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SiobhanSH

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  1. Community Post

    Surgical instrument safety

    SiobhanSH posted a topic in Infection control
    The Health Services Safety Investigation Body (HSSIB) investigation into the decontamination of surgical instruments produced the NHS England Estate Bulletin on Competency framework for Decontamination departments. With the new Care Quality Care (CQC) Premises Assurance Model (PAM) Safety Hard (section 16), does this go far enough in identifying the risks to patients? Medical devices are strictly Regulated by the MHRA yet the governance of the Surgical instruments is sitting in IPC, Decontamination. These high risk class IIa and Class III, medical devices under PAM technically cross Safety Hard (section 16) and Safety Soft (section 2) . Does the MDSO or the decontamination lead report on surgical instruments for PAM?
  2. Community Post

    Why work systems need redesign before AI can improve care

    SiobhanSH replied to Stefan's topic in Large language models (LLMs) and generative AI
    AI in Healthcare requires regulation by the MHRA as a medical device. I don't think that the department of Health has the capacity.
  3. Content Article

    Sterilisation instructions for surgical instrument MDR post market surveillance

    SiobhanSH posted an article in Surgical equipment
    This article relates to the change to the sterilisation process for the medical device the Omni-Tract abdominal surgical retractor. 
Registered address: Patient Safety Learning, China Works SB203, 100 Black Prince Road Vauxhall, London, SE1 7SJ

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