A Unique Device Identifier (UDI) is a numeric or alphanumeric code that is assigned to a medical device. These codes are entirely unique, designed as a method to easily identify and determine the use of devices sold in the United States and Europe. The purpose of a UDI is to enable the regulatory agencies, industry, device users, and healthcare systems to be able to recognize devices from manufacturing through distribution to patient use. In the U.S., in an effort to improve the process for...

Since their introduction two decades ago, hydrophilic and hydrophobic coatings on intravascular devices such as catheters, wires, and delivery systems have proven highly popular for decreasing the frictional force when the devices are introduced into the vasculature. By reducing the force required to manipulate intravascular medical devices during vascular interventional procedures, these coatings reduce the risk of damage to blood vessel walls and prevent vasospasm. According to the...

Virtual audits are our current situation; yes, it’s a bit out of our collective comfort zone, but it beats not performing audits at all during this time of uncertainty. Quality System compliance can still be assessed no matter the environment, with a few key changes in the way we performed audits a month or two ago. Maybe this experience will change the way we handle auditing in the future.   Ensure your Quality System can be accessed remotely. Not just your Quality System documents,...