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US warns on endoscopy processing

This article was originally published in RAJ Devices

Executive Summary

US healthcare facilities and manufacturers are being warned about the risks to patients if flexible endoscopes and their accessories are not properly processed. In a safety communication, the Food and Drug Administration, the Centers for Disease Control and Prevention and the Veterans Administration offer advice to healthcare facilities, including hospitals, ambulatory facilities and private practices, on how such risks can be reduced1. The communication also reminds manufacturers of their responsibilities in respect of helping to ensure proper endoscope processing in healthcare facilities.

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US warns on endoscopy processing

US healthcare facilities and manufacturers are being warned about the risks to patients if flexible endoscopes and their accessories are not properly processed. In a safety communication, the Food and Drug Administration, the Centers for Disease Control and Prevention and the Veterans Administration offer advice to healthcare facilities, including hospitals, ambulatory facilities and private practices, on how such risks can be reduced1. The communication also reminds manufacturers of their responsibilities in respect of helping to ensure proper endoscope processing in healthcare facilities.

Devices industry under scrutiny by US Justice Department

The medical device industry’s compliance with the Foreign Corrupt Practices Act in the US will come under close scrutiny from the Department of Justice in the months and years ahead, the head of the department’s Criminal Division has warned1. While his remarks were addressed to the pharmaceutical industry, assistant attorney general Lanny Breuer made it clear that they also apply to the medical device industry.

Devices industry under scrutiny by US Justice Department

The medical device industry’s compliance with the Foreign Corrupt Practices Act in the US will come under close scrutiny from the Department of Justice in the months and years ahead, the head of the department’s Criminal Division has warned1. While his remarks were addressed to the pharmaceutical industry, assistant attorney general Lanny Breuer made it clear that they also apply to the medical device industry.

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