I Fed The Bed Again: Connector Protectors as a Line Disconnection Solution
by Lori Irvin
Medical Devices & Digital Health
Background: Line, tube and drain disconnection is an under recognized problem in adult and pediatric patient populations. Identifying the frequency of line disconnections, and related solutions is discussed. Intravenous catheters, feeding tubes and drains are frequently used to deliver therapeutic interventions for patients in multiple care delivery settings. In a preliminary evaluation at a pediatric acute care hospital, nurse respondents reported that intentional and unintentional line disconnections occur frequently in daily practice which contributes to adverse patient outcomes. Providing tamper-resistant devices at connection points could reduce disconnections and improve patient safety and outcomes.
Objective: Preventing line, tube and drain disconnection remains an unmet need. When patients are bored, confused or left alone, they may intentionally or unintentionally disconnect their lines from life-saving devices. Feeding tubes that become disconnected can lead to loss of fluids and nutrition leading to dehydration and electrolyte imbalance. Intravenous access devices that are directly inserted into the body can cause severe adverse events when disconnection occurs. The Connector Protectors aim to provide tamper resistance with a novel closure mechanism that secures the connection points of lines, tubes and drains.
Methods/Design: In collaboration with Innovation Ventures and the Children's National Shared Nursing Leadership Resource & Innovation Council, nurses have received ongoing education on the biodesign process and developed several iterations of the devices. Nurses continue to build new concepts and test hypotheses. Tamper-resistance of the devices will be tested with children ages 3-21. Their ability to open the devices will be compared against US Code of Federal Regulations: Title 16: US-16 CFR 1700.15(b)(1).
Results/Discussion: Line disconnection remains a problem with an unmet need. We will examine the nurses' experience using the devices on patients' lines, tubes and drains in an IRB approved study to determine the feasibility and acceptability of the Connector Protectors. We will calculate the percent of subjects who were able to open the devices with a 95% confidence interval around that rate. REDCap surveys will be used to collect data. The results of this study will be disseminated as a publication discussing our findings and the importance of minimizing line disconnections to improve patient safety and outcomes. An international patent has also been filed and published.