Improper Instrument Reprocessing May Have Jeopardized Patient Safety at Pediatric Surgery Center

Seattle Children's Hospital announced on its website that it discovered that required cleaning processes for instruments at Seattle Children’s Bellevue Clinic and Surgery Center were not consistently followed. The hospital says it reported the issue to the Washington State Department of Health, the Centers for Disease Control and Prevention (CDC), and Public Health – Seattle & King County, and that leaders from Seattle Children’s infection prevention team are working closely with these agencies.

The hospital's announcement reads in part, "The instruments go through multiple cleaning and sterilization steps. We know that some of the cleaning steps weren’t always followed correctly. All instruments went through our sterilization process. The CDC has confirmed that the risk of infection to our patients is very low. However, we do not know the exact risk to each patient, so we are sending letters to patients who may be impacted to explain what happened and offer recommendations. We do not know exactly how many patients might be impacted, but we are currently reaching out to approximately 12,000 patients who were seen at Bellevue Clinic and Surgery Center for surgical procedures. We are also notifying patients and families who had procedures at Seattle Children’s Everett (not The Everett Clinic) and Mill Creek regional clinics. 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. Our patients’ safety is our top priority, and we are very sorry that this happened. We understand why families may be concerned. Keeping our patients safe is our top priority. We are deeply concerned about this situation and are taking it very seriously."

While the risk of infection to patients is very low, the hospital says it does not know the exact risk to each patient at this time. The hospital is offering free testing to these patients for hepatitis B, hepatitis C and HIV, and have set up a call center for more information: 1-855-855-8460. The hospital is also sending letters to patients who may be affected to explain what happened and offer next steps.

Seattle Children's Hospital offers the following frequently asked questions (FAQ):

Q: What happened?
A: We have multiple steps for cleaning and sterilization. Although surgical instruments went through our sterilization process, we discovered that some of the cleaning steps before the sterilization step weren’t always followed correctly.

Q: Why did this happen?
A: We don’t yet know for sure. We are investigating why some steps in the cleaning process were not always followed correctly.

Q: Did this happen at other Children’s locations?
A: The Bellevue Clinic and Surgery Center processes instruments for Bellevue as well as for Seattle Children’s Mill Creek and Seattle Children’s Everett. This issue only affects some patients who had procedures at these locations. A list of clinics that may be affected is to the left.
Patients who had procedures at our main hospital campus in Seattle or other Children’s locations are not affected. We have confirmed that these sites are following the required cleaning process for surgical instruments.

Q: Is my child affected?
A: If your child had a procedure at one of these sites from June 2010 to Aug. 20, 2015, and they may be affected, we will notify you with a letter. The letter will talk about next steps and how to get a blood test.

Q: What is the risk to my child?
A: There is a very low risk of infection for a few reasons:
• All instruments were steam sterilized, which kills bacteria and viruses.
• The instruments went through at least some parts of the cleaning process.
• Children have a lower rate of infection with hepatitis and HIV than adult populations. This makes it less likely that the instruments would ever have been contaminated.
The Centers for Disease Control and Prevention classified this infection control breach as Category B, which is considered less serious with very low risk of infection.

Q: How do I get my child tested?
A: If your child was affected, you will get a letter in the mail telling you about next steps. Your child can get a free blood test at any of Seattle Children’s labs or your local lab. Visit www.seattlechildrens.org/safety for locations and hours.

Q: What is Children’s doing?
A: We are offering free blood tests for hepatitis B and C and HIV to all patients who may be affected. These are the most likely infections that could be transmitted without symptoms showing up right away. We have launched an investigation, and have confirmed that all required cleaning and sterilization processes for instruments are consistently followed. We have started extra audits to make sure all steps are followed correctly and are researching why this happened and what improvements we can make.

Q: How quickly should my child be tested? When will I get results?
A: If we notified you, it is not urgent that you bring your child in right away. You can come to one of our labs or a local lab anytime. If your child has a blood test, we will notify you of results within 10 business days.

Q: How can I get more information?
A: Please call our call center at 1-855-855-8460. Or, visit www.seattlechildrens.org/safety.

To read the Seattle Times article, CLICK HERE.