leakage Re- or Incorrect Inadequate specification of earth measurement intended use current Erroneous data Inadequate disclosure of Chemical leakage patient transfer limitations current Exposure of airway, Loss or deterioration Electric fields tissues, of Operating instructions Magnetic fields environment or function property, e.g. Inadequate specification of to foreign materials: accessories to be used with Radiation energy Use error or alkalis the medical device Ionizing radiation acids Attentional failure Inadequate specification of Non-ionizing radiation residues Memory failure pre-use checks contaminates Rule-based failure Over-complicated operating Thermal energy additives or Knowledge-based instructions High temperature processing aids failure Low temperature cleaning, Routine violation Warnings disinfecting or Of side effects Mechanical energy testing agents Of hazards likely with re-use Gravity degradation of single-use medical products falling devices gasses suspended medical masses anaesthetic Specification of service Vibration products and maintenance Stored energy Moving Biocompatibility Torsion, shear and tensile Toxicity of chemical force constituents, e.g.: Moving and positioning of allergenicity/ patient irritancy Acoustic energy pyrogenicity energy ultrasonic energy infrasound sound High pressure fluid injection Standard Risk Matrix SEVERITY INDEX LIKELIHOOD INDEX 5 Multiple deaths caused by an loss; 5 Very Likely No effective control ≥£5m May result in Special Administration or chance ≥80% Suspension of CQC Registration; Hospital closure; Total loss of public confidence 4 Severe permanent harm or death caused by an 4 Somewhat Weak control; or event; £1m - £5m loss; Prolonged adverse Likely chance ≥10% publicity; Prolonged disruption to one or more CSU's; Extended service closure 3 Moderate harm medical treatment required up 3 Possible Limited effective control – to 1 year; £100k £1m loss; Temporary chance – ≥1% disruption to one or more CSU's; Service closure
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
Off-Label-Use-of-Medical-Device-Proposal-Form-updated-Nov-2017.docx