1. Agenda The role of MHRA, Hospitals and the Manufacturer
Incident Reporting
Signal Detection
Medical Device Regulation
Managing Medical Devices
Devices in Diabetes
Bed rails

2. The role of MHRA, Hospitals and the Manufacturer in adverse incident reporting.
Mark Grumbridge – Clinical Nursing Advisor, Medical Devices
NAMDET, MHRA roadshow
Bridgend July 2014

3. Content Who we are and what we do ! Roles & responsibilities
Facts and figures
Causes of adverse events
Why should I report ?
What to report
Ways of reporting
What happens to my report
Summary

4. Health and Care system (April 2013)

5. MHRA - Who we are and what we do
The MHRA is the competent authority (CA) for the UK. On behalf of the Secretary of State for Health, we administer and ensure compliance with medical device legislation in England, Northern Ireland, Scotland and Wales.

6. The MHRA meets its functions by:
Investigating allegations received about possible non-compliance with the regulations
Operating a proactive inspection programme where manufacturers are randomly selected for inspection by MHRA's own staff.
Designating UK notified bodies and audits them.
Investigates post-market surveillance reports received from medical device manufacturers.

7. MHRA in the spotlight – 2012/2013
PIP Breast Implants
Metal hip implants

8. The Media

9. EU Regulatory System Notified Body Competent Authority investigation
action
accredit
audit
compliance ERs
safety, performance
Notified Body
quality systems
design dossier
clinical data (literature, C/I)
Competent
Authority
post market surveillance
serious adverse events
European market

10. Roles and responsibilities
Manufacturer – to undertake post market surveillance , report issues with their products to the user and the regulator and to undertake corrective actions where necessary. To be vigilant.
Hospitals – to report incidents in a timely manner, action FSN and MDA, to provide feedback to the reporter.

11. Once a device is on the market….
Post market surveillance
Vigilance
Safeguard action

12. Why should I report ?
Professional accountability - NMC Code of Conduct - Manage risk;32. “You must act without delay if you believe that you, a colleague or anyone else may be putting someone at risk”
Trust Policy

13. Causes of adverse events
Inadequate training
Local modification
Too complex
Not monitored
Incorrect device
Incorrect use
Instructions not followed

14. What to report Device failures prior to use Device failures in use
Devices causing harm to patients
General safety concerns about a device
Instructions not clear

15. Ways of reporting Follow local Trust policy for incident reporting
On line reporting direct to MHRA
Direct report to manufacturer
SMTL
Combination of all the above

16. SMTL Devices syringes and needles dressings, bandages,
compression hosiery/stockings,
gloves - surgical and examination,
anaesthetic tubing and airways,
urinary catheters,
urine drainage systems,
IV cannulae and catheters,
disposable/reusable non-electrical surgical instruments, (tonsil snares, gags, forceps),
IV administration sets,
face masks,
nebulisers,
tubing (bubble, oxygen),
electrodes,
blood collection equipment (e.g., vacuum collection tubes),
sharps containers,
chemical and biological indicators used in sterilisation processes,
surgical gowns and drapes.
stethoscopes
sutures
vaginal speculums

17. Online reporting

18. Online reporting

19. Online reporting

20. What happens to my report ?
Pre Triage - responsible officers review all reported incidents on a daily basis and provide a preliminary grading
Triage - A daily meeting of team managers and the clinical team to review and make a final decision on grading.

21. What happens to my report ?
Trending & Surveillance - Not all incidents need active investigation.
Monitored - Manufacturers will investigate and provide a final report.
Specialist investigation - ALL reports from members of the public.
May conclude with a MDA

22. Why should I report ? You have a duty of care
You may prevent serious harm to others
You may be the first to identify a significant device problem of national significance

23. 83 Medical Device alerts issued in 2012
Two weeks to publish from a decision being taken to issue a MDA

24. Ongoing projects to improve incident reporting

25. Summary Incident reporting is a fundamental part of patient care
Document incidents in a timely manner
It is essential reporters get feedback
Direct reporting ensures a quicker response
Do not overlook your own internal systems
If in doubt report it!

26. Thank you
Any Questions?