1. 1 National Medical Device Safety Network Better Together ‘Comple ting the Picture’ NAMDET 2014 Annual Conference Manchester Conference Centre Dagmar Luettel Patient Safety Lead NHS England 19 th November 2014

2. 2 The National Reporting and Learning System (NRLS) Local Risk Management Systems 99% Open Access E-Forms 1% NHS net www The system collects all types of incidents from all care settings from all specialties from all staff groups Over 10 million incidents have been submitted to date since inception in 2003

3. Reported Incident Types Source: Apr 2013 - Mar 2014 (NRLS Quarterly Data Workbook Oct 2014)

4. 43,342 medical device incidents in 2013 Reported incident type level 2. Source: Incidents reported to the NRLS in 2013 and categorised by the reporter as incident type ‘medical device’, in percentage.

5. 43,342 medical device incidents in 2013 Reported degree of harm. Source: Incidents reported to the NRLS in 2013 and categorised by the reporter as incident type ‘medical device’. No HarmLowModerateSevereDeathTotal Number of reports 35,7296,4191,113 6316 43,342 Percentage 82153<1 100 All severe harm and death incidents are individually reviewed on a weekly basis by the Patient Safety Team.

6. 43,342 medical device incidents in 2013 Top 10 types of devices. Source: Number of incidents reported to the NRLS in 2013 and categorised by the reporter as incident type ‘medical device’.

7. Some examples of incident reports Patient vomited, so staff asked for the portable suction machine. When received, it had no power as it had not been on charge whilst on the crash trolley… … staff did not have the training to use the [xx] pump and had 1 patient with a pump in situ. A further 3 nurses were questioned none of which had been trained in the use of the device and they were unable to identify named trainers for their ward.. Nurse checked emergency equipment at bedside and found that suction unit was not correctly assembled. Tubing connected incorrectly…. I was called to see a CF patient due to trouble with NIV mask overnight. … On my arrival I reviewed the mask which was a non vented [xx] mask. I noticed no expiratory port in the ventilator circuit. The ventilator was alarming 'low leak'. I immediately replaced the mask with a vented [xx] mask. The patient was drowsy but rousable to voice. Spo2 91% and machine no longer alarmed.

8. Incidents involving ECG machines and categorised as ‘user error’ … one of the consultant cardiologists queried a trace and it was found that the chest leads had been wired in the wrong way round after repair. So all patients done that morning on this machine had inaccurate results. Call out to AMU regarding 2 x ECG recorders reported not printing traces. Questioned nurse if the paper was correctly fitted before coming in. Informed that paper was fitted correctly. Fault - Incorrect paper fitted. On closer inspection.. the machine on the ward had the left sided and right sided ECG electrodes plugged into the wrong parts of the terminal connector, not in concordance with the colour coding. No fail safe mechanism in place - both connectors fitted both plugs on the machine.. The HCA performed an ECG for a patient but clicked the wrong button. Instead of auto button, the HCA clicked on copy. Example of patient outcome: Blood tests were unnecessarily performed and patients could have been started on medications unnecessarily.

9. National Patient Safety Alerting System Stage One Alert: Warning This stage ‘warns’ organisations of emerging risk. It can be issued very quickly once a new risk has been identified to allow rapid dissemination of information. Launched in January 2014 to strengthen dissemination of patient safety alerts to healthcare providers via CAS. Stage Two Alert: Resource This alert may be issued some weeks or months after the stage one alert, and could consist of examples of local good practice, tools, resources, and access to learning resources. Stage Three Alert: Directive Organisations will be required to confirm they have implemented specific solutions or actions to mitigate the risk.

10. All Alerts are available at http://www.england.nhs.uk/ourwork/patientsafety/psa/http://www.england.nhs.uk/ourwork/patientsafety/psa/

11. MHRA to maximise reporting of all medical device incidents and ensure these reports are of high quality NHS to develop systems devoted to continual learning and improvement of patient care MHRA to maximise reporting of all medical device incidents and ensure these reports are of high quality NHS England and MHRA initiative Background

12. MHRA to maximise reporting of all medical device incidents and ensure these reports are of high quality NHS England and MHRA initiative Background Data quality issues in the NRLS Data miscoded Type of device reported as ‘other’ (30%) Delayed reports Incidents reported more than 4 weeks after the incident occurred (51%) Missing information Name of device (53%) Name of manufacturer (80%) Important information for learning not recorded in free text descriptions

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15. The role of the MDSO  active membership of the National Medical Devices Safety Network  improve reporting of and learning from medical devices incidents review all medical devices incident reports to ensure data quality for local and national learning, where necessary investigate and get additional information from reporters; make sure that medical device incidents are sent to the NRLS as soon as possible and a least every week;  receive and respond to requests for more information from the Patient Safety Domain in NHS England and the MHRA  work as a member of the medical devices safety committee  act as an additional senior point of contact for manufacturers and support local actions on Field Safety Notices; and,  support the dissemination of medical devices safety communications from NHS England and the MHRA throughout the organisation.

16.  ensure effective dialogue between all partners in the network;  ensure effective reporting of medical device incidents;  share learning from reporting;  disseminate relevant research; and  share information about new risks and best practices. The aim of the Network

17. Introduction – including ‘what’s new’ NRLS medical device incident panel review Presentation of 4-5 serious incidents reported in the previous month and comments from the review panel Detailed briefing – updates, new risks, safer practice Previous topics included: MHRA’ s One-liners and guidance on Field Safety Notices Implementation of alert: Risk of associating ECG records with wrong patients New risk: Accidentally switching of power and medical devices, Battery issues Patient story involving a hoist Presentation on the role of a medical device safety officer Presentation by an individual describing their role, governance, challenges and successes Web meeting structure

18. www.patientsafetyfirst.nhs.uk Material from six monthly online meetings available online (slides, recording, discussion forum and further resources) To access, you need to register, log in and go to Forum/ Resources, then look for medical devices – monthly webex

19. The network is intended to support the work of the MDSOs Get involved 1.Join the incident review panel 2.Present information about a new risk 3.Share a safer practice example 4.Talk about your role 5.Join in the discussions and share materials on www.patientsafetyfirst.nhs.uk www.patientsafetyfirst.nhs.uk 6.Suggest topics for future web meetings

20. Thank you for listening. Contact details: ENGLAND.Medical-Devices@nhs.net dagmar.luettel@nhs.net Tel: 07769 687490 Websites: http://www.patientsafetyfirst.nhs.uk http://www.england.nhs.uk/ourwork/patientsafety/