CE marking

Catriona Blake

Team Manager, Imaging, acute and community care.

EU Regulatory System

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

accreditaudit

CompetentAuthority

European market post market surveillance serious adverse events

investigation action

compliance ERssafety, performance

MHRA’s Regulatory Role

•Regulation of devices– must meet the Medical Device Regulations 2002

(SI no 618)• usually means must be CE marked (covers all Europe)• exception are custom made devices

– pre-clinical investigation applications– enforcement / compliance action

•No register of manufacturers

Aims of the MD Directives

• MD Directives are intended to deliver– a single market– a safe market– via a uniformly applied system

• To deliver a safe medical device market– the risks must be assessed and managed – pre-market– post-market

Classification System

• All devices are grouped into one of four classes based on level of risk

• Class I devices equal lowest risk eg bandage

• Class III devices equals highest risk eg cardiac ablation catheter

What the Directives do:

Directives specify Essential RequirementsAll devices must conform to essential requirements

•General: They must be safe and perform as intended. » State of the art. » Benefit over risk.

•Design and Construction: Chemical, physical and biological properties; infection and microbial contamination; Construction and environmental preparation; protection against radiation, electrical and thermal risks, etc

•Information supplied by the manufacturer: labels, instructions for use; Instructions forre-processing etc.

What the Directives do:

Conformity Assessment•Device classification defines how compliance can be demonstrated•Class I devices - self declaration by manufacturer•All others independently assessed by Notified Body•Devices are not approved by MHRA

Post market Surveillance Systems

•routine continuing appraisal of risk based on post-market experience (ISO/IEC 14971) to

–prevent adverse incidents

–avert patient or user injury–improve safety & quality of the device and future devices

MHRA Expectations from Manufacturers PMS

•Analysis & use of research into new techniques & technology (state of the art)•Ready access to up-to-date data on product distribution•Additional proactive scrutiny of sub-populations & use of post market follow-up studies •Proper analysis of adverse events reported to them

New Regulations

Possible date 2017

New Regulations

MHRA’s key areas that should be improved:•the inconsistent performance of Notified Bodies; •insufficient clinical evidence relating to the safety and performance of a device before it is placed on the market; •imprecise and variable post-market surveillance by manufacturers; •the need for traceability of devices to improve vigilance and post-market surveillance; and •greater coordination and transparency.

New RegulationsEuropean Parliament voted in favour of a number of changes to the proposed regulations including:•assessment of some high-risk devices to be undertaken by ‘special’ notified bodies designated by the European Medicines Agency, and an additional case-by-case check by a new expert body – the Assessment Committee for Medical Devices (ACMD); •all devices would be considered to be reusable in the absence of scientific evidence supporting a designation as single-use. Where a designation of single-use is approved, reprocessing would not be allowed; •making genetic counseling and informed consent mandatory

ANY QUESTIONS?

What do you do?

Scenario 1

Patient suffers a cardiac arrest following an over infusion from a Volumetric Pump. The pump was set to infuse at 10ml per hour but after an hour the whole 500mls had gone from the bag.

•

Scenario 2

At midday a new syringe was fitted in the MS26 pump and it was set to deliver the contents of the syringe by midday the following day. The pump was set to 48 mm per 24hours. At midday the following day the syringe was still half full and the pump had stopped.

Points to consider:

• Quarantine devices

• Retain infusion sets and any accessories

• Follow Trusts reporting guidelines e.g. MHRA/NPSA/Coroner

• Root cause analysis/ Internal investigation

Hot Topics

• Want more reports on Insulin pumps, needles• silicone tracheostomy tubes • Misconnections• TVT• Over the counter HIV test kits