On August 12, 2015, the FDA published a warning letter it sent to Olympus Corporation of the Americas, the manufacturer of the duodenoscopes involved in endoscopic procedures in which patients were infected by carbapenem resistant Enterobacteriaceae (CRE) bacteria at five different hospitals across the U.S. Investigators found no breach in duodenoscope reprocessing and no evidence of defects in the duodenoscope at three of those hospitals. This meant that even when the device was not defective and the device was cleaned according to the manufacturer’s instructions, CRE remained on the device and was transmitted to patients.
The FDA warned that Olympus failed to report to the FDA information that reasonably suggested that its duodenoscopes may have caused or contributed to a death or serious injury. Specifically, Olympus failed to submit individual reports for each of 16 patients who contracted a Pseudomonas aeruginosa infection, of which some resulted in abscesses, after undergoing an endoscopic procedure with a duodenoscope manufactured by Olympus. Olympus submitted one report to account for all the patients involved in the event and only submitted the single report over two and a half years after Olympus first became aware of the infections.
In addition to publishing the warning letter sent to the manufacturer of the duodenoscopes involved in the series of outbreaks in U.S. hospitals, the FDA provided a detailed list of supplemental duodenoscope reprocessing (sterilization) 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. This includes all Endoscopic Retrograde Cholangiopancreatography (ERCP) endoscopes (side-viewing duodenoscopes).
The FDA recognizes 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.
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 Endoscopic Retrograde Cholangiopancreatography (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, the 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.
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, and/or repeat high-level disinfection.
Microbiological culturing involves sampling duodenoscope channels and the distal end of the scope and culturing those samples to identify any bacterial contamination that may be present on the scope after reprocessing. Some facilities have successfully implemented routine or periodic surveillance culturing to assess the adequacy of duodenoscope reprocessing and to identify duodenoscopes with persistent contamination despite reprocessing.
Ethylene oxide (EtO) sterilization following cleaning and high-level disinfection involves the use of an EtO sterilizer, a non-portable device that uses ethylene oxide gas to sterilize medical products. Since it does not rely on heat, EtO gas sterilization may be an effective method for heat-sensitive instruments, like duodenoscopes, that can be damaged by high temperatures. Following cleaning and high-level disinfection, EtO sterilization is an additional measure that may eliminate the presence of micro-organisms on a device through the introduction of EtO gas.
Use of a liquid chemical sterilant (LCS) processing system following cleaning and high-level disinfection may also reduce the risk of infection transmission. An LCS processing system is a device that uses a chemical solution (liquid chemical sterilant) to destroy all viable forms of microbial life. Notably, because this process requires rinsing with highly purified (but not sterile) water following device sterilization, the device does not remain completely free of all viable microbes. The concentration, exposure time and temperature of an LCS are crucial because inappropriate dilution, insufficient exposure, or inadequate temperature may result in ineffective reprocessing outcomes.
Because a small number of duodenoscopes may have persistent microbial contamination despite reprocessing, some health care facilities have implemented repeat high-level disinfection (HLD) after the first HLD cycle in their duodenoscope reprocessing procedures, either manually or through the use of Automated Endoscope Reprocessors (AERs). HLD involves immersing the device with a disinfectant and is expected to inactivate all microorganisms except for large numbers of bacterial endospores. AERs are devices that wash and high-level disinfect endoscopes and scope accessories to decontaminate them between uses. AERs are designed to expose outside surfaces and interior channels of endoscopes to chemical solutions in order to kill microorganisms.
In addition to consideration of the supplemental measures described above, the FDA continues to recommend strictly adhering to the manufacturer’s reprocessing instructions and 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. Your reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.
- Refer to the Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011 consensus document for evidence-based recommendations for endoscope reprocessing.
See the FDA Warning Letter
See the FDA Safety Alert
See the FDA Safety Communication
See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who Is Liable and Why?
See the Medical Law Perspectives March 11, 2015, Blog: Uncleanable ERCP Duodenoscopes: Manufacturer, Hospital, and Physician Liability?