MEDICAL DEVICE ALERTS & OTHER HAZARD NOTIFICATIONS

Transcription

1 MEDICAL DEVICE ALERTS & OTHER HAZARD NOTIFICATIONS DACS/008 Date 01/01/11 Version 0.5 Adult Care & Support

2 Current Procedure/ Manual Status Version 0.5 Date issued 01 January 2011 Author / Issued by Sarah Edwards Review date January 2012 Location Date issued Date Effective Procedure ID Issue No. Updated by May 06 May 06 DACS RY Nov 06 Nov 06 DACS JLR May 08 May 08 DACS JLR Jan 10 Jan 10 DACS KL Equality Impact Assessment Record Date Completed by Medical Advice Alert DACS/008 2

3 Definitions:- 1. MDA Medical Advice Alert 2. DHCM District Homecare Manager 3. CELS Central Loan Store Introduction and Purpose The East Central Equipment Loan Store (CELS) Manager receives Medical Device Alerts/Hazard Notifications and Field Safety Notices from the Medicines and Healthcare Products Regulatory Agency. These alerts/hazard/safety Notifications fall into four categories. 1. Immediate action required (within 24 hours) 2. Action required (within 48 hours) 3. Update (within 5 working days) 4. Information request (within 5 working days) Procedure ID: DACS 008 Medical Advice Alerts Steps Task 1 When the Central Equipment Loan Store Manager (East) receives a Medical Device Alert/Hazard notification or Field Safety notice they will distribute these to Adult Care and Support, Tremorvah Industries, and any other Council Departments and independent clients as may be required and maintain an appropriate record system of these notifications. Notification to Adult Care and Support will consist of an to Senior Admin Officer (Support) and will include a list of those people who have been supplied with the equipment as detailed in the alert. Inputs/Further information CELS East Medical Advice Alert DACS/008 3

4 1.2 The Senior Admin Officer (Support) will forward the Alert/Hazard/Safety Notification via to managers in Adult Care and Support as per the circulation list (See Appendix 1), keeping a record of receipt of these s by managers, and so will maintain read receipts to be kept on file; these records to be kept for 3 years. Senior Admin Officer (Support) 1.3 On receipt of an detailing an Alert/Hazard/Safety Notification, all managers have the responsibility of ensuring the information is shared with their staff and that appropriate action is taken within the designated timescales set out in the introduction above. 1.4 If as a result of an Alert/Hazard/Safety Notification any positive action is required (e.g. equipment replacement or repair) then the Central Equipment Loan Store Manager (East) must be notified preferably by Managers Operational Staff/Managers, Tremorvah, Establishment Managers, DHCM s, Admin Officers (local Office) PROCESS On receipt of an Alert/Hazard/Safety Notification from their manager, all Case Coordinators, RAT s Teams, Occupational Therapists and Technical Officers should consider whether they are aware of any service users who may have the piece of equipment referred to in the Alert/Hazard/Safety Notification. 2.2 If the Notification is for Immediate Action, the Involved Worker will ensure that the appropriate action is taken to safeguard the service user from the hazard detailed on the Alert/Hazard Notification within 24 hours. This may involve the automatic replacement of the equipment or an alternative piece of equipment being issued. 2.3 If the Notification is for Action, the Involved Worker will ensure that the appropriate action is taken to safeguard the service user from the hazard detailed on the Medical Advice Alert DACS/008 4

5 Alert/Hazard Notification within 48 hours. This may involve the automatic replacement of the equipment or an alternative piece of equipment being issued. 2.4 If the piece of equipment referred to in the Alert/Hazard notification is either an item of lifting or electrical equipment, the name, address & DOB of the service user together with details of the equipment including the serial number, should be passed to the Admin Officer (local office). 2.5 On receipt of this information, the Admin Officer will contact Tremorvah Industries and CELS East with these details. 2.6 Tremorvah Industries and CELS East will check that the item of equipment and the service user is on their Maintenance/Servicing Equipment Database and take the necessary action with regard to the Alert/Hazard/Safety Notification. 2.7 If the item of equipment and the service user is not on the Maintenance/Servicing Equipment Database, Tremorvah/CELS East will if appropriate add the service user details to the database and ensure the necessary action to be taken with regard to the Alert/Hazard/Safety Notification. In the event that Tremorvah/CELS East is not to be the equipment service provider then written notification of the alert will be made to the equipment owner/user. 2.8 If the alert is a Field Safety Notice or just for information/updating category 3 and 4, workers have a responsibility to ensure the service user is contacted with this information within 5 working days. 2.9 When items of equipment are being serviced or under thorough examination, technical staff should ensure that there are no outstanding Safety Notifications relating to the specific item of equipment. Admin Officer (local office) CELS East, Tremorvah Industries CELS East, Tremorvah Industries CELS East, Tremorvah Industries Medical Advice Alert DACS/008 5

6 3 3.1 PROCESS INTERNAL HOMECARE SERVICE District Home Care Managers (DHCM) will receive the Alert/Hazard/Safety Notification from the Senior Admin Officer (Support). DHCM s, Admin Officer (local office) 3.2 DHCMs will determine if all staff need to take action, or if Team Leaders are to action, or no further action, depending on the nature of the alert. Any action taken must be within the timescales set out in the introduction. 3.3 DHCMs will ensure the alert is distributed to staff as appropriate. DHCM s DHCM s Process - Establishment Managers both Day Centre & Respite Establishment Managers will receive the Alert/Hazard/Safety Notification from the Senior Admin Officer (Support). Senior Admin Officer (Support), Establishment Managers 4.2 Establishment Managers will determine if all staff will take action, or no further action, depending on the nature of the alert. Any action taken must be within the timescales set out in the introduction. 4.3 Establishment Managers will ensure the alert is distributed to staff as appropriate. Establishment Managers Establishment Managers This is the end of the procedure. Output: To ensure that Medical Advice Alerts are communicated and action is taken accordingly Performance: Date Issued 01 Jan 2011 Date Effective 01 Jan 2011 Procedure number DACS008 Issue number 0.5 Page 7 of 9 Updated By Sarah Edwards Medical Advice Alert DACS/008 6

7 APPENDIX 1 Circulation List (by ): Heads of Service Graham Allen, OPPD Nick Fripp, LD Senior Manager Team Managers Therapy Manager Therapy Team Leaders Pete Wild, L/T Frances Tippett, S/T Sharon Cornellius, Cilla Holt, Gina Pearson, Jane Nicholas, L/T Paul Freeman, L/T Sally Bickle, L/T Jane McKenzie, S/T Kim Baker, S/T Annette Caston, S/T Sue Jago, LD Darren Priestland, LD Carol Liesse, LD Tina Sanford, LD Karen Roach Julia Parfit Gill Mead Vicky Crowther Ann Coker District Home Care Managers Senior Manager - Support & Finance Claire Woolcock Debbie Isted Katrina Leahy Gail Smith Linda Daw Mandy Blight Wendy Stumbles Robin Stephenson Health and Safety Officer Chy Koes Echo Andrew Wilkinson Anne Davis Helen Winchurch Medical Advice Alert DACS/008 7

8 Prepared by: Sarah Edwards Office Manager Projects Adult Care & Support 30 March 2011 If you would like this information in another format please contact: Cornwall Council County Hall Treyew Road Truro TR1 3AY Telephone: Please consider the environment. Only print this document if it cannot be sent electronically. Medical Advice Alert DACS/008 8