Hello,

I want to know what is the duration of sterility of a drapes pack sterilized with moist steam sterilizer and wich are the european norms.
Thank you

Alberto Franceschini
Sterilization Center
Servizi Ospedalieri S.r.l.
Ferrara
Italy

Hi Alberto,

It is impossible to recommend a universal standard for the duration a sterile package can remain sterile because of the enormous variations from Hospital to Hospital.

This means that directors and managers in processing departments in every facility must establish and justify their practices.

The length of time an item is considered sterile depends on factors that include the

• type and configuration of packaging material used
• number of times a package is handled before us
• storage on open or closed shelves
• condition of the storage room (e.g., cleanliness, temperature, and humidity)
• education of all health care staff who handle and use sterile products

Today, we see both time-related and event-related shelf life in Hospitals worldwide.

Event Related Sterility means: an item that has undergone a monitored and documented complete sterilization process will be considered sterile until some event causes the item to become contaminated (e.g., tear in packaging, packaging becomes wet, dropped on contaminated surface such as a floor, ect.)

Time Related Sterility means: an expiration date (in most hospitals usually 6 month from the time of sterilization) on a sterile item indicating a date that the item can no longer be considered sterile and must be reprocessed or discarded.

You may choose to use both a specific expiration date and event - related shelf life designation specific for certain packaging materials, areas of the hospitals, etc., as long as the policies is approved by the Infection Control Committee, and training of staff define this practice.

In any case, you need written policies e.g.;

1. Designation of a shelf life, with a specific expiration date, i.e. 30 das, 6 month, etc., based on manufacture's recommendation, a nationally recognized authority, or other standard approved by the Infection Control Committee.
2. Designation of shelf life for a event related shelf life if policies and procedures are approved by the Infection Control Committee including at least the following:
   1. Requirements for packaging materials, storage, and rotation of sterile supplies;
   2. Definition of an event that may cause a sterile item to be or be suspect of being contaminated, such as the package being wet or torn, or the seal being broken or tampered with;
   3. Clear direction that final inspection of the package and the ultimate decision to use the contents rests with the user, and
   4. Orientation and other follow-up in-service to assure that all necessary staff understand and implement the policies and procedures.

You see "all you need" is information, lots of time and patience.

We put such a lot of effort into cleaning, preparation, packaging and sterilization in the CS Department to insure that items are sterile for our patients. However, it also needs special attention towards the handling and storage of our items on the user side.

Information EFHSS-link: EN Norm 868 Parts 2-8 (packaging, shelf life etc.)

www.google.com enter, e.g., "Event-related shelf life" and you get plenty of good information.