New Standard Addresses Medical Equipment Servicing

New Standard Addresses Medical Equipment Servicing

This piece was originally published in the May/June 2019 issue of electroindustry.

Peter Weems, Senior Director of Policy & Strategy, MITA

In March, MITA published NEMA/MITA 2 Requirements for Servicing of Medical Imaging Equipment, a Standard that describes and defines the minimum quality management system (QMS) requirements for the servicing of medical imaging devices to ensure return to a safe and effective condition for its intended use. Until now, there have not been any QMS Standards developed specifically for servicing of medical imaging devices. MITA saw this as a critical gap that  needed to be filled in order to protect patient safety and device integrity.

Servicing a medical imaging device is a complex and often difficult activity that poses a range of serious risks to patients and operators if performed improperly. Performance of servicing activities within an appropriate QMS by properly trained personnel using qualified, properly sourced parts greatly reduces the risk of harm to the patient or operator and greatly improves the performance of the device. A QMS is a highly valuable tool for ensuring that medical imaging devices consistently meet applicable requirements and specifications.

Further, a properly implemented and managed QMS will drive an organization to continually improve and consistently deliver quality service to its customers. The requirements of this Standard are intended to be applicable to any medical imaging equipment servicing organization, regardless of size, or the specific equipment maintenance services  it provides. The provider of applicable services may be an individual organization or may be an operating unit within an organization.

It is our hope that this Standard will be widely adopted by interested stakeholders. Further, we anticipate future work that will lead to an ANSI Standard on this issue. ei

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