March 10, 2009

FDA Negligent in Delayed Response to Problems With Pediatric Breathing Device

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

On Monday, the Food and Drug Administration (FDA) belatedly announced a Class I recall of the Shiley 3.0 PED tracheostomy tube, highlighting the painfully slow and lethargic way that the agency responds to emerging problems with medical devices. This delayed and therefore negligent FDA announcement comes three months after the agency was first aware of problems with the device and two months after the company had warned its customers and begun a recall.

Class I recalls are reserved for cases in which the device may cause serious health problems or death. The recall of roughly 5,000 Shiley 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. Nellcor sent an urgent alert to customers Jan. 14 warning of the problem and initiated a recall. The company sent a second letter March 6, telling customers of the recall.

According to the company, 10 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 Nov. 19; it has received a total of nine unique reports of this problem from these now-recalled devices.

Another 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.

Often, the public does not become aware of a problem with medical devices until well after a company has already begun the recall process. In this case, when the FDA belatedly announced the company’s Jan. 14 recall, Nellcor had already resolved the problem for products shipped after Feb. 4 but not for those shipped between July 24 and Dec. 23.

The public expects the FDA to move quickly to protect it from dangerous and faulty medical devices. Unfortunately, the slow response to the problems with Nellcor’s tracheostomy tube is one more blot on the FDA’s already tarnished reputation. This is hardly the image of an agency taking seriously its responsibility to protect consumers from dangerous and faulty medical devices.

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