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Scope of the matter

Hospital Safety Insider, May 12, 2016

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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.

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.

Some hospital safety experts recommend the following best practices to help protect your facility:

* 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.
* 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.

This is an excerpt from the monthly healthcare safety resource Briefings on Hospital Safety. Subscribers can read the rest of the article here. Non-subscribers can find out more about the journal, its benefits, and how to subscribe by clicking here.
 

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