FDA and DOH Alert Providers That Endoscope Design May Impede Efforts to Sterilize Devices

On Feb. 24, 2015, the Pennsylvania Department of Health (DOH) distributed an alert in an effort to raise awareness among health care professionals that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing — a detailed, multistep process to clean and disinfect or sterilize reusable devices — according to the Food and Drug Administration (FDA).

Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.

From January 2013 through December 2014, the FDA received 75 medical device reports encompassing approximately 135 patients in the U.S. relating to possible microbial transmission from reprocessed duodenoscopes. It is possible that not all cases have been reported to the FDA.

The alert contained the following recommendations for health care providers:

  • Inform patients of the benefits and risks associated with ERCP procedures.
  • Discuss with your patients what they should expect following the ERCP procedure and what symptoms (such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools) should prompt additional follow-up.
  • Submit a report to the manufacturer and to the FDA via MedWatch, as described below, if you suspect that problems with reprocessing a duodenoscope have led to patient infections.

The FDA is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, continuing to evaluate information about documented and potential infections from multiple sources, and actively engaged with other government agencies to identify the causes and risk factors for transmission of infectious agents and develop solutions to minimize patient exposure.

Read more from the FDA.

Alerts from DOH are distributed to Pennsylvania physicians subscribed to its PA Health Alert Network (PA-HAN). To receive alerts like this from DOH, register here.

Tools You Can Use: Pennsylvania physicians can purchase an infection control plan from PMSCO Healthcare Consulting, a subsidiary of PAMED, which can be customized and includes policies and forms for your practice. PAMED members receive a discount.

We are also developing online education related to infection control practices in the office setting. We will notify members through the Daily Dose (PAMED’s daily, all-member email) when this resource is available.