As reports continue to come out regarding superbug outbreaks potentially linked to endoscope-related procedures, patients may find themselves questioning the safety of undergoing procedures that use an endoscope. The mainstream media has started to coach patients on how to evaluate the value of undergoing an endoscope-related procedure and how to select a hospital that’s right for them. With the concern for scope safety increasing every day, facilities must now prepare to answer tough questions about their scope-related infection rates and disinfection practices from potential patients.
A recent article by Deborah Abrams Kaplan of Cure shined the spotlight on the things that patients should be looking for when it comes to endoscope safety. The article also explains how patients can assess the risk of a procedure:
“The chances of passing along bacteria on endoscopes can be reduced in several ways: repeating the disinfection, implementing sterilization or using partially or completely disposable endoscopes.
Disinfection: Flexible endoscopes are considered semicritical devices that normally come in contact with mucous membranes but not blood or otherwise sterile tissue. Although the FDA prefers that they be sterilized, it requires only disinfection. However, in spite of health care facilities following manufacturers’ directions for disinfecting flexible endoscopes, including duodenoscopes, the FDA reported in a 2018 study that up to 3% of duodenoscopes tested were considered reprocessing failures after being found positive for high-concern organisms, and up to 3% tested positive for low-concern organisms. The agency had expected a total failure rate of less than 0.4%. After cleaning with brushes and a detergent, high-level disinfection includes immersing an instrument in a liquid chemical germicide for the FDA-recommended amount of time, at the right concentration and temperature. The agency suggests repeating the process to ensure that it is done properly.
Sterilization: Some health care organizations are switching their protocol to sterilizing, instead of disinfecting, flexible endoscopes. When it comes to duodenoscopes, the FDA recommends sterilization over high-level disinfection when possible and practical, though availability of this method is limited. Sterilization can be difficult because the heat can damage components. One technique uses pressurized steam, but for more delicate instruments, organizations can use a low-temperature liquid chemical processing system, a sporicidal technology. Ethylene oxide gas is another sterilization option.
In 2018, North Dakota’s Altru Health System was the first to sterilize the duodenoscope. “I’m encouraged to know that there are some hospitals out there that are using sterilization (for these instruments),” Carla Warner says.
“If tested, these should not grow any type of bacteria or show any signs of leftover biomatter.”
Some hospitals may be reluctant to sterilize bronchoscopes or rigid endoscopes, Muscarella says, especially if the central reprocessing area is in the basement, requiring more careful tracking and monitoring of the instruments. When scopes are reprocessed closer to procedure rooms, they spend less time out of commission for cleaning, so the hospital can keep a lower inventory of them, he says.
Using sterilized equipment, even if not mandated by the FDA, can still be cost-effective, according to Carla. If hospitals realize that sterilization is a deciding factor for patients, they can highlight the practice in their advertising, she says.
Disposable Parts: To give duodenoscopes a safety update, the FDA recommends that health care systems transition to instruments with disposable components, such as end caps, or to fully disposable devices, allowing for more effective reprocessing or eliminating the need for it.
Currently, five manufacturers offer disposable end caps, and singleuse duodenoscopes are entering the market. The FDA approved a Boston Scientific model in December 2019. Disposable bronchoscopes are available, Muscarella says, but not widely used in the U.S.
One problem with disposable devices is cost and who pays it. The Boston Scientific single-use duodenoscope is expected to cost $3,000, and insurance coverage is not yet guaranteed, according to The New York Times. Hospitals already own reusable scopes at upward of $40,000 each. “(If insurance doesn’t cover a disposable scope,) the burden could shift onto the patient to decide whether to purchase it themselves, and that doesn’t typically happen in medicine,” Muscarella says.
If hospitals can’t negotiate the price, disposable instruments could be too expensive, he says.
Other concerns with disposable scopes include reuse for economic reasons. Inexpensive disposable equipment is discarded, Muscarella says, but there could be a financial incentive to reuse costly single-use devices, which is counter to their purpose. Also, disposable scopes would not prevent infections caused by bacteria’s movement from one part of the body to another. “The infection rate is not entirely eliminated by single-use endoscopes, but clearly, it would prevent patient-to-patient transmission,” Muscarella says.
