On February 12, 2009, the FDA held a public workshop on the topic of unique device identification (UDI) in the medical community. The Amendment Act of 2007 mandated the use of such identification systems but the practical details are still being worked out. The gathering in February focused on a number of questions that need to be resolved. The eventual outcome should help healthcare facilities fully integrate this device tracking concept into their everyday workflow. Discussion revolved around such issues as where on each device the identifying mark would be placed (a major concern with small items such as needles). Also covered were considerations regarding what information the UDI should contain and how the related databases should be structured and maintained.
One goal of a device tracking program is to increase patient safety through accurate record keeping. Defective products can be traced and recalled much more easily using this type of technology. Other benefits of UDI include greater inventory control and the ability to keep equipment expenditures to a minimum. It has also been suggested that such a system can be used to display MSDS information and compatibility with other devices. Creating a single standard will make it possible for manufacturers, distributors, and health facilities to share data quickly and effectively.
Benefits For Sterile Processing & Distribution
UDI is of special interest to SPD departments because it delivers the ability to scan instruments each time they go through an autoclave cycle. This will permit technicians to track the number of times each item has been reissued. Metal instruments can even be etched with an information based indicia or 2-D barcode. Such a matrix based code can contain many times the amount of information available through standard barcoding. RFID technology has also advanced significantly. Now, there are chips being produced that can withstand the harsh environment of a steam sterilization unit.
At this time, the FDA has not selected a specific method for UDI. It is up to each facility to make this decision independently. Good sense does dictate that health providers choose platforms and processes that will integrate easily with a universal system in the future. Many interested parties are heavily promoting the GS1 standards. This organization is a global logistics and asset management leader with over 30 years of experience in supply chain tracking. The Health Industry Business Communications Council (a non-profit organization) has also been mentioned favorably in connection with UDI system development. This group advocates educating healthcare providers about ways they can utilize new informational technologies to streamline various processes.
A proposed ruling by the FDA on the topic of UDI is expected by the end of 2009. A final rule is anticipated sometime in 2010. Since implementation of new standards will take time, it makes sense to begin reviewing internal processes now. This will make it much simpler to upgrade existing systems once firm regulations are established. SPD personnel should be involved in the decision making process regarding the marking of reusable medical devices.
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