Class 1 Recall: Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication

Date Issued: August 4, 2015

Audiences:

• Gastroenterologists
• Gastrointestinal surgeons
• Endoscopy nurses
• Staff working in endoscopy reprocessing units in health care facilities
• Infection control practitioners
• Personnel conducting endoscope culturing (e.g. clinical diagnostic and laboratory staff)
• Patients considering Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures

Medical Specialties: Gastroenterology, Infection Control

Device: All ERCP endoscopes (side-viewing duodenoscopes)

Purpose:
FDA is providing a detailed list of supplemental duodenoscope reprocessing measures that emerged from an agency-led expert panel meeting earlier this year. Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these 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. 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. While the risk of infection transmission cannot be completely eliminated, the benefits of these devices continue to outweigh the risks in appropriately selected patients.

Summary of Problem and Scope:
Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices, and can result in infection transmission if reprocessing instructions are not followed in every step of the process. While there will always be a risk of infection transmission with devices used internally, it is important to take all possible steps to minimize that risk so that patients may realize the benefits of these devices.

For duodenoscopes, their unique and complex design improves the efficiency and effectiveness of ERCP, it also presents challenges for effective reprocessing, notably:

• Duodenoscopes are complex instruments that contain many small working parts. Proper cleaning and disinfection of the elevator mechanism is of particular concern. The moving parts of the elevator mechanism contain microscopic, hard-to-reach crevices. If not thoroughly cleaned and disinfected, tissue or fluid and residual bacteria from one patient may remain in device crevices of a duodenoscope, exposing subsequent patients to risk of infection.
• Meticulous adherence to the manufacturer’s reprocessing instructions is labor intensive and prone to human error. 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 FDA is aware of instances of persistent bacterial contamination even following strict adherence to manufacturer reprocessing instructions. Because of this, FDA recommends that facilities and staff that reprocess ERCP duodenoscopes establish and implement a comprehensive quality control program for reprocessing duodenoscopes.

At an expert panel meeting, representatives from several health care facilities and the panel discussed additional strategies that have been implemented to reduce the risk of infection transmission. In each case, staff applied these supplemental methods in addition to meticulous cleaning as part of strict adherence to the manufacturer’s reprocessing instructions, as recommended in previous FDA Safety Communications. Furthermore, these measures may not be feasible in all health care facilities and each of these options comes with its own benefits and limitations.

Supplemental Measures for Facilities and Staff that Reprocess Duodenoscopes to Consider:
Among the variety of infection mitigation strategies discussed at the Advisory Committee meeting, several specific supplemental measures have been implemented in individual health care facilities. Combined with strict adherence to the duodenoscope manufacturer’s reprocessing instructions, the following supplemental measures may further help reduce the risk of infection transmission associated with the use of duodenoscopes.

• Microbiological Culturing
• Ethylene Oxide Sterilization
• Use of a Liquid Chemical Sterilant Processing System
• Repeat High-Level Disinfection

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