Anesthesia Incident Reporting System (AIRS) Case 2025-01: Leaky Pipes

An 8-year-old patient with a complex medical history presented for posterior multilevel spinal fusion. The patient had a history of difficult I.V. access and complications from central venous access. After numerous attempts with ultrasound guidance, an I.V. was successfully inserted in the right saphenous vein and maintained open throughout the case with an infusion at 50 ml/hr. A second I.V. was obtained in the left arm. The case proceeded uneventfully. When the drapes were removed, the team discovered severe limb-threatening compartment syndrome of the right leg, and fasciotomies were performed. An infection set in, and despite appropriate antibiotics and four subsequent I&Ds, the distal limb was lost.

“Even with strong scientific evidence, adoption of safety or monitoring technologies is typically slow unless the device provides a compelling, easily visible benefit to front-line clinicians. A good example was the introduction of pulse oximetry.”

We addressed safety concerns associated with perioperative I.V. infiltration in 2022, but these events continue to occur. Here, we also review the history of infiltration detection technology and discuss expectations for the adoption of new safety technology.

Delayed detection of I.V. infiltration or extravasation. I.V. infiltration is more frequent (and potentially more serious) in neonates and children. Higher-risk situations include peripheral extremity catheters (especially from the ward/ED), positional I.V.s, and those in which blood cannot be withdrawn. It is good practice to check patency and security in the OR prior to induction and at routine intervals. For suspected tenuous catheters, especially if they cannot be monitored, higher infusion pressures should be avoided if possible.

Delayed infiltration detection can have significant safety consequences, ranging from temporary pain and swelling to compartment syndrome and loss of limb. An additional potential adverse effect of infiltration in TIVA is inadequate anesthesia or intraoperative awareness. When TIVA is being used through an I.V. that cannot be checked regularly, the use of depth of anesthesia (i.e., EEG) monitoring is recommended.

I.V. detection technology. For 30 years, a holy grail for intravenous therapy has been reliable infiltration detection that does not depend on human vigilance. While downstream occlusion detection is common, automated detection of infiltration has proven elusive. Many technologies have been explored. The earliest technologies used measurement of changes in flow rate or downstream pressure; both have proved unreliable, likely due to tremendous context dependency. With technology from the mid-1990s, Bob Butterfield and colleagues introduced flow resistance infiltration monitoring in the Alaris “Signature Edition” pump (J Clin Monit 1996;12:325-30). While results were promising, including in a 2020 study in three pediatric ICUs, the company chose not to obtain FDA clearance (i.e., to be able to make commercial claims as to efficacy and safety).

Other reported technologies include monitoring changes in skin temperature, ultrasound evidence of catheter movement, and bioimpedance tissue measurements (J Infus Nurs 2023;46:97-06; ACS Sens 2023;8:1017-32). More active detection methods have included the use of radio frequency waves to produce a response to differing tissue fluid properties, and the use of a “wobbler” to introduce a signal in the antecubital region, which is then sensed within the I.V. tubing (Personal communication October 2O24). While some of these proved to be quite sensitive to infiltration, they tended to be less specific and were cumbersome.

Any detection technology with too many false alarms (i.e., excessive false positive rate) will be clinically unacceptable. An impediment to infiltration detection technology adoption has been the need for a bulky sensor on or downstream from the I.V. site, especially in neonates and infants.

The only commercially available I.V. infiltration detection device, the ivWatch™, uses reflected light at visible and near-infrared wavelengths with a proprietary sensor placed adjacent to the catheter tip. ivWatch received FDA clearance in 2015-16 but has not gained widespread adoption for this ubiquitous problem.

The ivWatch website reports numerous validation studies, but only a handful are in the peer-reviewed literature. Published reports of ivWatch use are mostly smaller studies, most frequently in neonates (J Vasc Access July 2023; J Vasc Access July 2023; J Vasc Access 2016;21:255; J Vasc Access 2019;24:44-7; J Vasc Access 2019;5:38-41; Br J Nurs 2024;33:S18-S26). They suggest excellent sensitivity to detect early infiltration with modest specificity. The gold standard for efficacy evidence, a randomized controlled trial (RCT), has not been published, although the protocol for an open-label RCT has appeared (BMJ Open 2022;12:e047765).

What conditions are necessary for widespread clinical adoption of new safety technology? FDA clearance is necessary but typically insufficient for clinicians and institutions to decide whether a product should be purchased and under what circumstances it should be used. The FDA medical device clearance process focuses on product efficacy and safety. Most medical devices, including ivWatch, are approved through the 510K pathway, which requires the manufacturer to demonstrate “substantial equivalence” to a predicate (older similar) device. Clinical trials are neither required nor typically performed for 510K clearance. While moderate-risk devices like ivWatch must undergo human factors use testing, neither the efficiency nor acceptance of use in actual practice is considered.

Furthermore, the FDA device clearance process does not consider cost nor benefit in context. When a newly cleared device is more expensive than existing tools or processes, purchase typically requires real-world measurable benefit for purchasers. This level of evidence is more challenging for safety devices because they are intended to prevent infrequent events that are costly only when they occur. Devices that make clinicians’ tasks easier, quicker, or less frustrating are less likely to be viewed as “real” cost savings unless the facility can reduce staffing or other easily measurable costs. Of note, the ivWatch is currently approved for adjuvant use in combination with standard-of-care clinician vigilance.

Even with strong scientific evidence, adoption of safety or monitoring technologies is typically slow unless the device provides a compelling, easily visible benefit to front-line clinicians. A good example was the introduction of pulse oximetry. There were already FDA-approved noninvasive oxygen sensors (e.g., transcutaneous), but they were not widely used due to limitations and constraints. When pulse oximetry devices became available, they were rapidly and widely adopted in anesthesiology, even before scientific evidence for a favorable impact on patient outcomes.

In summary, intraoperative I.V. infiltration remains a significant safety issue. We encourage clinicians to work with companies to enhance the “business case” for new technology, including the performance of rigorous randomized controlled efficacy trials as well as thorough cost-benefit evaluations. We also encourage entrepreneurs to continue to innovate to develop low-cost infiltration detection technologies with a low patient footprint.