EFHSS Questions and Answers - Question Q00854

To whom it may concern:

I am inquiring information about resterilizing product, basically, anything that is cloth or cloth like that touches or could touch the patient or a patient's wound. Some items in particular I am inquiring about are OR towels, huck and ABS towels, gowns, bandages, baby blankets, baby hats, cotton balls, cotten swabs, back table covers, any type of surgical drape, etc... I don't know how or where to find the residuals for re-sterilization or have they not yet been validated?

Can you give me information on resterilization of these products. Basiscally, anything inserted into the patient, i.e. catheters, tubing, cautery pencils, guidewires, etc... What are the stats for risk of failure after a resterilization?

Dear Garrett
Top principle for the use of EO-sterilization is "EO-sterilize only what you MUST" i.e. EO gas sterilization should be limited to those material and supplies for which no alternative methods are available. All cotton items on your list can safely be steam sterilized. The EO gas concentration, temperature, humidity and exposure time inside the sterilizer are vital factors that affect the sterilization process. Cotton materials can absorbe not controllable amount humidity and negatively influence the other dependent parameters.
According to the European Agency for the Evaluation of Medical Products, EO may only be used "where safer alternatives can not be used". This means that the user has to prove that other methods of sterilization can not be employed and is responsibel for it's evaluation incl. documentation from the manufacturer.
About resterilization of SUDs you might know that the US FDA has determinded that any US entity that reprocesses a dispoable device becomes the legal manufacturer of the reprocessed device and as such, is subject to all current Good Manufacturing Procedures (cGMPs)
Please see on our site the topic of Paul J. Sordellini What Hospitals Need to Know about Re-sterilization of Single Use Devices.
Kind regards
Josy Holdener