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

Student Essay Contest

In 2021, the Safety Committee created the student essay contest which awards $1,000 in prize money to the top two writers of a safety essay about patient safety and their passion for patient safety and perfusion. 

Previous Winners
2021 -  Jeremy Bolick (Medical University of South Carolina) and Sophia Kero (University of Nebraska Medical Center)
2022 - Jennifer Gavin-Veyna (University of Nebraska Medical Center) and Zach Gorman (University of Iowa, Carver College of Medicine)

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:

• AHRQ TeamSTEPPS
• Standards and Guidelines For Perfusion Practice
• Alerts and Notifications
• National Patient Safety Foundation
• Patient Safety in the Cardiac Operating Room
• Orrum Annual Report 2023
• The Joint Commission
• WHO Patient safety

Failure Mode Effects Analysis (FMEA) Articles

ECMO FMEAs

• ECMO FMEA Introduction 10.9.2018
• ECMO FMEA: Trouble Shooting, Root Cause Analysis and the Failure Mode Effect Analysis Closed Circuit, Hollow Fiber Oxygenator, Centrifugal Pump, and Instrument Stack
• Narrative 4: ECMO FEMA D1 Failure Venous blood line jerking a/k/a chugging
• Narrative 5: ECMO FMEA E1 Failure: Pre-pump air in the venous cannula, venous line and compliance chamber
• Narrative 6: ECMO FMEA F1 Failure: Water dripping on the pump or floor
• Narrative Archives

CPB FMEAs

• Perfusion Safety and FMEA Powerpoint
• CPB FMEA Archives

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
Bharat Datt, FPP
Justin Farr, MS CCP
David C. Fitzgerald, DHA MPH CCP
Prakruti Hansaliya, MS
Tullika Saraf, Student Member
William (Scott) Snider, CCP LP
Zachariah Wilkes, MBA CCP