In February of 2019, the Medical Imaging and Technology Alliance (MITA) released a new standards whitepaper titled "Requirements for Servicing of Medical Imaging Equipment". It is the latest item to stir the ongoing debate on who should be servicing imaging equipment and how it should be serviced.
A document like this has the potential to be worrisome for some service entities. We don’t see it that way.
It's no secret that the MITA organization focuses heavily on the needs of the original equipment manufacturers. The list of entities that wrote the document include: Acertara, Agfa, Bracco, Canon, EIZO, Esaote, Fuji, GE Healthcare, Hitachi, Hologic, Philips, Siemens Healthineers, and many more.
While fewer third-party service organizations (like Block Imaging) were invited to weigh in. It doesn't hurt our feelings. It's a voluntary standard, it's written in classic QMS language, and it should be immediately recognizable by any legitimate service organization as a practical baseline to effectively and safely service imaging equipment.
What We’re Glad It Has
1. A simple and straightforward set of requirements that should always be part of maintaining medical imaging equipment.
2. The consistent focus on "intended use". It's crucial that service organizations NEVER make modifications to the intended use of imaging equipment. It opens up a huge risk to patient safety and liability.
3. A clear and consistent definition of "remanufacture". It includes any work "that significantly changes the finished device’s performance or safety specifications".
What We Wish It Had
While we would have loved to see a commitment to providing access to service documentation for third-party servicers, we didn't expect it, and frankly, that's not the focus of the standard or the MITA organization. On the other hand, they could have declared that everyone servicing imaging equipment should have OEM training, which is neither true nor what they said. That's good!
Instead, they said, “Each service provider shall have sufficient personnel with the necessary documented qualifications to assure that all activities required by this Standard are correctly performed. The qualifications may include a background in medical imaging technology, clinical application, and use, associated components, systems, and appropriate regulatory compliance knowledge.”
While there are some third-party service companies who fear the potential of regulation of imaging service, we don't see standards like this one as a bad thing- especially since compliance with it is voluntary. The more agreement and commitment we have as an industry to following ISO standards and maintaining effective quality management systems, the less need for regulation exists.
If you haven't seen the document yet, and you're in the business of servicing imaging equipment at your hospital or as a third-party service company, I'd encourage you to download it for free and share it with your team.
*UPDATE* An earlier version of this post referred to the new standard as a "proposed standard". Special thanks to G. Wayne Moore at Acertara for pointing out the needed correction.