Medical Devices UDI tracking required by 2020
The U.S. Food and Drug Administration (FDA) created unique device identification, often abbreviated UDI, a rule that requires medical device manufacturers to label their products, and in some cases, direct product markings, with both a unique device identifier and production identifiers (such as expiration date and lot or serial number). The FDA has also created a database called the Global UDI Database (GUDID) to which manufacturers upload product data and that is searchable by the public.
The FDA’s intent is to reduce medical errors and more quickly identify medical devices in the case of adverse events or recalls, in addition to providing an accessible source of definitive device identification information. Unique device identifier (UDI) in human- and machine-readable form class I and unclassified devices tracked by September 24, 2020
21 CFR 801.45, “[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."
Laser-based machine vision technology truly automates pharmaceutical manufacturing, making the process systematic, highly efficient and cost-effective. Lasers significantly increase production uptime, streamline the process and reduce costs, all while delivering new and improved capabilities ranging from product pill identification to GPS functionality. Adding identifying marks and bar codes to pills and packaging is important, but without automated inspection and quality assurance, this process would be inefficient. In over 2,500 companies, machine vision systems have been added to printing devices, ensuring that pills are registered, complete and unbroken, while also verifying package print quality. Pharmaceutical-adapted machine vision cameras are mounted on printing devices to inspect pills in real time. Cameras are mounted on production lines for several purposes. First and foremost, the camera captures the pill’s identity pattern. Second, if the pill is incomplete or broken, machine vision will send a signal to initiate a burst of air that pushs any single pill into the rejection bin. The image of the pill with it's unique speckled pattern, is either saved locally or transmitted to our secure cloud image database. For every pill marked with a unique identification pattern, this initial scan is also the first in the product’s supply chain tracing requirement. GPS Information about the pill, it's chemical formule, manufacturing date, batch number and factory location, usage, adverse reactions, is saved into our database. Using our DeepPill phone app billions of pills can be GPS located and authenticated instantly for recalls, inventory tracking, distribution, adverse reactions, patient compliance, anti-counterfeiting, monitoring compliance of opioid drug treatment, and more.
Mobile Phone Identification of Medications with DeepPill
TruMedicines DeepPill SDK provides easy JSON, C#, Java, TXT, interfaces for integration to existing Mobile Healthcare apps. Our secure encrypted data transfer schema supports secure data transmission to Medical Healthcare Record software including: eClinicalWorks, McKesson, Cerner, Allscripts, Athena health, GE Healthcare, EPIC, Care360.
TruMedicines Data Services is easy as 1-2-3
1. Upload product photos with unique identifier pattern (UIP) to your TruMed account
2. TruMed securely stores & indexes 100 million images using Machine Learning Ai
3. Using phone app, send a photo of UIP to TruMed, we verify and show product info
Non-disruptive to device manufacturers, pharmacies and consumers.
Turnkey to pharmaceutical manufacturing and packaging.
Compatible with cGMP manufacturing and standard pharmacy dispensing