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U.S. Department of Health and Human Services

Drugs

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About the Preventing Surgical Fires Initiative

Background

Surgical fires are preventable medical errors. To reduce the risk of fires, many healthcare organizations have developed tools, implemented strategies, and conducted education and outreach efforts. Yet there is more that can be done.

The FDA has a role in preventing surgical fires. FDA regulates the drugs (e.g. oxygen, skin preparation agents) and devices (e.g. ESUs, lasers and surgical drapes) that are components of the fire triangle and reviews product labeling to ensure that appropriate warnings about the risk of fire are included. However, the FDA’s regulatory authorities over the elements of the fire triangle are not sufficient to prevent these accidents.

The FDA is also committed to collaborating with relevant public and private partners to optimize the safe use of the products the agency regulates as part of its Safe Use Initiative. Under the Safe Use Initiative, the FDA convened a meeting with representatives from a variety of healthcare organizations to discuss ways to collaborate to prevent surgical fires. This meeting was an initial step in identifying barriers to safe practices, with the ultimate goal to engage all partners in developing specific, tangible interventions to reduce surgical fires.

As a result of these discussions and follow-up activities, the FDA and its partners launched the “Preventing Surgical Fires” initiative to increase awareness of the risks of surgical fires and promote the adoption of risk reduction practices throughout the healthcare community.

Initial launch Activities: October 13, 2011

Future Opportunities:

FDA will to continue to work with its partners to amplify and disseminate existing fire prevention tools and to search for new methods to prevent surgical fires.

 

 

 

On October 22, 2010, the Food and Drug Administration held a workshop to discuss FDA regulated products implicated in surgical fires and challenges in eliminating fires. The workshop was organized by the Center for Drug Evaluation and Research’s Safe Use Initiative team and the Center for Devices and Radiological Health Division of Patient Safety Partnerships.


 

 

 

Contact FDA

301-796-7432
Preventing Surgical Fires

Center for Devices and Radiological Health

c/o Tina Powell

WO 66-3216

10903 New Hampshire Avenue

Silver Spring, MD 20993