CADD-Solis Ambulatory Infusion Pump

Design Research was Key to Innovation

Pain narcotics and infusion pumps are both areas where safety is paramount and devices are under significant regulatory scrutiny. Bridge designed Smiths Medical’s CADD-Solis PCA pump, the next generation of Smiths Medical’s flagship ambulatory pain management pump, to reduce medication delivery errors and advance “smart” medication delivery.  Research with stakeholders in the entire chain of pump users led to a ground-up redesign of the user interface, including a PC-based medication management system for programming the pumps.

Safety & Comfort

Bridge’s redesign of the Smiths Medical CADD-Solis pump also delivered improved ergonomics for both patients and nurses (see video below).

The Challenges of Pain Medication Delivery

Invented in the 1970s, PCA (patient controlled analgesia) pumps gradually became more sophisticated in their programming of doses and limits. Multiple routes of administration were developed (intravenous, epidural, and peripheral nerve block), and the number of available drugs and concentrations proliferated.By the early 2000’s, regulatory groups such as JCAHO (the US Hospital auditing body) and watchdog organizations such as ISMP (Institute for Safe Medical Practices) noted a significant number of safety incidents with PCA pumps. They identified a set of contributing factors, many related to the design and programming of the pumps. These included drug labeling and concentration mix-ups, pump mis-programming, incorrect route of delivery (a safe dose intravenously can be fatal epidurally), incorrect transcription of prescriptions into pharmacy computers, and calculation errors when determining the patient’s dose or rate of infusion.From these safety reviews and the information gathered from the stakeholders–including pharmacists, hospital administrators, pain doctors and nurses, and ward nurses–it was clear that to improve safety, the whole system would have to be tackled. How can the pump that is just on the delivery end achieve this? The design solution was to treat the pump and its programming as just one piece of a medication error reduction system and create a new systematic approach to PCA medication safety.

Therapy-based Programming for Safety

The pump’s user interface is designed to reduce medication errors and to greatly simplify and expedite setting up a new patient or modifying pump settings. Solis provides a framework that is customized by the hospital. Using PC software, the hospital builds intelligence into its approach to PCA medication safety by creating a customized library of therapy protocols. A therapy might be named by route of delivery, further defined by a qualifier such as patient age and condition, and finally associated with a limited set of drugs and dosing selected for the protocol. The therapy protocol library is downloaded to all the Solis pumps in the hospital.

The Solution

To set up a patient for drug delivery, the user steps through a sequence of three questions. Only a limited set of safe choices are available at each step during programming, based on the therapy protocol selected. Once a protocol is selected, the user can adjust delivery parameters only within predetermined safe limits. The approach makes the user take into account the context of care. For instance, at the bedside, the clinician can see if a patient is pediatric or adult. The pump screen changes to a color associated with the selected therapy, providing a further check on the user’s therapy choice. The brief video below steps through pump programming. A more comprehensive explanation video is here.

Watch the extended video here