Device interface seeks to improve safety and usability of common devices.
Medication infusion pumps have transformed health care with their ability to deliver intravenous fluids in a controlled, precise manner. Today, about 90 percent of hospitalized patients receive medications and nutrients via infusion pumps.
However, these sophisticated devices are frequently involved in patient harm. Between 2005 and 2009 there were 87 recalls of infusion pumps, according to the United States Food and Drug Administration. The complexity of the pumps led to 56,000 adverse drug events—some of them harmful or fatal—over that time period, the FDA found. These events result not only from device malfunctions but are also due to confusing user interfaces and flawed designs.
In April 2011, a multidisciplinary team from Johns Hopkins, led by the Armstrong Institute and the Applied Physics Laboratory (APL), received funding from the Agency for Healthcare Research and Quality to design and evaluate a prototype for an infusion pump that aimed to reduce these risks. The project team, including systems engineers, human factors engineers, clinicians, software developers and project analysts, completed its work in late 2014.
First Phase: Understanding User Requirements for Infusion Pumps
Investigators used a systems engineering approach that began by seeking to understand the needs of infusion pump users and of other stakeholders. About 40 participants—including nurses, physicians, engineers, manufacturers and regulators—identified five categories of needs at a summit hosted by APL in January 2012.
- Better systems integration of infusion pumps with health information technology systems in hospitals.
- Greater context “awareness” of the patient’s condition and medical treatment, such as knowing that other pumps are flowing the same drug to the patient.
- Improved programming navigation of user interfaces, allowing clinicians to more easily find their way through menus and options, particularly in stressful situations.
- Enhanced presentation and prioritization of information on interfaces, improving visibility from different angles, from a distance, and in various lighting conditions.
- Standardization of controls through more consistent terminology and location of functions across different pump designs, particularly with critical commands such as Run and Stop.
Second Phase: Prototyping an Integrated Infusion Pump
The team created a prototype for an infusion pump interface that is integrated with other hospital information technology systems to meet many of the needs identified by users. In this system, nurses do not need to manually enter information such as drug name and rate of infusion from another computer screen—steps in which programming errors can occur. They can select an auto-programming mode in which drug orders are pushed to the pump interface from the electronic Medication Administration Record. After using a barcode reader to identify herself and the patient, the nurse selects the drug order from the pump interface. Next, the nurse scans the IV bag, infusion route and pump channel, as the pump confirms that they match what was ordered. The goal is to ensure that the right patient receives the right medication at the right dose, volume, and concentration, via the right route. A manual programming mode was also developed to allow an evaluation of both modes in a simulated hospital environment.
Other features of the prototype that support patient safety and usability include:
- Continuing infusion after a bolus. After a bolus of a medication is delivered, the pump continues the infusion. Forgetting to reset pumps was a risk identified by users.
- Reliable weight-based dosing. Rather than let users to enter patient weight information based on memory, that information is pushed to the pump from the electronic medical record.
- Supporting clinician workflow. The interface design aligned with user workflow based on feedback of subject matter experts.
- Easy-to-find commands. The location of important commands was standardized within the pump.
Third Phase: Prototype Testing and Evaluation
Forty-one clinicians were introduced to the new pump user interface design and were then asked to perform several tasks in a simulated hospital environment, both in auto-programming and in manual programming mode. Overall, participants felt that auto-programming could prevent misinterpretation of physician orders and reduce programming errors, with less mental load on users. There were also fewer high-risk errors committed in auto-programming mode than manual mode.
Participants reported that display in both modes was easy to read and navigate.
Obtain Software Source Code
Members of academia, business and industry who wish to evaluate or further develop this infusion pump prototype user interface are encouraged to request the software source code via the Office of Technology Transfer of the Johns Hopkins Applied Physics Laboratory. The OTT operates as a single point-of-contact to identify available technologies and research capabilities at the Laboratory and to secure both licensing and industry Research & Development agreements. Contact the office at 443-778-3541, firstname.lastname@example.org, or http://www.jhuapl.edu.