Meeting the FDA’s Mandates for Unique Device Identification
The FDA’s UDI rule is on its way and will impact virtually everyone in the industry in one way or another. While the rule has its benefits, getting to compliance will not be achieved overnight. This article provides an overview of the direct part marking technologies required to comply with the UDI rule and offers a solution that addresses the shortcomings of several other technologies.
Since passing the Food and Drug Administration (FDA) Amendments Act into law in 2007, the FDA has focused considerable efforts on the establishment of a Unique Device Identification (UDI) system for all medical tools, implants, and equipment. The goal of the initiative is to have one standardized labeling and barcoding system for the products used in medical settings and procedures, in order to better track their usage and facilitate important recalls should products fail in the marketplace.
While there are several factors slowing the implementation of this FDA mandate, including concerns over the privacy of patients and their medical records, the wheels are in motion. As noted in the most recent FDA proposal made public in July, UDI is coming soon and it will change the way the medical, and labeling, industries work.
Interestingly, the medical device industry, a market valued at more than $85 billion, lags behind others in terms of its standardized labeling practices. Other products, from automotive parts to pharmaceuticals, are tracked through universal systems similar to UDI to benefit patients and consumers.
Current Plan & Projected Timeline
The plan is expected to be finalized and published by May of 2013 and will call for standardized UDI barcodes to be present on virtually any device used in medical procedures and facilities. Some devices, such as surgical tools and implants, will need to be marked directly. However, due to the overwhelming number of devices manufactured each year and the vast inventory of tools currently in use worldwide, the plan will go into effect in stages. Class III devices, which are defined as “life supporting or life sustaining” (such as pacemakers and heart valves), are the first that will require the FDA approved labeling, followed by Class II devices (equipment), and then Class I devices, which include disposables and hand-held surgical instruments.
For many products that require direct part marking, the type of product identifier best suited for compliance with new FDA regulations is a GS1 or HIBCC DataMatrix barcode, a two-dimensional barcode capable of holding large amounts of data in a relatively small space. In fact, a 2D DataMatrix barcode can hold up to 2,335 alphanumeric characters. Compare that to a standard (1D) linear barcode, which is only capable of holding up to 15 characters of data.
While the FDA is working hard on establishing the guidelines, technology companies are working equally hard to provide the industry with the tools it needs to comply. The highest burden will be placed on manufacturers of equipment who will need to integrate UDI labeling and marking systems into their existing manufacturing environment. This will require not only an investment in labeling and marking products, but also a restructuring of their manufacturing processes and supporting IT systems. In the end, the barcodes they issue will facilitate tracking and traceability of their devices throughout their lifecycle, which in turn will improve patient safety and help companies refine and advance their technologies.
As a starting point to achieving compliance, manufacturers are looking at a number of industrial marking technologies capable of satisfying the FDA requirements. While some parts will feature packaging labels only, all equipment that is used repeatedly needs to be marked directly. This includes surgical tools and other instruments that go through sterilization and other chemical processes. The kind of information to be linked to the barcodes and labels includes the device identifier and product identifier, such as its manufacturing and expiry date, a serial or lot number, and any special attributes the device may possess.
Laser marking is one such technology used for direct part marking. As the name suggests, these systems use lasers to “engrave” or mark an object. For medical device marking, these systems are typically very fast and come complete with variable data printing for serialization of the barcodes. While well suited for volume production, laser marking systems have their limitations. First, the equipment is costly, with complete systems averaging in the $40,000 to $50,000 range. Also, because the laser actually heats the metal to a melting point, it alters the properties in that area. This makes the metal more prone to rust and chemical wear over time. Laser marking systems are also limited in terms of the depth of the engraving they can achieve, making the barcode less resistant to scratches and other physical damage.
Another direct part marking technology currently used in medical manufacturing is chemical etching. This is a manual process that enables the manufacturer to mark a tool by producing a mask for the barcode. Chemicals are applied to the mask, which etches the exposed area (a barcode) into the tool’s surface. Like laser marking, chemical etching alters the surface of the tool, making it more vulnerable to corrosion from the environment and from processes such as sterilization. Chemical etching is typically used to label individual devices or for very small production runs.
Another effective technology to consider is dot peen micro-percussion technology. This type of system features a “peen” or stylus that imprints an area to create the barcode, minimally impacting the surface of the tool or instrument. Dot peen systems are well suited for many types of equipment, but not for very small tools. Most systems can only imprint data as small as 5.0 mm, which is not small enough for many common tools such as scissors and tweezers.
To address this need in the marketplace, Roland recently introduced the MPX-90M, a unique direct part marking tool that uses the company’s proven impact printing technology to produce unique device identifiers on the smallest of surgical instruments and tools. Priced under $13,000, this specialized printer uses a diamond-tipped stylus to permanently mark barcodes in an area as small as 1.0 mm<V>2</V> (0.04 in.). With the MPX-90M, both 2D and linear barcodes are easy to produce, as well as numbers, symbols, text, logos, QR codes, and other graphics. It supports hard metal surfaces, including steel and titanium, and includes software that quickly converts numerical data into the 2D DataMatrix barcodes required for many products. Variable data printing automates the serialization process for marking tools with unique serial numbers, production lot dates, and other data. The MPX-90M is designed for small lot production, and is ideal for small to mid-size manufacturers as well as for hospitals, sterilization centers, and others that need to mark existing tools in use at their facilities.
Compliance with UDI regulations will be mandatory, so the sooner medical device manufacturers and others get prepared for it, the better. While the regulations will certainly change the way businesses and facilities are set up and operated, it will give everyone involved much more detailed information on how medical products are performing. Patient confidence and safety will be improved immeasurably. Manufacturers will have better insight into how and where their products are being used and access to information that can help them advance their technologies. Recalls will be simpler and more effective. While the path to UDI compliance may be long and complicated, the journey will be well worth it.
Author’s Note: For more information on impending UDI regulations, visit http://www.fda.gov/udi.