End-Users Evaluate Device Packaging at HcPIE

Medical device packagers received firsthand insights on the preferences and concerns of healthcare personnel at the Healthcare Packaging Immersion Experience (HcPIE) event held in October at Michigan State University.
As doctors, nurses, and a paramedic performed simulations in fast-paced care environments, packaging as often as not presented obstacles, as packages were not opened as designed and labels went unread.
Areas to improve packaging for easier use and to enable better outcomes were suggested as the practitioners shared their views with the audience after the exercises.
Audience members tested their skills in waste separation after a presentation on a waste mapping project by Kaiser Permanente.
Attendees witnessed the providers at work in a pre-hospital emergency room, an OB/GYN delivery, and a home care environment, in simulations produced by the MSU Learning and Assessment Center.
Caregivers didn’t have much time for reading labels or searching for package opening features in the harried setting of the trauma bay. Cramped space was cited as an issue in the emergency setting as well as by the paramedic working in an ambulance. Providers reported the challenge of finding the right package in cluttered cabinets, and the need for labeling that allows quick product identification. Packages that are difficult to handle and open inhibit product access and aseptic presentation, nurses reported.
Nurses cited the risk of being cut when opening glass ampoules and by packaging with foil edges. They questioned the practice of packaging first-line emergency drugs in boxes designed to be opened from perforated bottoms. The nurses reported pulling at these boxes from the top, after which the container sometimes drops through the bottom to break on the floor.
Nurses and paramedics reported tackling IV bag over wraps and header bags by tearing them apart or using scissors. One of the OB/GYN nurses cited IV bag opening as the number one packaging problem.
“The outer wrap on the IV bag really delays things. And a pre-tear can be very difficult to find. We need a plastic that is easily tearable regardless of the angle,” said the paramedic, who assisted simulated patient “George” with a severe leg injury in the pre-hospital exercise.
Event moderators Curt Larsen and John Spitzley of Spartan Design Group take a breather with Sparty.
Providers’ preferences and priorities for packaging vary significantly by the context of use. Packaging that is easily identified and that can be easily opened with one hand is a main concern for first responders, working in tight spaces and often in the dark of night, the paramedic said.
While an OB/GYN nurse favored tear-along-the-line pouches as providing easier access to the product, nurses in a presented study by Monica Cai, project manager, Orbis Corp., reported that tear-open packaging for sterile items was problematic as they were uncertain of their ability to ensure
The doctor handling George’s pre-operating room care and the doctor performing the OB/GYN simulation expressed preferences for trays that keep things organized and in one place, and for clear packaging.
“The last thing you want to be doing is searching for a device once you have started a procedure. I like everything right in front of me where I can see it. Everything should be visible. I prefer a clear package; there should be at least a [package] window,” said one doctor.
In the home care simulation, the caregiver was given gloves and eye glasses to simulate the compromised abilities of a stroke victim caring for her disabled father. The stroke victim struggled mightily in hooking up an IV.
“Within the home health environment, family care givers are frequently not properly trained, are dealing with incredibly stressful situations, and can have their own health issues, which can make administering care mentally, psychologically, and physically challenging at times,” says Laura Bix, associate professor, MSU School of Packaging.
Presentations explored industry placement of critical information in labeling such as for that of urinary catheters.
“There is much work to be done [particularly in] emergency care scenarios and in home heath environments. The people in these environments would greatly benefit from an inclusive [user-and-product focused] design approach,” Bix says.
The study by Monica Cai confirmed packaging preferences of perioperative personnel (primarily nurses and surgical technicians). In the study, focus groups provided feedback on the full range of packaging styles from rigid trays to corner peel pouches to header bags.
Package opening and aseptic presentation was found as the leading concern when personnel were asked to estimate the frequency of common problems. Of all problems reported, 41% were with aseptic presentation, followed by 31% in package opening.
The Chevron pouch was viewed favorably by a wide margin as a format that provides enough gripping area, control of the package and product, and even peel forces.
The clinical personnel reported uneven tearing that inhibits sterile presentation, and problems identifying where to tear when locations of tear open notches are inconsistent. Among their high ranking preferences were spots, color coding, graphic textures, or package morphology to assist in notch location, and trays designed to stabilize with one hand.
In labeling, package designers have to include a lot of information such as multiple languages on a label and use symbols as much as possible in order to conserve space, an audience member observed.
Yet the care givers reported often not noticing or understanding the symbols; reading the labels is a problem particularly in low light environments that can prevail in hospital settings besides ambulances.
“Reading goes out the window. The printing is so small you can’t read it anyway,” commented one nurse.
Cai’s study reinforced the labeling concerns expressed by the panelists. Non-critical information gets in the way of finding wanted information. Study participants favored that key data elements of product name, sterility status, latex content, and expiry should be highlighted and in standard locations.
A doctor suggested that perhaps non-critical label information could be relegated to an insert or packaging slip.
DoChan Seo, a doctoral student in the MSU School of Packaging, presented findings on a study for improving labeling on in-dwelling urinary catheters. Seo in initial work has benchmarked features of existing packaging, with a goal of developing new designs that promote enhanced attention capture and comprehension. The study will quantify the efficiencies that could potentially be gained by employing a standardized approach, Bix said.
ASTM D-7298-06, Standard Test Method of Comparative Legibility was used, with the Lockhart legibility instrument, to evaluate legibility.
The benchmarking shows significant variation in the placement of critical information—product name, sterility, latex, and expiry—in four defined sectors on the label lidding web.
“Seeing how scattered the critical information is was somewhat startling to me. By plotting out all the different places where we as industry are placing this information on the label, you can really begin to see why the healthcare providers are frustrated,” Bix says.
Improved packaging could have a significant impact on many of the issues confronted by providers, says Jane Severin, director, regulatory and standards, North America, DuPont Protection Technologies.
“Personally, I would like to see the industry tackle labeling issues such as developing standards for symbology, and making a dramatic move to the use of EIFUs [electronic instructions for use] to open up space on labels,” Severin says.
While device packagers are identifying areas for packaging improvement, participants discussed how user-centered design will be promoted by heath system initiatives and regulation. User-preferred designs will be favored as reducing system-wide costs, and changing regulations globally are emphasizing risk assessment with a focus on finding out how product is used in the field. —David Vaczek
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