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Seattle Children's Hospital: 12,000 patients at infection risk after failure of sterilization protocol

A potential failure to follow proper sterilization procedures for surgical instruments at a Seattle Children’s Hospital clinic has prompted hospital officials to issue a warning that up to 12,000 pediatric patients may be at risk for infection, according to a news release.

“Last week we discovered that required cleaning processes for instruments at Seattle Children’s Bellevue Clinic and Surgery Center were not consistently followed,” hospital officials wrote in a news release. “The instruments go through multiple cleaning and sterilization steps. We know that some of the cleaning steps weren’t always followed correctly.”

According to the news release, the hospital contacted the CDC and the Washington State Department of Health. CDC officials confirmed that the risk for infection related to the breach in sterilization protocol is very low, and have classified the breach as Category B. Children who underwent procedures at three clinic locations from June 2010 to Aug. 20, 2015, may be affected, the release said.

The cleaning and sterilization of surgical instruments involves four steps: manual inspection and hand washing of the tools, ultrasonic rinsing, washing through an industrial washing machine and steam sterilization at 270°F. Further steps are taken to ensure instruments are properly sterilized, such as individual labeling that indicates the amount of time each set of instruments spent at high temperatures. The process also includes a biological indicator, in which a bacteria, kept within a case, is tested with instruments to ensure the bacteria is eradicated during the process.

“We do know that the final step of steam sterilization did happen reliably,” Danielle Zerr, MD, director of infection prevention at Seattle Children’s Hospital, said in a news release. “That is why we are confident that this is a situation with very low risk of any infections being transmitted.”

Seattle Children’s Hospital is offering free blood testing for infectious diseases, including HIV, hepatitis B and hepatitis C, to the thousands of children potentially affected.

“We have formed a team of Seattle Children’s experts who are working hard to understand why this error occurred, and what improvements we can make so that standard cleaning processes are consistently followed,” hospital officials wrote. “Our patients’ safety is our top priority, and we are very sorry that this happened.”