FDA authorizes robotic blood draw device: ‘First-of-its-kind’
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WASHINGTON - The U.S. Food and Drug Administration has authorized the Aletta, a robotic device designed to draw blood from a patient’s arm without hands-on operator intervention.
The move, announced Wednesday, is the first standalone robotic device of its kind authorized by the FDA. The device is intended for use in adults in outpatient settings and must operate under the supervision of a trained phlebotomist.
How robot blood draw device works
Big picture view:
A trained phlebotomist initiates each blood-draw session and remains available to intervene if a problem occurs. One phlebotomist can supervise up to three Aletta devices at the same time.
The device first guides the patient on how to position their arm. Once the patient or supervisor presses a button to begin, Aletta uses near-infrared light and Doppler ultrasound to locate an appropriate vein and distinguish it from an artery. If the system cannot identify a suitable vein, it will not attempt the blood draw.
A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Credit: Sarah Silbiger/Getty Images)
After identifying a vein, Aletta performs the remaining steps autonomously. The system applies a tourniquet, prepares the skin, inserts and disposes of the needle, changes collection tubes and applies a bandage.
The supervising phlebotomist remains responsible for confirming that collection tubes are filled in the proper order and checking that each tube contains an adequate sample.
What they're saying:
"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," Michelle Tarver, the director of the FDA’s Center for Devices and Radiological Health, said in a statement. "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."
Safety measures built into the device
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The FDA said Aletta incorporates multiple safeguards intended to reduce risks during the procedure. The device continuously applies disinfectant to the skin while performing its ultrasound scan, and a trained professional cleans the system between patients.
If a patient moves excessively during the blood draw, the needle automatically detaches and the procedure stops. Additional onboard sensors can pause the procedure and alert the supervising phlebotomist when other potentially unsafe conditions are detected.
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According to the FDA, clinical testing showed that Aletta achieved successful blood-draw rates comparable to or better than those of trained human phlebotomists when the device proceeded with a needle stick. Testing included a broad range of patients, including people with different health conditions, varying skin tones and those who reported having difficult-to-access veins. Device-related adverse events were uncommon and mild.
The authorization comes as health care providers face a shortage of trained phlebotomists, potentially contributing to delays for patients who need routine blood tests.
The Source: The information for this story was provided by the U.S. Food and Drug Administration. This story was reported from Los Angeles.