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?
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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?