The Medical Imaging & Technology Alliance (MITA) has published a new voluntary standard addressing the servicing of medical imaging equipment. The document, NEMA/MITA 2—Requirements for Servicing of Medical Imaging Equipment, is available on the National Electrical Manufacturers Association (NEMA) website.
The standard covers the minimum quality management system requirements for medical imaging devices. It was specifically designed to apply to any organization of any size.
“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.” Dennis Durmis, chair of the MITA Board of Directors, said in a prepared statement.
The standard was also created to help organizations make sure they are not doing work viewed by the FDA as remanufacturing. Back in February, MITA released a white paper detailing the differences between servicing and remanufacturing and urged the FDA to clarify how it defines those terms.
“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,” according to the MITA statement. “This lack of oversight poses an increased risk to public health and patient safety.”