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EFHSS - Questions & Answers - Miscellaneous - Q00697
Record keeping of biological indicators
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From: Natali   Date: 14 December 2004, 15:03 [GMT]
Subject: Record keeping of biological indicators

Hello,

I would like to know the statement for record keeping of biological indicators. Is there a supportive standard for keeping or discarding processed biological indicators?

Thank you,

From: Josy Holdener (Switzerland)   Date: 16 December 2004, 16:45 [GMT]
Subject: Re: Record keeping of biological indicators

Hi Natali

All sterilization monitoring records: mechanical, chemical and biological, have to be filed.Should a situation arise where legal action becomes necessary, accurate records will protect you and your practice. In addition, if documentation procedures are properly constructed, they will motivate employees to acept greater responsibility on their duties and further awarness of the importance of their work in CSSD.
Check with your health care facilities risk manager, administrator and/or federal regulationn body how long sterilization records have to be maintained.In Switzerland we have to keep the sterilization records 5 years. In other countries the time can be anything between three, seven, ten or even twenty years.
The disposal of used biological indicators has to be in accordance with your facility's waste policy. Usually any positive indicators have to be autoclaved at 121°C for at least 15 minutes, at 132°C for 10 minutes in a gravity steam sterilizer, or at 4 minutes in a prevacuum steam sterilizer.

Kind regards
Josy

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