The Problem

Overview

Today’s infusion process is variable and inefficient, with significant opportunity to improve the status quo.

Potential impact on patient safety

  • Insufficient mechanisms to ensure drug library compliance
  • Non-intuitive and difficult to use pumps

Limited availability of timely, actionable data

  • Lack of timely infusion data
  • Incomplete integration into the EMR and information systems

Disruptive to clinical workflows

  • Complex drug library development and challenging maintenance
  • Lots of nuisance alarms

Adverse Drug Events

  • IV infusion is associated with 54% of all adverse drug events, 56% of medication errors, and 61% of serious and life-threatening errors.1 Averting highest-risk errors is first priority.2
  • ECRI Institute publishes an annual report of Top Technology Hazards for healthcare organizations to consider in their safety efforts. The 2014 report ranks Infusion Pump Medication Errors number 2 out of the Top 10 Technology Hazards, citing a number of pump-related medication errors that may not be addressed with the use of smart pump drug libraries alone.3

In the setting of critical care, where patients receive numerous IV medications each day, anything that can be done to decrease the frequency of IV medication administration errors is likely to have a substantial positive impact on overall patient outcomes and cost of care.4

Giuliano K.
IV Smart Pumps: The Impact of a Simplified User Interface on Clinical Use
AAMI Horizons, Fall 2015.

Use Errors & Distractions

  • Research suggests that the majority of adverse drug events are related to incorrect or incomplete programming.5
  • A 2010 study published in the Archives of Internal Medicine was the first to show a clear association between nurse interruptions and medication errors. Each interruption, the study found, was associated with a 12.7 percent increase in clinical errors. And, according to the Institute for Safe Medication Practices, nurses administering medications are distracted and interrupted as often as once every two minutes.6-8

Clinicians report that pump programming is frequently rushed and that they often feel forced to make hasty decisions about overriding alerts because of time constraints and competing work demands.5,9

McAlearney AS, Chisolm DJ, Schweikhart S, et al
The story behind the story: physician skepticism about relying on
clinical information technologies to reduce medical errors
Int J Med Inform

 

Cost to Healthcare System

It is estimated that infusion-related adverse drug events add more than $2B to annual healthcare costs in the US.10

Institute of Medicine. Preventing Medication Errors: Quality Chasm Series
Washington DC: National Academies Press

  • For a 250 bed hospital that operates within an 8 hospital health system, a ~$1M revenue opportunity was calculated for properly documenting actual start/stop times for infusions administered in outpatient areas.11
  • A “typical” ED loses as much as $30 – $40k/month in lost infusion and hydration revenues due to improper and insufficienct documentation of procedures.12
  • It is estimated that 30% of nurses on average report spending at least one hour per shift searching for equipment.13

Nuisance Alarms

  • The Joint Commission issued a National Patient Safety Goal in 2014 on clinical alarm safety for hospitals and critical access hospitals. As of January 1, 2016, hospitals are required to establish policies and procedures for managing alarms, including monitoring and responding to alarm signals.14
  • Infusion pumps as a group make up the largest number of mobile medical devices in the hospital and contribute much of the noise.15

Failure to respond to actionable clinical alarm conditions in a timely manner can result in serious patient injury or death.16

Top 10 Health Technology Hazards for 2016
ECRI Institute

Security Vulnerabilities

  • ECRI listed Cybersecurity for Medical Devices & Systems in its Top 10 Health Technology Hazards for 2015.17
  • In October of 2014, the FDA issued guidance for medical device manufacturers entitled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. In this document the FDA states, “Manufacturers should address cybersecurity during the design and development of the medical device, as this can result in more robust and efficient mitigation of patient risk”.18

Medical Devices have become the key pivot point for attackers within healthcare networks. They are visible points of vulnerability in the healthcare enterprise and the hardest area to remediate even when attacker compromise is identified. These persistent cyber-attacks threaten overall hospital operations and the security of patient data.19

Anatomy of an Attack
MEDJACK (Medical Device Hijack)

 

Innovation is Needed

  • Infusion devices are the subject of more adverse incident reports to the FDA than any other medical technology. Between 2005 and 2009, the FDA received more than 56,000 reports of adverse events associated with the use of infusion pumps.20
  • The FDA issued new guidance for infusion pumps in December 2014, “intended to improve the quality of infusion pumps in order to reduce the number of recalls and adverse events associated with their use.”21

In an era when people in the United States upgrade their smartphones every one to two years, it has been almost 20 years since most IV smart pump device manufacturers have substantially upgraded their basic device designs.4

Giuliano K.
IV Smart Pumps: The Impact of a Simplified User Interface on Clinical Use
AAMI Horizons, Fall 2015

Learn more about transforming

Infusion Management