Seminar PQ1: Materiovigilance (UDI – tracing – reporting)

Linked to EAHP Statements

Section 2 – Selection, procurement and distribution: Statements 2.1, 2.2, 2.6
Section 5 – Patient safety and Quality Assurance: Statements 5.2, 5.4, 5.6, 5.10, 5.11

ACPE UAN: 0475-0000-18-022-L04-P. A knowledge based activity.

Abstract

Every day a broad variety of new implantable medical devices find their way to the European market and will be implanted in patients where they may stay for many years. In order to guarantee patient safety, it is obvious to guard the quality of the products and the supply chain; as well as to build an (inter)national register of implanted devices so patients at risk can be contacted in case of a recall.

In 2011, Europe woke up after the PIP-implant scandal and authorities started on a master plan for materiovigilance and digitalization of traceability in which the hospital pharmacist plays a crucial role. To communicate about the implants, a unique identifier is mandatory and this will be covered by the UDI (Unique Device Identifier).

However, as patient safety could not wait for the promised deployment of UDI, hospital pharmacists already implemented procedures for traceability (some on paper; some with barcodes) and materiovigilance (from procurement to dispensing). UDI will bring opportunities to improve materiovigilance although practical issues will still have to be resolved.

Patients should be aware of what is implanted in their body and who to contact in case of a recall. Therefore, patient information should be part of the masterplan.

The Belgian authorities have a system in place. In this session, opportunities, hurdles and pitfalls will be shared with the audience.

Learning objectives

After the session, the participant should be able to:
• Understand the supply chain of medical devices and possible risks for patient safety;
• Estimate the hurdles for the hospital pharmacist when implementing a traceability and materiovigilance system; and,
• Understand the content and the possibilities of UDI.

Educational need addressed

In order to guarantee patient safety the traceability of implants is mandatory. Therefore UDI can be used in national initiatives. Hospital pharmacist must understand the need and opportunities for traceability and possible pitfalls. They can learn from realizations from other countries.

Keywords: materiovigilance, medical devices, recall, traceability, UDI, 2D barcode.