Industry Focuses On Endoscope Reprocessing
The proper cleaning and reprocessing of endoscopes and other semi-critical reusable medical equipment (RME) has taken on added urgency after recent news reports that contaminated endoscopes may have led to the spread of deadly infections within health care facilities.
For example, it is suspected that a superbug outbreak that killed two hospital patients in Los Angeles earlier this year was spread by two contaminated endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes. In addition, infections of antibiotic resistant bacteria like carbapenem-resistant Enterobacteriaceae (CRE) have also been reported at some hospitals, and some of these infections have been linked to ERCP duodenoscopes.
“As we’ve unfortunately seen by recent news reports, patients can be at risk of serious infections if these tools are not properly disinfected,” says Tejal Gandhi, MD, MPH, CPPS, the president and CEO of the National Patient Safety Foundation.
FDA Advisory Warning
According to the Food and Drug Administration (FDA), ERCP endoscopes are used on more than half-a-million patients each year to diagnose and treat pancreatic and bile-duct problems. While the FDA has issued an advisory warning to doctors about carefully following manufacturers’ reprocessing instructions, it notes that germs could still linger on endoscopes even if these 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,” the agency stated in an FDA Safety Communication in February. However, the FDA does not favor pulling ERCP duodenoscopes from the market, as this would deprive hundreds of thousands of patients of what it calls a “beneficial and often life-saving procedure.”
The FDA acknowledges that the ERCP duodenoscope’s complex design and tiny parts make complete disinfection extremely difficult.
“You can very easily do everything right and still have some contamination,” said Dr. Deverick Anderson, an infectious-disease expert at Duke University, in an article published by the New York Daily News in February.
However, none of this means that properly cleaning and reprocessing endoscopes is impossible, says Nancy Chobin, RN, CSPM, vice president, Sterile Processing Services at Barnabas Health System in West Orange, N.J. Chobin is the co-chair of the Association of Advancement for Medical Instrumentation’s (AAMI) committee that is drafting the Flexible and Semi Rigid Endoscope Processing in Healthcare Facilities document that will provide a national standard for endoscope cleaning and reprocessing.
“Today’s endoscopes aren’t like the basic medical and surgical instruments that were used 30 years ago,” Chobin says. “They are extremely intricate and sophisticated and require special cleaning protocols. For example, there are more than 100 steps involved in cleaning an ERCP duodenoscope.”
Adequate Training is Crucial
Chobin believes that one of the biggest problems when it comes to proper cleaning and reprocessing of endoscopes is a lack of adequate training.
“Only employees who are dedicated to endoscope cleaning and reprocessing and have received the right kind of training should handle this responsibility,” she says. “You can’t just assign this task to anyone.”
“I walk into facilities all the time that have policies and procedures that aren’t being followed,” she says. “Someone needs to monitor the cleaning process to ensure compliance — missing just one step can be disastrous.”
“Ultimately, OR leadership is responsible for making sure that endoscopes used in the OR are safe,” Chobin adds.
Teresa Wells, director, National Program Office Sterile Processing, Nursing and Patient Care for the U.S. Department of Veteran’s Affairs, emphasizes the importance of following the endoscope manufacturer’s instructions for use to the letter.
“This must be done with precise detail, making sure to adhere to every step the instructions require,” she says.
“Meticulous adherence to the manufacturer’s instructions for cleaning and reprocessing is essential,” adds Ramona Conner, MSN, RN, CNOR, editor-in-chief, Guidelines for Perioperative Practice, for the Association of periOperative Registered Nurses (AORN). She also stresses the importance of adhering to current nationally recognized guidelines such as the AORN Guideline for Cleaning of Flexible Endoscopes.
Conner adds that the Centers for Disease Control and Prevention has recently issued an Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing.
“All health care facilities should review this protocol and determine the appropriate action for their organization to take,” she says.
In a statement, the manufacturer of the ERCP duodenoscope said it emphasizes the importance of meticulous manual sterilization of its instruments, and that it is now giving new supplemental instructions to users of the ERCP duodenoscope.
Visual Inspection… and Beyond
According to Conner, OR nurses should visually inspect the end of the endoscope — especially the elevator mechanism, if it has one, to make sure it is clean and free of all debris.
“When the endoscope has an elevator channel, it should be visually inspected, preferably under magnification, with the elevator in the ‘open/raised’ position and the ‘closed/lowered’ position to ensure there is no visible debris above or below the elevator mechanism,” says Conner.
However, all of the experts stress that visually inspecting endoscopes is an inadequate method of making sure they are clean and safe.
“Although visual inspection before use is a good idea, bacterial and other contamination on endoscopes often cannot be detected visually,” says Conner. “Additional methods of surveillance are necessary, such as process monitoring, culturing and testing for retained organic material — for example, adenosine triphosphate (ATP) bioluminescence assays.”
“There can be bioburden inside the endoscope that you can’t see — that’s where the biggest vulnerability is,” says Chobin. Wells agrees.
“You can’t see bacteria and other byproducts that could contaminate the endoscope,” she says.
The experts are also unanimous in terms of what OR nurses should do if they suspect that an endoscope has not been properly cleaned before a procedure begins.
“If there is any doubt that the device may not be clean, it should not be used — period,” says Conner.
“In any instance where an unsafe practice is about to occur, it is imperative that OR staff speak up on behalf of the patient’s safety,” says Gandhi. “The leadership of the organization must foster a culture where staff members are encouraged and expected to speak up.”
“If you have even the slightest inkling that an endoscope may not be clean enough for use, then you should send it back to be cleaned and reprocessed again,” adds Wells. “The rule should be: When in doubt, send it back.”
This points to the importance of a good relationship between the OR and the sterile processing department.
“The OR and sterile processing should be a collaborative unit and feel free to talk to each other about how endoscopes have been cleaned and reprocessed,” says Wells. “OR leaders should feel free to inquire about what quality measures are in place during reprocessing to ensure patient safety.”
One is One Too Many
Chobin strongly believes that one patient infection due to an improperly cleaned endoscope is one too many. However, she notes that of the half-a-million procedures performed last year using the ERCP duodenoscope, there were only about 130 infections.
“If these endoscopes were impossible to clean like some are suggesting, we would have much higher infection rates than this,” she says.
“The bottom line is that no patient should ever undergo a procedure that uses an endoscope that hasn’t been properly cleaned and reprocessed,” says Chobin. “This is the patient’s expectation, and it’s a realistic one.”