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EFHSS- Questions & Answers- Q000-193
Implants: quarantine loads until BI neg.Web Search]
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From:    Date: 10 September 2002
Subject: Implants: quarantine loads until BI neg.

If we do daily BI testing on first loads each morning, does anyone have info regarding the guidelines for quarantining further loads during day which have implants?
Ta!
E

From: Wim Renders   Date: 20 September 2002
Subject: Re: Implants: quarantine loads until BI neg.

Dear Eleanor,

Pete Bobb describes in the answers he gave on questions 27 and 131 the AAMI requirements. But there is a big difference in approach between the United States and Europe.
In Europe the use of biological indicators for routine control of sterilization processes by moist heat (EN 554), even for cycles with implants, is not required when parametric release, on the basis of the control of the temperature, pressure and time, doesn't pose problems. A condition is that validated processes are used in a controlled environment.
I hope this answers your question.

Kind regards,
Wim Renders

p.s. If you use biological indicators rapid read out tests can limit the response time.

From: Wim Renders   Date: 28 October 2002
Subject: Re: Implants: quarantine loads until BI neg.

Dear Eleanor,

In the discussion article (see the discussion page) about biological indicators you can find information and even more questions over the use of BI.

Best regards,
Wim Renders


EFHSS  European Forum for Hospital Sterile Supply