Scope of the matter
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May 1, 2016
Scope of the matter
What hospitals need to consider following Olympus' recall of its controversial duodenoscope
Earlier this year, Olympus Corp. announced a voluntary recall of its TJF-Q180V model duodenoscope blamed for infecting patients who had procedures performed with the device. Olympus will also apparently redesign part of this scope (replacing the forceps elevator mechanism) to enable easier disinfection.
The move was expected. Three deaths and at least 250 people (over 140 Americans) affected by 25 incidents of antibiotic-resistant infections were associated with dirty scope devices manufactured by Olympus, Fujifilm, and Pentax, according to a U.S. Senate Committee report entitled Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients. Olympus was, in fact, aware of the problems with its flexible gastrointestinal endoscope?used in procedures like endoscopic retrograde cholangiopancreatography?back in the spring of 2012 but failed to alert officials or medical care providers, according to a report in the Los Angeles Times. The story also cites reports that 21 people have died and at least 24 more became ill from infections linked to scopes in Pittsburgh, Seattle, and Los Angeles between 2012 and 2015.
Although the FDA has cleared the TJF-Q180V with modifications to its design and labeling, the industry is still reeling from the infection fallout. Olympus has issued new, validated manual reprocessing instructions and special cleaning brushes for the aforementioned model. However, many hospitals and clinics that use these and other scopes remain concerned about potentially infecting patients, absorbing astronomical costs to remedy the problem, and suffering lawsuits.
Walking the scope tightrope
With their narrow and complicated designs and parts, endoscopes can be extremely challenging to successfully reprocess (i.e., clean, disinfect, and sterilize). Contributing to the problem are the increasingly intricate parts, nooks, and crannies of newer models, which can be near impossible to clean properly. (The FDA distributed a warning last year to hospitals that tiny elevator grooves and channels in the design of the TJF-Q180V scope could make it impossible to adequately eradicate biofilm and other infectious residue from the device.)
To further add to the difficulty, quality control procedures, reprocessing instructions, and operating manuals can differ widely by manufacturer and model; additionally, many healthcare facilities outsource the job of reprocessing to a contracted provider, while other organizations handle the matter in-house with specially trained technicians.
Considering all of these complications, adversities, and risks, it's no surprise that infections from flexible endoscopes recently topped the list of the ECRI Institute's Top 10 Health Technology Hazards for 2016. And when you factor in the statistics?it's estimated that up to 20 million endoscopy procedures are performed in the United States using reusable endoscope devices annually, and that duodenoscopes are used in roughly 500,000 endoscopy procedures each year?it's easy to see how disruptive and alarming the issue has become for the facilities that regularly use these scopes.
Removing the controversial Olympus scope from the market is a bad idea, according to the FDA, because it could result in a scope shortage among healthcare organizations. The good news is that recalled TJF-Q180V scopes can be modified by Olympus within four days of receiving the device, according to the FDA, and the manufacturer anticipates being able to repair all of the approximately 4,400 original scopes in the United States by August 2016.
The big short
The bad news is that it remains to be seen if other manufacturers will have to issue recalls of their scopes, and the Olympus recall alone could lead to a serious scope scarcity. Consider that Olympus makes approximately 85% of duodenoscopes and other diagnostic gastrointestinal scopes used in American hospitals.
"It is possible that there could be a shortage of these scopes. There might also be a shortage because of changes in cleaning, disinfection, and sterilization procedures, which might prolong the time needed to turn over a scope between patients," says Donna Swenson, president/CEO of Sterile Processing Quality Services, Inc., in Berwyn, Illinois.
One hospital that took steps to stave off a potential shortage is Virginia Mason Medical Center in Seattle, where 39 patients were infected by Olympus scopes between 2012 and 2014. Recently, the facility acquired 20 additional scopes to meet its clinical volume demands and significantly enhanced its scope cleaning protocol, including the implementation of a rigid culture and quarantine process as well as manual and automated cleaning?increasing the reprocessing procedure from what was a 60-minute exercise to one that can take longer than 48 hours. Also, if a scope fails the hospital's expanded reprocessing protocol three times, it is regarded as defective and taken out of service.
Previously, the defect rate for duodenoscopes at the hospital was approximately 1.9%, according to Andrew Ross, MD, section head of gastroenterology for Virginia Mason, who was quoted in an article published by Becker's Hospital Review.
"That's a big deal," he said in the report. "What that tells us is that in a percentage of cases the guidelines as they have existed with the scopes … up until recently don't do what they're supposed to and what we've been told they were doing."
What to do now
Some healthcare safety experts say other organizations should take a cue from Virginia Mason and follow similar enhanced safety and cleaning protocols.
