UCSF Reports Cystoscope Problem

As reports surfaced earlier of patients being impacted by improperly sterilized medical equipment used for exploratory procedures, UC San Francisco Medical Center has reported an issue of its own.

The hospital quietly issued a statement last week that 471 patients whose bladders were examined earlier in the year had been exposed to a medical device that had not been thoroughly cleaned.

The device, known as a flexible cystoscope, was used to probe inside the bladders of patients seeking care at the outpatient urology practice UCSF Medical Center operates on its Parnassus campus. It includes a thin optic tube and a camera that is inserted into the bladder through the urehtra.

According to a statement issued by the hospital, “a step was inadvertently omitted in the cleaning of equipment used in their procedure.” As a result, the hospital said the patients may have been “exposed to blood-borne viral pathogens including, potentially, Hepatitis B, Hepatitis C and HIV.” However, UCSF said the likelihood of exposure was extremely low, a less than 0.1% probability.

The improperly cleaned instrument or instruments were used on patients between Jan. 23 and June 26 of this year, UCSF said.

The hospital said it had apologized to the patients, is offering them free blood testing to determine if they had been exposed to any pathogens, and that it had established a call center with a dedicated nurse and physician to answer questions. It also notified authorities of the issue, including the San Francisco Department of Public Health and the California Department of Public Health.

UCSF Medical Center officials declined to comment further on the matter and would not provide details on what cleaning step had been missed, the manufacturer of the cystoscope, or any other information. 

Flexible cystoscopes used at U.S. hospitals are distributed by three major companies: the Japanese electronics giant Olympus; Vision Sciences, which is based in Orangeburg, N.Y. and Karl Storz, a German manufacturer with U.S. headquarters in El Segundo.

The incident at UCSF has some parallels to an outbreak of the superbug carbapenem-resistant Enterobacteriaceae (CRE) reported earlier this year at the Ronald Reagan UCLA Medical Center in Los Angeles that was linked to three patient deaths, eight infections and exposed more than 170 others.

In those cases, the outbreak was connected to a duodenoscope manufactured by Olympus that had been properly disinfected after it was used on a liver transplant patient carrying an unusually potent strain of CRE, even though the hospital had followed procedures for cleaning the instrument. A second scope also became contaminated with CRE and spread it to patients.

The U.S. Food and Drug Administration issued new guidelines last week for cleaning duodenoscopes. “It is critical that staff responsible for reprocessing duodenoscopes have the manufacturer's instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks,” the FDA said in a statement.