The United States prides itself for having high standards when it comes to healthcare.
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 health care 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.