James Rudolph: Understanding the Infusion Pump Crisis

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.

For more on the challenges to the safe and effective use of infusion pumps, click on this link.

James Rudolph

Senior Industrial Designer

Farm Design, Inc.


One thought on “James Rudolph: Understanding the Infusion Pump Crisis

  1. James – you hit the nail on the head by referring to use issues and multiple systems been a cause – On the use issue , hospital based engineering departments and risk management have systematically removed all the normal user functions which ensure ongoing competence of the nursing and clinical staff when it comes to bedside technology . They are no longer allowed or encouraged to do point-of-care user troubleshooting, an essential task to ensure user skills and confidence is maintained over the 5 to 10 yrs they will use the device . This is reflected in the NO FAULT FOUND ( NFF ) outcome of devices sent for repairs – Biomeds very seldom get more than one item from a department when for e.g. a pump is reported faulty and the outcome is NFF . If it was a training issue one would expect 2 , 3 or more pumps at one time as the user struggled to get it to work , all NFF – but what happens is staff try setup a pump for e.g , if the encounter a problem they toss it aside and grab another one – in most cases they are able to get it to work 2nd time around – I put this down to lack of attention to detail these complex ( not complicated ) require and do not get when in use . Dealing with these user issues is a skill which should be applied to all devices staff use yet over the last few years their roll in this has been greatly reduced.

    Biomed and Safety Departments should also be measuring NFF – these are metrics which objectively allow Clinical staff to be informed of areas where their performance needs to be improved , before anyone gets hurt – there is no need to react to every NFF – it’s the trend by Make and Department which should be followed as that is the indicator which informs us of when and how to intervene with support for these users ( experience qualified professionals generally don’t ask for help – especially when they have been using something for a few years )

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