associates LLC.
“Consequently, it could become a requirement for anyone who services imaging equipment,” said Grimes, who participated in the committee that worked on the draft standard.
“In the future, it is possible that these standards will be incorporated by reference into the accreditation standards or by CMS,” said Andrea D. Browne, a diagnostic medical physicist in The Joint Commission’s Department of Engineering. In such case, TJC would look at the “numerous policies and procedures that must be developed to comply with this standard” and “determine if the accredited organization is following their policies,” much like the organization does with the NEMA XR-29 standard for radiation safety.
The possible jump from voluntary standard to regulatory requirement is what concerns many HTM professionals and ISOs.
“Generally, we all can agree that quality assurance is desirable,” Grimes said. “But if the finalized standard is adopted by regulators under the theory it will ensure higher quality service, it will certainly place additional burdens and costs on existing servicers and may force some to abandon the service of imaging equipment altogether.”
Third-party service providers also are concerned about the lack of requirements in the standard for OEMs to provide service documentation, training, parts, diagnostic software, or other similar materials.
“It’s our belief that it is all well and good to establish standards for training, calibration, and testing, but the common issue of a manufacturer’s ‘withholding of important equipment information’ necessary to implement these standards continues to be the ‘elephant in the room’ that’s being sidestepped,” Robert Kerwin, general counsel for the International Association of Medical Equipment Remarketers and Servicers, wrote in a recent editorial.
Call for Public Comments
The draft standard is circulating for formal balloting and public comment until December 18. Free electronic copies of the document can be requested from Peter Weems, 703-841-3238 or firstname.lastname@example.org. Comments can then be submitted to Weems via email with a copy sent to email@example.com.
“The work doesn’t end when a standard is drafted. It’s critical that all interested parties – even those who were not part of the committee – consider submitting comments during the public comment period,” said Patrick Bernat, director of HTM at AAMI.
These comments are crucial for making sure that a true consensus is reached, according to Dave Francoeur, senior director of brand and quality for Sodexo Clinical Technology Management.
“Anyone who has opinions related to these initiatives should make their thoughts known,” Francoeur said. “Regardless of which camp you fall in, staying focused on patient safety and health care quality are the primary concerns. Everyone’s voice should be heard.”
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