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 MITA’s 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 group of stakeholders, is meant to apply to any medical imaging device servicing organization regardless of size or the specific services it provides, MITA officials say.
“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 healthcare providers alike,” says 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, MITA officials say. 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 its own white paper outlining its framework for establishing the distinction between the two activities. “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 concludes.
