Feature Story: Laser Marking

July 7, 2017 No Comments
Print Friendly

Creating High Quality UDIs For Traceability

by Faycal Benayad-Cherif Ph.D.

toc_features50pxSince the Food & Drug Administration (FDA) announced the upcoming implementation of obligatory Unique Device Identification (UDI) marking for medical devices, manufacturers have been searching for feasible and economic marking solutions. The regulatory process – started in September 2014 and ending in 2020 – requires that all medical devices need to be equipped with a unique product number and Datamatrix code to ensure their traceability throughout the product life cycle.   

Direct part marking, in that context, is becoming increasingly important: if the product is reused and/or reprocessed before each use, the UDI marks need to be applied directly on the device. Starting with implantable, life-saving and life-sustaining products belonging to high risk category III in September 2015, compliance will be extended gradually to all risk categories and their corresponding products. This requirement leads to the special significance of laser marking on plastic and metallic devices, which appears to be the only technology that is able to pass passivation processes while guaranteeing long-lasting marks that can resist high wear and abrasion as well as frequent sterilization cycles. In order to meet the labeling requirements, laser markings must be of high contrast, precise, long lasting, and able to fit into small spaces.

The goal of the UDI system is to increase patient safety and to allow for sustainable traceability. The FDA directive applies to medical devices that are produced or imported and distributed in the U.S. Equivalent directives are being introduced internationally: the European Union has just released a resolution on UDIs within the Medical Device Regulation (MDR), becoming effective gradually from 2020.

Both systems have in common the central allocation and registration of product numbers in a common database. The center of the American UDI system is the “Global Unique Device Identification Database” (GUDID), which acts as a registry and as a reference catalog for every device with an identifier.

UDI codes consist of a Device Identifier (DI) and a Production Identifier (PI), the first of which identifies the manufacturer/labeler and the specific version or model of the device (also reference code). The DI is a globally unique product code which allows the clear identification of a device and must be entered in the central registry. The PI is optional and represents the variable portion of a UDI that identifies variables like the lot and batch numbers, serial numbers, expiration or manufacturing dates, etc.

The FDA has accredited three organizations as UDI issuing agencies: GS1, HIBCC (Health Industry Business Communications Council), and ICCBBA (International Council for Commonality in Blood Banking Automation). Both the Health Industry Bar Code (HIBC) and the GS1 code are equally suitable for the UDI-compliant marking of medical products and devices. The ICCBBA UDI code, as approved by the FDA, is best adapted to identify products of human origin (like plasma or transplants).

UDI codes are depicted graphically in an assembly of two forms: a human readable plain text of alpha-numeric characters and a machine-readable code. There are different forms of machine readable codes available: the GS1-128 linear bar code, the GS1 data matrix code from GS1, the HIBC linear bar code and the HIBC data matrix code, and the linear ISBT 128 and 2D code from ICCBBA. Depending on the accredited issuing agency, each product can receive its unique code in any of the above formats.

Screen Shot 2017-07-07 at 10.35.29 AM

The UDI system addresses all of the following aspects:

  • More efficient product recalls.
  • Improved counterfeiting protection.
  • Simplification of data entry and accessibility with different systems.
  • Security throughout the entire supply chain.
  • Field Safety Corrective Action – FSCA.
  • Better identification, documentation, and prevention of incidents.
  • Prevent medical errors from occurring.

Additionally, the labeling system enables the simplification of logistics, ordering, and delivery processes.

Where and when a UDI code has to be applied to a product depends on its risk class and intended use. The UDI system differentiates between the marking of the packaging of labels and direct marking on the product. The last deadline for the marking of packaging and labels will be reached in 2018. At that point, the packaging and labels of all class I – III products must carry a UDI code in plain text and machine-readable form, using automatic identification and data collection (AIDC) technology.

The FDA has defined three risk classes, based on the degree of control needed to guarantee the safety and effective use of the products.

  • Class I (low risk, general controls): e.g. bandages, stethoscopes, surgical scissors, dental floss, mechanical wheelchairs.
  • Class II (moderate risk, general and specific controls): e.g. infusion pumps, surgical sutures, bone screws, syringes, condoms, powered wheelchairs.
  • Class III (high risk, general controls and premarket approval, life-saving and life-sustaining): e.g. heart valves, knee prosthesis, pacemakers, automated external defibrillators.

The UDI marking compliance deadlines are phased in stages based on product risk classifications. Codes must be applied on labels and packages or on the product itself (Direct Part Marking DPM). According to the FDA, DPM is required for implants and devices intended to be reprocessed or reused over an extended period of time (several months or years). The permanent marking is required as it is expected that such devices will be separated from their original packages.

The compliance deadlines of the FDA regarding Direct Part Marking (for devices that are intended to be used more than once and intended to be reprocessed before each use) are as follows:

  • 09.2015: Implantable, life-saving, life-sustaining products.
  • 09.2016: Class III products.
  • 09.2018: Class II products.
  • 09.2020: Class I products.

(Visit the FDA-website: https://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/compliancedatesforudirequirements/default.htm for the latest information).

A directly marked UDI code is only required if the corresponding products are processed, for example cleaned, sterilized or passivated, before their use. Even products that do not necessarily have to bear a directly marked code (like sterile packaged implants for single use) get marked for functional reasons and fraud prevention.

By 2020, all manufacturers of medical devices will have to comply with UDI marking requirement. Finding a suitable marking solution not only requires additional workforce in the first instance, but also extra costs. Manufacturers need to make a decision either to buy their own marking system or to task a successful tenderer.

As the marking takes place at the end of the production cycle, scrap must be kept to a minimum and repeatable results and process stability are imperative. For a reliable identification, laser marking has become the chosen technology: it enables both a safe marking as well as a lean production.

Although many manufacturers are requested to implement several essential modifications in their production process, one can assume that the traceability of medical devices will pay off in the end – not only for the safety of patients, but also for streamlining the companies’ manufacturing and logistics supply chain. Laser marking with integrated vision appears to be a sustainable and economic solution in response to the actual marking requirements.  pm_endmarkblue-e1320337140493


FAYCAL BENAYAD-CHERIF, Ph.D., is the Business Manager for Software and Vision at FOBA. For more information on the company, go to www.fobalaser.com. MPMA member, Productivity Inc., located in Plymouth, is a U.S. technical center for FOBA.

Copyright © 2017 Minnesota Precision Manufacturing Association. For permission to use or reprint this article please contact Nancy Huddleston, publications manager for Precision Manufacturing Journal.

Share
Features

Sorry, the comment form is closed at this time.

E-clusive: Enhancing the Image of Manufacturing

By Nancy Huddleston Let’s face it – we’re humans and it’s in our nature to care about our looks...

E-clusive: It’s Time to Evangelize Manufacturing

By Nancy Huddleston It’s not every day that you hear someone say, “we need to evangelize manufacturing as a...