From left to right: Kate Hoffman, RN; Deborah Mulloy, PhD, RN, CNOR; and Jackie Somerville, PhD, RN, FAAN

Over the past four months, Deborah Mulloy, PhD, RN, CNOR, associate chief nurse for Quality and the Center for Nursing Education (CNE), and Susan Lee, PhD, RN, CNP, senior nurse scientist in the CNE, conducted educational sessions for staff in four BWH inpatient units for a study that began enrollment in April. They are evaluating the effectiveness of the transluminal intravenous access (TIVA) device, which offers a much sought-after solution: blood draws without needle sticks. The reactions from staff at these trainings were overwhelmingly positive.

“BWH nurses, physicians and staff are thrilled about this groundbreaking technology and the compassion it brings,” said Mulloy, co-principal investigator of the study.

The device is an FDA-cleared Class II medical device that is sterile and single-use. The needle-free device, created by Velano Vascular, is designed to allow clinical staff to draw blood from peripheral intravenous (PIV) catheters, reducing the need for venipuncture, or blood draw, procedures. The TIVA device works by attaching to the PIV system and introducing a syringe to collect a blood sample. Once the draw is complete, the inner tube is retracted and the device is detached from the PIV line and discarded.

A New Solution for Blood-Draw Concerns

Venipuncture is the most common invasive procedure in the U.S., with more than 400 million performed annually. Blood tests are invaluable, informing more than 70 percent of medical decisions; however, they come at a price. Renowned for being unpleasant, blood draws can cause pain, bruises and hematomas, hindering patient comfort. Research conducted by Velano Vascular shows that 30 percent of blood draws result in insertion failures, requiring additional needlesticks to produce a viable blood sample.

“Traditional blood draws are one of the most common and problematic health care procedures,” said Karen Daley, PhD, RN, past president of the American Nurses Association and former BWH nurse. “It is an antiquated technology that creates pain and anxiety for many patients.”

Additionally, the Occupational and Health Safety Administration (OSHA) reports that more than 5.6 million healthcare workers are affected by needlestick injuries per year, which can result in the transmission of life-threatening diseases.

A device enabling needle-free blood draws would eliminate each of these problems.

“When BWH was invited to be a site for this study, I was extremely interested in this research because of its potential to improve the care experience for our patients and to eliminate needles from the care environment, ultimately protecting staff,” said Chief Nursing Officer Jackie Somerville, PhD, RN, FAAN.

The TIVA device is designed to allow clinical staff to draw blood from peripheral intravenous (PIV) catheters, reducing the need for venipuncture, or blood draw, procedures.

Evaluating the Device with a Comprehensive Study Design

The BWH TIVA team, led by Mulloy and co-Principal Investigator Stanley Ashley, MD, chief medical officer, has been planning this project for more than a year. The study began enrollment in April, seeking to enroll 150 inpatients from surgical gastroenterology on Tower 15. A control group is receiving standard care, in which their IV site is monitored and traditional blood draws are taken as needed. In the second group, the TIVA device is attached to the patient’s IV to draw blood. Investigators will track two key measures in this group: length of time an IV stays in and quality of blood samples obtained. Patient satisfaction and feedback on comfort and pain will be assessed in both groups.

“Length of time an IV stays in is a very important measure. We need to be able to show that the TIVA device does not shorten the life of an IV,” said Mulloy, explaining that lines must be changed every 96 hours per infection control guidelines. “To be considered successful, the device must not have an impact on the performance of the IV.”

Another measure of device effectiveness is the quality of blood samples it yields. Blood samples taken directly from PIV lines (without the TIVA device) typically result in clotting and hemolysis, or damage to red blood cells. This results in unreliable blood tests and inaccurate diagnoses. Therefore, this method cannot be used for blood draws. To prove that the TIVA device can be used for this purpose, the study must demonstrate that it produces non-clotted, non-hemolyzed blood samples that are suitable for accurate testing. A recently completed pilot study of the device has shown promise, but further study, especially of the device’s effects on IV lifespan, are needed.

Compassionate Care for BWH Patients

Study investigators and participants alike are enthusiastic about the possibility of a future without traditional blood draws. “What gives the TIVA device remarkable potential is its ability to draw blood without the discomfort, anxiety and bruising caused by needle sticks,” said Ashley. “So many patients, most notably pediatric patients, have a negative experience with blood draws. This study could be a step towards changing that.”

Added Lee: “Every patient we’ve spoken to about TIVA is excited to be involved in testing something that, if approved, would drastically improve care and reduce pain,” she said. “Not only is there a possible benefit to them in the long run; they want to contribute to the scientific process.”

The study approval and educational process has required extensive collaboration. The TIVA team has worked with Perioperative Services, the Wiener Center, the Operating room/PACU, the surgical intermediate care units on Tower 15, along with gastrointestinal and oncology surgeons, and many other nursing and physician colleagues.