Unregulated and untraceable medical equipment open the door to counterfeit and poorly made products, patient safety concerns, and legal problems for healthcare facilities. To prevent such issues, the FDA’s unique device identification (UDI) system provides a framework that improves traceability, reduces medical errors, and keeps organizations in compliance.
The FDA requires that most medical devices feature a UDI, with many items requiring a mark directly on the component itself. This way, even if the equipment is removed from its packaging, the item can be properly identified and accurate reporting can take place.
Using laser marking and engraving is the best way to add precise, permanent, and legible marks on medical equipment, fulfilling the FDA’s UDI requirements.
Does Your Device Require Direct Marking? – Understanding 21 CFR 801.45
Not every reusable medical device requires a direct mark. Under rule 21 CFR 801.45, direct marking must be conducted on devices that are intended to be used more than once and also undergo reprocessing, which is defined as high-level disinfection and sterilization. Devices that are only intended to be cleaned with regular soap and water or low-level disinfectants are excluded.
What the Mark Must Include
The FDA requires that UDI markings incorporate:
| Component | Description |
|---|---|
| Device Identifier (DI) | Uniform for all devices of a specific model type; denotes the device and the labeler. |
| Production Identifier (PI) | A unique code for specific products, based on lot/batch numbers, manufacturing date, expiration date, or serial number. |
Additionally, the mark added must be present in two forms. The first is an easily readable plain text for humans, and the second is a system for automatic identification and data capture (AIDC), such as a barcode.
Why Laser Marking Is the Industry Standard for Compliance
Labels peel and ink fades, making older marking methods obsolete and ill-suited for meeting FDA compliance guidelines. Laser marking, though, is a modern solution that gets the job done and withstands the full lifecycle of a reusable device.
Permanence and Durability
Since many medical instruments and devices have to undergo repeated cleaning and sterilization cycles, including those that use autoclaving and hydrogen peroxide, facilities need a marking solution that endures.
Laser marking is permanent, with information remaining in place and legible for the useful life of a part. Plus, it holds up to the harsh cleaning requirements these tools must face while lowering the risk of unexpected chemical interactions when compared to other methods.
Biocompatibility and Precision
Laser marking also stands out by:
- Being 100% biocompatible and not affecting the functionality of a part
- Accommodating diverse geometries, such as those of cylindrical and 3D components
- Providing high resolution (up to 1,000 dots per inch) that creates legible text as small as 0.5 mm
- Producing high-contrast, corrosion-resistant marks via processes like black marking which uses ultrashort pulse lasers, ideal for marking stainless steel and preventing thermal damage
Avoiding Compliance Pitfalls: Corrosion and Validation
When marking on titanium and stainless steel, a proper multistage process must be completed to avoid these dangers: marking, passivation, and cleaning. This is because marking is a chemical and physical alteration to a piece of equipment, so post-processing care must be undertaken to ensure the device’s integrity and the maintaining of biocompatibility.
Key insight: Remember that validation is mandatory as stipulated by rule 21 CFR Part 820 under the FDA’s quality management system regulation for medical devices. Your systems can’t just be capable of creating the required marks; they have to be able to work consistently and with precision.
Systems you use will need to:
- Meet Good Manufacturing Practices (cGMP) and U.S. Food and Drug Administration regulations
- Adhere to installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) guidelines
- Feature signed documentation that proves the equipment consistently creates products that meet outlined specifications
Improve Your Medical Device Production and Meet Compliance Needs with Our Systems
At TYKMA Electrox, our laser experts and engineers have designed diverse systems to help companies meet essential marking needs and fulfill government regulations. We offer desktop, integration, and freestanding units, all featuring high-powered lasers that create crisp, permanent marks.
Our systems are ideal for producing:
- Serial numbers
- QR codes
- Dates
- Item numbers
- Barcodes
- Branding information
- Logos
- And more
These elements, along with the FDA’s UDI codes, facilitate proper traceability, prevent counterfeiting, and ensure health and safety guidelines are met.
FAQs on UDI Laser Marking
Do single-use devices require direct UDI marking?
No, generally they don’t. Direct marking is required for devices that are intended to be used more than once and will be reprocessed before each use. This is for sterilization and patient health and safety reasons.
Are implants required to be directly marked with a UDI?
No, implants are specifically excluded from the direct marking requirement, though manufacturers must still ensure the UDI is still present for items, with it often being featured on packaging.
What if my inventory was manufactured before the compliance date?
The FDA does not intend to enforce direct marking requirements for devices that were consigned, loaned, or manufactured prior to their applicable compliance date.
Choose TYKMA Electrox for UDI Code Laser Marking
Avoid FDA noncompliance by using laser marking systems from industry experts. Our equipment will let you engrave permanent marks that last the full useful life of a component.
Contact our team today to discuss product options.
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