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EFHSS Questions and Answers - Answer to Question Q00538

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EFHSS - Questions & Answers - Sterile Storage - Q00538
sterilization
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From: (Saudi Arabia)   Date: 8 July 2004, 14:41 [GMT]
Subject: sterilization

I've been working in one of the hospital in saudi arabia but the problem i encountered for the past 10 years was, why our hospital is putting an expiry date of 30 days for single packed items and 45 days for double packed in both ethylene oxide and steam.

From: miki   Date: 9 July 2004, 08:27 [GMT]
Subject: Re: sterilization

Jerson.

Technology, know-how and standards had been developed and progressed dramatically through the last 10 years.
Initiate a change! do the following: (this is a suggestion)

  1. Take validated packages (bags, pouches, etc.) intended for EO sterilization.
    "Validated" means Manufacturer "Declaration of Conformance".
  2. Use a validated EO sterilizer (CE xxxx marked). If you have such or not, continue and
  3. Follow manufacturer instruction for sterilization. Use Bio indicators to challenge the process. Study the outcome and develop a process that will be acceptable.
  4. If you can use a 3rd party lab to validate this process - do it
  5. Establish or revise your documented procedures and trace them.
  6. Base your activity on appropriate Standards: ISO, EN. ANSI or others.

Check the possibility to outsource this job. (consider safety, time, menpower, cost).

Feed-back the Forum with your experience
miki

From: (Belgium)   Date: 26 July 2004, 19:51 [GMT]
Subject: Re: sterilization

Dear,

An excellent guideline for the determination of the shelf-life of sterilised medical devices you can find in the interview with Tim Galekop: "European expert condemns the re-use of sterilization packaging". You find it under Articles on our Education pages.

Best regards,
Wim Renders

EFHSS  European Forum for Hospital Sterile Supply

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