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FDA issues new anti-infection duodenoscopes guidance

Reacting to the association between the use of duodenoscopes and some patients' development of drug-resistant infections, the U.S. Food and Drug Administration issued new industry recommendations March 12 aimed at helping manufacturers to develop safer reusable medical devices.


Duodenoscopes are used during ERCP, "a potentially life-saving procedure to diagnose and treat problems in the pancreas and bile ducts," according to the FDA. The agency explained in February that the infections stem from "Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli," adding, "In total, from January 2013 through December 2014, the FDA received 75 medical device reports encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes."


Response to the infection rates originated in the fall of 2013. Back then, the Centers for Disease Control and Prevention alerted the FDA of a potential association between the use of duodenoscopes, which are reusable, and the emergence of multi-drug resistant bacteria. Unfortunately, reports of serious infection surfaced even in situations in which the users were following the cleaning, disinfection and sterilization instructions.


"This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them," said Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health. "Doing so should provide greater assurance to patients that the devices used on them are safe and effective."


The FDA's guidance pertains to the instructions for reuse that manufacturers provide along with their products. "The guidance also recommends," according to an FDA statement, "that manufacturers consider reprocessing challenges early in device design. Manufacturers will be expected to conduct validation testing to show with a high degree of assurance that their cleaning and disinfection or sterilization instructions will consistently reduce microbial contamination."


On a separate track, the FDA, in addition to the dissemination of new industry guidance, has called a meeting of experts to address the issue. Per the announcement, "The agency's Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will hold a public meeting on May 14 and 15, 2015, to discuss recent reports and epidemiologic investigations of transmission of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in hospitals in the United States."


The committee, according to a Federal Register announcement, will make recommendations on:

  1. The effectiveness of cleaning, high level disinfection, and sterilization methods;
  2. The amount and type of premarket validation data and information needed to support labeling claims and technical instructions;
  3. The appropriate use of other risk mitigations, such as surveillance cultures;
  4. Best practices and guidelines for reprocessing duodenoscopes and endoscopes at user facilities to minimize the transmission of infections; and
  5. Approaches for ensuring patient safety during ERCP procedures, including a discussion of appropriate patient selection


Medical science has known about the infection risk for some time now.


For instance, a Canadian researcher wrote about this phenomenon in an article that appeared in the May 2013 edition of the American Journal of Infection Control. As the article's abstract reads, "high infection transmission rates have been related to inadequate reprocessing of arthroscopic shavers and flexible duodenoscopes. Monitoring of manual and automated cleaning is needed to ensure that inadequately cleaned medical devices are recleaned prior to disinfection or sterilization."


The infection risk may be low; nevertheless it is an infection risk of which patients needed to be informed, and it is a risk that manufacturers implicitly have a duty to minimize; thus the seedbed of duodenoscope lawsuits is firmly planted.


A Washington state woman already has filed a wrongful death lawsuit against a maker of these medical devices. She alleged that her husband, who was 57, died of a "superbug" to which he was exposed during a duodenoscope procedure.


The product liability attorneys at Reich & Binstock offer a free consultation to anyone who has been diagnosed with Carbapenem-Resistant Enterobacteriaceae (CRE) after undergoing a duodenoscope procedure. Reich & Binstock, which operates in all 50 states, has 30 years of experience in trying product liability cases, and it offers the specialized expertise that a victim wants on his or her side. Contact Reich & Binstock either by calling the toll-free number below or by submitting an electronic message through its website.

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