Post: Contact number: E-mail: Department: Date: Please print completed form and send to your CSU clinical governances group. Also send an electronic copy to Medical Physics at riskassessment@medphysics.leeds.ac.uk and to Infection Prevention at 10) Approval Medical Physics and Engineering Approval The evidence has been reviewed by a senior manager in Physics and Engineering. It is line with Trust policy to ensure medical devices are safe and used correctly for the benefit. Name: Signature: Manager …………………… …………….Senior Date: …………… Yes No Additional RA completed? Infection Prevention and Control Approval (Only required for Non-R&D applications) The above evidence has been reviewed by Infection Prevention and Control. It is line with Trust policy to ensure medical devices are safe and used correctly for the benefit of patients. Name: Signature: Clinician …………………… ……………………….Senior Date: …………… Yes No Additional RA completed? CSU Clinical Governance Approval (Only required for Non-R&D applications) The evidence has been reviewed by the CSU Clinical Governance Group. The benefits outweigh the residual risk of using this medical device off licence. Name: Signature: Governance chair …………………… ……………………….Clinical Date: …………… Supporting Information Examples of Hazards Energy Biological or Operational Information Chemical Electromagnetic energy Biological Function Labelling Line voltage Bacteria Incorrect or Incomplete instructions for Leakage current Viruses inappropriate use Other agents (e.g. output or functionality Inadequate description of leakage enclosure current prions) performance characteristics
Post: Contact number: E-mail: Department: Date: Please print completed form and send to your CSU clinical governances group. Also send an electronic copy to Medical Physics at riskassessment@medphysics.leeds.ac.uk and to Infection Prevention at 10) Approval Medical Physics and Engineering Approval The evidence has been reviewed by a senior manager in Physics and Engineering. It is line with Trust policy to ensure medical devices are safe and used correctly for the benefit. Name: …………………… Signature: …………….Senior Manager Date: …………… Additional RA completed? Yes No Infection Prevention and Control Approval (Only required for Non-R&D applications) The above evidence has been reviewed by Infection Prevention and Control. It is line with Trust policy to ensure medical devices are safe and used correctly for the benefit of patients. Name: …………………… Signature: ……………………….Senior Clinician Date: …………… Additional RA completed? Yes No CSU Clinical Governance Approval (Only required for Non-R&D applications) The evidence has been reviewed by the CSU Clinical Governance Group. The benefits outweigh the residual risk of using this medical device off licence. Name: …………………… Signature: ……………………….Clinical Governance chair Date: …………… Supporting Information Examples of Hazards Energy Biological or Chemical Operational Information Electromagnetic energy Line voltage Leakage current enclosure leakage current Biological Bacteria Viruses Other agents (e.g. prions) Function Incorrect or inappropriate output or functionality Labelling Incomplete instructions for use Inadequate description of performance characteristics
Off-Label-Use-of-Medical-Device-Proposal-Form-updated-Nov-2017.docx