Advice for Assessing Disease Transmission Risk After Disinfection or Sterilization Failure

As part of a larger lecture on "Emerging Issues in Environmental Infection Prevention and Control" at the annual SHEA scientific meeting held earlier this week, William Rutala, PhD, MPH, of the University of North Carolina School of Medicine, reviewed the steps to to assess risk to patients when a disinfection/sterilization failure occurs. Rutala explained that failures can usually be attributed to human errors, equipment failures and systemic problems, and that healthcare institutions must be prepared to investigate a failure, communicate the findings of the investigation to the appropriate stakeholders, and take steps to prevent future failures.

Rutala provided attendees with a 14-step protocol:

1. Confirm that a failure has indeed taken place. If a failure has occurred, immediate steps must be taken to reprocess the implicated surgical instrument or medical device.

2. Embargo the improperly disinfected/sterilized items; be certain to visit all areas of the facility where these items may be used and/or stored.

3. Determine the process involved in the failure.

4. Inform key stakeholders (risk management, SPD, infection control, etc.) about the disinfection/sterilization failure.

5. Investigate the cause of the problem, with key analysis from infection control.

6. List potentially exposed patients and evaluate the degree of the exposure.

7. Review the literature and national guidelines when determining the level of exposure risk to patients.

8. Inform aforementioned stakeholders with an update of the risk assessment.

9. Develop a hypothesis for the disinfection/sterilization failure and initiate corrective action.

10. Assess adverse patient events by designing a prospective cohort study; review the medical records; examine patients for infections, etc.

11. With the healthcare institution's legal department, notify the appropriate health authorities.

12. Consider when/if patient notification is advisable; this notification should provide as much information as possible about the exposure, the risk of infection or other adverse events, recommendations for follow-up, etc.

13. Develop a long-term plan for future action to help avoid disinfection/sterilization failures.

14. Perform an after-action report.

More information from Rutala can be found at