Tag: medical device safety

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Why Post-Market Surveillance Is the Real Test of Medical Device Safety

Effective post-market surveillance depends on HTM teams to bridge the gap between regulatory oversight and real-world performance.

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Radimed Infusion Pump Device: Urgent Medical Correction

IRadimed Corp. issued an Urgent Medical Device Correction Letter regarding a potential issue with some 1057 Syringe Adapter Sets.

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Bill to Improve Process for Reporting Medical Device Safety Issues Introduced

Two congressmen introduced a bill to improve the FDA process of reporting an adverse health event, or safety signal, due to a medical device.

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Why Post-Market Surveillance Is the Real Test of Medical Device Safety

Effective post-market surveillance depends on HTM teams to bridge the gap between regulatory oversight and real-world performance.

VA Hospital Warns 4,000 Patients of Infection Risk Tied to Unsterile Equipment

Feb 23, 2022

A VA Medical center briefly halted medical procedures this year after discovering concerns involving the reprocessing of reusable medical equipment.

Joint Commission Issues Safety Advisory on Critical Instruments, Medical Devices

Feb 18, 2022

The new advisory highlights the importance of how surgical instruments and other critical devices are reprocessed and reused every day in healthcare.

New Medical Device Risk Assessment Toolkit Combats Cybersecurity, IoT Risks

Feb 8, 2022

CORL launched a medical device security assessment toolkit to combat medical device and IoT risks that may be introduced by third-party vendors.

FDA Must Improve Medical Device Interoperability Through Data Standards: JAMA

Feb 1, 2022

Medical researchers are calling on the U.S. FDA to place more emphasis on initiating conformity of medical device interoperability in the healthcare industry.

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.

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

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