Helene Petrovich, BS, RN, CCP, LP
Clinical Manager, Perfusion
July 14, 2016
When I learned of a concern regarding Nontuberculous Mycobacteria (NTM) infections from use of LivaNova’s (previously Sorin) 3T heater-cooler devices and a change in their Instructions for Use (IFUs), I brought it to the attention of my OR director at Memorial Medical Center. The situation has led to the development of best practices in team collaboration and infection control.
The field safety notice from LivaNova in the wake of the NTM outbreak, in addition to SpecialtyCare’s internal guidelines and recommendations from the Pennsylvania Department of Health, encouraged us to culture, culture, culture. This, of course, elevated the interest of not only the OR director but also a team that included the hospital’s infection preventionist, hospital epidemiologists, surgical services, and the chair of pathology.
Our multidisciplinary team began meeting every two weeks to address the issue. I mastered and wrote simple protocols for my perfusion team on new cleaning techniques. Cultures were taken pre- and post-disinfection every two weeks, and included testing for pseudomonas and additional organisms beyond the recommendations in the field safety notice. The infection preventionist observed our cleaning and culturing techniques and oversaw my protocols.
Since no evidence of NTM has been found in our cultures, we now we meet every month. We culture on a monthly basis and share the results with the multidisciplinary team. We log our weekly cleanings and follow a monthly checklist suggested by the US Food and Drug Administration (FDA). With our consistently good results, we plan to move to quarterly cultures, but infection control is an ongoing process.
We continue our surveillance program and are happy to share our process with others, so we were honored when the Association for Professionals in Infection Control and Epidemiology (APIC) invited our team to present a poster regarding our techniques and culture findings. This situation, and our response to it, has reinforced the importance of multidisciplinary teams and communication with product vendors. With continued emphasis on accountability, good process management, and collaboration, we are confident that we will sustain our success in infection control.
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Editor’s note: SpecialtyCare’s Alfred Stammers, MSA, CPBMT, CCP, Director of Clinical Quality and Outcomes Research, is a member of the FDA’s Circulatory Devices Panel, which convened in June to examine information associated with infections originating from heater-cooler devices. His post-meeting update for limiting the occurrence of NTM infections can be found in our Resource Library.