Vyaire Medical Device Recall
When children and adults are unable to breathe on their own, they rely on medical technology to breathe for them. This technology comes in many forms; tracheal tubes and resuscitation devices are common examples of equipment that can help people take in one of life’s most important elements—oxygen.
Tracheal tubes are inserted into a person’s nose, mouth, or throat and provide a channel to the lungs where life-sustaining oxygen is pumped in and used by the body. Resuscitation devices are an important companion to tracheal tubes; if a person is still unable to breathe following the placement of a tracheal tube, resuscitation devices provide constant ventilation and serve as life-saving support.
What happens when those life-saving devices fail? What happens when they fail due to faulty manufacturing? People’s lives are put at risk. That’s exactly what happened when AirLife Resuscitation Devices were recalled from the market in 2017.
AirLife Resuscitation Devices and Broselow Convenience Kits Recalled by FDA
The U.S. Food and Drug Administration issued a medical device recall of Vyaire Medical’s AirLife Resuscitation Devices and Broselow Convenience Kits on May 11, 2018.
The AirLife and Broselow devices are manual resuscitation devices used together to provide constant ventilation to children and adults who cannot breathe on their own after a tracheal tube has been placed. They are used in hospitals or other acute healthcare settings by doctors and healthcare providers.
In a press release, the regulatory agency warned doctors and other healthcare providers of the risks associated with the devices, specifically the risk posed by the devices’ defective design.
According to the FDA, the cushioned mask can stick to the elbow of the resuscitator, making it difficult or nearly impossible to remove the mask. This design flaw could cause a delay in a patient receiving life-sustaining ventilation, or result in a patient not receiving ventilation at all. This could result in injury to or even the death of the patient.
Due to risks posed by these faulty devices, the FDA issued a class I recall, the most urgent type of recall initiated by the agency, in May 2018. The recall came after the manufacturer of the devices, Vyaire Medical, issued a recall of its own the previous year.
In addition, the FDA received adverse event reports about the AirLife system in the agency’s adverse event reporting system. This system gives patients and doctors a platform to submit problems with medical devices to the FDA. This reporting system can help with improving patient outcomes by helping the FDA identify problematic drugs and devices.
How Do Resuscitation Devices Work?
Resuscitators help get oxygen to people who are unable to breathe on their own. Resuscitators use pressure to inflate and force air into the lungs. Manual resuscitation devices, like Vyaire’s AirLife device, are made up of a mask that is placed over the person’s mouth and nose and a plastic bulb that is squeezed by hand to deliver oxygen. These manual resuscitation devices can also be hooked up to an oxygen tank to supply consistent oxygen to the patient.
The AirLife resuscitation device is typically used by doctors and other healthcare providers after a person has received a tracheotomy or other advanced airway devices. A tracheotomy, or tracheostomy, is a surgical procedures in which an incision is made in the neck and an opening is created in the trachea (the windpipe). Before the procedure, patients are put under anesthesia to make the procedure more comfortable. The patient is monitored during the entire procedure in case problems arise. Like with all surgeries, there are inherent risks including the anesthesia delivery itself.
The AirLife system comes with a companion device called the Broselow Convenience Kit. Broselow Convenience Kits are patient monitoring devices used together with the manual resuscitator to make sure the correct amount of oxygen is delivered to the patient.
Vyaire Medical Tells Customers to Destroy Bad Products
Vyaire Medical first notified its customers about problems with its AirLife Resuscitation Device and Broselow Convenience Kits due to their manufacturing defects in April 2017.
The company sent an Urgent Recall Notification letter to doctors and healthcare providers on April 27, 2017 telling them to inspect their inventory and destroy any bad products they had on hand. They also informed customers to call their customer service line if they wished to obtain replacement devices. The affected devices were manufactured between January 2016 and January 2017.
More than a year after Vyaire initiated its own recall, the FDA initiated its own class I recall of the devices in May 2018.
About Vyaire Medical
Vyaire Medical was founded in October 2016 through the partnership of global medical technology company BD and global private equity firm Apax Partners. The medical device company is headquartered in Mettawa, outside of Chicago, Illinois with several locations in the United States, including Yorba Linda, California.
“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,” boasted Apax Partners’ senior management in an October 2016 press release.
In March 2018, just two months before the FDA issued its product recall, Apax announced it was purchasing the remaining minority stake in Vyaire Medical from BD. Executives at Apax were banking on the increasing value of its respiratory diagnostics and ventilation business, but the class I recall the company is now facing may cast a shadow on their sunny profit forecasts.