The FDA said one phlebotomist can oversee up to three Aletta devices simultaneously, potentially helping ease a growing shortage of trained blood-drawing professionals in the United States.
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The US Food and Drug Administration (FDA) has authorized the first standalone robotic device capable of drawing blood from a patient without hands-on intervention from a medical professional.
Called Aletta, the device is cleared for use on adults in outpatient settings under the supervision of a trained phlebotomist.
The FDA said one phlebotomist can oversee up to three Aletta devices simultaneously, potentially helping ease a growing shortage of trained blood-drawing professionals 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,” FDA Center for Devices and Radiological Health director Michelle Tarver said.
Aletta automates nearly the entire blood collection process. After a phlebotomist initiates the session, the device guides the patient in positioning their arm before the patient or supervisor presses a button to begin.
Using near-infrared light and Doppler ultrasound, the robot identifies a suitable vein and distinguishes it from arteries. It will not attempt to draw blood if it cannot find an appropriate vein.
Once a vein is located, Aletta automatically applies a tourniquet, disinfects the skin, inserts the needle, changes collection tubes, disposes of the needle and applies a bandage.
The supervising phlebotomist remains available throughout the procedure and checks that the collection tubes are filled in the correct order and contain enough blood.
The device also has safety features designed to stop or pause the procedure when necessary. If a patient moves excessively, the needle automatically detaches and the blood draw stops, while onboard sensors can detect other potentially unsafe conditions and alert the supervisor.
According to the FDA, clinical data showed Aletta achieved successful blood-draw rates comparable to or better than trained human phlebotomists when the device proceeded with needle insertion.
Testing covered patients with different health conditions and skin tones, including those who reported having difficult-to-access veins. Device-related adverse events were uncommon and mild, the agency said.
The FDA granted Vitestro marketing authorization for Aletta through its De Novo pathway, which is used for novel medical devices considered to pose low to moderate risks.
The authorization also establishes special requirements covering areas including labeling, performance and clinical testing to ensure the device's safety and effectiveness.
