This piece was originally published in the November 2016 issue of electroindustry.
Jim Nestel, Manager Service Projects and Installations, Hitachi Medical Systems
Only original equipment manufacturer (OEM) service providers are required by the Food and Drug Administration (FDA) to have a quality management system (QMS) to assess medical imaging equipment.
Although many non-OEM medical imaging device service providers perform excellent work, the lack of such a requirement leaves the door open to low quality and unsafe practices that may be hidden from equipment owners, patients, and healthcare providers.
What could go wrong?
If a magnetic resonance image (MRI) is blurry due to poor calibration, a tumor could be missed. If a computed tomography (CT) scanner is out of operation, an emergency room patient might wait hours for a complete exam. If an ultrasound is improperly sealed, the patient or provider could be electrically shocked.
Why, then, would a medical device servicer forgo a QMS?
Unfortunately, the answer may come down to short-sighted concerns about finances. The development and implementation of a quality system require upfront costs of money and time. Adoption of new processes means that resources may be temporarily diverted to bringing about necessary changes.
Change, however, can be rewarding. Adoption of a quality system is a rigorous process in which an organization undergoes thorough self-assessment and documentation. These processes allow management to understand not only specifics, such as day-to-day operations, but also larger issues, such as the organization’s overall direction and integrity.
An in-depth development and registration process often exposes opportunities for improvement, yet improved efficiency may save time and money. Quality systems may also help an organization become more efficient and productive through better business intelligence and increase marketability. A QMS registration conveys credibility and integrity. It proves the organization is dedicated to quality, whether negotiating with existing customers or acquiring new ones. This commitment to quality may result in increased customer satisfaction, acquisition, and retention in new and existing markets.
A properly implemented and managed QMS will drive an organization to improve continually. When new problems are investigated in an organized and timely manner, root causes can be identified and solutions developed and implemented to prevent problems from reoccurring. Persistently identifying and eliminating impediments to product quality improves overall performance and reliability; reduces costs from product defects, work errors, and liability claims; and increases safety for employees, customers, and patients
Given all of these benefits, how can an organization afford not to adopt a QMS?
MITA recommends that the FDA require that everyone who services a medical device is held to minimum quality, safety, and regulatory requirements that include the implementation of a QMS. The MITA Service Committee is developing a standard that outlines what must be included in a proper servicing program to ensure patient safety and device performance.Read the November 2016 issue of electroindustry.