Contextual Inquiry of Central Line Placements: Opportunities for Improved Device Design Based on Placement Practices (Preprint)

BACKGROUND Central venous catheters (CVC) are indispensable to contemporary critical care, perioperative management, and emergency resuscitation, yet their insertion remains fraught with preventable harm and inefficiency. Large contemporary syntheses estimate that approximately thirty in every thousand patients with a central venous catheter in place for three days will experience at least one serious complication, be it arterial cannulation, pneumothorax, central line-associated bloodstream infection, or deep venous thrombosis, while catheter malfunction alone occurs at roughly six events per thousand catheter-days [1]. OBJECTIVE While epidemiologic surveillance and randomized trials may have helped to refine insertion checklists and sterility protocols, far less attention has been paid to the concrete interaction between users, tools, and environments that shapes everyday practice. Human factors frameworks may be an impetus to study actual work as done rather than work as imagined. The US Food and Drug Administration’s (FDA) 2016 guidance on applying human factors in medical devices and the Association for the Advancement of Medical Instrumentation (AAMI) TIR51 on contextual inquiry may provide the grounding for early, field-based observation and interview techniques to surface latent use errors, cognitive burdens, and design mismatches before devices reach market or are iterated for safety. METHODS This qualitative study is a contextual inquiry of CVC placement, which includes observation alongside a brief face-to-face interview with physicians. It is aimed at providing a depth of understanding using evidence to demonstrate causality. A detailed description of the process, tools, and people involved is provided below. The technique, contextual inquiry, is promoted by FDA Human Factors Guidance (2016) to determine user needs at the start of any design process. The data collected in this study includes both observational and interview data with three main areas of focus: the user, environment, and tasks as part of the steps and workflow. This study was conducted at three different hospitals, within the Emergency Department (ED), the Intensive Care Unit (ICU), and operative rooms (OR). Where possible and with additional consent, sessions were recorded in video or still photography, or at times both. The study included a total of 19 observations and 24 interviews. RESULTS Viewed through the intersecting lenses of safety, efficacy, and usability for patients, providers, and products, our findings provide the basis for an argument that a device ecosystem should simultaneously consider the following precepts: (1) shields patients from infection, vessel injury, and the cascade of “extra” procedures (intubation, deep sedation) by shortening setup and puncture time and by making correct J‑wire orientation and tip control essentially foolproof; protects clinicians from sharps and blood under tension, awkward postures, and protocol drift by embedding ergonomic grips, one‑handed aspiration aids, and closed, labeled receptacles that keep contaminated instruments off ad hoc trays; and (3) streamlines the product itself with sequential, memory‑light assembly, color/texture coding, and built‑in safeguards (e.g., wire funnels, depth markings visible through bloodied gloves, lockable sharps wells) that are robust and attuned for real‑world conditions like low light, urgent timelines, moving patients, and gloved, fatigued hands. In effect, an intuitive kit that aligns with predictable human behavior and eliminates unnecessary multistep detours can reduce novice failure rates, cognitive load, and practice inconsistency just as it could serve to curb non‑recyclable waste from “backup” kits opened for a single missing item. By reframing CVC systems as socio‑technical solutions rather than static assortments of parts, the same design moves that minimize improvisation and coordination errors for providers also compress dwell time and manipulation events for patients, thereby advancing the core triad of safety, procedural efficacy, and everyday usability CONCLUSIONS By looking closely at how clinicians actually place central lines, this study exposes modifiable design faults that perpetuate risk despite decades of procedural standardization. Contextual inquiry provides the evidentiary bridge between clinical imperatives to reduce complications and the practical realities of device use.