Significant Risk Device

Medical Device Competency Statement for Clinical Staff
NB DO NOT USE THIS MEDICAL DEVICE UNLESS YOU ARE COMPETENT TO DO SO

Medical Device: Electrosurgical Generator Surname: Job Title/Designation: SBU/Supporting Service: Department:

Make: Valleylab Model: Force Range (Various) Forename: Personal Number(on payslip): Extension/bleep:

Verification of competence is undertaken by assessment against the following statements: These statements are designed to indicate competence to use this device. Responsibility for use remains with the user, so if you are in any doubt regarding your competence to use the device, you should seek education to bring about improvement. Various methods including, self directed learning, coaching and formal training may be initiated. You must be able to answer “yes” to all the questions before considering yourself to be competent. If you are not competent, instigate learning and then repeat assessment. If you have never used the device before or have not used the device for over a year, then you are required to be assessed by an approved assessor for the named device. Self assessment must occur for all staff. Please circle: assessor assessment / no assessor assessment Can you correctly answer the following questions? Self Assessor Assessed Assessed Pre-operational inspection and correct set-up of the device: 1. Ensure that the electrosurgical generator is connected to the electricity supply and Yes / No Yes / No switched on, is visibly clean and free from dust 2. Ensure that the electrosurgical generator performs and passes the start up self test Yes / No Yes / No cycle Ability to operate the device safely: 3. Securely apply a patient return electrode (where necessary), in an appropriate position avoiding metal prostheses, damaged skin and skin prep solutions 4. 5. 6. 7. 8. 9. Ensure the patient is not in contact with any earthed metal Correctly connect active electrodes / handpieces Apply appropriate power / effect settings Use smoke evacuation / personal protective equipment Monitor use of the electrosurgical generator Check the return electrode site after use Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No

Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No

10. Maintain Patient’s privacy and dignity 11. Follow manufacturers instructions Maintenance and appropriate action: 12. Troubleshoot and rectify problems 13. Decontaminate after use and document appropriately

Yes / No Yes / No If you have answered no or been assessed as no to any of the above questions then further training and reassessment must be obtained. Is further training required? Yes/No I certify that I have assessed myself as competent in the use of the above named medical device, and am aware of my personal responsibility for continuing professional development. I have read the relevant policies/ guidelines relating to this device. Signature: Assessor signature if assessment undertaken: Signature: Name: Date: Please circle: Pass / Re-assessment Designation: Date:

Verification of competence will be reviewed during annual staff appraisal in accordance with the Policy for the Management and Use of Medical Devices and Systems. Re-assessment can occur at manager’s discretion

Copy to line manager and retain personal copy

Date:14.12.11 Author: CTaylor

Version:1.1 Reviewed by: L Sonley

Date Ratified by PDG

Feb 2012

CTaylor

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14/12/11