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EFHSS Questions and Answers - Question Q00353

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EFHSS - Questions & Answers - Quality Assurance - Q00353
Tracking and Traceability

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From: (United Kingdom) Date: 14 November 2003, 16:50 [GMT]
Subject: Tracking and Traceability

Dear Colleagues

Can you tell me where to find legislation and guidelines for the tracking and traceability of surgical instrumentation. Is there a time period or date when all instrumentation must be fully traceable?

Regards,

Nicholas Richardson
Quality Manager
Sterile Services

From: Paul Holland Date: 17 November 2003, 21:35 [GMT]
Subject: Re: Tracking and Traceability

Dear,

In the UK NHS, Health Service Circular HSC 2000/032, "Decontamination of medical devices", page 3, states "By 31 march 2002 trusts should have taken steps towards having systems in place to enable the tracing of surgical intrument sets to patients on whom they have been used".
In addition, the Controls Assurance Standard - Decontamination of Re-usable Medical Devices, Criteria 3 & 4 in particular, also apply.
I hope this is of help.

Paul Holland

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