Tag: medical device safety

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ASDSA Calls for Enhanced Medical Device Safety for Patients of All Skin Types

The ASDSA is calling for changes to minimize risk to patients caused by inaccuracies in medical device readings due to diverse skin tones.

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ISMP Launches New Perioperative Medication Safety Guidelines

The ISMP published the first set of safe practice guidelines in addressing identified national gaps in medication safety.

Smiths Medical Issues Device Correction Related to Fast-Flow Fluid Warmers
Scientists Devise Method to Prevent Deadly Hospital Infections Without Antibiotics
Bill to Improve Process for Reporting Medical Device Safety Issues Introduced
National Evaluation System for Health Technology Coordinating Center Forges Medical Device Partnership
ECRI Workflow Solution Improves Healthcare Product, Standardization Decisions
Extensive Updates Made for Endoscope Cleaning, Patient Safety Standards

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UL Acquires Korean-Based Medical Device Safety Company

Global safety science provider UL acquired KBW Corporation, a testing and market access services provider for medical devices.

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ASDSA Calls for Enhanced Medical Device Safety for Patients of All Skin Types

The ASDSA is calling for changes to minimize risk to patients caused by inaccuracies in medical device readings due to diverse skin tones.

Contaminated Medical Devices Used in Open Heart Surgery Caused Severe Infection in Patients

Jan 20, 2022

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.

FDA’s Health of Women Strategic Plan to Better Inform Medical Device Research, Regulation

Jan 19, 2022

The plan seeks to strengthen regulatory science and identify current and emerging issues in medical device research and regulation for women’s health.

Utah’s Project Embrace Refurbishes Medical Devices for Those in Need

Jan 7, 2022

Project Embrace offers the provision of necessary medical resources to low-income, isolated, marginalized, or low-resource communities.

Unpacking Averages: Likelihood of FDA Medical Device Inspections

Jan 5, 2022

The FDA’s new medical device inspections dashboard indicates that there are county level hotspots for inspection rates, but not state or region hotspots.

HTM: The Unsung Hero in Your Patient Satisfaction Strategy

Dec 21, 2021

Having an optimized HTM program that delivers efficiency and effectiveness to a hospital is an often-overlooked part of the patient satisfaction equation.

Playbook for Threat Modeling Medical Devices Aims to Strengthen Cybersecurity, Safety

Nov 30, 2021

The playbook for threat modeling aims to provide insights to organizations developing or evolving an approach to creating threat models for medical devices.

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Device Used by Many Diabetics at Center of Wrongful Death Lawsuit in Georgia

An Atlanta resident died of hypoglycemia after his Dexcom G6 glucose monitoring device failed to sound an alarm; his widow is pursuing a wrongful death suit.