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IAHCSMM Announces Board of Director Election Results

The International Association of Healthcare Central Service Materiel Management (IAHCSMM) announced the election results for four board of director positions.

Medtronic Recalls Valiant Navion Thoracic Stent Graft System

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module

Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

Metrex Surface Disinfectant Portfolio Secures EPA Approval

The U.S. Environmental Protection Agency (EPA) has approved all eight surface disinfectant products made by an infection prevention leader, Metrex, as effective against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Proposed Medical Devices Standard Helps Validate Cleaning Methods

A proposed ASTM International standard presents methods for detecting and quantifying cleaning markers (analytes) on reusable medical devices. ASTM’s committee on medical and surgical materials and devices (F04) is developing the proposed standard.

The objective of the proposed standard (WK63284) would help medical device manufacturers, testing laboratories, and regulatory bodies identify the appropriate method(s) for evaluating whether a medical device can be adequately cleaned. The committee is developing a series of guides for validating cleaning instructions for medical devices.

“The proposed standard would be helpful in determining the quantitative test methods for accurately determining the analyte concentration in clinically relevant soils,” says ASTM International member Kaumudi Kulkarni of Healthmark Industries Co.

ASTM welcomes participation in the development of its standards. Become a member at www.astm.org/JOIN.

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