The View from the End-User
Published: October 19th, 2011
Simulations with doctors, nurses, and EMTs point to opportunities for improved packaging.
Medical device packagers received an eye-opening perspective on how their packaging is used by care providers in fast-paced and often hectic environments at the Healthcare Packaging Immersion Experience at Michigan State University. Nurses and emergency medical technicians struggled to open flexible packages, spilled the contents of kits, and seemed to pay scant attention to the labeling in simulations of a hernia operation, an emergency room procedure, and an ambulance case.
“Watching these simulations, it is clear the providers’ first priority is not the packaging, but rather completing the tasks at hand,” said Charlie Robnett, packaging development engineer, global packaging, Smith & Nephew.
In debriefings after the simulations, end-users joined the audience to evaluate the simulations in the context of four factors that impact success or failure: the context, the task, the user, and the packaging. Ease-of-opening and clarity and consistency of labeling were prominent concerns for the doctors and nurses.
“The doctor wants a lot of things at once, and the nurse has to triage these requests. That’s why it’s important to be able to open these things easily and correctly,” said Dr. Douglas Segan, who performed in the simulated emergency room care of a head wound patient. “We don’t give a lot of thought to the packaging other than that it is in our way. We want to get to what is inside. Good packaging is like good acting—you don’t notice it,” Segan said.
Packaging needs to be intuitive and designed for opening with gloves on, nurses said. “You don’t look at the instructions for opening. You feel for the corner. For sterile items, we are looking for a peel pack for peel and toss,” said ER nurse Barbara Tatroe. “I hate something new if I have to spend time thinking about it. My favorite is when you can see how to open it. The best package is one you are familiar with.”
Labeling on large bags for oxygen cannulae presented a problem in the ER simulation. “There’s too much writing on the bag. It’s hard to focus on reading fine print. You can’t tell if it is for a child or an adult. You are doing six things at once sometimes and following the doctor’s requests. We keep them all on hand because we don’t know who the patient will be,” said ER nurse Melissa Gray.
What should the package size be relative to the device? asked an attendee. “If the package is too tight, the device will spring out. If it’s a peel pack and it’s too wide, it’s harder to dump,” said Tatroe.
While labeling clarity was favored, so was clear packaging. “The ideal package is clear on both sides. The labeling has to be clear. You will have nurses with reduced vision, or color blindness. Paramedics [may be performing] on dark, rainy nights,” Dr. Segan said.
“End-users may want the clarity, but they also need to see the print, which is hard to see on a clear structure,” notes Evan Arnold, packaging engineer, Glenroy Inc. Glenroy supplies custom foil laminations in premade pouches and rollstock that can be paired with its line of clear high-barrier films. “The lamination is very receptive to print, which shows up very clearly against the foil backing,” Arnold adds.
An ER nurse shredded an IV overpouch bag with a tear notch that wouldn’t budge. “We saw pouches that were supposed to be tearable, but that were completely untearable. You can build the strongest and best package, but if the end-user can’t open the package, it’s really failing. As a supplier, we need to find a middle ground, with structures that meet rigorous protection requirements but also allow the nurse to access the product,” Arnold says.
Nurse preferences for single- or double-barrier sterile packaging seemed to vary based on the care setting. “We’d like to toss all of it; then I can arrange the table. But that said, you don’t get a second chance if you drop it. Double packs give you a second chance, which we like to have with expensive products,” said a nurse in the OR simulation.
“The emergency room nurses favored single-barrier packages for quick access to the product,” observed Robnett. “In the operating room where they have more time to prepare, they preferred to have the extra layer of protection for more-expensive devices. If the package is compromised, they will have another chance to present the inner pouch or tray. We often classify a hospital as one entity, but different levels of design may be required for the emergency room, operating room, and the ambulance.”
Chevron pouches could create problems with insufficient area for gripping. Pouches with corner peels are often harder to control. “There is more risk for contamination with the peel at the corner. You don’t know what will happen if you use a lot of force,” said Gray.
With a Chevron pack, “you want to get a good grip at the top with thumb and finger. If not, you are trying to peel from the sides and [the device is] going to roll [to the seal perimeter],” she said.
Package inspection in the operating theaters and ambulance did not seem to be a priority. An expired IV kit and a package with a channel defect that were planted for the hernia operation went unnoticed, though the doctor questioned a mesh with an unfamiliar look and feel. A nurse held a pouch up to the light to check on the expiration date only after the device was tossed to the field.
“[Devices] are generally pulled for us and packed on the cart. We will check the carts before they go into the room, and I’ll double check when opening it. Certain products such as thinner paper, which is more likely to tear, show problems, and you tend to be more careful with those,” said one nurse.
Kits created problems in the cramped confines of the hospital rooms and the ambulance, where surface space for placing them down for opening was limited. Dr. Segan struggled with an unstable intubation clamshell kit, and an EMT was forced to turn to a second airway device after a combi tube popped from a tray like a jack-in-the-box.
“Kits organized by use where product is grouped by procedure are wonderful. Overall, packaging has improved tremendously in the last 25 years,” said Tatroe.
In the ambulance, technicians favor peel-apart packs with big or offset tabs that are easily manipulated with gloves on, said EMT Brian Beckwith. “This is a high stress environment—the adrenaline is pumping. Our biggest concern is that we have enough hands to do the job. Creating a sterile field environment goes out the window. We are working in people homes, in roadside ditches. We use Betadine and try to keep things in the package until we need them,” he said.
The more packaging is preassembled, the better. Prefilled syringes are helpful. “Epinephrine and cardio drugs are pre-filled, but we have to use vials for some drugs. Dopamine was premixed in a bag, but now we get it in vials,” he said.
In veterinary practice, some devices intended for one-time use are commonly resterilized to keep costs down, reported Laura Nelson, assistant professor in small-animal soft-tissue surgery, MSU. “We sterilize a lot of things never intended to be reused. Sometimes you have to hunt for the sterile [designation]. We need a clear indication. It would help if the package indicated how it was sterilized, then we would know how to resterilize it,” she said.
“End-users in veterinary practice, and in the ambulance, are making do. They take what is designed for the mainstream and adapt,” says Jane Severin, PhD, vp of technology, Oliver-Tolas Healthcare Packaging. “One is paid by the pet owner, the other by taxpayers. So the cost constraints are even greater than we are used to in mainstream healthcare. There may be a need to design product specifically for these segments.”
“[Veterinary practice] seems like a forgotten market,” says Glenroy’s Arnold. “They are resterilizing one-time use devices or taking items from multiple-piece packs. It looks like there is a need for reusable packaging such as a recloseable pack secondary to the original packaging. The user could use one or two devices, resterilize and seal the package, and put it back on the shelf.”
Package design is shifting increasingly to a user-centered approach driven by factors including the aging of the nurse population, presenters said. The MSU event provided an opportunity for packagers to sharpen their tools, when access to OR environments and nurses has become more difficult, one engineer commented. “Based on standards of practice, package designers expect that the practitioners are performing a thorough visual inspection of the device packaging before use; looking for open seals, reading the labels, looking for expiration dates. The real disconnect is that in certain contexts of use, such as in an ambulance, paramedics don’t have much time to inspect the packages or read the labels,” Severin says.
“The context of use in each one of those scenarios is so dramatically different. Nurses and doctors are so absorbed in other activities, [so] trying to figure out how to open a package is not something they need to or can focus on,” she adds.
Jim Bagian, MD, a former NASA astronaut and director of the Center for Health Engineering, Department of Anesthesia, University of Michigan, stressed the need for engineers to witness packaging performance through end-users’ eyes. “Our breakage rate is extremely high,” Bagian said, referring to the percentage of patients injured in hospitals.
Through usability studies and simulations, packagers can find errors waiting to happen. “Patient safety is not the elimination of errors—that’s retrospective. It is ensuring no harm,” Bagian said.