Here are five ways that laser marking could provide advantages to medical device companies when it comes to meeting permanent marking requirements under FDA’s Unique Device Identification program.
Ashir Thakore, SABICAs the U.S. Food and Drug Administration (FDA) implements its phased Unique Device Identification (UDI) program across medical device classes, OEMs are considering methods for complying with the permanent marking requirement. The FDA does not specify a method, citing the wide variety of devices, use conditions and reprocessing methods. However, for multiple-use devices made from plastic parts, the most viable option may be laser marking.
Under 21 CFR 801.45, any device required to carry a UDI on its label must also have this information directly marked on the product itself, if it is intended to be used more than once and intended to be re-processed before each use. UDI goals include improving device traceability and recall in the case of a safety risk or adverse event, and reducing medical errors.
Choosing a marking method
Permanent marks, which must last throughout the device lifecycle, are also known as direct part marks (DPMs), and are used widely in industrial part tracking. They can be created using laser etching, electrochemical etching and dot peen. Attaching a permanent plaque or tag (e.g., an RFID tag) is another option, according to the FDA.
Laser marking is potentially well suited for UDIs on thermoplastic device components, even those treated with a coating. The laser creates a permanent mark that can withstand the repeated cleaning and sterilization to which medical devices are subjected. Lasers can produce small or intricate marks with high resolution. As a digitally programmable system, laser marking can accommodate diverse part geometries and types of marks. Further, the process is fast and can be cost-effective in the long term, once the necessary equipment has been purchased.
Potential advantages of laser marking for UDI
1. Permanence through the lifecycle
Laser marking delivers an intense, directed beam of energy to the surface of the thermoplastic part. By converting a high percentage of light energy into heat, the laser permanently burns the marked area of the surface, making it difficult to remove or tamper with. Because the only way to remove the mark is scratching off layers of the plastic to a depth sufficient to obscure visibility, regular cleaning – even with harsh disinfectants – should not harm direct markings. Typical sterilization methods for reusable devices should not cause unexpected interactions with laser marks.
2. Flexibility through digitization
Laser marking systems are digitally programmable, allowing easy customization. In the case of UDI, which is a unique numeric or alphanumeric code, the FDA stipulates only that a permanent mark contain all required information:
- Device identifier (DI) – Mandatory fixed portion identifying the device and device labeler
- Production identifier (PI) – Conditional, variable portion denoting data like batch numbers and expiration dates
A UDI directly marked on a device may be in either/both of these formats:
- Human readable – Easily legible, plain-text format
- Machine readable – Able to be interpreted by automatic identification and data capture technology
The versatility of laser marking can help give manufacturers the freedom to create an FDA-compliant UDI mark based on the geometry, size and surface texture of the device, quickly mark products and release them for commercialization.
The software-based system allows marked devices to be digitally coded and all information to be stored in a database for efficient tracking and recall. Manufacturers and the FDA can quickly isolate reports related to a particular device to identify any underlying problem and take corrective action.
3. High resolution and accuracy
While laser marking is most effective when a flat, fixed, focal point is used, non-flat surfaces can also be successfully marked. In the first scenario, resolution can be as high as 1,000 dpi, and legible text can be as small as 0.5 mm. As a result, laser marking can produce intricate details in tight spaces.
4. Speed and efficiency
The laser marking process can help increase throughput, thanks to writing speeds of up to 2,500 mm/sec. Because the machines do not use chemicals or solvents, manufacturers can avoid the expense of buying and storing them. Additionally, laser marking systems can be used by manufacturers in-house, making it an efficient process.
Compared to affixing a plaque or tag to the device, laser marking does not require additional steps and materials, such as application of special glues and adhesives, which need an additional compatibility assessment. Additionally, plaques and tags can potentially fall off during the device lifecycle.
Laser marking carries a few caveats. One is the need for a capital investment in equipment, if this is a new process for the device manufacturer. However, because UDI is a long-term requirement, this expenditure can be offset over time by avoiding costs of third-party marking services.
Another potential pitfall is inconsistency of materials and parts. Because laser marking is a precise, specialized process, achieving the highest resolution requires uniformity in resin composition and processing. It is important to work with a thermoplastics supplier offering good production control for lot-to-lot consistency.
Specialized thermoplastics can help drive success
Material suppliers with a dedicated focus on healthcare can provide guidance on the suitability of specific thermoplastics for laser marking, and advise on contrasting colors and equipment settings that help improve readability. Leading global suppliers, such as SABIC, offer thermoplastics for healthcare that are formulated to produce laser marks with high clarity and precision, as well as color customization and compliance with good manufacturing practices for consistency. In addition, they can perform testing to help ensure the thermoplastic and its color are likely to produce high-quality laser marks.
Ashir Thakore is Global Segment Leader – Healthcare for Riyadh, Saudia Arabia–based SABIC. During his career, Thakore has worked in multiple leadership roles for several companies, including Ford, Visteon and Kalypso.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.