The Food and Drug Administration has authorized a robotic device that can draw blood from a patient’s arm without hands-on intervention from a phlebotomist.
The Aletta uses near-infrared light and Doppler ultrasound to locate a suitable vein and distinguish it from an artery, according to an FDA news release. If it does not find an appropriate vein, the device will not attempt the procedure.
The device handles the blood draw on its own, from preparing the patient’s arm and inserting and disposing of the needle to changing collection tubes and applying a bandage.
A trained phlebotomist must start each session and remain available to respond if problems arise. However, the FDA says one phlebotomist can oversee up to three devices, potentially helping address a shortage of trained phlebotomists in the United States.
"This authorization reflects the FDA’s commitment to advancing innovative medical devices that help meet a critical public health need while maintaining the safety and effectiveness patients deserve," said Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health.
The device includes several safety features. It continuously applies disinfectant to the skin during the ultrasound scan, and a trained professional cleans it between patients. If a patient moves too much during the procedure, the needle automatically detaches and the blood draw stops. Additional onboard sensors can pause the procedure and alert the supervisor if other unsafe conditions are detected.
The FDA said clinical data showed the Aletta achieved successful blood draw rates comparable to or better than trained human phlebotomists when it proceeded with a needle stick.
The results included a broad range of patients, including people with varying health statuses, people who reported difficult vein access and people with varying skin tones. Device-related adverse events were uncommon and mild.
The FDA granted marketing authorization to Vitestro, the device's manufacturer. The authorization also establishes special controls covering requirements such as labeling, performance testing and clinical testing.
The FDA said those controls, combined with general controls, provide reasonable assurance of the device's safety and effectiveness.
