Federal agency for medicines and health products ... · products Traceability of Implantable Medical devices Implant card ... –Link to the leaflet ... –Consultancy of the patient

Federal agency for medicines and health products

Traceability of Implantable Medical devices Implant card

Vanessa Binamé – 13/03/2015

Subject

famhp/entity/Division-Unit-Cell Date

2

Agenda

• Introduction

• Traceability of implants

• Implant card from an EU perspective

• Implant card from a Belgian perspective

• Conclusion

Subject


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Agenda

• Introduction




• Conclusion

Subject


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Introduction

European proposal – New Regulations

Now

Regulation Medical Devices

Regulation In-vitro-dignostic Medical Devices

2 Regulations ► Directly applicable

Tomorrow

3 Directives ► Transposed

into national law

Directive 90/385/EEC Active Implantable Medical

Devices

Directive 93/42/EEC

Medical Devices

Directive 98/79/EC In-vitro-diagnostic Medical Devices

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Introduction

• 3 Directives 2 New Regulations The New EU regulation about medical devices will

envisage :

– Reinforcement of the public access to clinical data for both patients and health professionals,

– ‘CE’ mark delivered by experts only

– Clearer responsibilities for reprocessing “single use” devices

– Introduction of an implant card provided with the implanted device

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Agenda

• Introduction




• Conclusion

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Traceability of implants

Initial context

PIP Breast implant scandal

Actually, one of the weaknesses of the previous system was that patients were not aware of what was implanted to them

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What would an excellent system for implantable devices look like?

• Allow a full traceability from the manufacturer to the patient for each medical device implanted

• Able to know at every moment where a specific device is

• Opportunity for the patient to consult which medical device was implanted to him

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What would an excellent system for implantable devices look like?

Manufacturer Intermediate

Distributors

Distributors

Pharmacy

(Hospital / Retail)

Patient

Distribution

/ Implantation

Information

exchange

Authentic source

Health

Professionals

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What are the essential requirements to make such a system possible in a national health care system?

• Participation of all the actors concerned

• Simple, friendly, should not be an additional burden for

Industry

Health professionals

Authorities

• Focus on the essential >< take into account specific requirements from all the actors

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What are the essential requirements to make such a system possible in a national health care system?

• Use international standardisation and national conversion tables when really needed

• Connexion with the Belgian eHealth plateform

• Exchange data with Eudamed II / III

• Respectful for the private life of implanted patients

• Strict and controlled path for distribution, delivery and use (POMD)

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How can regulators, industry and health care providers work together on this

• Should be a win/win situation for everyone

• Communication – Concertation - Step by step approach

• Development of interfaces system to system

• Let all the doors open and pay attention to the SMEs

• Take into account the advanced states of technological development (eg UDI, Combined Products, Combination Packages,…)

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Goals

– Strengthening of our vigilance system

– Able to inform health care professionals in case of incident

– distribution pathway with clear responsibilities' => easier to control => better protection of the patient

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What does the Agency in case of incident ?

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• Responsabilities of distributors :

Have to notify FAMHP to the “Authentic sources of

distributors”

Have to notify the FAMHP – NIHDI (INAMI-RIZIV) the IMD (Implanted Medical Device) commercialised in Belgium

Have to distribute their IMD through a pharmacy

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• Responsabilities of Pharmacy :

Check of the legal requirement for the IMD

(distributers – ASND, Authentic source of notified distributers – CE mark)

Can deliver only if asked by a health professional (“pre/postscription”)

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• Responsabilities of the healthcare professional:

Order IMD through pharmacy

Notify the file in the ‘Traceability Central Register’ (TCR)

Provide the implant card to the patient

• Responsabilities of the patient :

Ask an implant card

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• Responsabilities of the FAMHP:

– Publish the list of distributers

– Publish the list IMD ASND

– Control

– Materiovigilance

– Information

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What’s going on:

– Pilot project with hospitals

– Use existing solutions (eHealth, EHR)

– Promote “system to system” solution

– Integrate codification standards (i.e. GS1)

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• In the Central Traceability Register, will be identificated :

– Patients : ID number (NISS), sex and birth date

– Health professionals, prescribers, pharmacists and health institutions : ID number (NISS)

– Implantable medical devices and relatives information : brand, manufacturer, distributor

– Date of : prescription, delivery and implantation/withdrawal

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• The TCR is fed by health professionals through two channels :

• A web service and a web application

WebService concerns healthcare providers who work inside a health institution

WebApplication concerns healthcare providers who work outside a health institution

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Agenda

• Introduction




• Conclusion

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Implant card from an EU perspective

• Currently, a physical card is sometimes provided by the manufacturer (for some type of implants).

• Several information are mentioned (but not standardized)

– Surgeon’s name,

– Patient’s name,

– Type of implant,

– Origin of implant,

– Date of implantation,

– Serial number.

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Implant card from an EU perspective

• With the coming new regulation, the implant card will serve several functions :

– Identifies surgery and possibly implant in case of medical emergency

– Gives something for the patients expecting to negotiate metal detectors, such as at airports and government buildings

– Can contain important information on it, such as : antibiotics for life, medical record, number, allergies, etc.

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Agenda

• Introduction




• Conclusion

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Implant card from a Belgian perspective

Information who should be mentioned on the implant card

– Identification of the patient

– Identification of the device (Serial number, Unique Device identification)

– Manufacturer / authorized representative

– Date of implantation, withdrawal

– Identification of the healthcare professional

– Identification of the health institution

– Identification of pharmacy

– Link to the leaflet

– Link to information regarding materiovigilance

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Implant card from a Belgian perspective

Information who should be mentioned on the implant card

The patient will receive an implant card, that not only provides information about the implant, but also guarantees that the implant has followed the legal distribution circuit. This card will be an extract of the electronic notification of implantation

Added-value of the forthcoming “TCR” :

– Traceability

– Knowing where a specific device is

– Consultancy of the patient about the IMD

– Faster reaction in case of incident

– Standardization

– Saving time for administration

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Agenda

• Introduction




• Conclusion

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Conclusion

Challenges / Opportunities

– Unique Device Identification

– Private Clinic

– Administrative simplification

– Extension to other products

– BE/EU consistency

– HCP commitment

– Patient awareness

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Federal agency for medicines and health products - famhp

Place Victor Horta 40/40

1060 Bruxelles

tel. 0032 2 524 80 00

fax 0032 2 524 80 01

e-mail [email protected]

www.afmps.be

Contact

mailto:[email protected]



http://www.fagg.be/

http://www.afmps.be/

Your medicines and health products, our concern

Documents

Federal agency for medicines and health products ... · products Traceability of Implantable Medical devices Implant card ... –Link to the leaflet ... –Consultancy of the patient