Soapbox

Product Myths Put Patient Safety at Risk

By Scott Hensley
March 18, 2019


• Categories: 03-Manufacturing Execution, 04-Product Design & Development, 05-Quality/Regulatory, Market Access, Soapbox

There is hope for transparency in a post-Theranos world. To restore trust as promising medical technology is developed, both up-and-coming as well as established medical technology companies must have the ability to back up lofty claims with deep-rooted science. Unfortunately, healthcare institutions and consumers continue to be misled—this time by the industry goliaths.

Walking the show floor at one of the world’s largest gatherings of medical professionals focused on innovation, I was blatantly lied to by the regional marketing manager from an infusion pump company. This individual stated, “Our pressure detection technology is extremely sensitive and can be used to detect infiltrations and extravasations unlike our competitors.” I’ve heard pump companies have implied pressure alarms/modules within the infusion pumps can detect infiltration and extravasation events from customers for several years, but this was the first time I heard the claim directly from a company representative. If they are having these discussions here, can you imagine what they are saying behind closed doors to the clinicians who depend on these device representatives to provide training on proper use of their product? Even when pushed, it took some time for them to admit they have no indications that support the statement.

Infiltrations are an IV-related complication that continue to receive attention especially since it’s an issue that clinicians encounter on a regular basis. Infusion pump and several other companies have tried various methods to solve this problem for many years. To date, there is no regulatory body in the world that has given any pump currently on the market clearance to include infiltration or extravasation detection as part of their indications. Yet companies continue to try and connect early identification of occlusions to reducing sub-therapeutic medication and thus reduce the risk of IV complications such as extravasation or infiltration. Is this a far-fetched reach with good intention or a tactic to perpetuate an infusion pump myth that allows for an inappropriate reliance on a tool that can have severe implications for patient safety?

Why is this (pun intended) alarming? According to a medical device hazard report published by the independent patient-safety organization, ECRI Institute, “We have received several reports from clinical engineering personnel that infusion pumps were considered faulty by clinicians because infiltration occurred and the occlusion alarm was not triggered.¹ Clinician expectation and a common misconception is that as an infiltration progresses, sufficient extravascular pressure will develop to trigger an occlusion alarm.” In addition, there are thousands of complaints in the FDA MAUDE (Manufacturer and User Facility Device Experience) database—including those related to infusion pumps not indicating an infiltration.

In fact, infusion pumps should not be relied upon in any clinical setting to detect infiltrations on any patient population. Any claims made otherwise are false and misleading to the hospital or clinician, and ultimately a risk to the patient. Because this has been an ongoing tactic by infusion pump companies, there is a significant mindset in the marketplace that the pump pressure alarm and nurse assessment is enough to detect infiltrations and extravasations.

We’ve had conversations with all of the major infusion pump companies across the world who have stated there is a huge clinical need for technology that can detect these events. (Full disclosure: The company that I work for provides the only device to receive clearance, globally, to offer early detection of infiltrations/extravasations.) We also have publicly announced relationships with two of the top infusion pump players and through our partnerships, they’ve reinforced the market demand for infiltration detection technology that has a high degree of sensitivity and specificity.

In addition, many leading associations have made outward statements warning against the use of infusion pumps to detect these events, including:

• Infusion Nurse Society: “Do not rely on electronic infusion device (EID) alarms to detect intravenous IV infiltration or extravasation, as these alarms are not intended to detect disruption of the fluid flow pathway.”²
• Pennsylvania Patient Safety Advisory: “Occlusion alarms on infusion pumps do not detect or prevent infiltration or extravasation. Infusion pumps are equipped with downstream occlusion (pressure) sensor circuitry used to detect elevated pressures in the IV administration set between the infusion pump mechanism and the patient. Relying on an infusion pump’s downstream occlusion alarm to identify an infiltration condition is not good practice.”³

Conflicting information from the industry provided to clinicians have further reinforced some of the misconceptions about this issue and can severely affect patient safety and outcomes. Limited studies on the issue provide leeway for falsifying claims, and addressing this lie is long overdue.

As an industry, we must be transparent to hospitals, so they are best equipped to use technology to impact and provide better clinical outcomes for the patient.

References

1. ECRI Exclusive Hazard Report: High Priority- H0265: Infusion Pump Occlusion Alarms Cannot Detect Infiltrations” Published: 2015 Jul;8.
2.  Infusion Nurses Society (January/February 2016). Infusion Therapy Standards of Practice. 39 (1S), S49. Retrieved from http://source.yiboshi.com/20170417/1492425631944540325.pdf.
3.  ”IV Infiltration: Be Alarmed When Your Infusion Pump Isn’t” PA PSRS Patient Saf. Advis. 2007 Sep;4(3):97-9.