Companies Work to Help Combat IV Infiltrations

By John Palmer

Intravenous (IV) therapy is so commonplace that most of us have had it at some point in our lives. Whether it’s to administer a simple blood test, hydrating fluids, or lifesaving drugs, a needle to the vein is as typical in healthcare as sunscreen at the beach.

A peripheral venous catheter (PVC), also known as a peripheral venous line or peripheral venous access catheter, is a small, flexible tube placed into a peripheral vein (in the arms, hands, legs, or feet). Upon insertion, the PVC can be used to draw blood or for IV therapy such as medication fluids.

Peripheral veins are the most common IV therapy line access method in both hospitals and paramedic services, as they’re generally the least invasive way to get fluids in and out of the body during therapy. By some accounts, more than 25 million patients in the United States get a PVC each year.

What isn’t given much thought, however, is the harm that an IV can cause to a hospitalized patient. A primary complication is called “IV infiltration” in the healthcare industry, and it happens when fluid or medication intended for the vein leaks into the surrounding tissue—potentially with life-threatening consequences.

The Infusion Nurses Society (INS), which establishes the standards of care for IV therapy, has published statistics claiming that PVC insertion is associated with a variety of complications and an overall failure rate of 35%–50% in most healthcare settings. Of those failures, the organization claims that 20%–23% are due to infiltration events.

IV infiltration most often occurs when a catheter punctures the vein wall during insertion or backs out of the vein due to patient movement. Poor vein health, restrictions to normal venous blood flow, and increased vein porosity can all also lead to infiltration. It’s not about whether an infiltration will occur, but when it does, how severe will it be if it goes undetected for too long?

This is not uncommon, and in fact some 34 million patients in the U.S. suffer from an infiltration every year. There’s no nationally defined reporting mechanism for the condition, and CMS and other accreditation agencies don’t consider it a healthcare-acquired condition, so there tends to be little awareness of the harm that can be done.

Education programs within the hospital environment seek to prevent infiltrations, or at least detect them through periodic visual and tactual examinations. Still, they’re not easy to catch. In critical care settings, patients are more vulnerable to infiltration risks due to the severity of their injuries or illnesses, which are often coupled with a hindered ability to communicate with their caregivers and medical team. Other areas where IV complications are more likely to progress without detection include the operating room, where visibility of the IV site may be limited during a procedure, and on medical-surgical floors, where the staffing level can be as low as one nurse per five patients and patient assessment may not be as frequent.

In recent years, several companies have developed technologies with the ability to address the infiltration issue quickly before they can cause pain to the patient or irreversible life-threatening conditions.

ivWatch

“With more than a billion IV catheters sold globally every year, the drug delivery errors caused by IV infiltration and extravasation urgently needs to be addressed,” says Gary Warren, president and CEO of ivWatch, a Virginia-based medical device and biosensor technology company specializing in continuous monitoring solutions for the early detection of IV infiltrations and extravasations.

The company provides the first and only FDA-cleared medical device and biosensor technology that continuously monitors the IV site for infiltrations. Specifically, the ivWatch^® Model 400 is indicated to detect peripheral IV infiltrations with a low volume of fluid and high sensitivity.

According to the company, the device can detect miniscule amounts of fluid leaking into tissues that human intervention cannot. In fact, the average volume for detection during clinical studies was 3 milliliters, and the device has detected infiltrate volumes as low as 0.22 milliliters.

The device, which has been likened to pulse oximetry for its early detection of blood oxygen saturation changes, uses an optical sensor to illuminate tissue near the IV insertion site to detect IV leakage. If changes in the optical properties of the tissue near the insertion site are consistent with an infiltration, the ivWatch monitor will provide audible and visual notifications, alerting clinicians so they can better manage IV therapy and minimize patient risk.

The company touts its ivWatch Model 400 as a clinician partner helping to deliver improved patient care with constant monitoring of the IV site. Implementing continuous monitoring can improve clinician and financial performance through the reduction of extra medication, moderate and severe events, additional procedures, and length of stay as a result of an infiltration.

The company also notes infusion pumps should not be relied upon in any clinical setting to detect infiltrations on any patient population, and that common misconception is ultimately a risk to the patient.

I.V. House

This St. Louis–based company was established in 1991 and claims to produce innovative IV therapy joint stabilization and IV insertion site protection products that improve patient safety and increase nurse efficiency in leading hospitals worldwide. I.V. House products are used in hospitals around the world, including in the United States, Canada, Australia, Italy, the Philippines, and Saudi Arabia.

The company’s ergonomic products allow nurses to quickly and thoroughly inspect IV catheters for signs of complication such as changes in color, swelling, and temperature. By stabilizing the affected joint and protecting the IV insertion site, I.V. House claims its products reduce the need for painful and time-consuming IV restarts caused by accidental dislodgment, infiltration, or extravasation.

I.V. House’s UltraDome^® was created by pediatric nurse Lisa Vallino, BSN, RN, and her mother Betty Rozier, after watching nurses construct makeshift IV covers from specimen cups, gauze, and tape. The clear, ventilated, plastic dome of the UltraDome shields, secures, and protects the IV catheter hub and loop of tubing while making it easier for nurses to visualize and inspect the IV insertion site without disturbing the patient. A padded flange ensures the device is comfortable against the patient’s skin. I.V. House also offers an UltraDome Plus that features extra padding on its outer rim, increasing comfort for more active patients while protecting against dislodgment from an errant bump or snag.

Since creating the UltraDome, I.V. House has expanded its product portfolio to include the TLC^® Splint, available for the elbow, wrist, and foot, which stabilizes the joint for ideal IV therapy infusion, and the tape-free UltraDressing^® for protection of the IV insertion site. Results of a recent trial at St. Louis Children’s Hospital showed no IV infiltrates in the patients wearing the company’s TLC Splint compared to 12 IV infiltrates in patients wearing traditional arm boards.

Centurion

Michigan-based Centurion produces IV securement kits designed for stabilization. Featuring Centurion dressings and securement products that provide proven site and catheter protection for up to 96 hours, kits are customized to the specific needs of clinicians and hospitals.

Centurion IV securement kits help reduce IV restarts and lower the risk of complications, according to the company. They also comply with both INS standards of practice and CDC recommendations, Centurion states.

The company claims that using Centurion custom kits helps contain costs and promote standardized procedures, encourages consistent product usage and adherence to hospital protocol, and eliminates the need to search for missing procedural components or the waste of extra, unused items.

Securement kits designed with J-loop technology and foam cushioning are meant to prevent catheter movement and dislodgement, and help direct tension away from the insertion site, with access close to the site. There are both adult and pediatric kits available, and kits can be customized to include the valve of your choice, along with many other options including T and Y connector sets.

John Palmer is a freelance writer who has covered healthcare safety for numerous publications. Palmer can be reached at johnpalmer@palmereditorial.com.