Team Consulting introduced a new approach to medical device packaging at the Pharmapack Europe show in Paris, which it says has the potential to minimise user error. The packaging concept, in cooperation with Burgopak, was designed on Japanese principles of ‘poka-yoke’.
Poka-yoke (pronounced “poh-kah, yoh-kay) translates into English as error-proofing or mistake-proofing. Dr Shigeo Shingo, a renowned authority on quality control and efficiency, originally developed the mistake-proofing idea. Realizing its value as an effective quality control technique, he formalized its use in Japanese manufacturing as the poka-yoke system. Poka-yoke results in operations with fewer inadvertent human errors as well as less wasted energy, time and resources. In relation to the aftermarket parts and components in the packaging industry, poka-yoke includes “one-way fit”, colour-coding and ergonomic design.
This is particularly of importance for packaged products, which require being unpacked and assembled by the consumer himself. This is even of crucial importance when the product is a health care device.
Studies show that users make more mistakes if they are given all the components of a to-be-assembled-at-home device at the same time with only paper instructions for guidance.
Poka-yoke is based on prediction and detection. That is, recognizing that a defect (a part wrongly fitted) can occur or recognizing that a defect (a wrongly fitted part) has occurred. Poka-yoke does not allow an assembly process to begin or continue after an error has occurred. It takes the response to a specific type of error out of the hands of the customer.
Poka-yokes can be as simple as a pin on a fixture that keeps incorrectly placed parts from fitting properly.
That technique Team Consulting used for its medical device packaging with the intention to minimise assembly errors by the customer.
Rather than relying on a paper IFU and user intuition, Team’s poka-yoke packaging presents users with each part of the device in order, with clear graphical instructions on how to construct and use the device at every stage. This ensures users cannot put the wrong pieces together or miss out key steps. By applying poka-yoke principals to packaging, medical device developer Team hopes to remove some of the fear and anxiety patients experience when using a medical device and to avoid the need for time-consuming and costly design overhauls of the products themselves.
According to Team, patients don’t get to grips with new drugs and delivery devices in an environment devoid of emotion and confusion. Their minds are clouded with feelings of anxiety or they are trying to take a lot of new information in.
Team also believes the principles can be applied to far more than patient-facing devices, reaching in to the clinician-facing world. Recent research from the USA suggests that more than one in four hospital patients suffer some form of harm as a result of mistakes in the usage of medical equipment by professionals. In other words, if you look at a surgical environment, a poka-yoke approach to packaging may prevent staff mishandling equipment whilst setting up, not only to avoid errors, but also to help maintain the sterility of devices used in surgery. With human errors continuing to account for such a high level of patient harm, even when experienced professionals are involved, the impact this could have is huge.