Robotic Phlebotomist Stand-In Gets FDA’s Blessing

The FDA authorized the first robotic device that can independently draw patients’ blood without a hands-on operator, the agency announced on Wednesday.

The Aletta device uses near-infrared light and Doppler ultrasound to locate an appropriate vein. It is authorized for use in adults in outpatient settings, under the supervision of a trained phlebotomist.

“Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists,” said Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, in the press release.

One phlebotomist can oversee up to three devices at once, which may help mitigate the current phlebotomist shortage.

While a trained phlebotomist initiates each session, “once a vein is identified, the Aletta proceeds through the remaining steps on its own: applying a tourniquet, preparing the skin, inserting and disposing of the needle, changing collection tubes, and placing a bandage,” the FDA explained.

If a patient moves too much during the draw, the needle automatically detaches, and if unsafe conditions are identified, onboard sensors can halt the procedure, the agency added.

The supervising phlebotomist verifies that the collection tubes are filled in the right order and adequately full.

The authorization was based on data that showed that the Aletta achieves successful blood draw rates similar to or better than trained human phlebotomists when it proceeds with a stick.

In a multicenter study across three outpatient phlebotomy departments, the first-stick success rate with the device was 94.5% when an appropriate vein was identified. This rate remained high in patients with obesity (97.4%), those with self-reported hard-to-access veins (92.7%), and adults ages 65 and older (93.4%).

Adverse events occurred in 0.6% of participants — all were mild and included vasovagal reactions, vasovagal syncope, hematoma, and self-limiting paresthesia.

In addition, 90% of patients said they experienced far less (19%), less (32%), or similar pain (39%) when compared with manual phlebotomy, and 82% said they either had no preference (35%), would strongly prefer (16%), or prefer (31%) the Aletta over manual phlebotomy.