The Medical Imaging & Technology Alliance (MITA) has announced the publication of NEMA/MITA 2 – Requirements for Servicing of Medical Imaging Equipment, a voluntary standard outlining the minimum quality management system requirements for medical imaging device servicing.
The standard, whose development was sponsored by the National Electrical Manufacturers Association – the MITA parent organization – in conjunction with a diverse group of interested stakeholders, is the first quality management system standard developed for servicing of medical imaging devices. It is meant to apply to any medical imaging device servicing organization regardless of size or the specific services it provides.
“This first-of-its-kind standard fills a critical gap in the servicing field and will serve as an important resource for both servicing organizations and health care providers alike,” said Dennis Durmis, chair of the MITA board of directors. “It is important to have sound processes – such as training, verification and validation – in place to ensure that servicing activities are performed in a manner that protects patient safety and device integrity.”
Additionally, effective implementation of this Standard will enable stakeholders to ensure that their servicing activities do not cross into remanufacturing. While remanufacturing is regulated by the FDA, the agency does not currently require third-party medical device servicers to have controls in place to determine if their servicing activities constitute remanufacturing. This lack of oversight poses an increased risk to public health and patient safety.
The FDA has acknowledged the need to clarify the distinction between servicing and remanufacturing and has announced its intent to issue future guidance on this issue. Last month, MITA released a white paper outlining a framework for establishing the distinction between the two activities to serve as a resource for the FDA and the broader stakeholder community.
“We look forward to further engagement with stakeholders over the coming months to adopt quality management system principles that ensure the safe and effective servicing of imaging devices,” Durmis concluded.
On October 24, 2017, the proposed standard was balloted as an American National Standard for final approval. Public review of the document was also announced in the November 3 issue of ANSI Standards Action. The ballot closed on December 8, 2017, and was supported by the majority of stakeholders, but did not meet the required two-thirds support for approval.
MITA has previously indicated an interest in developing an American National Standard for quality management of servicing of medical devices. Although NEMA/MITA 2 was developed by medical imaging device stakeholders, its principles and processes can be applied more broadly to other serviceable medical device types, and it will serve as a foundation for future servicing standards development activities.
To view the standard, click here.
The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is a collective voice of medical imaging equipment manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology. For more information, visit medicalimaging.org.
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