lasermarking I cleaning I passiviation I verification (UDI) I packaging I labeling
Medical technology continues to evolve with every single day, new and innovative instruments dominate the market. New technology, however, always brings new legal requirements. Nowadays, a surgical instrument must not only defy several operations, but also have to stand up in the process of spreading. But a proper cleaning during the development and particularly before the first employment requires experience and know-how. Because even this process entails a considerable effort in documentation and execution. New and existing standards in the QM area have forced a considerable amount of time to be spent in the final price. In order to meet this effort, there are only limited possibilities, you invest or you store it out and make a service out of it. We have made it our mission to offer exactly this performance. Through our validated procedure in the final cleaning and passivation of surgical instruments, we guarantee process safety. If desired, your instruments can also be packed and labeled separately. Please call for detailed information.
The MARKING TECHNOLOGY is an extension in terms of service. In this field, we offer you a validated marking process for all types of common instruments *, surfaces and materials *. We only us a closed laser system, and we also offer this process as a pay service.
More and more legal requirements in medical technology are forcing manufacturers to make more and more complex processes and restructurings for medical devices. However, not every company is in the warehouse to take this step to balance or to go along, since this effort is usually associated with considerable costs and with additional effort. However, in the near future, many small and medium-sized enterprises will try to outsource these processes. We have made it our task to relieve you of this burden.
UDI - unique device identification
Barcode for the marking of medical devices was previously a voluntary achievement of the manufacturers, now it becomes obligatory. The dates are set by the American Food and Drug Administration (FDA), nothing can be done without the accredited standards HIBC, GS1 and ISBT. Each of the standards has its features that make it possible to take advantage of it. The responsible persons for purchasing, materials management and IT can now refer to official guidelines, which are distributed worldwide and are reflected in central databases. This is a great advantage. The indication "UDI compliant" states that a medical device is clearly identified, other prescriptions are still valid.
What does UDI mean?
UDI (Unique Device Identification) is more than one product code, UDI is a system. This is followed by the International Medical Device Regulatory Forum (IMDRF). Drivers are the US FDA, the European Commission, key players around the world, and affiliates such as the World Health Organization WHO. Legislators want to ensure that the traceability of medical devices is guaranteed at all times throughout the entire supply chain. This allows the authorities to initiate immediately necessary steps in the case of undesirable incidents and to recall products. UDI as a system includes both a unique code on the product or the packaging as well as the master data entries in a central database. The code requires an ISO-compliant, optical code carrier as an AIDC medium (bar code, 2D code). In addition, RFID is permitted. The ISO / IEC 16022 Data Matrix is widely used because of the low space requirements and automatic error correction. But Code 39 and Code 128 are also in use. The data content with manufacturer, product reference and product variable shall be encoded according to ISO-compliant structures by accredited bodies. The master data are set and maintained directly by the manufacturer / labeler in the central database "Global Unique Device Identification Data base (GUDID)". The FDA creates the GUDID as a public reference catalog. UDI The product serves the traceability, UDI in the database serves the registration and thus the accreditation, but also offers potential for the optimization of logistics and material management.
Who wants UDI?
On 24 September 2013, the US authority FDA adopted the requirements for UDI. Accordingly, from 25 September 2014, UDI becomes compulsory for medical devices of the highest risk class. In Turkey, the requirement for "Unique Device Identifiers (UDI-DI)" and database entry has existed since 2008 for all medical devices. According to the activities of the ministries and parliaments, UDI is expected to be a worldwide requirement in the medium term. For manufacturers' plans, the FDA's legal requirement can be accepted as a general basis.
The US agency FDA has specified a specific timetable for the introduction of the UDI system. This refers to the delivery of medical devices with coding, including the corresponding entry in the database "GUDID". Timetable for Europe The timetable for the introduction of the UDI system in the European countries is subject to the final decisions of the European Parliament. The European Commission (EC) has already created the necessary prerequisites for this and published the "Final Document, UDI Guidance Unique Device Identification (UDI) of Medical Devices" together with the members of the IMDRF, together with the FDA, on 9 December 2013 (IMDRF / WG / N7FINAL: 2013). The document aims at a uniform UDI system with comprehensive compatibility, that is, on the same functionality worldwide. Therefore, it is reasonable that manufacturers who do not deliver exclusively to the US or Turkey, Medical devices for other countries with UDI-compliant codes. Thus the advantages of UDI are used immediately and not only according to legal requirements.
What is the code?
A UDI-compliant code contains the data required for traceability. The UDI-compliant code consists of two components. A distinction is made between "UDI-Device Identifier (UDI-DI)" and "UDI-Production Identifier (UDI-PI)". The "UDIDI"
As the static component, the manufacturer / labeler's ID, the reference code of the product, and an optional label for a particular packaging level. The UDI-PI is the dynamic component and can contain the expiration date, the LOT specification, a serial number or the production date (see Table 2). The exact field selection depends on the product (eg chargeable). The data elements for the UDI-DI are defined in the UDI specification of FDA and IMDRF, but the structure is determined, among other things, by the chosen code system. The manufacturer selects the data elements for the UDI production identifier (UDI-PI) according to the legal requirements and the product class (see table 3). UDI-DI is placed together with key data from the manufacturer in the central database. "UDI-PI" data are not currently included in the central database. However, the UDI PI field selection (for example, chargeable) is announced by the database. The term "manufacturer" includes the person responsible in each case as "in-the-traffic-provider" of the product, which does not necessarily manufacture it himself and is also referred to as "labeler".
Coding system for udi-di and -pi
The HIBC, the GS1 and the ISBT system are currently accredited as interoperable coding systems. The distinction lies in the characteristics of the product codes and their attributes. ISBT is designed for the identification of blood and transplants. For HIBC and GS1, the attributes are essentially the same as the data media used, eg ISO / IEC 16022 DataMatrix. However, the product reference capacities differ from one to 18 digits for HIBC and approximately 3 to 5 digits for GS1 (depending on the country and the labeler code). Therefore, a second reference is customary or necessary in the latter case. Table 4 shows the example of a 5-digit and a 7-digit REF carried in a suitable code. Example 2 in Table 4 applies to a REF defined between 6 and 18 digits. Since a REF can be coded directly at HIBC, it is also referred to as a "direct coding system". A second reference on the product and in the databases is not necessary with the direct coding system.
UDI data elements for the central
The central database is used to register medical devices with associated manufacturer data for access by the authorities, but also by the public.
New logistical possibilities through "Public User Interface"
Access to the UDI-DI data set of a product offers users new possibilities for logistics. Wherever a reported UDI product appears, all key data will also be available.
UDI made easy
It is easy for everyone who already has one of the accredited standards. Apart from checking whether UDI-DI and UDI-PI are correct, no change is required here. Manufacturers who have been using HIBC since the 1990s are well prepared for UDI, including those who use GS1 codes (but with tracking data). UDI beginners can choose the right system.
For the manufacturer, UDI provides a clear framework for how and which information to encode the product or packaging to be placed in the database. The framework currently provides for the bar code HIBC, GS1 and ISBT. UDI is thus made easy for longtime users, for them there is no extra barcode and also not for the user to re-set up the REF numbers. For those responsible in the clinics for purchasing, materials management and IT, the UDI system offers enormous advantages, as the official requirements can be met which are met by the manufacturer. The "UDI-compliant" specification includes all necessary features, uniqueness and interoperability for future-oriented barcode-supported systems. In addition, access to the barcode content and. Master data via networked central databases. This offers new logistical possibilities.
Source: © MTD-Verlag GmbH, Amtzell 2014,
Author: Heinrich Oehlmann