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 regulationsOperating 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 ImplantsMetal hip implants
9 EU Regulatory System Notified Body Competent Authority investigation actionaccreditauditcompliance ERssafety, performanceNotified Bodyquality systemsdesign dossierclinical data (literature, C/I)CompetentAuthoritypost market surveillanceserious adverse eventsEuropean 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 surveillanceVigilanceSafeguard 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 trainingLocal modificationToo complexNot monitoredIncorrect deviceIncorrect useInstructions not followed
14 What to report Device failures prior to use Device failures in use Devices causing harm to patientsGeneral safety concerns about a deviceInstructions not clear
15 Ways of reporting Follow local Trust policy for incident reporting On line reporting direct to MHRADirect report to manufacturerSMTLCombination 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.stethoscopessuturesvaginal speculums
20 What happens to my report ? Pre Triage - responsible officers review all reported incidents on a daily basis and provide a preliminary gradingTriage - 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 othersYou 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
25 Summary Incident reporting is a fundamental part of patient care Document incidents in a timely mannerIt is essential reporters get feedbackDirect reporting ensures a quicker responseDo not overlook your own internal systemsIf in doubt report it!