Infusion systems have undergone significant technological developments over the past decade. However they have struggled to deal with air-in-line issues, indicative in growing “Alarm Fatigue”(1)(3), over 70 FDA recalls of infusion pumps (2007-2017) due to air-in-line issues (2) and a rising number of deaths and injuries due to air-in-line issues as reported to the FDA in relation to infusion pump devices (6).
Infusion systems and pumps have become increasingly complex due to significant technological developments over the past 20 years. Gravity fed infusion pumps have progressed to become electronic infusion pumps and further advanced to include tubing sets, electronic “eye” detection to control flow rate, silence/restart buttons, and in some infusion pump systems, the addition of optical air detection. The advancement of air detection sensors were created to improve patient safety by alarming clinicians of air in the infusion pump, so that clinicians may be alerted to remove the air before reaching the patient. However these air-in-line alarms often do not work and have led to the development of “Alarm Fatigue,”(1) as well as over 70 FDA recalls due to air-in-line issues over the past decade, including the 2017 Carefusion/Alaris recall of over 300,000 pumps due to faulty air detection sensor.(2)
Frequency of air-in-line alarms creates “Alarm Fatigue” whereby a clinician is exhausted of hearing the air in line alarms. This has led to an increase in interventions – to silence the alarm (by clinicians, patients, or visitors), restart the infusion pump, change air bubble detection size, and deactivate accumulated air sensors, which places patient at risk of dangerous air infusion.(1)(3) Intravenous air infusion and air embolism can cause significant patient morbidity and mortality, from neurological complications to stroke and death.(4)
Issues with infusion pumps are well documented. The FDA undertook an Infusion Pump Initiative in 2010 aimed at establishing additional regulations, improve the devices and minimize risk associated with infusion pumps.(5) Yet over the past five years, reports to the FDA (MAUDE database) of deaths, injuries and malfunctions associated with infusion pumps have risen exponentially.(6)
The current standard of care, when an alarm sounds, is to perform visual inspection and manual intervention. This approach, has proven ineffective alongside the advancements in infusion therapy.
ClearLine IV is the only FDA-cleared device that automatically detects and actively removes air from IV lines. ClearLine IV reduces the risk of patient harm by air infusion, faulty infusion pump air-in-line sensors, and alarm fatigue issues, making it the next step in the continuous improvement of IV infusion systems.
- Vanderveen, T. Fifty Year History of Air in IV Therapy – Detection, Sources, Removal, Clinicians’ Attitudes. 2018.
- FDA Recalls: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm
- Major, K. Sounds of Silence: Reducing Nuisance Alarms in IV Pumps. Infusion Nurses Society. 2015. Webinar available at: http://www.perspectivesinnursing.org/
- Muth CM, Shank ES. Gas embolism. N Engl J Med. 2000 Feb 17;342(7):476-82. Review
- FDA MAUDE Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm