Medical device makers must mark most medical devices distributed in the United States with a unique device identifier, or UDI. This is mandated by the Food and Drug Administration. Manufacturers use a variety of methods to mark their devices. The preferred method for medical device marking is laser marking.
What is a UDI?
According to the US Food and Drug Administration, a UDI is a unique code consisting of:
- A device identifier which identifies the labeler and the specific version or model of a device, and
- A production identifier which describes various production details such as lot or batch number, expiration date, manufacture date, serial number of the device, and/or identification codes for tissue-based products regulated as medical devices
From the FDA's perspective, the UDI system is intended to “improve the quality of information in medical device adverse event reports”, reduce medical errors, enhance analysis of medical devices, improve recall management, address counterfeiting, and establish worldwide standards for medical device identification.
From the manufacturers' perspective, medical device marking helps ensure compliance as well as addresses issues such as: product liability, product safety, product traceability, product identification, and quality assurance. Many medical device manufacturers used laser marking to mark their devices with serial and production numbers long before mandated to use a UDI by the FDA.
Other Medical Device Marks
Though the UDI is mandated, medical device manufacturers may also use laser marking to mark devices beyond the UDI. For example, medical devices may be marked to include logos, graphics, and barcodes along with the UDI.
What is Laser Marking?
According to Coherent, lasers “serve a wide range of materials processing and industrial applications and are used to process an abundance of materials from metal, plastics, and fabrics to organics like diamond, glass, paper and wood“. A laser beam from a carbon dioxide or DPSS laser is typically used. A vector-based procedure is usually used to create the mark as vector-based marking allows for the fastest mark speeds. Non-tactile laser marking processes do not induce mechanical stress, and they allow for precise, sustainable marks.
Why Laser Marking?
Medical devices take all sorts of shapes and forms ranging from medical clamps and scalpels, to titanium joints, plastic tubes, mesh stents, silicon implants, dental appliances, and more. Some devices are extremely small in size; others are made from heat sensitive materials; others may require a high contrast mark. Meanwhile, medical devices intended to be implanted in the human body have their own unique marking requirements. For example, marks must be produced to in such a manner to ensure that the device's surface remains smooth and doesn't attract microorganisms. Other methods of marking, such as etching, may introduce harmful chemicals, making them unsuitable for medical implants.
Laser marking is the preferred method for marking medical devices because it is precise, fast, permanent, and legible. Laser marking is a non-contact method that results in a smooth surface and does not introduce contaminants. Laser marking is also extremely precise and can be used across any number of materials including metals, plastics, and organics.
"Unique Device Identification (UDI)", U.S. Food and Drug Administration, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm?utm_source=Members-Only%20Updates
"Materials Processing and Industrial Applications", Coherent, http://www.coherent.com/Applications/index.cfm?fuseaction=Forms.page&PageID=250