Proposition 53K3057

Projet de loi en matière de dispositifs médicaux.

General information ¶

Submitted by

PS | SP the Di Rupo government

Submission date

Oct. 9, 2013

Official page

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Status

Adopted

Requirement

Simple

Subjects

fine health policy paramedical profession public health health insurance

Voting ¶

Voted to adopt

Groen CD&V Vooruit Ecolo LE PS | SP ∉ Open Vld N-VA MR VB

Contact form ¶

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Discussion ¶

Nov. 7, 2013 | Plenary session (Chamber of representatives)

Full source

Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker.

Effectively, on 23 October last year, our public health committee unanimously adopted the bills submitted by Ms. Onkelinx concerning medical devices. Such unanimity should be emphasized.

It must be said that we were all eager to get acquainted with this project, which helps to secure, from manufacture to implantation through implantation, the chain of medical devices. And this is ⁇ not anodin, as remember the scandal of PIP breast prostheses.

At the first revelations of this scandal, I had also taken the initiative to ask multiple questions to the minister, who had then committed to bring together as soon as possible all the actors in the sector to find a solution to the fact that, until now, the health authorities were unable to know the number of prostheses implanted in Belgium, the providers who have used this or that prosthesis, and the patients concerned.

Thus, from last fall, the large lines of the Plan Implants came into being and the bills that are being discussed today formalize this plan. These projects enable the establishment of an effective and rapid system of traceability of medical devices with a clear objective of health safety. This chain recording will be perfect: distributors and products marketed, suppliers who buy them, then the patient to whom the product is intended. All this information will now be recorded and can be used in the event of a health alert. With the proposed system, the risk inherent in all medical devices will be properly measured before the product is marketed and will be monitored accurately after implantation.

In addition, the position of the patient is significantly strengthened through, in particular, new information obligations for service providers.

The provider must provide the implanted patient with a certificate containing all the essential data relating to the implanted device. This obligation will also allow to exclude non-compliant devices that have not been purchased through the legal circuit. This is an additional guarantee for the patient.

Finally, I would like to thank the Minister for her remarkable work in this matter and in consultation with the sector that will fund this reform.

This reform was highly needed to reassure and secure current and future implanted patients.

Our healthcare system is based on trust. This project strengthens it. My group will approve this bill.

I would like to congratulate the rapporteur for her excellent report. I will not comment further because it was voted in a committee without opposition.