The ASDSA is calling for changes to minimize risk to patients caused by inaccuracies in medical device readings due to diverse skin tones.
Tag: medical device safety
In October 2015, Canadian Paul Johnson underwent open heart surgery to correct a defect in his aortic value. Unfortunately, the surgery didn’t go as expected due to a contaminated medical device. And now litigation is pending.Read More
The plan seeks to strengthen regulatory science and identify current and emerging issues in medical device research and regulation for women’s health.Read More
Project Embrace offers the provision of necessary medical resources to low-income, isolated, marginalized, or low-resource communities.Read More
The FDA’s new medical device inspections dashboard indicates that there are county level hotspots for inspection rates, but not state or region hotspots.Read More
Having an optimized HTM program that delivers efficiency and effectiveness to a hospital is an often-overlooked part of the patient satisfaction equation.Read More
The playbook for threat modeling aims to provide insights to organizations developing or evolving an approach to creating threat models for medical devices.Read More