More Information on Device Recalls

More Information on the Shiley 3.0 PED Tracheostomy Tube

FDA Negligent in Delayed Response to Problems with Pediatric Breathing Device

March 10, 2009

Sidney Wolfe, M.D, Director, Health Research Group at Public Citizen

Yesterday, the Food and Drug Administration belatedly announced a Class I recall of a tracheostomy tube (breathing tube inserted in the windpipe or trachea) used for pediatric patients who cannot breathe on their own. Class I recalls are reserved for cases in which the device may cause serious health problems or death. This delayed and therefore negligent FDA announcement comes three months after the Agency was first aware of the problem and two months after the company had warned its customers and begun a recall, highlighting the all-too-often lethargic stance of the Agency when presented with a developing device problem.

The recall of roughly 5,000 Shiley 3.0 PED tracheostomy tubes is due to a modification that led to difficulty inserting the tube into the neck and difficulty inserting a secretion suction device into the tube. On January 14, 2009, the manufacturer, Nellcor (a subsidiary of Covidien, formerly known as Tyco) sent an urgent alert letter to patients warning of the problem and initiated the recall. A second letter was sent by the company March 6, 2009, providing further details of the recall. The FDA finally publicized the January recall yesterday, March 9, 2009. Apparently, the problem had already been resolved for products shipped after February 4, 2009, but not for those shipped July 24, 2008 through December 23, 2008.

According to the company, ten patients encountered difficulty inserting the tube or suction catheter, including one case that required additional medical intervention. The FDA was first aware of this problem on November 19, 2008; they have received a total of nine unique reports of this problem from these now-recalled devices. 

Another related device made by Nellcor, the Shiley TracheoSoft XLT Extended Length tracheostomy tube, was recalled in 2004 after 17 reports of the outer tubing breaking. Once broken, the tubing could travel further into the patient’s airway, potentially interfering with ventilation.  This problem was associated with the death of two patients.

One more blot on the device center’s already tarnished reputation, the delayed public notification about this recall illustrates the sluggish response to emerging problems with medical devices by the FDA. Often, the public is only apprised of an event sometime after the company has begun the remedial efforts and the recall has already occurred. This is hardly the image of an Agency taking seriously their responsibility to protect consumers from dangerous and faulty medical devices.

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