After covering the nurses’ panel at HealthPack 2020—in which healthcare veterans open device packaging and offer honest feedback—I spoke to Virginia Lang, PhD, President & Chief Scientist at HirLan, Inc., who offered her feedback as a human factors (HF) expert to translate the panelists’ in-the-moment wishes to potential actionable insights.
1. Panelists expressed repeatedly that tamper-evident stickers represent a hurdle that creates paper cuts when they jam their thumbs in to open a package.
HF Comment: What they are saying is that there is a potential safety issue with anything that results in a paper cut.
HF Solution: Incorporate half-moon shaped perforated areas on the carton.
2. Clear small parts in clear trays can inadvertently be tossed out, and the nurses expressed desire for small parts in bright colors.
HF Comment: Colors alone are not a compliant solution as different companies can use conflicting color cues and nurses could be color-blind/deficient. The package needs contrast between tray “color” and component “color.”
HF Solution: The placement of components in “clear” trays should be obvious and not “stacked.” Don’t use multiple layers with important components underneath. When trays are stacked, place the first used first out sequence.
3. They also said they like colorful flaps or snaps in trays to cue device removal.
HF Comment: Affordances that are visual, tactile, and/or auditory are required.
HF Solution: Place “rough” paper indicators in the appropriate places.
4. They noted that they often work in low light, and blue devices can blend in to the blue table drapes.
HF Comment: Users’ environment such as lighting, additional “tools”, etc. must be taken into account.
HF Solution: DON’T use color as a differentiator! Use contrast: namely, use WHITE instead of clear plastic. Take into consideration environmental lighting standards for different hospital environments.
5. Because they search for products closer to expiring, they wished for big, bold expiration dates they can see when products are stacked on the shelves.
HF Comment: Users risk using devices that have exceeded the expiration date.
HF Solution: Place the expiration date in several locations so that when stored, the location is not obstructed. Use BOLD fonts and LARGER font sizes for the expiration date.
6. For products that have different iterations (same line, different size or latex-free version), they said there has to be differentiation to make it obvious which version of the product it is.
HF Comment: Again, DO NOT use color as the only cure for differentiation.
HF Solution: Use fonts and BOLD test to differentiate differences. For example, state “NO LATEX” for non-latex versions and “LATEX MATERIAL” for the latex versions. A black background with white text for the LATEX MATERIAL version, versus white background with bold black text for the NO LATEX.
7. Whether a nurse dumps a device on the table or hands off the device to the scrub nurse depends on the device and the situation: if time is of the essence, they may have to dump the item, even if the item is small or the field is crowded.
HF Comment: Users need both speed and precision in removing components from packaging.
HF Solution: Components must be secure in the packaging for shipment, but must be “loose” enough to dump onto a sterile field. Components must be of a shape that is NOT conducive for “rolling.”
8. They noted that certain header bags can rip when the top is pulled, particularly if there’s not enough room to grip the bag.
HF Comment: The header size isn’t taking into account hand ergonomics.
HF Solution: Refer to MIL-STD-1472 G for different Hand/Finger ergonomics data.
9. One nurse described a product that requires flushing, but because the device doesn’t have any cues, they were concerned that it does not get flushed if the nurse is inexperienced with the product. They look for spots for Luer-Lok or common syringes.
HF Comment: Users look for “affordances” as indications of usage.
HF Solution: Users’ typical “affordances” must be taken into account for the accurate usage of the device. HE 75: 2009 (R) 2013 lists these.
10. The nurses both described that in some busy cases, they have to juggle multiple products, holding an item under an arm or between knees to keep it off the floor while opening another package.
HF Comment: Environment, physiological constraints, and device size are an interaction when setting up device usage/package opening.
HF Solution: Understand the interaction of different device components and sequence of “opening” the components.
11. Outer cartons may be tossed, leaving the item in its primary packaging when it gets picked for a case. Often the IFU is thrown out as well.
HF Comment: Cartons used for shipping are different than cartons used for device maintenance, e.g. breakage, sterility. IFUs are trashed.
HF Solution: Critical device information must be duplicated on component packaging. IFUs must be accessible, e.g. with a hole for hanging (with the packaging or to hang onto a pole in the patient area) and key points should be printed on the inner packaging.
12. The expressed desire to know the contents of a package without having to open it first.
HF Comment: Users need to work in a specialized environment and not every situation is the same.
HF Solution: List of contents must be on the inner-most packaging as well as outer packaging.
13. One nurse noted that diagrams on packaging can be very helpful while gaining experience with a device, especially in high-pressure, time-sensitive cases.
HF Comment: Users don’t always get training on devices/components.
HF Solution: Device usage should utilize pictures AND words. Words should be for actions, pictures for the components plus actions.
Key takeaway
Dr. Lang explains, “If the packaging contributes to use errors with the device, then the users’ inputs are extremely important. Whether the users like the packaging is not the important takeaway, it’s whether the users can interact with the packaging safely and effectively. Hence, packaging design needs to be tested UPFRONT in the Design Controls process. Packaging is NOT a marketing message, packaging is a SAFETY and EFFECTIVENESS fundamental.”
Common Threads Observed
Users:
Do not work alone
Have to work quickly
Have constrained working space
Are both male and female hence the ergonomics for hands, fingers, opening forces, etc., can be very different
Do not feel that their input is important
Environment:
Extremely different lighting conditions
Workspace is constrained in size
Supply stocks are in different places than the components are used
Devices are “transported” between different locations
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