A Pictorial Guide for Enabling Placement of Intra-Osseous Infusion Tools1 (2016)

The World Health Organization (WHO) declared the Ebola outbreak in West Africa to be the “most severe, acute health emergency seen in modern times” [1]. Individuals infected with Ebola virus experience severe dehydration which can ultimately lead to death. A key treatment strategy for Ebola is rehydration of the patient. However, limitations associated with vascular access in dehydrated patients, combined with concerns about the safety of healthcare workers in Ebola treatment units, have made conventional IVs impractical. Intra-osseous (IO) infusion, already a common emergency procedure in the U.S., enables delivery of fluids at equal or greater rates than two large-bore IV lines [2]. Placement of an IO needle in the proximal tibia requires knowledge of lower extremity anatomy and palpation of the tibial tubercle. Thus, current placement techniques require training, which may not be available to community responders, as well as direct patient contact, which places healthcare workers at risk of infection.An alignment guide that works with existing IO placement drills has been developed for use by healthcare workers and lay-persons alike (Fig. 1). The design is human centered, and has been built around sound, diverse anthropometric data. This device has the potential to provide lifesaving capability to anyone in the world in need of rapid rehydration. However, before it can be broadly deployed, an instructional component is needed to ensure fast learning and reliable results on first use.The aim of this work was to develop an instructional pamphlet to complement the existing alignment tool. The pamphlet was designed in consultation with anthropologists and graphic design experts to ensure clear communication of the instructions for use independent of the end-user's literacy, languages spoken, and cultural background.Based on the need and in consultation with anthropologists and healthcare workers with experience in emergency medicine and in global healthcare, a set of specifications were developed:Upon reviewing these specifications, the team identified a model for the instructions: the airline safety manual. While these safety cards do typically contain some words, they are designed such that the pictures can stand alone to communicate procedures to passengers of all backgrounds. The team reached out to several firms with experience in designing these safety cards, and ultimately partnered with a firm with experience both in airline safety cards and in instructional manuals for medical devices.The design of the information card was an iterative approach, incorporating a 24 hrs “Design, Test, Criticize, Iterate” cycle, guided by the design criteria. Under an IRB-approved protocol, each day up to five participants with no prior knowledge of the study were invited to use the alignment guide and an existing IO placement system to place an IO line on a mannequin. Participants were volunteers with no formal medical training, and nearly half of the participants had never used a power drill.Participants were presented with a kit containing the alignment tool, IO placement system, and pictorial instructions, and were instructed which side of the patient to place the line on (left or right). No other information was provided. Participants were observed and recorded as they attempted to place the IO line, and post-task interviews were also performed to identify particular challenges.Based on the day's testing, a new version of the instructions was generated each evening to address all concerns identified during observation and in post-task interviews. This process was repeated until no new edits were needed for three consecutive days.The initial draft of the instruction manual consisted of 11 steps divided into nine panels. An example of one panel from the initial guide is illustrated in Fig. 2.The feedback from each day of testing was essential to creating the final version of the manual. Some examples of changes made to the guide based on specific feedback from testing are: (1) images added to clarify that the placement device is a drill, not a spring-loaded mechanism like some drug delivery devices; (2) arrows to clarify when pressure should be applied to the guide or placement device; (3) an inventory of components at the top of the sheet; (4) some steps were divided out to add clarity, adding an additional line of panels; (5) insets were added to encourage verifying guide placement along the way; and (6) a warning at the top encouraging users to review the instructions before beginning the process.In total, nine versions of the manual were produced over a 2-week period.A representative panel from the final version of the manual is shown in Fig. 3, illustrating the same step of the process as in Fig. 2 from the original version. The complete instruction manual is illustrated in Fig. 4.An ongoing usability study was conducted with the final guide design and the final pictorial guide. Participants ranging from trained doctors (n = 5), nurses (n = 15) and EMTs (n = 20) to lay-persons with no medical knowledge (n = 15) and with no medical or technical knowledge (n = 15) were asked to place an IO needle into the proximal tibia of a mannequin using only the provided IO drill, alignment guide, and pictorial manual. Success was defined as a needle located within the target zone defined by anthropometric data and with intracancellous access. Every individual successfully placed the IO needle into the cancellous bone of the proximal tibia.In 2 weeks, a pictorial manual to aid in the use of an alignment guide for placement of an IO infusion device has been developed and tested with positive results. The design is based on an extensive consultation with anthropologists and design experts. This device has the potential to provide lifesaving capability to anyone in the world in need of rapid rehydration, even under the most challenging of environmental conditions.