Avoiding UDI Implementation Pitfalls

When getting ready for Unique Device Identification, medical device manufacturers do face a number of challenges, but they can be addressed. Debara Reese, vice president, quality and compliance for Maetrics, explored such challenges and potential solutions during the MD&M East 2014 conference, “Common Pitfalls of UDI Implementation and How to Avoid Them.”

From the Editors' Desk

Avanir Pharmaceuticals Receives FDA Acceptance of IND for AVP-786 for the Adjunctive Treatment of Major Depressive Disorder

Avanir Pharmaceuticals, Inc., Aliso Viejo, CA, announced July 21 that the U.S. Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for a Phase II study assessing the safety and efficacy of AVP-786,...

Medical Plastics Material Expands Elongation of Pouches

Pouches are a standard packaging format in the healthcare industry, but some pouches are easy to break or puncture, which can result in significant risk for patients. Dennis Siepmann, Business Development Manager at Actega, says that using a film made...

IV Solutions Recalled after Particulates Found

FDA reports that Baxter International Inc. is voluntarily recalling four lots of intravenous (IV) solutions after particulate matter was found and identified as cellulosic fibers and/or plastics. Baxter received four complaints over a period of six...

ASTM International Approves New Committee, Packagers Encouraged to Participate

Packaging professionals have another reason to get involved in ASTM International. In June, the ASTM board of directors approved the formation of a new committee, E62 on Industrial Biotechnology, formed by professionals from the medical and...

Inventive examples of smarter compliance packaging

July 3 was a banner day for smarter pharmaceutical and medical packaging when two patents were published that leverage technology to improve patient compliance and consumer safety. One was for a Smart Label container and the other for an RFID-enabled...