Daphne Allen

January 4, 2016

3 Min Read
Factor in humans during medical device package design

Lyrics from the 1980s Human League song “Human” have been running though my mind lately. While it could be because they’re used in a current insurance ad campaign, I suspect it could also be because human factors are being discussed more and more today when it comes to healthcare product packaging.

I’ve just RSVP’d to an invite to attend a meeting on “Human Factors in Packaging Engineering” hosted by the Southern California chapter of the Institute of Packaging Professionals on Tuesday, April 22, at 06:30 PM in Irvine, CA. If interested, join SoCal IoPP’s Linked In group or send me an email at [email protected] and I’ll put you in touch. I am looking forward to hearing Virginia A. Lang PhD of HirLan Inc. and its division--Medical Device Human Factors (MDHF) discuss the implications for packaging development. (According to the invitation, MDHF offers design, evaluation, and validation services for products consistent with the FDA 510(k) Human Factors Guidance and ANSI/AAMI HE75:2009 Human Factors Engineering-Design Specifications.”) 

At HealthPack speakers Dr. Ondrea Kassarjian, PhD, principal engineer, packaging technology, at Cardinal Health, and Dr. Laura Bix, PhD, associate professor at Michigan State University, School of Packaging, discussed how to examine the end-user experience when designing medical device packaging. 

At the recent RxAdherence 2014 conference hosted by the Healthcare Compliance Packaging Council, I heard FDA’s Irene Chan, associate director of the Division of Medication Error Prevention and Analysis, discuss two draft guidances out of the Center for Drug Evaluation and Research, “Safety Considerations for Product Design to Minimize Medication Errors” and “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” While these are pharma-focused draft recommendations from FDA, you should appreciate the applicability to medical device packaging. In the first draft guidance, FDA writes that “errors can be minimized by assessing, prior to marketing, how users interact with the drug product within the medication use system or environment of use. This can be accomplished by employing proactive risk assessments using well-established human factors engineering analytical methods.” And in the second draft, FDA writes that “poor label design can contribute to medication errors by making it difficult for healthcare professionals, caregivers, and/or patients to readily locate and understand critical safety information.” I’d like to think medical device errors, too, could be curbed by assessing product use early during development and ensuring that all packaging and labeling support safe and effective use, not hinder or delay it.

And Medical Design & Manufacturing East speakers will explore such medical-device related themes in “A New Era in Consumerization, Usability, and Human Factors” at the upcoming conference June 12 in New York City. Presentations include “Getting to the bottom of user errors: Is it the device or user at fault?” and “Beyond determining user needs: Collaborative medical device design” and “Reading between the lines of standards and guidances for human factors validation testing.” 

I am thankful that industry experts are coming together to discuss end-user needs and how to prevent errors. I hope packaging continues to be part of these discussions. Humans err every day. Manufacturers and packagers should make every attempt to better understand the roots of errors made during medical device use, including reading packaging and labeling, opening packages, keeping records, updating inventory, and disposing, recycling, or reprocessing products. Errors at every step could seriously impact patients, practitioners, caregivers, and others.

Test your knowledge on medical packaging performance. Register, login and access these seven Q&As under Resources in Medical Packaging Community

Daphne Allen
Editor

About the Author(s)

Daphne Allen

Daphne Allen is editor-in-chief of Design News. She previously served as editor-in-chief of MD+DI and of Pharmaceutical & Medical Packaging News and also served as an editor for Packaging Digest. Daphne has covered design, manufacturing, materials, packaging, labeling, and regulatory issues for more than 20 years. She has also presented on these topics in several webinars and conferences, most recently discussing design and engineering trends at IME West 2024 and leading an Industry ShopTalk discussion during the show on artificial intelligence.

Follow Daphne on X at @daphneallen and reach her at [email protected].

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