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Managing Risk Associated with Contaminated Heater-Cooler Devices Used in Cardiac Surgery

Managing Risk Associated with Contaminated Heater-Cooler Devices Used in Cardiac Surgery
Author Information (click to view)

Gwen R. Stokes, BSN, MPH, CPHQ, CPHRM, DFASHRM

Vice President

Healthcare Risk Management Group

AWAC Services Company

A member company of Allied World

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Gwen R. Stokes, BSN, MPH, CPHQ, CPHRM, DFASHRM (click to view)

Gwen R. Stokes, BSN, MPH, CPHQ, CPHRM, DFASHRM

Vice President

Healthcare Risk Management Group

AWAC Services Company

A member company of Allied World

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Between 2010 and 2015, the Food and Drug Administration (FDA) received 32 Medical Device Reports of patient infections associated with heater-cooler devices and 25 of these cases were reported during 2015 alone.
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Heater-cooler devices used during cardiothoracic surgeries and other surgical procedures to warm or cool a patient have been linked with infections from bacteria called M. chimaera, a species of Nontuberculous Mycobacteria commonly found in soil and water.

More than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year. 3T, the type of device linked to these infections, represents about 60% of all heater-cooler devices in the country.

Naturally, there are risk factors involved in these cases but hospitals and health care organizations can take proactive steps to ensure they are doing the most they can to manage the risk:

  • Maintain documentation of biomedical inspections on equipment including the date and time of the inspection and name of the technician who performs the inspection.
  • Notify the FDA via Med Watch report and also notify the manufacturer of the unit If a contaminated heater-cooler device is identified.
  • Require the manufacturer to perform its inspection at the hospital and monitor the inspection that is performed. Establish a chain of custody for any tubing, connectors or parts that are replaced. Do not release the device to the manufacturer if requested.
  • Develop a plan to transition away from the 3T device per FDA guidance.
  • Follow manufacturer’s recommendations for disinfection and cleaning, as well as guidance issued by the FDA.
  • Ensure perfusionists and other staff are following FDA recommendations for the use and maintenance of 3T devices to reduce exposure risks.
  • Establish a team to develop the hospital’s plan of action to notify patients and physicians and to conduct training for physicians and employees. Include the hospital risk manager on the planning and implementation team.
  • Share Centers for Disease Control (CDC) and FDA advisories, alerts and guidance with physicians and employees.
  • Use the CDC toolkit which helps hospitals address their responsibilities: https://www.cdc.gov/hai/outbreaks/heater-cooler.html#hct
  • Develop the patient notification letter and implement the plan for notifying patients and the public. Involve media relations. Maintain a database that identifies each patient notified. Determine how returned mail undelivered will be addressed and the additional measures the hospital will take to notify potentially exposed patients.
  • Inform employees of the hospital’s plan of action and how employees should manage any inquiries presented to them by concerned patients or community members.
  • Notify risk management of all patients identified infected with M. chimaera.
  • Submit a notice of potential loss report to the facility’s professional liability insurance claim representative for all M. chimaera infected patients identified. Report any threat of legal action regardless of infection to the facility’s professional liability insurance claim representative.
  • Notify the facility’s directors and officers (D&O) and errors and omissions (E&O) carrier(s) of all M. Chimaera infected patients identified as well as any threats of legal action regardless of infection.

In addition, facilities should ensure that they are implementing current FDA recommendations to minimize patient risk to infections associated with these heater-cooler devices. Hospitals should notify cardiothoracic surgeons, cardiologists, infectious disease physicians, internal medicine, primary care physicians, and other clinicians who evaluate patients that have had open-chest cardiac or other bypass surgery, about the risk of infection.

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