FDA Safety Notice Letter “Recommends The Continued Use Of Forced Air Thermal Regulation Systems During Surgery”

Does the August 30, 2017 FDA Medical Device Safety Notice Letter Impact the BAIR HUGGER MDL 2666 FORCED AIR WARMING DEVICES Litigation? 

3M™ Bair Hugger™ Blanket System

 

 

 

 

 

 

 

 

US Food & Drug Administration Healthcare Provider Notice, August 30, 2017

FDA Safety Information Notice: Forced Air Thermal Regulating Systems: Healthcare Provider Letter – Information About Use

08/30/2017 – Dear Health Care Provider Letter – FDA]

AUDIENCE: Surgery, Nursing, Anesthesia

ISSUE: The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.

The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.

Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process.

The FDA will continue to actively monitor this situation and will update this communication if significant new information becomes available.

BACKGROUND: Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient’s temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.

To determine if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publicly available medical literature, operating room guidelines, and ventilation requirements.

RECOMMENDATION: FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. As always, please follow the manufacturer’s instructions for use in the operating room/and or the post-operative environment.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

 

FDA Medical Device Safety Notice

“Official Notice Letter”

 Information about the Use of Forced Air Thermal Regulating Systems – Letter to Health Care Providers

August 30, 2017

Dear Health Care Provider,

The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.

The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.

Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process.

Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient’s temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.

To determine if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publicly available medical literature, operating room guidelines, and ventilation requirements

As always, please follow the manufacturer’s instructions for use in the operating room/and or the post-operative environment.

FDA ACTIONS

The FDA will continue to actively monitor this situation and will update this communication if significant new information becomes available.

CONTACT US

If you have questions about this communication, please contact CDRH’s Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.

Sincerely,
/s/
William Maisel, MD, MPH
Deputy Center Director for Science
Center for Devices and Radiological Health
U.S. Food and Drug Administration

 

Leave a Reply

Your email address will not be published. Required fields are marked *