When medical technology fails, patients’ lives are put at risk. When medical technology fails due to errors in manufacturing design, the manufacturer should be held accountable for the dangers at which they put patients.
This situation occurred when Vyaire Medical recalled its AirLife Resuscitation devices in 2017. Patients’ lives were put at risk due to errors in the devices’ manufacturing design; now it’s time to hold Vyaire Medical accountable.
Advances in medical technology have made it possible for children and adults to take in life-sustaining oxygen even when they’re unable to breathe on their own. Tracheal tubes and resuscitation devices are just some of the devices that help people take in oxygen—one of life’s most important elements.
Tracheal tubes assist with breathing when inserted into the nose, mouth, or throat to provide a pathway for air to travel to the lungs. After a tube is placed, resuscitation devices step in to start the flow of oxygen. Together, they provide life-saving support to children and adults.
On May 11, 2018, the U.S. Food and Drug Administration initiated a class I recall of Vyaire Medical’s AirLife Resuscitation Devices and Broselow Convenience Kits.
The two manual resuscitation devices are used together to provide constant ventilation to kids and adults who are unable to breathe on their own following the placement of a tracheal tube. The AirLife and Broselow devices are used in hospitals and other healthcare settings by doctors, healthcare providers, and even first responders.
The FDA warned doctors and healthcare providers in May 2018 press release about the risks associated with the devices, including the dangers posed by the devices’ faulty designs.
According to the press release, AirLife’s cushioned mask can stick to the elbow of the resuscitator making it hard or almost impossible to remove the mask. The error in design could result in a delay in oxygen being supplied to the patient; it could also result in the patient not receiving oxygen at all, resulting in injury or death.
Because of the severity and due to the risks, the FDA issued a class I recall of the devices. Class I recalls are the most severe type of recall initiated by the FDA. The recall of the AirLife and Broselow devices came more than a year after Vyaire issued a recall of its own in 2017.
Before the recall, the FDA also received adverse event reports in the agency’s adverse event reporting system. This system provides a platform for patients, doctors, and hospitals to submit problems with drugs and medical devices to the FDA. The FDA uses these reports when initiating recalls or other warnings. The adverse event reporting system helps to improve patient outcomes by promoting the regulatory agency identify problems with drugs and devices.
Resuscitation devices like the AirLife system help deliver oxygen to people who cannot breathe on their own. These devices use pressure to force air into the lungs. Manual resuscitation devices, which include Vyaire’s AirLife device, consist of a mask that is placed over the patient’s airways (nose and mouth) and a hand-squeezed plastic bulb that delivers oxygen to the patient’s lungs. Manual resuscitation devices can also be hooked up to an oxygen supply to deliver constant ventilation to the patient.
Doctors and other healthcare providers generally use the AirLife resuscitation device after a person receives a tracheal tube or other advanced airway devices. Tracheal tubes are placed during the surgical procedure known as a tracheotomy, during which an incision is made in the neck, and an opening is created in the trachea or windpipe.
Before the procedure, the patient is placed under anesthesia and then monitored throughout the surgery in case there are problems. All operations come with inherent risks, including the anesthesia delivery itself.
Vyaire’s AirLife system is used along with the companion device, Broselow Convenience Kits. This patient monitoring device is used together with the manual resuscitator to ensure the right amount of oxygen is given to the patient.
In April 2017, Vyaire Medical notified customers about problems with its AirLife Resuscitation Devices and Broselow Convenience Kits a manufacturing defects. Vyaire sent an Urgent Recall Notification to healthcare providers on April 27, 2017, informing them that they should destroy any affected products they had in their inventory.
The faulty devices were manufactured between January 2016 and January 2017, according to the recall notice. Vyaire also told customers they should call their customer service line if they wanted to get replacement devices.
The FDA initiated its recall of the AirLife and Broselow devices in May 2018—more than a year after Vyaire first notified customers of the problem.
Formed in October 2016, Vyaire Medical is a partnership between global medical technology company BD and the private equity firm Apax Partners. Vyaire is headquartered in Mettawa, Illinois, just outside of Chicago, Illinois, and has several locations in the United States, including in Yorba Linda, California.
The founding partners BD and Apax believed in the vitality of Vyaire Medical, boasting in an October 2016 press release that it expected the new company to rake in hundreds of millions of dollars each year.
“Vyaire Medical includes all business lines within BD’s Respiratory Solutions business, including Ventilation, Respiratory Diagnostics, Vital Signs and AirLife, and will have estimated annual revenue of over $800 million,” Apax Partners’ senior management said in the press release.
Just two months before the FDA issued its class I recall of AirLife, Apax Partners announced it would buy BD’s minority stake in Vyaire Medical. Apax executives were confident in the increasing value of the company. The current class I recall may put a damper on that outlook.
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