FDA Authorizes Robot That Can Independently Draw Blood

en.Wedoany.com Reported - According to Phys.org, the U.S. Food and Drug Administration (FDA) has approved Aletta, the first robotic device capable of independently drawing blood from a patient's arm.

The device is authorized for use on adult outpatients under the supervision of trained phlebotomy personnel. One phlebotomist can oversee up to three Aletta devices simultaneously, initiating the device and handling any anomalies, while Aletta autonomously completes the entire blood draw process.

The device uses near-infrared light and Doppler ultrasound to locate suitable veins, then automatically carries out the subsequent steps: applying a tourniquet, disinfecting the skin, inserting the needle, changing collection tubes, and dressing the puncture site. The supervising phlebotomist then confirms that the collection tubes have been filled in the correct order and verifies that each tube contains an adequate volume of blood.

This authorization is based on clinical data showing that Aletta's blood draw success rate is comparable to, or even better than, that of well-trained human phlebotomists. The trials covered patients with varying health conditions, including those who self-reported difficult-to-find veins and individuals with different skin tones. Device-related adverse events were rare and mild.

Dr. Michelle Tarver of the FDA's Center for Devices and Radiological Health stated in a release that this authorization reflects the agency's commitment to advancing innovative medical devices that meet critical public health needs while upholding the safety and efficacy standards patients deserve. Blood draws are among the most common medical procedures in the United States, but due to an increasing shortage of trained phlebotomy personnel, patient care may face delays, and the new device is expected to help alleviate this challenge.