If you don’t get your kits from Danlee Medical Products, is that company FDA and UDI compliant? Check for yourself at https://accessgudid.nlm.nih.gov/.
Although the acronym looks like it pertains to either a medical condition or a new gluten-free dieting aid, neither could be farther from the truth. UDI, simply put is a unique device identification system specifically designed to improve the quality of information in medical device adverse event reporting, helping the FDA and other global entities to identify product problems promptly for far more efficient target recalls, and vastly improving patient safety. This unique numeric or alphanumeric code includes a device identifier and a production identifier such as the lot or batch number, serial number, and/or the expiration date; specific to a device model and includes the current production information for that specific device.
Furthermore, the FDA database includes this standard set of basic identifying elements for each UDI, making most of it available to the public. This will enable users of a medical device, like Holter hook-up kits, ambulatory stress test kits and cardiac event recording kits, to easily look up information regarding their specific device. The database does not contain any information about those who use a device or their personal privacy information, just the device-specific information pertinent to keeping the public at large safe. Partnering with foreign regulators in Europe, Canada, Japan, and Australia, the FDA has developed regulations establishing this innovative and overdue international standard for identifying medical devices and their apparatuses.
An exceptional component of UDI is that it provides a consistent way to enter information about devices in electronic health records and clinical information systems. This element allows for all regulating entities, foreign and domestic; to allow manufacturers, distributors, and healthcare facilities to more effectively manage medical device recalls, providing a foundation for a global, secure distribution chain, that addresses counterfeiting and diversion, but more importantly, to prepare for medical emergencies. The significant reduction in medical errors by enabling healthcare professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device will undoubtedly save millions of dollars and countless lives.
Danlee Medical Products, your trusted cardiology and medical supplies partner for over 20 years, has taken the lead by becoming UDI compliant years ahead of the industry launch date. The rollout of the UDI system was initially slated for September of 2016 with Danlee Medical leading the way primed, ready and compliant in the summer of 2016 for all Holter hook-up kits, ambulatory stress test kits and cardiac event recording kits. However, with the majority of the medical industry not quite prepared the FDA pushed the launch date back to September of 2018. Many manufacturers and distributors breathed a collective sigh of relief in the adjourned launch of the UDI system, but Danlee Medical pressed on, business as usual, and operates today as one of the few UDI compliant entities operating in the US, as well as the first Holter hook-up kits, ambulatory stress test kits and cardiac event recording kits manufacturer to become UDI compliant.
As an industry leading manufacturer of single-use medical-professional-grade cardiology testing kits, Danlee Medical prides itself as a company that puts public health first, taking any and all opportunities to fight the good fight, evolving and improving the healthcare system. Partnering with a trusted cardiology supplies and equipment provider that understands the importance of compliance, its direct correlation with a healthy patient and a healthy provider-patient relationship, like Danlee Medical, is what gives your practice the edge in today’s more than competitive healthcare market. Helping guide you through the intricacies of the UDI system, while providing you with the tools you need to maintain your reputation as a premier cardiology services and healthcare provider. We’re here for you, standing by your side every step of the way.