Unique device identification regulation has many facilities and teams asking questions about how to respond to the release, what steps to take to update their processes, and more. To ensure you and your team don't miss a single step in becoming compliant, check out the FAQs below.
Q: When did unique device identification go into effect?
A: In September 2013, FDA published the Final Rule for a Unique Device Identification System that outlines how and when device labelers must include Unique Device Identification (UDI) on device labels and packages, and in certain cases, directly on devices themselves. A UDI is a unique numeric or alphanumeric code that comprises two parts: the device identifier (DI) and a production identifier (PI). The rule specifies that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. Compliance dates for Unique Device Identification implementation will be phased in based on the existing risk-based classification of medical devices:
- September 2014 for devices classified by FDA at the highest risk level (Class III)
- September 2015 for implantable, life-supporting, or life-sustaining devices
- September 2016 for moderate risk (Class II) devices
- September 2018 for low risk (Class I) devices
Q: What device class do surgical instruments fall into for compliance?
A: There are only a small percentage of surgical instruments/devices that are Class II devices. Most stainless steel instruments are Class I medical devices.
Q: What are the deciding factors to a device needing to be marked?
A: According to the FDA’s 21 CFR 801.45 § 801.45 Devices that must be directly marked with a unique device identifier: A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
Q: All of the surgical instruments in my instrument sets are intended to be used more than once. What are examples of reprocessing?
A: The term “reprocessing” has not yet been fully defined by the FDA and discussions continue to determine all that is included. At this point, “cleaning” is not yet identified as a part of the above-mentioned reprocessing, however sterilization has been clearly identified.
Q: What solution does CensiTrac™ offer in order to become compliant with the FDA’s ruling on UDI?
A: CensiTrac offers full traceability for instruments in its unique direct part marking by using a 2-D data matrix, chemically-etched mark on each surgical instrument. The mark encodes the required information for UDI, including manufacture make, model, and catalog number.
Are You UDI Compliant?
Censis offers CensiMark, a proprietary surgical instrument marking barcode that is applied by embedding a 2-D electro-chemical mark below an instrument’s passivation layer. This electro–chemical marking process (ECMP) applies a guaranteed corrosion-free mark to the instrument and does not alter the surface like etching or engraving. With two different sizes of instrument marks, CensiMark can be applied to all different types of assets, including flexible scopes, neurosurgery, and cardiovascular instruments.