A group of claims involving endoscopic medical device manufacturers, as well as hospitals and endoscopy centers across several states, has occurred over the last few years. Plaintiffs assert that the use of duodenoscopes (a type of endoscope) causes carbapenem-resistant enterobacteriae (CRE) infections when used during gastrointestinal procedures. Duodenoscopes are inserted down a patient’s throat during a procedure called endoscopic retrograde cholangiopancreatography (ERCP), allowing physicians to evaluate the bile and pancreatic ducts.
CRE, often described as a “superbug,” includes several types of bacteria that are resistant to most, if not all, available antibiotics. The Centers for Disease Control and Prevention (CDC) reports that 42 states have CRE in at least one medical facility. While several hospitals reported CRE outbreaks involving these devices in 2014, arguably the most highly publicized CRE outbreak occurred in early 2015 at the Ronald Reagan UCLA Medical Center. On February 18, 2015, UCLA reported two patients who died after being infected by CRE during endoscopic procedures. Five additional patients were identified as infected, and 179 patients were exposed to CRE between October 2014 and January 2015. The source of the CRE outbreak was linked to a duodenoscope used in ERCP procedures. The UCLA outbreak spawned a group of product liability lawsuits involving the Olympus Medical Systems Group.
UCLA reported that the scopes used during the ERCP procedures were contaminated despite the hospital’s sterilization and decontamination efforts—“reprocessing” of reusable scopes—which they claimed exceeded instructions provided by the manufacturer Olympus, as well as national guidelines. After the sterilization process, the crevices of the device were found to have organic debris and residual body fluid, exposing patients to CRE. UCLA asserted that the manufacturer’s cleaning instructions were insufficient to eradicate CRE, and that a product redesign is required to allow for thorough cleaning, or alternative cleaning techniques would be necessary. Many patients quickly filed suits against Olympus, including in The Estate of Antonia Torres Cerda v. Olympus Am. Inc., No. BC573665 (Cal. Super. Ct., Los Angeles Count, filed February 25, 2015) and Young v. Olympus Am. Inc., No. BC573399 (Cal. Super. Ct., Los Angeles Count, filed February 23, 2015).
State and Federal Response
Regulatory reaction to the CRE outbreak was swift. On February 19, 2015, the Food and Drug Administration (FDA) released an alert to healthcare professionals defining the challenge of cleaning ERCP duodenosopes with their unique mechanisms and design. And on March 12, the FDA issued a final guidance document entitled “Reprocessing Medical Devices in Health Care Settings: Validation of Methods and Labeling.” A draft of this document was previously released in 2011 and its completion was accelerated in response to the CRE issue at Ronald Reagan UCLA Medical Center. In addition to the FDA’s involvement, the CDC provided consultation to the Los Angeles County Department of Health in its investigation and worked with the FDA on the protocols for reprocessing.
Emerging Issue—Heater-Cooler Devices
A developing contaminated-device issue—with potential for class-action-level litigation—involves heater-cooler units and nontuberculosis mycobacteria (NTM) infections. Heater-cooler devices are used during cardiac bypass procedures to regulate the temperature of the patient’s blood. The NTM primarily at issue is mycobacterium chimaera. The CDC reported that the devices “might have been contaminated during manufacturing.” The manufacturer, LivaNova PLC (formerly Sorin Group Deutschland GMbH), identified the mode of transmission as fluid leaking from the device or aerosolized from a contaminated water circuit during operation. These defects created a potential scenario where organisms could contact the patient and contaminate the surgical site.
On June 15, 2015, Sorin Group USA issued a field safety notice, followed by a Class II recall of the Stockert 3T heater-cooler system. The field safety notice stated that “An Error in Labeling” was identified and revisions were made to the instructions for cleaning and disinfecting. On October 15, 2015, the FDA released a safety communication regarding heater-cooler devices with specific recommendations for facilities that continue to use the device during procedures. The CDC quickly followed with interim practical guidance. An official CDC Health Advisory was published on October 13, 2016, urging facilities to advise potentially exposed patients to seek medical care if they are experiencing symptoms.
It appears that early complaints have been filed in both Iowa and Pennsylvania, and likely in several other states, against various healthcare systems and the manufacturer.
- Advocate on behalf of your device manufacturer and healthcare system clients by staying abreast of FDA and CDC guidance on devices of interest.
- Assist healthcare facilities faced with similar issues with emergency planning and responsiveness via communication with local departments of public health, the CDC, the FDA, and manufacturers.
Julie Davis, JD, MPH, RD is a product liability product manager at the Medical Resource Network, Inc. in Portland, Oregon.