Agenda

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

1

The role of MHRA, Hospitals and the Manufacturer in adverse incident reporting .

Mark Grumbridge – Clinical Nursing Advisor, Medical DevicesNAMDET, MHRA roadshow Bridgend July 2014

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

Health and Care system (April 2013)

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.

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.

MHRA in the spotlight – 2012/2013

• PIP Breast Implants• Metal hip implants

The Media

EU Regulatory System

compliance ERssafety, performance Notified Body

• quality systems• design dossier• clinical data (literature, C/I)

accreditaudit

CompetentAuthority

European market post market surveillance serious adverse events

investigation action

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.

Once a device is on the market….

• Post market surveillance

• Vigilance

• Safeguard action

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

Causes of adverse events

• Inadequate training

• Local modification

• Too complex

• Not monitored

• Incorrect device

• Incorrect use

• Instructions not followed

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

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

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

Online reporting

Online reporting

Online reporting

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.

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

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

83 Medical Device alerts issued in 2012

Two weeks to publish from a decision being taken to issue a MDA

Ongoing projects to improve incident reporting

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!

Thank you

Any Questions?