This piece was originally published in the March/April 2019 issue of electroindustry.

Andrew Kuhls-Gilcrist, Chair, MITA Interventional Fluoroscopy Working Group; Senior Manager, XR/VL, Canon Medical Systems USA, Inc.

A patient suffering from a heart attack is wheeled into the emergency room of a busy hospital. The doctor calls for an emergency angioplasty to quickly open the blocked artery and reduce the amount of damage to his heart. ER workers set up and switch on an interventional fluoroscopy system, which will guide the doctor through the procedure by imaging the patient’s heart in real time. However, the LED backlight on the display monitor is too dim. The doctor can’t get a good picture of the heart, and the emergency surgery is called off, all while the patient struggles without treatment. What happened?

Interventional fluoroscopy equipment are complex systems of fine-tuned medical x-ray equipment. Serious issues can occur when someone alters equipment without consideration for the long list of components and connections, including the image display system and image display device. If displays not validated to the exacting Standards manufacturers adhere to during production and installation replace validated displays, patients can end up in a situation just like the one described  above. Additional safety concerns may include electric shocks, trauma, misdiagnosis, inadequate or unexpected image quality, and unnecessary radiation dose—all caused by something as seemingly mundane as display monitors.

That is why it is so important for potential users of third-party displays, and for the servicers that install them, to be aware of the requirements and Standards for which manufacturers design medical devices. Any organization that plans to perform a modification to a medical device that could affect the image display system needs to develop a validation plan that incorporates the appropriate Standards, technical reports, guidance documents, and design inputs. Awareness of these requirements protects patients, and adherence to them ensures that users meet device safety and performance requirements.