Unique Identifiers for Medical Devices
Should bar codes—or other means of automatically identifying medical devices—be required?
The GS1 global Healthcare User Group (GS1 HUG; www.gs1.org/hug) is a voluntary and open group formed by 40 leading pharmaceutical and medical device companies, wholesalers, hospitals, and trade associations from around the world. They have come together to develop automatic identification standards specific to the needs of the healthcare industry. Given FDA’s recent exploration of unique medical device identification, PMP News sought the perspectives of industry leaders involved in GS1 HUG. Volker Zeinar, a freelancer for B. Braun who is handling the coordination of auto-ID affairs and is HUG cochair, and Peter Tomicki, global project manager for Baxter and HUG leadership team member, offer their insights below.
Why is (or why isn’t) unique medical device identification necessary?
Zeinar: Unique device identification could no doubt improve patient safety. Nevertheless, all-inclusive statements are not very helpful. Medical devices are extremely diverse in size, materials, processing, use, and criticality. There is a huge range of products (e.g., cannulas, syringes, IV sets, catheters, adaptors, lines, stopcocks, needles, pumps, filters, motor accessories, cardiovascular systems, gloves, bandages, clothing, surgical instruments, implants, cement, sutures, tissue staplers, utilities like wheelchairs or beds) with different characteristics (e.g., sterile or nonsterile, single or multiple use, very high or very low value, always in contact with a patient or never in direct contact with a patient, large or very small). Differentiating them according to international accepted risk classes (Classes I–III) could be a suitable method of resolution.
Tomicki: For patient safety, unique medical device identification may not be necessary in all circumstances for all products, but cases can be made for the value it adds in certain circumstances. Unique medical device identification will be helpful in some areas. These include track-and-trace functions, adverse-event reporting, supply-chain and reimbursement-efficiency gains, references to databases of product attributes, and additional details not able to be carried by a data carrier, allowing reductions in keystrokes leading to error when handling product, and others.
Are the current systems being used for medical device identification appropriate for unique identification?
Tomicki: Appropriate systems are in use today. However, the key is the harmonization and-or global standardization of these approaches. I believe that Global Trade Item Numbers (GTINs) following GS1 HUG allocation rules offer the strongest approach to global harmonization and are pervasive in healthcare today.
Zeinar: GS1 offers tools for numbering systems, data carriers, etc., that are variable and powerful enough to identify medical devices. The GTIN, in combination with various application identifiers, is sufficient to fulfill the requirements.
All product-related characteristics (e.g., size, color, route of administration, etc.) should never be part of the identification system. Instead, this information has to be stored in a master database. The GTIN serves as a key to the material master data.
There may be a special situation regarding very small items, such as instruments for neurosurgery, which have to be serialized and need direct marking. To address space issues with these products, we need a compressed serialization schema—the less digits or characters, the better. That’s a typical business requirement that we have to discuss in the HUG Work Teams in the next months.
Is serialization necessary?
Zeinar: Yes, partly. But not all products have to be serialized. The business driver for serialization of medical devices is not counterfeiting—it’s traceability. Track-and-trace requirements for surgical instruments could be extremely important in the case of Creutzfeldt-Jakob Disease (CJD). In France, for instance, it is mandatory to document the last five patients on which an instrument has been used.
Implants also have to be documented in the patient files. Administration of electronic machines (motor systems) is based on serial number level (asset management, maintenance activities, etc.). But serialization is not necessary for all mass products, such as syringes or cannulas.
Tomicki: All the stakeholders responsible for healthcare products in the supply chain need to help answer this question. This is a great question for two current GS1 HUG Work Teams: AIDC Data and Serialization.
What technologies are viable?
Tomicki: Printing and direct part-marking technologies currently offer the most pervasive and standardized technologies for implementation of these types of products and packaging, including standard bar codes or symbologies. RFID is possible for some applications and is being investigated for many others.
Zeinar: For marking of packaging, linear bar codes and two-dimensional codes would work, using all print technologies, especially laser technology. For marking directly on the product, Data Matrix can be applied through laser etching, laser bonding, micropercussion, or ink jet. RFID tags could also be applied directly to the product.
Should the pharmaceutical industry serve as a model?
Tomicki: There are likely many overlaps in possible applications and business cases for various stakeholders. It will therefore be important to have pharmaceutical and device industry participation in the discussions to develop global standards that may affect all healthcare products. The pharmaceutical industry certainly has a jump on the device industry when it comes to implementation, and brings much experience to the table.
Zeinar: I don’t think so, because we don’t have a global standard available. For pharmaceuticals, there is a wide range of country-specific models (bar code types, numbering systems, packaging levels to be marked, Italian Bollino sequential-marking rules, etc.).
Should the identification systems and standards developing for both be the same?
