HPRA Medical Device

Communications

Orla Keane

Product Manager - Medical Devices

HPRA Medical Devices Information Day

Dublin, 23rd October 2014

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HPRA

Healthcare

professional /

user

Manufacturer

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Agenda

•Types of HPRA Medical Device Communications

- Website - Safety Notices

- Information leaflets - Surveys

- Targeted letters - Information Days

- Journal articles - Newsletter

- Presentations at conferences

- Information Notices

- Communications with other Competent Authorities

-Ad-hoc communications (SCENIHR etc.)

•Areas of focus for 2014/2015 and beyond

•Vigilance liaison officer

•Encouraging user reporting

Background

• HPRA circulated a communications questionnaire to healthcare

stakeholders in Ireland in 2012 requesting feedback on our medical

devices communication mechanisms

• HPRA has used this feedback to implement key improvements

– Revamp of HPRA website

– New Format for Safety Notices

– New Process for Safety Notices – (UK MDAs are no longer being

circulated)

• User report form facilitates upload of supplementary documentation (e.g.

pictures)

• Not all incidents are being reported to the HPRA

– Feedback from clinical community – Regulatory systems is sometimes like a ‘black box’.

The more information that we issue the more feedback / engagement with system

Website

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• Improved navigation and design

• Enhanced alert system

• Sub homepages for:

⁻ Medical Devices “Safety & Quality”

⁻ Medical Devices “Regulatory Information”

⁻ List of latest product updates, FSN summaries, news updates etc. specific to medical devices

⁻ Quick links e.g. Consumer leaflets, reporting adverse incidents and medical devices newsletter

• Sub homepages for Industry, Health professionals and Members of the Public

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Field Safety Notices

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• User’s Role – FSCAs

• Forward field safety notices to appropriate personnel

and acknowledge receipt of the field safety notice, as

applicable

• Develop procedures to ensure that all medical devices

are traceable, from hospital, to equipment used in

patient homes to implanted devices.

• Develop procedures to ensure there is appropriate

medical device equipment management including

purchase, training, repairs, servicing and storage

• Field Safety Notices uploaded to HPRA website monthly

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Safety Notices

The HPRA circulates safety notices in many instances. Examples include:

• To highlight a serious public health issue

• To draw attention to field safety corrective actions which, following a HPRA risk

assessment, are deemed to be related to medium or high risk safety issues

• To highlight an issue that has already been communicated by a manufacturer

via a field safety notice but where the manufacturer has indicated to the HPRA

that they have experienced difficulty reaching all customers or obtaining

feedback from all customers

• To highlight an issue when either the device manufacturer or distributor to the

Irish market no longer exists. For example, where the manufacturer has gone

into liquidation or where the manufacturer is not known e.g. counterfeit devices

• To communicate concerning trends identified by the HPRA in relation to

particular product families

• To communicate safety concerns identified by the HPRA monitoring vigilance

issues e.g. equipment management issues and traceability issues

• Number of Safety Notices has increased 39

to date in 2014 (16 for all of 2013)

• No longer circulating the UK MDA alerts in

Ireland

– HPRA review the UK MDA alerts to determine if

HPRA is aware of the issue (Manufacturer may

have omitted to report to Ireland)

Updated Process

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HPRA Information Leaflets

The HPRA has published 8 medical device brochures / leaflets providing advice

on specific medical device issues

– Implantable Medical Devices

– Medical devices in the home

– Buying Medical Devices for Personal Use

– Buying Medical Devices Online

– Safety Tips for Blood Glucose Meters

– Safety Tips for Contact Lens Wearers

– Automated External Defibrillators

– Selling Medical Devices in Ireland – A Guide For Retailers

– Self-Test Products (Draft)

• Aim: to engage with patients / members of the public in relation to incident

reporting

• Provide information in an easy to understand format

• HPRA has identified the need for further

regulatory guidance for distributors, healthcare

professionals and users to highlight specific

aspects of medical device legislation

• Examples

– When must be a notified body number appear

alongside the CE mark on labelling/packaging

– Understanding information on device labels e.g.

sterility, single use

Information Notices

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• Involves appointing a senior member of hospital

staff

– Act as the contact person for medical device issues

(HPRA and manufacturer)

– Close the loop on any action

• HPRA plan to revisit this initiative, building on

previous pilot scheme

Vigilance Liaison Officer

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Key Messages

• Variety of HPRA Medical Device Communications

• Field Safety Notices on website

• HPRA Safety Notices supplement FSNs, where necessary

•Additional guidance / general information

• How to engage with HPRA

•Request information

•Provide feedback / ideas / suggestions

• User reporting

•HPRA welcomes and values input from healthcare

professionals, important stakeholders in the regulatory system

for medical devices

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