By Elizabeth Whitman | December 10, 2016
Patients at Sacramento, Calif.-based Sutter Health’s hospitals and clinics across Northern California could soon have their blood drawn a little differently. Instead of sticking a patient with a needle, nurses will tap into existing peripheral IV lines using a device called a PIVO.
Sutter has begun using the device on one floor of its Alta Bates Summit Medical Center in Berkeley, Calif. The pace and extent of its use on other floors and in other hospitals depends on the results of Sutter’s evaluation of the device.
“I’m optimistic,” said Eric Stone, co-founder and CEO of Velano Vascular, the San Francisco-based medical device company that developed the PIVO. A handful of health systems besides Sutter are using the PIVO, including Salt Lake City-based Intermountain Healthcare, or planning to use it. Brigham and Women’s Hospital Boston is studying the device.
The PIVO, a single-use, Class II device cleared by the FDA, draws blood through a peripheral IV line already inserted into the patient. Once attached to the IV catheter, a plunger is drawn back, pulling blood into a vacuum tube or syringe.Blood draws are one of the most common and frequent procedures in hospitals. Patients have blood drawn wherever they get care: hospitals, doctor’s offices, skilled-nursing facilities and elsewhere. But the conventional method is imperfect.
According to Velano, the current method of drawing blood leads to 200 “needle-related injuries” daily among healthcare providers. Among adult patients, 28% have to be stuck at least twice to draw blood successfully; among children, it’s 44%.
Nurses also contend with difficult intravenous access in patients, depending on their medical conditions. Obesity, chronic illnesses, chemotherapy and other issues, such as intravenous drug use, can render it difficult for providers to access a patient’s veins. That translates to repeated attempts to insert needles into veins and treatment delays that can hurt patient satisfaction rates and increase the costs of care.
Patients typically have their blood drawn at least once per day, said Anna Kiger, chief nursing officer for Sutter. During extended hospitals stays, these frequent needlesticks add up, and not all patients have veins that tolerate repeated puncturing. Using the PIVO, however, eliminates bruising and other effects of repeated blood draws with a needle. The process also doesn’t wake the patient.
Training nurses to use the PIVO took about 20 minutes, Kiger added, and those who have used the device for several days said they would rather not return to using needles. They’re not the only ones.
“It’s a definite wow factor for patients,” Kiger said. A few groups in particular stand to gain from PIVO use, including geriatric, oncology and major surgery patients. And it would be a welcome change for pediatric patients because it alleviates needle anxiety, she said.
From Stone’s perspective, if a nurse has trouble finding a patient’s vein in the first place, why subject them to being jabbed a second, third or fourth time if a peripheral IV is already embedded in the patient?
The idea violates every hospital policy and convention, Stone admitted.
In its guidelines for best practices in drawing blood, for instance, the World Health Organization warns against drawing blood through IV lines, at least in hospitalized patients, saying that drawing blood in this way “may give false results.”
But with the soft polymers that are used in catheters today, drawing blood through an IV line doesn’t actually result in hemolysis, the damage and subsequent breakdown of red blood cells, Stone said, citing studies and analyses from hospitals that have used the PIVO.
Sutter’s labs monitor the quality of blood drawn through a needle and via the PIVO, and they have not detected a difference. Blood drawn with the PIVO has not been hemolyzed or clotted. Kiger also said she did not have concerns about safety, including the risk of infection.
The PIVO’s first FDA clearance came in January 2015. The FDA also cleared a tweaked version of the system in January 2016.
But even as more hospitals adopt the device, published clinical data are limited. There are no data, for instance, comparing rates of bloodstream infections from the PIVO with that of the standard needle draw. “To date, we have not seen any bloodstream infections that have been directed toward our technology,” Stone said.
Stone also said more research is underway. In a clinical trial sponsored by Velano, Brigham and Women’s Hospital is evaluating the PIVO’s ability to produce quality blood samples. The prospective, randomized study involves an estimated 150 patients and will in part analyze samples for hemolysis.