Certain Class II Medical Devices, such as surgical scissors, scalpels, and vascular clamps, are intended to be reprocessed and reused. These will need to carry UDIs starting in September.
Patient safety doesn’t just lie in the hands of doctors and nurses. Medical devices and surgical instruments also have a huge impact on the accuracy of diagnostics and the proper execution of treatment plans. The reliability of devices used to treat or diagnose patients can be a matter of life or death, and flaws might not become apparent until it’s too late.
Traceability systems using unique product identifiers have proven to be a highly effective means of helping protect the public from faulty devices. By ensuring that each device acquires a permanent identification code—known as a “unique device identifier” or UDI for short—it has become much easier to implement recalls should manufacturing problems come to light. FDA keeps a running list of medical devices that have been recalled on the basis that they could pose a significant risk to patients. Thanks to FDA’s comprehensive, UDI-based traceability system, there is data available on the manufacturer and model number of the device. Optionally, manufacturers may also encode important information such as date of manufacture, lot number, and expiration date, but this is not tracked by FDA in the case of medical devices.
What Do the Upcoming UDI Regulations Involve?
For medical device manufacturers, September 24, 2018, is a date of great import. This is the compliance date for comprehensive identification of reprocessable devices categorized as Class II, which have the potential to pose an intermediate-level danger to patients. Such devices include reusable surgical instruments such as surgical scissors, scalpels, etc. They are less risky than the life-sustaining Class III devices like implanted pacemakers and heart valves, but riskier than the elastic bandages and examination gloves that fall under the category of Class I. The September deadline is part of the gradual rollout of FDA’s comprehensive UDI system, which began in 2014 with Class III devices and is scheduled to continue through 2020 with Class I. Other Class II devices, particularly those intended for one-time use such as catheters, had their UDI implementation deadline in September 2016.
Under FDA regulation 21 CFR 801:20, both the device label and its packaging need to include a UDI. If the device is intended to be used more than once and reprocessed between uses, then the identifier must be directly applied to the device itself in the form of a direct part mark (DPM). This is because the reprocessing would probably cause any non-permanent label to disintegrate. The sterilization of surgical instruments, for instance, generally involves high heat and possibly the application of harsh chemicals. To ensure that the UDI markings weather such processes, they need to be applied in the form of permanent direct part marks (DPM) such as laser marks or dot-peened symbols. FDA doesn’t specify which method a manufacturer should use, as long as the mark remains readable throughout the lifetime of the device.
A few of the numerous options for applying DPMs. FDA doesn’t specify which method to use as long as the mark remains readable throughout a device’s lifetime.
One question many manufacturers have is what they should do when a Class II device is part of a so-called “convenience kit” consisting of two or more devices packaged together, such as a standard first-aid kit. Such a device does not need to bear a UDI, provided that the kit’s components are always used together and will never be substituted, sterilized, or repackaged. The set must not be unwrapped or unsealed before its use, and the container must always contain a UDI. This exception to the FDA rule on marking Class II devices is detailed in 21 CFR 801:30, and it does not apply to implantable devices or any reusable devices that happen to come in a single package.
Other exceptions to the UDI marking requirement include instances in which the markings could interfere with a device’s safety or effectiveness. The primary purpose of the regulations is to promote patient safety, so if the direct marking would do more harm than good, the requirement will be waived. Similarly, there is no obligation to include a UDI directly on a device if this is not technologically feasible with the marking methods currently available. To obtain such an exemption, device labelers will need to submit the proper application materials to FDA.
What Information Do UDIs Hold, and How Do They Promote Traceability?
UDIs consist of two numbers: A Device Identifier (DI) relating to the specific device model and its manufacturer, and an optional Production Identifier (PI) that provides such details as lot or batch number, serial number, manufacture date, expiration date, and any other important production-related data. All mandatory information must be included both as human-readable plain text and in a format suitable for automatic identification and capture (ASIC).
Device labelers are required to submit relevant information about their devices to the Global Unique Device Identification Database (GUDID) that is run by FDA. The information contained in this database is available to the public through a portal known as AccessGUDID. The portal is updated daily to ensure that patients and healthcare professionals alike have access to the latest data.
What Must Manufacturers Do to Comply with UDI Regulations?
Manufacturers that produce any Class II devices that are intended to be used more than once and reprocessed before each use will need to make sure that these devices are directly and permanently marked with UDIs. These UDIs must be issued by an FDA-accredited agency, such as GS1, HIBCC, or ICCBBA. In most cases, the step of acquiring a UDI has already been taken care of during previous UDI-related compliance deadlines. Manufacturers also must be sure to submit all the device information to GUDID in the proper format.
The requirement to directly mark all reprocessable Class II devices can be a bit of a challenge. Some of these devices are fairly small and have little available room for a two-dimensional code. Fortunately, DPM marking technology has been advancing steadily and some methods—particularly laser marking—can produce exceptionally tiny codes that are barely visible to the human eye. These codes can easily fit on surgical instruments like arterial clamps that are only a few millimeters across at their widest point.
How Can Manufacturers Ensure the Readability of Their DPMs?
There are several different methods for direct part marking, including dot peening and electrochemical etching in addition to laser marking. Each method poses specific challenges relating to contrast and overall readability. To ensure that DPMs of all types can be read across the supply chain and throughout the lifetime of their devices, manufacturers should invest in a comprehensive verification system for two-dimensional codes. Advanced verification systems grade DPMs to a variety of criteria, such as contrast, modulation, fixed pattern damage, and deviation from the ideal grid formation. This grading system indicates whether a code will be readable by a certain class of bar code readers.
Can you spot the DPM? Handheld barcode verifiers like Omron Microscan’s LVS-9585 can check bar codes as tiny as 2 mil.
The September deadline may find some manufacturers scrambling to comply, but it’s a step toward a safer world in the big scheme of things. The new UDI requirements are meant to assure patients and care providers that the most up-to-date information about medical devices will always be readily available. Should problems arise, FDA’s system will help ensure that faulty devices are taken out of the picture without delay. With the cooperation of manufacturers, this comprehensive web of device traceability will continue to promote safety and confidence throughout the world of healthcare from here on out.
[All images courtesy OMRON MICROSCAN SYSTEMS]