Archive for the ‘Labeling’ Category
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 ...
Posted in Design, End-Users, Hospital, Labeling, Medical Devices, Pouches, Senior Friendly Packaging, Testing | Comments Off
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 ...
Posted in Design, Handling, Labeling, machinery, Quality, Sustainability | No Comments »
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 ...
Posted in Baby Boomers, Blisters, Bottles, clinical trials, Design, Labeling, Safety | No Comments »
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 ...
Posted in Design, End-Users, Handling, Hospital, Labeling, Medical Devices, Medical Errors, Package Inserts, Printing and Coding, Safety | No Comments »
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 ...
Posted in Bar Coding, Counterfeiting, Diversion, Electronic Pedigrees, FDA, Labeling, Medical Devices, Medical Errors, Printing and Coding, Recalls, Safety, security, serialization, standards, Theft | No Comments »
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 ...
Posted in FDA, Labeling, Medical Devices, sterilization | 1 Comment »
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 ...
Posted in Drug Delivery, FDA, Labeling, Safety | No Comments »
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 ...
Posted in Diversion, Hospital, Labeling, Medical Devices, Printing and Coding, Safety, security, Theft | No Comments »
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 ...
Posted in Bar Coding, Counterfeiting, Labeling, Safety, security | No Comments »
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 ...
Posted in FDA, Labeling, Medical Devices, Recalls | No Comments »
