Perfusion Safety

PERFUSION SAFETY

Perfusion Safety avoids unnecessary incidents that result in adverse patient outcomes, categorized into four groups:

  • Malfunctioning or defective equipment and supplies
  • Communication failure between healthcare professionals
  • Human error or incorrect execution of procedures
  • Failure to anticipate adverse events

Safety Resources

With patients’ lives in the balance, Perfusionists must prioritize safety while implementing best practices to mitigate risks and improve safety procedures. Utilize the following resources in your practice:

Failure Mode Effects Analysis (FMEA) Articles

ECMO FMEAs

CPB FMEAs

Patient Handoff Tool

The Safety Committee has developed a communication tool to standardize safe handoffs between perfusionists, called I PASS THE CLAMP OFF. The I PASS THE CLAMP OFF video describes the tool's use in everyday practice. A PDF copy is also available.

If you have a suggestion for a failure mode that you would like to see formalized in the FMEA or have questions about the FMEA or Perfusion Safety Program, contact amsect@amsect.org.

Alerts & Notifications

January 21, 2021: Medical Device Notice: Updated notice for Heartware HVAD systems ref #1103

In December 2020, Medtronic International Ltd issued a notice regarding Medtronic Heartware TM Ventricular Assist Device (HVAD). Medtronic has identified an issue with implanted HVADSs where the pump may experience a delay to restart or failure to restart. Pumps at a greater risk of failure are due to an internal component specific to (3) lot numbers. The issue only occurs in pumps that are stopped after the initial startup phase. Please refer to the following link for Medtronic's notice and patient management recommendations. Be advised: This issue does not impact the performance of a pump while it is running.

https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/heartware-hvad-medical-device-correction-december-2020.pdf

October 15, 2020: Safety Notice - FDA Alert

On September 30th, 2020, the U.S. Food and Drug Administration posted a letter to health care providers regarding reports of nontuberculous mycobacteria (NTM) infections in patients who had undergone cardiothoracic surgery involving the use of CardioQuip Modular Cooler-Heaters.

On September 30th, 2020, the U.S. Food and Drug Administration posted a letter to health care providers regarding reports of nontuberculous mycobacteria (NTM) infections in patients who had undergone cardiothoracic surgery involving the use of CardioQuip Modular Cooler-Heaters.
https://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-infection-during-cardiac-surgery-when-using-cardioquip-modular-cooler-heater-device

While the root cause of infection in these cases is unknown and continues to be evaluated, the FDA provides general recommendations to reduce the risk of infection during cardiac surgery when using any heater-cooler device. We will update the community if more information becomes available.

Safety Committee Members

Amanda Crosby, MS, CCP, Interim Committee Chair
Mike Colligan
Susan Englert, RN CCP CPBMT
John Englert, CCP
David C. Fitzgerald, DHA, MPH, CCP
Barbara Braley Hendrix, CCP
Prakruti Hansaliya, MS
William (Scott) Snider, CCP LP
Zachariah Wilkes, MBA CCP