From the April 2017 issue of HealthCare Business News magazine
Imagine this scenario: an endoscopy unit at a major hospital is in the midst of a large construction renovation project. The endoscopy equipment and accessories were just cleaned and sterilized by the appropriate hospital staff for use on the next patient. Various construction vendors carrying potentially harmful debris unknowingly on their shoes and clothing are walking in and out of the area where these sterilized devices are being stored. If even the smallest amount of dust or other bacteria-laden debris becomes airborne and falls onto sterilized endoscopy equipment that then enters a patient, specifically an immunocompromised patient, the result could be deadly.
Additionally, some ventilation systems in the endoscopy units were not sealed securely, causing bacteria from the construction site to enter the clean areas in the facility. Due to poor surveillance and recordkeeping, this health care facility’s role in HAI prevention could be in jeopardy. Although this scenario is not a direct result of improper endoscopy reprocessing, it is a very plausible and preventable situation that should be considered.
When the FDA investigated other cases concerning endoscopy reprocessing issues, the investigators identified the same source of transmission: a specialized endoscope, threaded down the throat of a half-million patients a year to treat gallstones, cancers and other disorders of the digestive system. They found that the duodenoscope devices accumulated bacterium that was not fully removed by conventional cleaning techniques, causing an infection to pass from patient to patient. This bacterium is known as Carbapenem-Resistant Enterobacteriaceae (CRE), an antibiotic-resistant superbug that can kill up to 40 percent of the people it infects.
Endoscope cleaning machines can cost roughly $30,000 to $50,000 and typically take about 30 minutes to wash with disinfectant following some manual cleaning. The FDA estimates that about 1,000 hospitals and clinics nationally rely on the manufacturer’s equipment to prepare reusable endoscopes for the next patient. Most hospitals that do these procedures are not even looking for this problem, or they may not be aware. Even when the devices are cleaned strictly in accordance with manufacturer and FDA-approved guidelines, there is still a great risk of infections being transmitted.
While the FDA is studying the problem and working with manufacturers to determine whether new cleaning protocols should be mandated or the endoscopes should be redesigned entirely, health care facilities must act now to do what they can to maintain patient safety and prevent exposure to endoscope-related infections. Ensuring a safe and reliable endoscope program requires a multidisciplinary approach and is truly a team effort in order for it to be successful.