"It is very time-consuming to dismantle, pre-clean, and reprocess these devices, but it's absolutely necessary?especially in this era where multidrug-resistant organisms like carbapenem-resistant Enterobacteriaceae are increasingly resistant to antibiotics, which also contributes to this problem," says Pamela Dembski Hart, BS, MT(ASCP), CHSP, principal and founder of Healthcare Accreditation Resources, LLC, in Plymouth, Massachusetts. "Additionally, facilities may need to buy additional equipment to meet clinical needs, look closer at scope cleaning and maintenance procedures, provide better oversight of the staff who are doing the actual cleaning and reprocessing, perform competency assessments of these workers, provide correct training, and stress preventive measures like better hand hygiene protocol."
Organizations also need to schedule procedures carefully going forward so that adequate time is given to cleaning and disinfection/sterilization of endoscopes.
"This might mean scheduling procedures that use these scopes every day instead of doing all the procedures on one or two days a week," says Swenson.
Facilities that are considering changing a scope brand should consider certain criteria carefully, as well.
"Every hospital needs to review its procedures and look at what is being processed and then assess the ability of its facility to follow the manufacturer's instructions for use. The hospital then needs to make sure they have the equipment to perform these procedures as the instructions state," Swenson adds. "Hospitals should also retrain all employees on how to perform the procedures and ensure by return demonstration that the employee is competent in performing the procedures."
Above all, organizations that use scopes need to ask tougher questions today, says Peggy Prinz Luebbert, MS, MT(ASCP), CIC, CHSP, president/founder of Healthcare Interventions, Inc., in Omaha, Nebraska.
"I think one lesson we all learned after [the Olympus] recall was to look deeper into other scopes besides the duodenoscope," says Luebbert. "Do you know where and how all the other scopes are used and disinfected in your facilities, including scopes such as laryngoscopes, ENT scopes, and even ultrasound probes? It was surprising in some of the facilities I consult for how many issues were discovered with other scopes in response to this recall."
Taking action steps
Swenson recommends the following best practices:
- Assess current inventory. Determine if the number of scopes in your facility is adequate for the number of procedures being performed, and if any scopes are older and potentially of a design that will be very difficult to adequately clean. Use cleaning verification testing and critical thinking of basic cleaning procedures and requirements to make this assessment. Order additional scopes if needed.
- Remove and replace any scopes identified as being extremely difficult or impossible to clean.
- Assess manufacturer's instructions for use and ensure that adequate time is being provided between cases.
- Have employees responsible for cleaning of endoscopes retrained in these procedures, then assess their competence to perform these procedures with a written test and return demonstration.
- Implement a cleaning verification testing program. Each employee should also be tested for competence with the cleaning verification process. If a scope does not pass cleaning verification, it needs to go through the cleaning process again. "No scope should move to the next step until it has passed the cleaning verification step," says Swenson.
- Complete initial cleaning verification for every scope until it is determined that the facility's scope cleaning program is firmly established and that assigned employees are competent to perform the procedures.
- Repeat employee competence in these procedures at least annually, and preferably semiannually or quarterly for extremely complex devices.
- Implement a quality audit survey program to ensure that the quality of processed medical devices is not compromised.
"Hospital departments involved in scope acquisition, sterilization, and use must be vigilant," says Kenneth S. Weinberg, BA, MSc, PhD, principal consultant at Safdoc Systems, LLC, in Stoughton, Massachusetts. "Hospital administrators must take responsibility for all aspects of patient safety and cannot merely accept the word of manufacturers and suppliers. Strict oversight and control of all instruments entering the facility for use on patients must be carefully watched, and claims made by suppliers and manufacturers must be tested and proved."
Weinberg suggests the following supplementary tips:
- Request a copy of the sterilization confirmation report from the manufacturer/supplier with each batch.
- Randomly test scopes for sterility as they enter the hospital supply chain.
- Place an experienced person, such as the chief of the OR equipment sterilization and maintenance, in charge of all scopes as they enter the facility. "I know these people are overworked, but this is a critical part of the hospital's operation and is related to patient safety," adds Weinberg.
Lastly, remember to follow key Joint Commission standards related to endoscopes that can guide healthcare organizations, including IC.02.02.01 (reducing infection risks from medical equipment or devices); EC.02.04.01 (managing risks involved with using medical equipment) and element of performance 3 (medical equipment maintenance, inspections, and testing procedures are put in writing); EC.02.04.03 (medical equipment is inspected, maintained, and tested); and LD.04.03.09 (safe provision of contracted care, treatment, and services).