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Archive for the ‘Labeling’ Category

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 ...

Westpack Panel Addresses Automation and Cost Control

Friday, February 3rd, 2012

Packagers are under enormous pressure to reduce production costs without compromising product quality. Through upgrades in packaging machinery technology, peripheral equipment, and processes, manufacturers can improve production line efficiencies and reduce the errors that lead to product recalls and put consumers and patients at risk. Approaches for improving packaging line performance and ...

Upping the Bar for Packaging: Up and Away

Friday, December 16th, 2011

I was intrigued to see packaging mentioned in the new child safety program promoted by the Centers for Disease Control and Prevention (CDC) and other partners, Up and Away. The program is part of the PROTECT Initiative, with drug manufacturers, packaging suppliers, and ...

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 ...

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 ...

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FDA has issued draft guidance to help medical device manufacturers understand when a change to a previously cleared 510(k) device may require a new premarket notification submission.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 ...

Does Your Drug-Dosing Device Deliver?

Tuesday, June 21st, 2011

Do you know whether the delivery devices included with your OTC liquid pharmaceutical products match your product's dosage instructions down to the half teaspoon? They better match exactly---otherwise your drug could be considered misbranded. In addition, how well does your device deliver your intended dosage? As one potential solution, a drug-delivery ...

The Package Says Sterile but . . .

Thursday, May 5th, 2011

Yikes! Here is a risk to stolen and diverted medical devices that I had barely considered. How about you? Nonsterile products! Today in our daily newsletter we reported on a story from the Star Tribune in Minneapolis that Boston Scientific Corp. has warned hospitals to look for endoscopic and urological medical devices ...

Brazil Looking for Global Input

Friday, March 18th, 2011

With its safety stamp on hold, Brazil is studying alternatives. Will the EU’s Falsified Medicines Directive or FDA’s hope for a national electronic pedigree system serve as potential models? Brazil has officially revoked its proposal to satisfy the requirements of its pharmaceutical safety law, leading some stakeholders to breathe a sigh ...

Are Your Packaging and Labeling Processes Ready for Unique Device Identification?

Wednesday, January 26th, 2011

We are all patiently awaiting FDA's draft regulations on Unique Device Identification. Could they come in February? How far will they go? FDA's Jay Crowley, senior advisor for patient safety, will be speaking at an FDAnews event February 24, "Complying with FDA's Unique Device Identification Rule: Unlocking the Secrets of Effective ...