A Medical Device Recall Workflow is an Underrated Thing

Nurses, software developers, patients, and caregivers have a simplified way to verify if a digital health application or medical device has been validated or recalled

Image by Rondell Melling from Pixabay

Clinicians must create a workflow to stay up to date on recalls in this digital age.

They must understand the U.S. Food and Drug Administration’s (FDA) role in recalls, especially medical devices (48% of the total share of the regulated products as of 2018). Nurses, for example, need a workflow in triage to manage the influx of patients with recalled products to give the best education and verify the recall.

“The FDA regulates a wide range of products” FDA, Fair Use.

The FDA in 2019, has added digital health under their product oversight to cover “mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and…