The use of smart infusion pumps has become ubiquitous in many U.S. and international clinical settings due to the tremendous patient benefits these devices offer. However, these benefits do not eliminate use-related risks. Improper use of and/or malfunctioning smart infusion pumps can cause serious adverse health effects and even death.
The dichotomy is clear, but what is not clear is why smart infusion pumps have become so dangerous. Unfortunately, many stakeholders, including FDA, have been quick to point out inadequacies in infusion pump designs as key obstacles to patient safety. While design flaws have been identified, the real problem is more complex and involves multiple systems and stakeholders. Design alone cannot solve the entire problem.
The opportunity for errors occurs across multiple steps of the infusion pump process, with many occurring both before and after actual use of the smart infusion pump.
One of the biggest challenges to understanding the root cause of problems associated with infusion pump use is the lack of infusion pump standards. There is little agreement on what should be standardized, let alone what the standards should be. Many stakeholders believe consensus on infusion pump standards would lead to immediate, short-term benefits and safer infusion pump use. As a starting point, standards should include drug name, recommended minimum and maximum dosages, upper and lower administration rate limits, standardized concentrations, and dosing units. The standards should also address special cases, including certain patient populations and clinical conditions, medication administration techniques (i.e., IV push), and monitoring requirements.
Despite the relative acceptance of these measures, there are still many challenges to overcome. For example, the culture of fear propagated by liability concerns has made it increasingly less likely that practitioners will share their drug libraries. Nothing short of a cultural shift will help to overcome the secretive nature of this information, which would allow drug libraries to be more accurate and comprehensive.
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Senior Industrial Designer