Could robots one day replace phlebotomists in performing routine venipuncture? Researchers at Rutgers University–New Brunswick demonstrated the efficacy and safety of using a hand-held robotic device to draw blood in a small cohort of patients, setting the stage for this possibility. “A device like ours could help clinicians get blood samples quickly, safely, and reliably, preventing unnecessary complications and pain in patients from multiple needle insertion attempts,” said lead author Josh Leipheimer, a biomedical engineering doctoral student, in a statement.
Leipheimer and his colleagues said this is the first study to assess an automated blood drawing and testing device in human subjects.
Phlebotomy success rates vary, depending on patient physiology and the experience of the phlebotomist. Although venous blood draws are a common clinical procedure, they fail often in vulnerable patients who are emaciated or those who don’t have palpable or visible veins. “Difficulties in obtaining venous access result in missed sticks and injury to patients and typically require alternative access pathways and additional personnel that lengthen procedure times, thereby creating unnecessary costs to healthcare facilities,” the authors summarized.
The device, an ultrasound image-guided robot, combines miniaturized robotics with 2D ultrasound imaging to identify and cannulate vessels in a patient, said Leipheimer, who developed it with colleagues Martin Yarmush, MD, PhD, Max Balter, PhD, and Alvin Chen, PhD. Ultrasound imaging provides the position of a vessel, which the device uses to determine where to insert the needle. Force sensors along the needle axis record the insertion force and detect when the needle has successfully punctured the vessel.
“Because of the precise needle placement and control, along with the 2D ultrasound imaging, the device provides improvement in first-stick accuracy and completion time and in theory would require minimal training compared to traditional venipuncture,” Leipheimer explained to CLN Stat.
To make it easier to use, the team modified the technology from a benchtop to a hand-held format. The new model still has that “human-supervised” element but retains the benefits of automated vessel identification and cannulation, Leipheimer said. He and his colleagues used the device to obtain a venous blood sample from the peripheral forearm veins of 31 participants, 25 of whom had easy-to-access veins.
Among this small cohort, the device had a success rate of 87%, reaching 97% among those whose veins were easily accessible, meeting or exceeding clinical standards. The research team was quick to point out that it wasn’t trying to directly compare the device against experienced phlebotomists. “The intention of this device is to improve venipuncture success rates among all patient demographics, without requiring clinicians to have extensive past experience in obtaining venous access,” they clarified.
The hope is this tool could improve success rates and procedure times, especially in patients who have had a history of difficult venous access, Leipheimer said.
Next steps are to conduct a larger and more controlled study, comparing the device’s performance directly against trained clinicians in a clinical environment. Larger studies would help assess risks and benefits, to ready the device for the U.S. Food and Drug Administration’s approval process for medical devices.
“Additionally, we are investigating extending the applications of this technology into other areas of vascular access as well, such as arterial line placement and other percutaneous procedures,” Leipheimer said.