How to assess risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines.
BACKGROUND
Disinfection and sterilization are critical components of infection control. Unfortunately, breaches of disinfection and sterilization guidelines are not uncommon.


OBJECTIVE
To describe a method for evaluating a potential breach of guidelines for high-level disinfection and sterilization of medical devices.


METHODS
The appropriate scientific literature was reviewed to determine the frequency of failures of compliance. A risk assessment model was constructed.


RESULTS
A 14-step protocol was constructed to aid infection control professionals in the evaluation of potential disinfection and sterilization failures. In addition, a model is presented for aiding in determining how patients should be notified of the potential adverse event. Sample statements and letters are provided for communicating with the public and individual patients.


CONCLUSIONS
Use of a protocol can guide an institution in managing potential disinfection and sterilization failures.
Rutala
William A
WA
Department of Hospital Epidemiology, University of North Carolina at Chapel Hill, NC 27599, USA. brutala@unch.unc.edu
Weber
David J
DJ
D003428:Cross Infection / Q000517:prevention & control* / Q000635:transmission*; D004203:Disinfection / Q000592:standards*; D019983:Guideline Adherence; D006801:Humans; D017410:Practice Guidelines as Topic; D018570:Risk Assessment / Q000379:methods; D013242:Sterilization / Q000592:standards*