Especially the global inter-
connectedness makes it necessary
to design a more uniform trace-
ability system; © Klicker/pixelio.de
COMPAMED.de asked Doctor Matthias Neumann when we can expect the first steps in this direction and what advantages this identification has for the manufacturers. Neumann works as Deputy Head of Unit “Medical Devices” at the German Federal Ministry of Health and as a member of international committees is actively involved in the discussion about the implementation of this international standard.
COMPAMED.de: The process of identifying medical devices will dramatically change in the future. Why should the legal requirements be further tightened and finalised?
Matthias Neumann: During the practical application of the existing regulations, the different regions of the world discovered that it is necessary to improve the traceability of medical devices. Especially the global interconnectedness makes it necessary to design more or less uniform traceability systems that enable a consistent traceability of medical devices in the best way possible, for example all the way to the patient. Precisely with worldwide product recalls, it is important to be able to retrieve the devices at any time to take appropriate corrective measures. The present identification regulations resulted in several traceability systems being created, subject to the manufacturer’s chosen solutions, which generally showed large gaps and were only functional with considerable financial expense by the users.
COMPAMED.de: Now you are working on an international identification standard. What is the current state of affairs?
Neumann: The project to introduce the UDI (Unique Device Identification) system was originally initiated in 2006 by the U.S. Food and Drug Administration (FDA). The Global Harmonization Task Force (GHTF) has recognized the importance and necessity of a global uniform identification system in time and in this collaboration developed the framework for a UDI system. Now it is essential to incorporate these basic regulations into the national, regional and European legislature. To do this, several detailed questions still need to be answered. The international task force of the IMDRF, the International Medical Devices Regulator Forum and successor of GHTF, is already processing that.
For several devices, special solutions still need to be found. One initial regulation drafted by the FDA could become law at the end of 2013 and would be binding starting 2015 for companies that want to sell medical devices on the U.S. market. In Europe, the UDI system will most likely be introduced in the context of the revision in medical device legislation that is already being developed.
COMPAMED.de: Does the new Unique Device Identification System (UDI) only have advantages for manufacturers of medical devices?
Neumann: The UDI system does not automatically mean improved traceability. It is rather an important tool to achieve timely traceability of devices. The new requirements will commit manufacturers to furnish the devices with a machine-readable universal unique code. The manufacturer then has to enter particular, clearly defined data into a central database system that will be made available to all other parties in the supply chain and service provision. As a valuable secondary effect, this creates a standardized infrastructure for the handling of orders, sales, delivery, shipment, warehousing, and application all the way to proper disposal.
All of the participating stakeholders in the trade chain and patient care should use the machine-readable identification and integrate the data that is stored in the code for their own processes. This way significant process optimization and increased efficiency can be achieved in these areas. Initially, the introduction of the UDI system will be a considerable challenge for the manufacturers. Aside from technical and technological issues for example during the application of the machine-readable coding, organizational changes of the manufacturing and design processes are also going to be necessary. Among other things, manufacturers have to make sure that all data connected to the product and the specific UDI located on it, will also be consolidated, collected, stored, updated and evaluated if applicable. The UDI system will consequently also have a significant impact on the manufacturer’s quality management.
Thanks to harmonised stand-
ards, a device can be identified
anywhere in the world;© Maren
COMPAMED.de: What does the technology that enables the detailed identification and traceability of medical devices need to achieve? How is the UDI made up?
Neumann: One is going to use machine-readable coding systems with globally harmonised standards, so a device can be identified anywhere in the world. The static part of the UDI contains data that provides more detailed information on the type of product and presents a form of product identifier. In the dynamic part, you find data that identifies the individual device: for instance the serial numbers, the expiration date, batch number or the like. The static part of the UDI is going to be the access code to a UDI database that needs to be built up, with which ultimately all data that’s needed by the parties in the supply chain can be retrieved. Currently the IMDRF aims to cross-link the UDI databases with each other, so a global uniform system can be created.
This would create an efficient tool for an international market observation system. In case of recalls, public authorities and hospitals all over the world could quickly and efficiently identify the affected products. The UDI will make the set up of implant registries more efficient. The UDI of implanted devices for instance could thus be efficiently registered in electronic patient records, and in case of emergency, this would enable quick identification of the affected patient. The UDI code will ultimately also be used for billing of medical treatments.
COMPAMED.de: When will UDI be mandatory worldwide for all medical device manufacturers?
Neumann: In addition to the UDI relevant new requirements for manufacturers, in the new medical device legislation the European commission plans to also set up special regulations for the supply chain parties, the so-called ”economic operators“. They are to be obligated to “scan” all incoming and shipped devices and to keep corresponding records on them. This is meant to ensure that the location of devices along the supply chain can be quickly determined if necessary.
The commission would like to publish its official proposal for revision of the medical device legislation in July of 2012 and act on the assumption that proceedings in the assembly and parliament can be concluded at the earliest in 2013. Under consideration of the usual transition periods, the first products would have to be identified accordingly in 2015 at the earliest. Whether all other regions will have participated by then is questionable. However, if this identification system established itself in the large marketplaces U.S. and Europe, this standard will then be easier to implement worldwide.
The interview was conducted by Diana Posth and translated by Elena O'Meara.