The Medical Imaging & Technology Alliance (MITA) announced that it is expanding the scope of the NEMA American National Standard for Servicing of Medical Imaging Devices to cover all medical devices, not just medical imaging technologies. MITA officials say this decision—which is likely to be met with criticism from many in the medical device sector—“comes after the consideration of extensive stakeholder feedback indicating a desire for one, universal standard for the medical device industry.”
The voluntary NEMA Standard will outline the minimum quality management system requirements for medical device servicing, MITA officials say. “When followed, the standard will ensure servicers consider operational, performance, and safety factors to ensure safe and effective device operation,” they add.
Patrick Hope, MITA’s executive director, explained the decision in greater detail, commenting: “With an expanded scope, MITA will now leverage its existing consensus across various stakeholder groups to codify what quality management of medical device servicing should look like for the industry. Given the many perspectives on this issue, MITA is committed to an open and balanced development process.”
Interested stakeholders, including manufacturers, independent servicing organizations, clinical engineers, healthcare providers, regulators, accreditors, and others are welcome to apply by May 11, according to MITA.
In May 2017, Jim Spearman, president of Consensys Imaging Service, Inc. (which is now a Merry X-Ray company) discussed the MITA-backed “Medical Device Servicing Safety and Accountability Act” in a Viewpoint article. It’s a controversial topic, indeed, and one that has many differing opinions.
24×7 Magazine editorial board member and The LynchPin columnist Patrick Lynch, CBET, CCE, CHTM, CPHIMS, FACCE, for one, is not a fan of MITA’s move. “MITA is doing exactly what most biomeds thought they would—taking a simple, limited standard and expanding it to over-reach the necessary scope,” Lynch tells 24×7 Magazine exclusively. “I predict that this will not be the last time that MITA uses ‘extensive stakeholder feedback’ to justify expanding the scope to create further barriers to entry for medical device repairers.”
To Lynch, it’s simply a bid to reduce the number of players in the marketplace. “I challenge MITA to disclose exactly where this ‘extensive stakeholder feedback’ came from,” Lynch adds. “I will wager that it is primarily from MITA members, which translates to the equipment manufacturers who want to exclude others from repairing medical devices.”
So, do you agree with this assessment? Why or why not? Please comment below and share your thoughts and opinions about MITA’s latest decision.