AIM North America allotting expertise as a resource to direct and guide organizations of the UDI regulation for medical equipment during Pandemic.
June 23, 2020 – Pittsburgh, PA – The COVID-19 Pandemic had a detrimental impact on both Healthcare Organizations and individual persons in our backyard and around the world. According to the CDC, the number of cases continues to increase, and the future of this virus remains uncertain. In this time, many non-traditional companies from outside industries have stepped up to manufacture medical devices for hospital groups, employees working under new safety guidelines, and patients. AIM North America (NA) has announced that they will be providing their expertise in advising organizations on the accurate way to ensure traceability for their own lines of devices.
Devices including respirators, face masks, and other essential medical equipment are required by the FDA to be uniquely identified, tracked, and traced to ensure the safety of both the patient and the supply chain. The Unique Device Identifier (UDI), seeks to improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation. Product data can be uploaded to the AccessGUDID database which is made available to patients, caregivers, healthcare providers, hospitals, and other industry professionals providing transparency and traceability. UDI markings can be found on device labels, the device’s package, and even directly on the device.
“As a manufacturer of medical devices, we understand the need for traceability for patient safety and brand integrity. The UDI standard is critical to visibility of our product and working with AIM NA and its members has provided us with a wealth of knowledge and guidance,” stated Patti Blessing, Chair, AIM NA UDI Work Group and Vice President of Business Development, CAVU Group.
“COVID-19 Pandemic has pushed many more players to enter the medical equipment manufacturing market to meet the rising demands. We see a trend of faster product release without following the correct guidelines. Guidelines are in place to offer both visibility and safety; therefore, education and implementation of these guidelines are critical,” stated Debangana Mukherjee, Chair, AIM NA and Director of Business Development + Sales, CISC Semiconductor.
Before this pandemic took place, the manufacturing workflow was substantial in nature. With new manufacturers in the market, the need for these standard processes becomes more critical. Companies, small and large, have banded together to support demands of the industry. AIM NA has guaranteed their assistance in educating how to accurately follow the FDA/UDI regulated guidelines.
For more information on how you can start the conversation today, be sure to fill out our form and read through the AIM NA Digital Supply Chain Whitepaper.