However, while conserving assets through refurbishment fulfills the need for affordable products and ecological thinking, suitable guidance is needed. In general, the two most important aspects of medical imaging equipment are safety and effectiveness. By redesigning equipment to incorporate emerging technology, it is easy for a refurbisher to neglect a manufacturer’s original requirements.
Luckily, the practice of quality assurance in refurbished materials has been in use for some time now, with several medical imaging equipment companies having a quality management system in place to provide reliable and affordable products. IEC has recently published IEC/PAS 63077 ED. 1.0 EN:2016 - Good refurbishment practices for medical imaging equipment, a document describing such a process.
While not a standard but a publicly available specification (PAS), IEC/PAS 63077:2016 still provides guidance on the refurbishment of medical imaging equipment so the products are reintroduced into the market and can function in a manner identical to their original performance. The PAS restoration process includes actions such as repair, rework, software and hardware updates, and the replacement of worn parts with original parts.
This follows a process that, in adherence to ISO 13485:2016 quality management guidelines, makes use of planned corrective action to replace the appropriate parts. This should incorporate knowledge on the device’s history and intended use after its refurbishing, along with an evaluation of market access requirements. IEC/PAS 63077:2016 also calls for a post-market surveillance process by which the refurbisher collects feedback from customers to note whether the devices actually meet their intended use.
At the end of all this, there should be a record of refurbishment, labeling all changes made to the medical imaging equipment and noting the time when those changes were made.
IEC/PAS 63077 ED. 1.0 EN:2016 - Good refurbishment practices for medical imaging equipment is now available on the ANSI Webstore.