Marking Medical Devices, UDI Compliance and Dealing with Difficult to Mark Materials
The Challenge for Medical Device Manufacturers
According to the U.S. Department of Commerce, there are more than 6,500 medical device companies in the U.S. with a total market size of $148 billion. The most active sub-category in the industry is surgical and examination instruments (based on value of export shipments), which includes products ranging from scalpels to intricate catheters. Combined with strict regulations and proposed new rules (Unique Device Identification system) by the U.S. Food and Drug Administration and the European Union, the opportunities are enormous for Telesis. Telesis is well positioned to offer a wide variety of reliable and innovative solutions to often difficult and challenging marking tasks.
Many medical devices, especially those found in a surgical environment, are made of stainless steel. Our EVC and Fiber Lasers are ideal for marking on stainless. For maximum flexibility and robustness, our FQ Series (now known as FQDS indicating Dual Sensor for the shutter mechanism, a key advancement in laser safety) is the preferred choice and available in many different wattages.
The Telesis Solution – Fiber Laser Marking
The FQ fiber laser series is a versatile product robust enough for heavy industrial etching and delicate enough for annealed marks. Typical for medical applications are annealed marks which does no damage to the surface or the material and maintains the corrosion resistant nature of the medical instruments. This form of non-invasive processing is crucial in the prevention of bacterial accumulation. Whether it’s banded titanium needles or high-grade stainless steel scalpels, this laser can mark them with precision, consistency and reliability. Our Vari-Z technology allows for 3D and 3 Axis control of the beam to maintain perfect resolution and consistency over curved surfaces without mechanical rotation.
Referencing the photos below, we see an annealed mark of a serial number, an annealed mark with precision measurement graduations, and a light etching of a serial number on curved surface with virtually no inconsistencies in text shape or quality despite a variation in surface Z plane.
While stainless Steel is a common material in surgical instruments, we also find a products with plastic molded details. Plastics can be difficult to mark and while fiber lasers have some capabilities for marking plastic, traditionally, CO2 lasers have been used to create “melt marks” in different plastics. Of ocurse, this does change the surface quality of the material, which can lead to less effective sterilization, as well as limiting contrast and thus readability.
The Telesis Solution – Green Laser EV4G
Coupled with the appropriate F-Theta lens, the EV4G laser with its 532nm wavelength can create high contrast marks with absolutely no damage to the polycarbonate or ABS plastic housing assembly of catheters (shown on the right). Whether in-focus or off-focus, the green laser can create color change in the material that achieves the annealed effect without damaging the surface. Click here for more info on Telesis Green Lasers
The photo below shows a high contrast mark on Polycarbonate with a cycle time of 10 seconds
Another challenging material group would be Silicone and PVC. And while traditional lasers create a mark through heat imparted on the material, in some cases a “cold mark” may be preferred. In addition, when marking a part with graduated measuring positions, spot size resolution and control is paramount to a quality product.
The Telesis Solution – UV Laser Marker
The Telesis UVC laser, with the combination of short wavelength (355nm) and excellent M2 value, produces a small spot size, which makes it an ideal choice for creating delicate marks on sensitive materials. For example, the UV laser reacts well with silicone or PVC to create fine graduated markings that denote depth of insertion on the catheter tubes below. Since the laser beam only creates color change on the surface, the material is not damaged and is free from bacteria contamination. Thus, this laser allows a safe and reliable process for medical device manufacturers. The photo on the left depicts very small characters (2.5 X 1.5 mm) and were marked in 1.4 seconds; the graduations on the left were marking is 2.1 seconds.
Unique Device Identification (UDI) Regulation
As with any safety-centric product, traceability has become a requirement in order to maintain high quality and track any problems from the field. In the medical device market, UDI (Unique Device Indentification, has been adopted by the FDA and the EU. While it is impossible to delve into all the details around this regulation, we can offer a few key insights, as it related to marking:
- UDI offers benefits on identification, traceability, reduction of errors, prevention of counterfeits, management of recalls, and more.
- UDI is a system that includes a unique device identifier in human- and machine readable- form.
- Proposed UDI regulations between the FDA and the EU are very similar as they wish to bring uniformity and consistency to global manufacturers, users and other partners.
- The system will be phased in over several years.
- Telesis lasers markers can apply GS1 compliant standard and 2D barcodes. See below for a typical example.
Telesis offers a diverse lineup of marking systems to satisfy UDI marking requirements on a wide variety of materials. Customers can count on our years of experience to provide dependable and complete marking solutions.
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Department of Commerce – International Trade Administration: 2016 Top Market Report Medical Devices