Now that a year has passed, we thought it would be beneficial to provide you with an updated timeline around FDA UDI. While nothing is official, the following is the most recent information on how the FDA UDI rollout might look:

12 Months after the FDA UDI Standard is Published (2013)

The first set of deadlines focus on Class III Medical Devices. These are devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury to the patient, such as implantable pacemakers, replacement heart valves, automated external defibrillators, and implants.

• UDI will apply to all levels of packaging
• An engraved UDI may be required for some Class III medical devices
• If a device has a serial number, the UDI will also be serialized

36 Months after the FDA UDI Standard is Published (2015)

The next class of medical devices to be effected is Class II, which are items like x-ray systems, gas analyzers, pumps, and surgical drapes.

• UDI will apply to all levels of packaging

60 Months after the FDA UDI Standard is Published (2017)

The final group is Class I Medical Devices, such as tongue depressors, arm slings, examination gloves, and hand-held surgical instruments.

• UDI will probably just apply to the device (not packaging)

Medical devices are classified by intended use and potential risk to the patient, and as you can see from the timeline above, the UDI regulations address the most critical devices first. The years listed are based on the FDA UDI standard being published in 2012, which is the current plan. Stay tuned!

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HIBC (Health Industry Bar Code) was created in 1983 as a way to track data via bar codes and has been the method of choice for creating barcodes and tracking medical and pharmaceutical products for many years. Healthcare products need to be treated differently than consumer products since human safety requirements apply and they are monitored by the government. Labels for patient use must be error-free, and must contain specific, required information. HIBC meets the unique needs of the healthcare and medical manufacturing industries.

GS1 is an international, non-profit association that develops and implements global standards and solutions to improve supply chain management for all sectors. GS1 developed GTIN, or Global Trade Item Number, as the unique identification number on a product. GTIN ensures that every variation of a product is allocated a single reference number that is globally unique. Another GS1 identification number, GLN or Global Location Number, identifies physical locations, such as place of departure, place of delivery, and point of storage, adding security and sustainability which is so important when dealing with pharmaceuticals and medical devices.

While HIBC focuses on the healthcare industry, the GS1 standards are used across many different industries, including retail, healthcare, transport and logistics, consumer electronics, defense and collaboration.

Most in the healthcare industry agree that having two different barcoding systems is not efficient, but the more difficult task is selecting one option as the standard. The Association for Healthcare Resource and Materials Management supports GS1 and is asking for the industry to implement its Global Location Number standards by December 31, 2010 and the Global Trade Item Number by December 31, 2012. The FDA has not backed either option, but has concentrated more on the concept of developing a Unique Device Identification (UDI) system for pharmaceuticals and medical devices.

Do you support HIBC or the GS1 standards? What are your thoughts?

GS1 approved standards provides a global system of standards for the accurate identification and communication of information regarding products, assets, services and locations.

GS1 approved Codebar

The GS1 Identification Keys are numbering schemes for products, locations, patients, caregivers and assets. They are the basis for the four key technology areas covered by the GS1 systems:

• GS1 Barcodes – Global data and application standards for bar codes that use the globally recognised GS1 Identification Keys to automatically identify things such as trade items, locations, logistic units, and assets
• GS1 eCom - Global standards for electronic business messaging that allow rapid, efficient and accurate automatic electronic transmission of agreed business data between trading partners. Based on two components: GS1 EANCOM and GS1 XML
• GS1 GDSN – The Global Data Synchronisation Network” (GDSN”) is an automated, standards-based, global environment that enables secure and continuous data synchronisation , allowing all partners to have consistent item data in their systems at the same time. Global Product Classification (GPC) is a key component of GDSN , enabling effective category management
• GS1 EPCglobal – A new global standards system that combines RFID (radio frequency identification) technology, existing communications network infrastructure and the Electronic Product Code (a number for uniquely identifying an item) to enable immediate and automatic identification and tracking of an item through the whole supply chain globally, resulting in improved efficiency and visibility of the supply chain

GS1 standards cover identification standards across all industry sectors but the standards below related to healthcare;

• GTIN Allocation Rules for Healthcare
• EPCglobal Pedigree Messaging Standard

Any company supplying products to the healthcare sector needs to be aware of these standards and work towards implementing them in order to future proof their auto id systems.

Why are GS1 approved standards important?

Traceability and efficient handling of products within the healthcare sector relies on the operation of effective auto id systems by manufacturers and distributors. This can only be achieved with consistent standards for identification regardless of technology utilised. GS1 provides an open, collaborative, technology independent system of standards that help achieve this goal.

Many global healthcare businesses are already implementing the GS1 healthcare standards for example Merck, Novartis Pharma, Baxter, Smiths Medical, Johnson & Johnson and many more.

How will it affect my labelling system?

GS1 standards will impact the structure of the barcodes and RFID messages your system uses. Current labelling / rfid systems will need to be adapted to create GS1 compliant barcodes and RFID messages.

If you are looking to upgrade your auto id system ensure that your supplier is up to date with GS1 standards in healthcare and that the product is able to produce compliant barcodes and RFID messages. The software should also be able to verify GS1 barcodes and RFID messages and automatically flag up any non compliant items.

To find more about GS1 approved standards, visit www.gs1uk.org for more information. You may also, search through the worldwide web pages to find your nearest GS1 group.

There are regular industry related newsletters to subscribe to which will keep you up to date with the latest developments and useful events and publications.

What is PRISYMID doing about GS1 approved Codebar?

PRISYM ID are members of AIM (Association for Automatic Identification and Mobility) and are involved with the Global GS1 Global Healthcare Group as part of work teams looking into different aspects of GS1 adoption.

Our software products incorporate GS1 standards allowing users to create, print and verify GS1 approved barcodes and RFID messages to GS1 standards. We are dedicated to a continuous programme of development ensuring our software complies with changes to the GS1 approved standards in addition to industry regulations such as FDA 21 CFR part 11 and MHRA standards.
Our commitment to the “Good Manufacturing Practice” (GMP) process underpins our development approach and life cycle documentation is available for all our healthcare and life sciences products.

For information on PRISYM ID GS1 healthcare labeling systems please contact the PRISYM ID Life Sciences team or leave a comment below.

The GS1 Sunrise date for GS1 Global Location Number (GLN) to standardize location identification is 2010 and 2012 for GS1 Global Trade Item Number (GTIN) to standardize product identification.

This of course means many drug and medical device manufacturers supplying healthcare providers are going to be looking very closely at their identification systems to ensure that they can meet health providers’ expectations.

The PRISYM ID team has been working hard to support our medical device and drugs manufacturing customers in their adoption of the GS1 standards.  Our software includes a handy GS1 bar code checker that means a non compliant bar code can’t be accidently printed.  This along with the easy creation of GS1 bar codes in PRISYM software means our customers can quickly adapt their systems.

Learn more about the GLN 2010 and GTIN 2012 Sunrise dates at www.gs1us.org/hcsunrise