Al Stammers, MSA, CCP
Director of Clinical Quality and Outcomes Research
August 25, 2106
The source of nosocomial infections can be elusive. For investigators, infections stemming from slow-growing bacteria are particularly difficult to identify and combat when symptoms do not present for months, or sometimes even years, after exposure. Add to these challenges the severity of potentially deadly infections and a bacterial outbreak can have devastating consequences. Such is the case with nontuberculous mycobacteria (NTM).
In 2013, two post-operative cardiac surgery patients in Zurich presented with infective endocarditis that developed from NTM. The University Hospital of Zurich reported the cases and gene sequencing verified both patients were infected with an identical strain of Mycobacterium chimaera, leading a multi-disciplinary team of investigators to look for a hospital-acquired source. The team, knowing that M. chimaera is often found in a water supply, conducted an exhaustive evaluation and retrospective histopathological review that uncovered six cardiac surgery patients who met case definition criteria. Additional cases were identified in Germany and the Netherlands. Ultimately, contaminated water in the heater-cooler devices (HCD) used in conjunction with cardiopulmonary bypass was identified as the source of the bacteria.
In 2014, the United States Food and Drug Administration (FDA) received reports from a single hospital that four patients had died from Mycobacterium abscessus, a related organism also often found in water and linked to use of heater-cooler devices. The FDA and the Centers for Disease Control and Prevention (CDC) have issued national safety alerts and additional information for healthcare providers and the public (see below). The FDA also convened the Circulatory Devices Panel of its Medical Devices Committee to study NTM infections associated with heater coolers used during cardiothoracic surgery.
My colleague, Jeffrey B. Riley, MHPE, CCP, CCT (Mayo Clinic) and I sat on the FDA’s Circulatory Devices Panel and have authored a report that summarizes the NTM outbreak and includes important information on ways to limit the risk of patient infections. We gratefully acknowledge the American Society of ExtraCorporeal Technology (AmSECT) for allowing access to this paper, which appears for a limited time as the feature article in The Journal of ExtraCorporeal Technology, no. 48, August 2016. In addition to the article, my post-meeting summary from the FDA meeting can be found in the Resource Library on our website.
Editor’s note: Founded in 1964, AmSECT has over 2,000 members throughout the world and is dedicated to promoting perfusion by giving members a voice and the opportunity to contribute to the profession. The Journal is the longest continuously published periodical in the field, and has served as the official publication of the American Society of ExtraCorporeal Technology since 1967. To learn more about AmSECT, visit http://www.amsect.org/.
Related FDA and CDC Communications
Concerns about Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices
Information for Healthcare Providers
Information for Patients