Are the Days of Needle-Free Blood Draws Close?
By John Palmer
The dreaded needlestick in the healthcare environment is a source of nightmares for many people, ranging from young children getting their first inoculations to adults with high cholesterol going in for periodic blood tests. People have dreamed about getting rid of needles for years, not only to help patients relax when getting their blood drawn, but also to keep healthcare workers safe.
The Houston-based group International Safety Center in July 2017 released surveillance data from hospitals in 2015 that showed a marked increase in injuries from sharps and needlesticks sustained by training physicians (i.e., residents and interns) compared to 2014, and an overall increase in injuries sustained in the operating room, along with an unexpected decrease in the use of safety-engineered medical devices.
Worker safety watchdogs have been lobbying for safer ways to give injections and draw blood, but until recently the thought of doing away with the needlestick completely was only a pipe dream.
University Hospitals (UH) in Cleveland announced in July that it has implemented the PIVO needle-free device from San Francisco–based Velano Vascular at UH Cleveland Medical Center for inpatient blood draws. UH claims to be the first hospital in Ohio to deliver this enhanced experience to patients and is helping to pioneer a national movement to adopt a more humane standard of care for blood draws.
“As an institution, we continually look for innovative new technologies that improve the delivery and quality of care we provide,” said Daniel I. Simon, MD, president of UH Cleveland Medical Center, in a statement. “As caregivers, we strive to serve our patients in the most humane and personal way possible. This new procedure makes it possible for us to do both, eliminating the pain and anxiety associated with blood collection while advancing our own high standards and practices.”
Two other hospitals, Griffin Hospital in Derby, Connecticut and Brigham & Women’s Hospital in Boston, are also testing the PIVO device. Its name comes from “peripheral intravenous catheter” (PIV), which is the medical term for the standard IV most hospital patients are hooked up to.
In typical practice, an IV needle is used to puncture the skin, but that needle is then withdrawn and replaced with a plastic tube that becomes soft and almost noodle-like over time. The tube is designed to be more comfortable and less dangerous to the patient. But while a “noodle” is fine for injecting fluids and medications into a patient, it’s bad for drawing fluids out of a patient, as the negative pressure of suction causes the tube’s soft walls to collapse. Also, clots that form at the ends of the IV catheter can disrupt the blood testing process.
The PIVO uses a narrower-gauge, stiffer tube inside the existing IV tube for the purpose of taking a blood draw. The device is used once and then thrown away, after which the IV catheter is reattached to the bag containing whatever fluids were being delivered to the patient prior to the blood draw. PIVO allows practitioners to extract high-quality blood samples from the vein, eliminating the need for multiple needlesticks.
The device was created by Velano Chief Executive and co-founder Eric M. Stone and President Pitou Devgon, MD. Velano won FDA approval for the PIVO in 2015; it has also obtained two U.S. patents for the device, according to published reports, with additional applications outstanding in the U.S. and abroad. Velano has publicly acknowledged receiving a total of $8.5 million in investments to improve the device.
The adoption of PIVO at UH’s flagship academic campus follows evaluation of the technology and the procedure in multiple UH Cleveland Medical Center inpatient units, the hospital said in a statement.
“Our evaluation and collaboration proved that PIVO delivers high-quality blood draws in an elegant manner that enhances the patient-practitioner relationship, reduces rejected blood samples, and provides an alternative to accessing central lines for blood collection,” said Cheryl O’Malley, vice president of patient care services and nursing at UH Cleveland Medical Center. “We are excited to bring this procedure and technology to our entire academic hospital, especially for our most vulnerable patients like those at UH Rainbow Babies & Children’s.”
Founded in 1866, UH serves the needs of patients through an integrated network of 18 hospitals, more than 50 outpatient health centers, and 200 physician offices in 15 counties throughout northern Ohio. The system’s flagship academic medical center, UH Cleveland Medical Center, is affiliated with the Case Western Reserve University School of Medicine. Its main campus also includes University Hospitals Rainbow Babies & Children’s Hospital, ranked among the top children’s hospitals in the nation.
Safer sharps slow to evolve
More than 400 million blood draws occur annually in hospitals in the U.S., informing as much as 70% of all clinical decisions. Many of these are conducted in a hospital setting on patients that receive as many as three blood draws daily. This number of daily draws can increase dramatically for the 30% of U.S. hospital patients that are classified as “difficult venous access,” or DVA, due to obesity, age, or disease.
Stone is a Northeast Ohio native and former UH Rainbow Babies & Children’s Hospital patient. “As a chronic disease sufferer and over the course of multiple hospitalizations as a teenager, I developed a clinical fear of needles,” said Stone. “My personal experience as a patient has informed our person-centered mission at Velano to enable more humane care. Coming full circle, back to UH and Rainbow, to make this technology a national standard of care will enable our children and their parents to have their blood drawn in a gentler fashion.”
It may have important benefits for healthcare staff, too. According to OSHA, up to 5.6 million workers in the U.S. are at risk of exposure to bloodborne pathogens, such as HIV and hepatitis, because they use needles and other sharps like scalpels as part of their everyday job. In fact, every year, about 1 million workers in hospital and clinic settings suffer a needlestick or other sharps-related injury. What’s worse, it’s estimated that as many as half of the actual number of needlestick injuries go unreported.
Sharps have been a presence in healthcare as long as healthcare has been in existence. While needlestick safety is considered paramount, distracted and busy healthcare workers still get stuck with needles. In 1991, OSHA introduced the Bloodborne Pathogens (BBP) standard, which mandated that employers take steps, including implementation of universal standards, designed to reduce worker exposure to blood and potentially infectious diseases.
In 2000, President Bill Clinton signed the Needlestick Safety and Prevention Act, which instructed OSHA to revise the BBP standard with a new emphasis on preventing needlesticks. The new law encouraged the use of newer safety devices designed to cap themselves with safety sheaths or with retractable needles, and healthcare supply manufacturers have developed such devices in response to the legislation. The law also requires healthcare facilities to evaluate new sharp safety devices annually.
Safe in Common (SIC), a nonprofit organization based in York, Pennsylvania, issued a list of guidelines in 2013 that serves as a “wish list” of attributes for sharps safety. Established in 2010, SIC is an organization of healthcare professionals and advocates that work to raise awareness of needlestick injuries and save lives of healthcare workers.
The guidelines, titled “The Top Ten Golden Rules of Safety,” were released at the Association for Professionals in Infection Control and Epidemiology conference in Fort Lauderdale, Florida. Specifically, the guidelines seek to make needlestick injuries a “never event,” an incident so rare that it almost never happens, by lobbying for sharps that are easy to use in even the most distracting environments. In addition, safety devices should be activated automatically so that they’re safe and easy to use with one hand. Sharps should also be “rendered safe prior to removal or exposure to the environment,” should not cause additional harm or discomfort to the patient, and should not add to the already-high cost of medical waste.
John Palmer is a freelance writer who has covered healthcare safety for numerous publications. Palmer can be reached at safetyjohn@yahoo.com.