Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to firstname.lastname@example.org so that we can defer those challenges. Your health and safety are paramount to us.
Posted 29 May 2013 | By Alexander Gaffney, RAC,
When it comes to medical devices, some of the biggest approvals by the US Food and Drug Administration (FDA) in recent months have been for the smallest devices. Now the agency has announced the clearance of yet another diminutive device, one that could have an outsized impact on the safety of the human blood supply.
In a 28 May 2013 announcement, FDA said it had approved a medical device known as iTrace through its 510(k) premarket notification system. The device uses Radio Frequency Identification (RFID) technology, the same commonly used by companies in access cards to control access to buildings.
The iTrace for Blood Centers device leverages that same technology in conjunction with software to control the process of collecting, testing, processing, labeling and verifying blood products.
A cursory glance at FDA's enforcement reports, which are published on a weekly basis, shows that problems associated with the control of biological products are endemic, with many companies accidentally releasing products that were collected incorrectly, collected from a donor at risk for a disease (such as Creutzfeldt-Jakob's Disease), improperly stored or expired.
By assigning an RFID chip to each collected blood product, companies will be able to streamline collection, processing, tracking and reconciliation procedures, said Karen Midthun, director of FDA's Center for Biologics Evaluation and Research (CBER). "The iTrace for Blood Centers device has the ability to enhance blood safety by helping to ensure that unsuitable units are not released," she added.
FDA explained that the device works with existing blood bank systems and "is designed to augment" those systems, including approved barcode identification and labeling processes.
The device, manufactured by Wisconsin-based SysLogic, Inc, is the first blood tracking device that uses RFID technology, according to FDA.
FDA: Clearance of iTrace
Tags: 510(k), medical device
Regulatory Focus newsletters
All the biggest regulatory news and happenings.