Enhancing Patient Safety: An Insight into Medical Device Servicing Standards  

Wes Bonebright has over two decades of experience in the medical device servicing industry. As an engineer, Bonebright knows that medical imaging devices are highly complex pieces of capital equipment, and even small repairs require extensive expertise and oversight. And with experience in both Independent Service Organizations (ISOs) and Original Equipment Manufacturers (OEMs), he saw firsthand the disparities in training requirements between the two.  

Unlike OEMs, non-manufacturer ISOs are unregulated by the U.S. Food & Drug Administration (FDA) and largely escape any oversight or accountability. Little is known about how many ISOs are operating or what experience or qualifications ISO servicers typically have. Even the FDA has noted that the precise number of entities that perform servicing of medical devices in the U.S. is not known.

By sharing his own service engineering story, Bonebright sheds light on the vital role played by OEMs in ensuring the reliability and quality of medical device servicing and emphasizes the need for the FDA to enforce uniform standards for servicing regulated medical devices.  

Underscoring the immense investment made by OEMs in training their service engineers, Bonebright highlights the rigorous safety training requirements, time, and resources devoted to developing the skills necessary to maintain and repair medical devices effectively:

Through our advocacy work, Right Scan Right Time (RSRT) and the Medical Imaging & Technology Alliance (MITA) are working to enhance patient safety and improve the overall quality of medical device servicing. We believe the FDA should hold all servicers to the same quality, safety and regulatory requirements, including registration, quality management system, and reporting of adverse events.

To learn more about MITA’s commitment to patient safety and accountability through medical device servicing, CLICK HERE.