ASSESSING THE RISK
Patients don’t always know what to ask their doctors regarding recommended endoscopies.
When Carla had to schedule a spinal fusion after her husband died, she asked the doctor to explain each step from beginning to end, telling her how every item in the operating room would be reprocessed, which ones would have been sterilized, and which would be new or unused. “He was a little taken aback by the question, and it was something he had not discussed with a lot of patients,” she says. She also asked why he chose to work at that hospital.
When he said it was because of lower infection rates, she was satisfied. After she shared her reasons for asking such detailed questions, the doctor said, “I should be having this discussion with all my patients.”
Carla recommends also asking about the equipment and model numbers, steps taken to clean the endoscopes, whether the scopes are sterilized or disinfected, and whether they are inspected with a borescope, a small instrument that helps detect tears and defects that can harbor bacteria. Not all physicians understand how reprocessing works because they are involved only with the procedure, but Carla encourages physicians to visit the central reprocessing area to learn. “The first red flag for me is if a physician can’t tell me the steps, they take to make sure the patient is safe,” she says. If the medical staff, including the receptionist, do not take concerns seriously and provide answers, patients should find a new doctor or facility, she says.
Muscarella agrees that patients have some control and power because they can decide where to have procedures done. They can tell doctors or clinics that they plan to call several facilities and choose the one that best meets their requirements. For instance, patients could look for a facility with a robust safety program, which could include using a certain type of endoscope or sterilizing instruments instead of disinfecting them.
These conversations are one positive result of the infection outbreaks, says Andrea Dwyer, director of the Colorado Colorectal Screening Program and adviser to the patient advocacy group Fight Colorectal Cancer. In addition to asking about procedure risk, “it’s OK to ask how many procedures the doctor does per year, the volume — and, if something happens, how to follow up and who to follow up with,” she says.
RECOGNIZING THE SIGNS
Infection following an endoscopic procedure could occur within 24 hours or longer, says Robilotti. During diagnosis, doctors consider the severity of the illness and may test for infection in multiple sites, such as blood, urine and possibly bile, if a bile drain is involved. “We have to put the whole clinical picture together to establish if certain signs or symptoms are from an infection,” he says, and, if so, where it arose.
Determining causality is important. If a patient develops an infection but does not inform the doctor who performed the endoscopy or tell the doctor treating the infection about prior procedures, the doctors may not connect the dots. One remedy is for the doctor’s office or clinic to contact patients after the procedure and ask if they have any infection symptoms. “The FDA is reporting reduced infection rates,” Muscarella says, “but if the medical facility doesn’t track all infections, then the risk could be underreported.”
The risk of getting an infection from a diagnostic procedure is real. But when a doctor recommends an endoscopy, it’s important to consider the risk versus benefit, Dwyer says. Colonoscopies, for example, carry a small risk of complications but a high rate of effectiveness for identifying potentially cancerous polyps.
In spite of her husband’s death from the CRE infection, “I will never advocate for someone to go against what their physician recommends they need in treatment,” Carla says. What if her own doctor recommended an ERCP?
“I wouldn’t say I would not do the procedure,” she says. “I’d have to do my research really well. If I couldn’t find a satisfactory local provider, I’d go somewhere else that has technologies available for true sterilization.””
Read the entire article here: Coming Clean: Protecting Yourself From Bacteria on Endoscopes
The infection risk with flexible endoscopes continues to be a major worry for patients and hospitals alike. Facilities must ensure staff are trained on general infection control principles and must adhere to reprocessing best practices, and they must be prepared to discuss the risks of endoscope-related procedures with their patients. To ensure that your staff is following reprocessing best practices on every scope they disinfect or sterilize, install additional checks and balances into your workflow so that you can document that your staff is following the same process each time. Endoscope tracking software such as iRIScope has been introduced in recent years to help hospitals and surgery centers ensure that each of their flexible endoscopes is reprocessed the proper way each time, and documentation of their reprocessing is kept electronically using advanced RFID technology. These systems safeguard the scope disinfection process by employing machine-based data processing to determine of scopes are adequately reprocessed before their next use. With these systems in place, staff and patients can be more confident that their endoscope-related procedure won’t result in a life-threatening infection.