The U.S. prides itself for having high standards when it comes to healthcare.
It’s one of the reasons America’s healthcare system is among the best in the world. From highly skilled doctors and nurses to state-of-the-art medical facilities, American patients have come to expect quality in every part of the health system. Meeting high standards goes hand in hand with patient safety, and we often take for granted the fact that the tools health professionals use to diagnose and treat diseases must be well-maintained to work as intended.
However, when it comes to ensuring that medical imaging devices are serviced in a manner that protects patient safety and device performance, there is a current lack of consistent standards.
Equipment that includes staples of diagnostic imaging such as MRI machines, CT scanners and ultrasound systems that healthcare professionals rely on daily to assist with diagnosis and disease monitoring are left open to the interpretation of what is unsafe, ineffective or too expensive to maintain appropriately.
While many other industry sectors have a common set of guidelines and best practices for safety, such standards are not currently in place for the entire medical device servicing industry.
Federal oversight of medical device servicing now only extends to the device’s original manufacturer leaving maintenance and repairs performed by third-party servicing companies without even basic standards of practice to implement in servicing complex equipment.
Third-party servicing companies are largely unregulated. This means there is no oversight in place to ensure the quality and safety of the devices or determine whether their servicing activities have crossed over into unauthorized remanufacturing (which is regulated by the FDA).
This means any serviceable medical device used for patient care may be maintained or repaired by technicians with no training or experience, may lack a detailed service history records or may include unqualified parts which could result in poor or unsafe device performance. This lack of oversight poses an increased risk to public health and patient safety.
Mindful of these needs and the gap in applied standards for servicing medical devices, a diverse group of imaging device stakeholders led by MITA collaborated to develop a voluntary, industry-wide standard for medical device servicing.
The NEMA/MITA 2 - Requirements for Servicing of Medical Imaging Equipment outlines the minimum quality management system requirements for device servicing, including the training, verification, and validation to ensure that servicing activities are performed in a manner that protects patient safety and device integrity.
Though developed for imaging devices, this standard can be more broadly applied to other serviceable medical device types and aims to serve as a foundation for future standards development.
Organizations conforming to the practices described in the standard will benefit from having a clear set of guidelines in place to ensure they are servicing devices in a safe and effective manner, while providers and imaging centers that use these devices will have peace-of-mind knowing that their equipment is in good hands. Crucially, the standard ensures that servicing activities remain servicing activities—and do not cross into remanufacturing.
A recent FDA report found that there are between 16,000 and 20,000 entities engaged in medical device servicing throughout the country. And while most of them are proud to perform high-quality work that may already adhere to the new standard, the gaps in accountability across the industry ultimately leave patients and providers vulnerable. For example, manufacturers routinely receive reports of instances where devices were serviced improperly, using unauthorized parts or materials that cut corners or even modify the device’s original functionality.
These short cuts pose a great danger to patients, as adverse events stemming from improper servicing or remanufacturing activities can lead to serious injury or even death.
The new MITA servicing standard helps reduce this risk by promoting the adoption of quality management principles in device servicing, something the FDA itself has acknowledged needs to happen. It also provides needed clarity to the distinction between remanufacturing and servicing, so third-party servicers can ensure they are compliant with existing regulations.
Complex equipment like imaging devices should be held to robust servicing standards—regardless of who’s doing the work. Patients and providers alike deserve the peace of mind that comes with knowing that the devices they depend on are safe and effective.
Dennis Durmis is Senior Vice President Bayer Radiology, Americas Region and serves as chair of the Medical Imaging Technology Alliance (MITA) Board of Directors.