FDA issues additional safety measures for ERCP devices

In a new FDA Safety Communication report, the FDA provides supplemental measures for enhancing duodenoscope reprocessing for hospitals and health care facilities that use duodenoscopes, in an effort to continue reducing the risk of infection and increase the safety of endoscopic retrograde cholangiopancreatography medical devices.

“We recognize that not all health care facilities can implement one or more of these measures, which require specific resources, training, and expertise,” the FDA stated in the report. “Therefore, it is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device and maintain proficiency in performing these reprocessing tasks.”

The key recommended safety measures include health care providers adhering to manufacturer instructions on how to use the devices and that facilities and staff who reprocess ERCP duodenoscopes create and initiate a quality control program for the reprocessing procedure.

“It is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device and maintain proficiency in performing these reprocessing tasks,” according to the FDA report.

A recent expert panel meeting took place which included representatives from several health care facilities that discussed additional strategies that have been implemented to reduce the risk of infection transmission, according to the report. The following supplemental measures were discussed, recommended and may further assist in reducing the risk of infection transmission associated with the use of duodenoscopes: microbiological culturing, ethylene oxide sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection.

“The FDA recommends health care facilities performing ERCP evaluate whether they have the expertise, training and resources to implement one or more of these options,” the report said.

In addition, the FDA recommends facilities strictly adhere to the manufacturer’s reprocessing instructions by following these best practices: “meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using AER; raise and lower the elevator throughout the manual cleaning process to allow brushing of both sides; implement a comprehensive quality control program for reprocessing duodenoscopes; include written procedures for monitoring, training and adhering to the reprocessing program”; and document all equipment tests, processes and quality monitors used during the reprocessing procedure.

The FDA also encourages staff and facilities to use the Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011 disclaimer icon consensus document for evidence-based recommendations for endoscope reprocessing, according to the report.

Patients are also encouraged to discuss the benefits and risks of procedures using duodenoscopes with their physician, according to the report. The benefits of ERCP outweigh the risks of infection for most patients. However, ERCP often treats life-threatening conditions that can lead to serious health consequences if not addressed.

Reference:

FDA. Supplemental measures to enhance duodenoscope reprocessing: FDA safety communication. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed August 4, 2015.