Since October 2015, hospitals have been grappling with the impact of the announcements by state and federal agencies that certain widely used devices for cardiopulmonary bypass during cardiothoracic surgery may be contaminated with nontuberculous mycobacterium (NTM). Specifically, those announcements informed much of the medical community that Stöckert/Sorin 3T heater-cooler devices manufactured by LivaNova PLC (formerly the Sorin Group) may be contaminated with Mycobacterium chimaera (M. chimaera) and pose a risk of patient infections through the aerosolization of mycobacteria into the operating room during surgery. In addition to presenting numerous internal quality review issues and patient notification considerations, the recently identified phenomena has already generated numerous lawsuits in several jurisdictions by patients against both hospitals as well as the product manufacturer.
Our dedicated Heater-Cooler Device team utilizes its experience and knowledge to assist and counsel healthcare systems, hospitals, and clinicians in the face of this evolving phenomenon. Our lawyers are working on pending cases involving alleged M. chimaera infections and analyzing these issues collaboratively with some of the country’s finest experts in microbiology, bioengineering, infectious disease, and epidemiology.
Saxton & Stump has a unique team of experienced trial attorneys, infectious disease specialists, a cardiac surgeon, a former general counsel of a health system, a former CMO of a hospital, and a nationally recognized infection control nurse. Together, we have thoroughly investigated this new phenomenon and continue to do so as the science, medicine, and legal issues evolve. Through the course of our practice, our team is well-versed and knowledgeable about the following:
- FDA, CDC, and State Department of Health’s recommendations and communications addressing this issue
- Scientific and medical literature and research addressing atypical mycobacteria
- Research being conducted into the aerosolization of M. chimaera from heater-cooler devices
- Stöckert/Sorin 3T Heater-Cooler Device Operating Instructions and Field Safety Notices
- Hospital and Health Systems, nationally and internationally, that have provided notification to patients.
Our team has provided the following services and can assist with:
- Risk assessment investigations
- Advice regarding compliance with state, federal, and local regulations
- Navigating notification recommendations and risks involved therein
- Representing hospitals with confirmed infections that are targets of litigation or are institutions that are collateral to suits against the manufacturer
- Analyzing the risks involved
- M. chimaera Safety Communication – 10/13/16
- M. chimaera Safety Communication – 6/1/16
- NTM Safety Communication – 10/15/15
- FDA’s Ongoing Investigation of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices
- Heater-Cooler Devices: Information for Health Care Providers and Staff at Health Care Facilities
- Heater-Cooler Devices: Information for Patients
- Heater-Cooler Device Informational Page with Notification Toolkit
- Morbidity and Mortality Weekly Report (MMWR) – 10/14/2016
- Health Advisory – 10/13/2016
- Press Release: Contaminated Devices Putting Open-Heart Surgery Patients at Risk – 10/13/2016
- Interim Guide for Identification of Possible Cases of NTM Infections Associated with Exposure to HCUs – 5/13/16
PA DOH Communications:
- Guidance Regarding NTM Infections with Case Definitions – 12/11/15
- Alert sharing information from FDA and CDC – 10/27/15
- Health Statement – 10/26/15
Medical and Scientific Literature:
For more information on Heater-cooler Devices
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