Zeinar: In healthcare, the most important data are product ID, expiry date, and batch number. A selected group of products each additionally needs a serial number. Many manufacturers produce products of both categories, and medical institutions (hospitals, pharmacies, and doctors) handle a mix of these products.
To manage different systems (IT, master data, etc.) in parallel would cause higher costs. Therefore it makes sense to develop a common standard, independent from the category. Standard means to use the same numbering system and data structure. It doesn’t mean to have the same information machine readable at the item level for all products.
What challenges do medical device manufacturers face?
Tomicki: Variety and practical technical solutions are the two most significant challenges. The standardization of machine-readable data encoded on the wide array of device products in healthcare is not a simple task. There are also the additional technical considerations of where and how to apply machine-readable data onto products and/or packaging. The question of which data should be answered, and then the technical solutions to carry that data, should be sought.
Zeinar: Different requirements from different markets (regions, trade channels, authorities, and customers) are challenging.
Often the surface of the packaging material is critical. Absorbency of materials, color, transparency, shine, smoothness, etc., influence bar code printing and legibility. Requirements for sterile packaging and bar code legibility may contradict each other. In some cases, the consequence of introducing bar codes could be a modification in the design of the packaging as well as changing packaging material or working with additional labels.
Another issue concerns data content, which has to be included in the bar codes. If the product ID is sufficient, preprinted packaging materials can be used. If variable data (expiry date, batch number, serial number) are required, then online printing during production would be necessary.
Also, the different distribution channels have to be taken into account. Currently the auto-ID requirements of hospitals and retail trade are often different. It may therefore be necessary to keep an old solution (e.g., linear EAN13) and, in addition, make a new solution (e.g., expiry and batch numbers in GS1-128) available.
Global manufacturers have production plants all over the world. The technical levels of the packaging lines are often very different. Validating production equipment after installing additional or new printer or reader technology and software integration has to be done by engineering specialists.
Of course, the necessary investments and the impact of manufacturing costs have to be considered. Therefore it’s almost impossible to fulfill auto-ID requirements short-term.
Is this a global issue? Is one region or country ahead of the rest?
Tomicki: Without question it is a global issue. The United States is one of the leading countries in these discussions.
Zeinar: It is a global issue. In contrast to pharmaceuticals, we can produce medical devices for the world market (usually pharmaceuticals are country specific, given license numbers, mandatory texts and symbols, etc.). The packaging and labeling of medical devices are often multilingual, often up to 20 different languages. Country- or customer-specific auto-ID requirements would have an extremely negative impact on manufacturers—it would increase product assortments, supply-chain efforts, and product costs.
What needs to be done?
Tomicki: Standards need to be developed, incorporating all of the patient safety and business rationale required for a viable solution. After the standards are in place, it will be up to the stakeholders to begin implementing or using them appropriately.
Zeinar: The developers of a global standard need to consider the needs of all supply-chain stakeholders. As much as possible, supply-chain stakeholders should be actively involved in the development process. We must convince authorities and healthcare providers to adopt the global standard.
What is the HUG proposing?
Tomicki: Currently, the GS1 HUG is working toward global application standards for supply-chain stakeholders to implement and use AIDC technologies on all regulated healthcare products for the purposes of patient safety. The GS1 HUG also will be moving toward data management and synchronization, and other work associated with standards use in healthcare supply chains. The development of global standards will be according to the HUG roadmap.
Zeinar: We must expand HUG membership and keep in close contact with legal bodies. We must try to involve more representatives from the hospital side.
How have these ideas been received around the world?
Tomicki: The GS1 HUG has a measure of success in the attempt to use the global nature of the GS1 organization, and all of its member organizations around the world, to draw stakeholders to participate at the table and to communicate further the progress and results of the standards development work.
Zeinar: We now have regular HUG conferences in the Americas (or the United States) and Europe and in the future, the Asia Pacific region. We are establishing HUG-LITs (local-interest teams). GS1 member organizations, currently more than 100, are forwarding the HUG messages and solutions in their domestic markets.
What do you predict will happen in the next two years? Five years? Ten years?
Zeinar: In two years, there will be global standards developed by the HUG and approved by GS1. In five years, a significant number of products will carry unique identification at the unit-of-use level (2D codes, linear codes). Hospitals will be more prepared to use the information in terms of their hardware and IT systems. In ten years, a significant number of products will carry RFID tags. The costs of tags will decrease significantly. RFID technology will offer new opportunities to improve processes. An increasing number of hospitals will be ready to use this technology.
Zeinar: Machine-readable product identification is an appropriate tool to improve patient safety and decrease costs in healthcare systems. But before we can get these benefits, all supply-chain stakeholders must make investments and process changes. To put bar codes or RFID tags on products is only one task. Using this information during daily business processes, such as in bedside scanning at hospitals or in the OR, is another challenge.