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Archive for the ‘Medical Devices’ Category

Plan Now to Attend ASTM International Committee Meeting in Spain

Monday, May 7th, 2012

ASTM International Committee F02 on Flexible Barrier Packaging will meet this fall in Barcelona, Spain, offering a number of technical and regulatory presentations. Speakers will include representatives from both Europe and the United States, including the U.S. FDA. "Since ASTM International Committee F02 on Flexible Barrier Packaging met in Prague in ...

USP Workshop To Focus On Common Approach For Supply Security

Friday, May 4th, 2012

The U.S. Pharmacopeial Convention (USP) has pulled together a broad swath of  stakeholders for a workshop this month on the complexities of protecting the supply chain. The May 22-23 event in Rockville, MD will feature regulatory officials from Europe, South American, and Africa, and coverage of developing track-and-trace standards, among other ...

Cardinal Health Bag Offers Easy, Consistent Opening

Friday, February 24th, 2012

FDA guidance and developing standards from ISO and AAMI/ANSI have shifted more attention to device and package designs that consider the needs of end-users and reduce the likelihood of human error. At Cardinal Health, the usability of product and packaging is formally considered as human factors in design are captured and ...

Study Evaluates Impact of Pouch Size on Contamination

Wednesday, October 26th, 2011

A first concern of nurses is avoiding contaminating the inside of sterile packaging when devices are flipped to a sterile field or handed off to the scrub nurse. At the Healthcare Packaging Immersion Experience organized by Michigan State University and Oliver-Tolas Healthcare Packaging, Tony Trier, a masters degree candidate at the ...

Reduce End-User Confusion

Wednesday, October 26th, 2011

Doctors and nurses are often tripped up by product packaging and labeling, putting patients and themselves at risk, warns Dr. John Gosbee, Human Factors Engineering & Healthcare Specialist at Red Forest Consulting and University of Michigan Health System. Gosbee spoke at the Healthcare Packaging Immersion Experience, organized by Michigan State University’s ...

Solving Shortages through Serialization

Thursday, September 29th, 2011

The Institute for Safe Medication Practices (ISMP) has surveyed pharmacists and purchasing agents on drug shortages and the "gray" market again, and the bad news is that we could have just reposted our blog on last year's survey and been just as timely. Hospitals continue to struggle with drug shortages, ...

Help Save George and Real-Life Patients in Emergency Situations

Friday, September 23rd, 2011

The role of a paramedic is to stabilize a patient in an emergency situation. Seconds count---so ask yourselves this question: Does your package ease emergency care, or get in its way? In just a couple weeks (October 5-6), Michigan State University (MSU) and Oliver-Tolas Healthcare Packaging will offer the chance to ...

GS1 Standards Pick Up Support

Wednesday, September 14th, 2011

GS1 Healthcare standards are gaining traction. As the latest country to support GS1, India has called for serialized codes following GS1 data formats for exported pharmaceuticals. Most of the top pharmaceutical and medical device companies, wholesalers, and many hospital systems in the US have embraced GS1 Healthcare’s system for product ...

Invest in UDI’s Success

Thursday, August 25th, 2011

Before proposing regulations for unique device identifiers (UDIs), FDA wants to hear from all stakeholders about any barriers and incentives to UDI adoption and use. The agency is holding a public workshop September 12-13 in Bethesda, MD, and while this workshop will not address FDA's UDI regulatory framework, it will ...

Packagers: Get to Know Your 510(k)s

Tuesday, July 26th, 2011

FDA has issued draft guidance to help medical device manufacturers understand when a change to a previously cleared 510(k) device may require a new premarket notification submission. According to the agency, most packaging changes do not require a new 510(k). But there are some areas you should study closely. In the ...