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
earth leakage current patient leakage current Electric fields Magnetic fields Radiation energy Ionizing radiation Non-ionizing radiation Thermal energy High temperature Low temperature Mechanical energy Gravity falling suspended masses Vibration Stored energy Moving Torsion, shear and tensile force Moving and positioning of patient Acoustic energy ultrasonic energy infrasound energy sound High pressure fluid injection Re- or Chemical Exposure of airway, tissues, environment or property, e.g. to foreign materials: acids or alkalis residues contaminates additives or processing aids cleaning, disinfecting or testing agents degradation products medical gasses anaesthetic products Biocompatibility Toxicity of chemical constituents, e.g.: allergenicity/ irritancy pyrogenicity Incorrect measurement Erroneous data transfer Loss or deterioration of function Use error Attentional failure Memory failure Rule-based failure Knowledge-based failure Routine violation Inadequate specification of intended use Inadequate disclosure of limitations Operating instructions Inadequate specification of accessories to be used with the medical device Inadequate specification of pre-use checks Over-complicated operating instructions Warnings Of side effects Of hazards likely with re-use of single-use medical devices Specification of service and maintenance Standard Risk Matrix SEVERITY INDEX LIKELIHOOD INDEX 5 Multiple deaths caused by an ≥£5m loss; May result in Special Administration or Suspension of CQC Registration; Hospital closure; Total loss of public confidence 5 Very Likely No effective control ≥80% chance 4 Severe permanent harm or death caused by an event; £1m - £5m loss; Prolonged adverse publicity; Prolonged disruption to one or more CSU's; Extended service closure 4 Somewhat Likely Weak control; or ≥10% chance 3 Moderate harm – medical treatment required up to 1 year; £100k – £1m loss; Temporary disruption to one or more CSU's; Service closure 3 Possible Limited effective control ≥1% chance