Are European Bar Code Requirements on the Horizon?
Over the last several years, dialogue regarding medical device bar codes has cascaded throughout the industry. European reimbursement plans may require bar codes, but unlike medical device regulation, there is no pan-European process for medical device reimbursement. As a result, reimbursement decisions concerning which medical devices will be qualified by the government or patient's health insurance provider, pricing as well as what the data requirements will entail (including bar coding), are driven by local government healthcare policy - if they exist at all. As such, there often is considerable variation of bar code technology and requirements between countries. Unfortunately, this variability hinders device and adverse event tracing, post-market surveillance and, ultimately, patient safety.
The Impetus for Bar Codes on Medical Devices
A single mechanism that would facilitate device traceability, help track device-related medical errors and assist in the fight against counterfeit devices would unify the European medical device landscape. A main issue that is impeding progress, however, is that there is no harmonized definition or agreement within the European Union at present regarding such a mechanism. As a result, discrepancies exist at the national level.
Support for the creation and implementation of a harmonized bar coding system has grown, and this column will address the background of the issue and some of the benefits. It is important to note, however, that as with all legislation, there are always two sides to an issue. A bar coding requirement would be an enormous and onerous undertaking, and likely would be disproportionately costly for manufacturers, particularly small- and mid-sized companies.
The Benefits of Bar Codes to the Medical Device Industry
The Global Harmonization Task Force (GHTF) has issued draft guidance that advocates the creation of a Unique Device Identification (UDI) system and delineates the advantages of such a system. The end goal of this mechanism, of course, is better patient care. On this note, the benefits of device-specific bar codes in conjunction with a single, central database to be used for cross reference, all culminate in improved patient safety. These advantages include the following:
- In cases of adverse events, bar codes would help to facilitate the identification of devices.
- Bar codes would enhance traceability and simplify the tracking of medical devices, and thus, improve market surveillance.
- Improved market surveillance would, in turn, help to track device-related medical errors.
- Bar codes would allow for greater efficiency throughout the process, including faster processing and identification.
- Bar codes would assist in the identification of counterfeit devices.
- Uniformity would decrease regulatory costs because there would be a single process and not varying requirements, each with its own fee.
- Bar codes would help to maintain safety/quality assurance.
The Early Stages
In 2004, Eucomed, a European medical technology industry association, tried to establish a harmonized approach to bar code technology by proposing that "all parties involved in the manufacture of and use of medical devices"1 implement synchronized bar codes. A few years later, the Council of Europe Expert Group on Safe Medication Practices recommended the use of barcodes for all medicines in its 2007 report, "Creation of a Better Medication Safety Culture in Europe: Building Up Safe Medication Practices."2 In addition for use with pharmaceuticals, several European Union competent authorities, including France's health regulatory agency, have lobbied support for the use of bar codes on medical devices. At the same time, the United Kingdom's Department of Health, for example, advocated the use of bar codes on a voluntary basis. Turkey, an EU candidate member state, required bar codes on medical devices, and the United States was in exploratory stages regarding its implementation. The bar code fervor within the life sciences industry had been ignited.
Fast Forward to 2009
In 2009, the GHTF drafted guidance on the creation of a UDI system, which, according to the task force, would put forth a "globally accepted data exchange." 3 The draft guidance recently was available for public comments.
In addition to establishing a harmonized definition of a UDI mechanism, the GHTF explained that its guidance was developed in order to "avoid prescriptive country-specific requirements regarding the core elements of the UDI mechanism," which would mitigate many of the issues previously discussed. Lastly, the GHTF advocates of the benefit of a harmonized approach in making the "trade of medical devices more secure for all ... stakeholders" involved, including health authorities, hospitals, manufacturers and distributors.
In the 2009 draft guidance, the GHTF highlighted important steps in designing a uniform approach to the UDI mechanism and implementation timeline. As one example, the group noted the importance of considering the risk of the device. Specifically with the aim of ensuring immediate patient safety, the GHTF recommended that device identification be implemented first for high-risk devices. Additionally, the GHTF noted that a critical element in successfully implementing a harmonized UDI mechanism is that it be implemented by all stakeholders in order to ensure sustainable and proper functionality of the system. Specifics on the bar code and database are detailed below.
The UDI Decoded
The GHTF draft guidance on UDI code proposes a two-part system to create bar codes: static information, which is described as the device identifier; and dynamic information, which is understood as the production identifier. The following explanation of the coding is excerpted from the official guidance document:
"The static part of the UDI code uniquely identifies the specific device (manufacturer, type of device, including model number, and other characteristics of the device such as sizes or quantities per pack)... [This device identifier] is a ‘non-intelligent' alpha-numeric number that has no inherent meaning, i.e., information cannot be directly extracted from the UDI code. The device identifier is globally unique and is the primary key used to access "intelligible" information about the device stored in the UDI Database (UDID). The UDI code dynamic part (production identifier) specifies the particular production unit i.e., serial number, and/or batch, or lot. Where appropriate the product expiration date shall also be part of the UDI production identifier."
The GHTF stated that the format of the bar codes would be determined by universally recognized standards. Furthermore, it appears that discussion on which type of bar codes (e.g., two-dimensional) would be used is ongoing. The GHTF has noted, however, that it is crucial that the UDI code be "technology neutral, that is, it should not be restricted to a particular method of automatic identification and data capture." What this means is that if the identification of bar codes and thus, cross-referencing with database is not equally accessible to all entities (because the degree of technology, for example, is not feasible for all stakeholders), then the benefits and reasons for the use of bar codes will have been obviated. It will be interesting to see what is decided regarding the format of the barcodes, particularly: one-dimensional vs. two-dimensional technology.
UDI Database, Delineated
The database is as important as the creation of UDI code because without the database the "non-intelligent" coding cannot be decoded. The database would serve to streamline information and eliminate discrepancies between each EU member state and greatly facilitate traceability. In order to do this, the GHTF draft guidance proposes the collection and maintenance of details about the medical device manufacturer such as the Global Nomenclature System (used to help indentify devices using a predetermined list of terms, the device's model and reference numbers, special instructions for use, and other pertinent information. Once again, the wealth of information a user would gain by accessing this electronic database would facilitate device identification and tracking and improve patient safety.
There is no requirement for bar coding in Europe yet, although there certainly is ongoing discussion and dialogue. We anticipate there will be a requirement in the future, although the details and timeline of its implementation remain unclear. This column will provide updates as they become available.
- Eucomed Position Paper on Bar Coding for Medical Devices, Sept. 7, 2004
- European Association of Hospital Pharmacists, Council of Europe recommends bar codes on medicines, March 19, 2007
- GHTF, GHTF/AH(PD1)/N2R1: 2009, Unique Device Identification (UDI) System
Originally published in April 2010