Female Infertility

February 21, 2013

About 10% of couples in the United States are affected by infertility. Both men and women can be infertile. According to the Centers for Disease Control, 1/3 of the time the diagnosis is due to female infertility, 1/3 of the time it is linked to male infertility, and the remaining cases of infertility are due to a combination of factors from both partners. For approximately 20% of couples, the cause cannot be determined.

When public health agencies recognized the signs of an emerging Salmonella outbreak in early September 2012, they could tell that the bacterium was contaminating a food popular with children.

And there aren’t many foods more loved by kids than peanut butter.

The outbreak of Salmonella Bredeney in peanut butter produced by one company has infected 41 people in 20 states, according to the Centers for Disease Control and Prevention (CDC). The majority of those who have fallen ill with diarrhea, fever and abdominal cramps are children under age 10.

More people would have fallen ill if not for fast action by federal and state public health agencies.

Those actions culminated on Nov. 26, 2012 with the Food and Drug Administration’s suspension of the food facility registration for Sunland Inc., of Portales, N.M. Sunland produced the peanut butter product linked to the outbreak—Trader Joe’s Creamy Salted Valencia Peanut Butter made with Sea Salt.

This is FDA’s first use of the suspension-of-registration authority since the authority became effective in July 2011. Provided by the FDA Food Safety Modernization Act, this authority enables FDA to suspend a facility’s registration when the agency has determined, in part, that a food that is manufactured, processed, packed, or held by a facility is likely to cause serious illness or even death.

Sunland will not be able to distribute food from this facility until the suspension is lifted.

Donald Zink, Ph.D., a senior science advisor at FDA, says that peanut butter is particularly vulnerable to Salmonella contamination. “Salmonella is in the soil and peanuts come right out of the ground,” he says.

Great care has to be taken to produce peanut butter in a “highly sanitized” environment, he says. Special protections have to be in place to make sure the finished product isn’t contaminated after the nuts are roasted, the only “kill step” for the Salmonella.

However, FDA inspectors report finding insanitary conditions at Sunland, including conditions that likely resulted in cross-contamination between raw and roasted peanuts, such as unclean equipment that comes into contact with food, employees who didn’t wash their hands or wear clean gloves, and the use of totes to transport both raw and roasted peanuts without any cleaning or sanitizing process.

Medical Devices at Home

February 10, 2013

Patients and consumers are using medical devices more often at home—not just in health care facilities. Many medical devices are now portable, and this feature enables patients to live active lives outside of the confines of the hospital room or treatment center.

“(Home use) devices once were designed only to keep you alive. Now they’re designed to keep you as independent as possible,” according to Mary Brady, MSN, RN, a senior policy analyst at FDA’s Center for Devices and Radiological Health (CDRH).

However, the Food and Drug Administration (FDA) has long been concerned that consumers may sometimes be literally left to their own devices—depending upon medical devices they might not know how to operate and for which they might not understand the safety risks.

There have been serious, and even fatal, problems reported to FDA associated with medical devices used at home. For example, a woman with kidney failure got cat hair in her dialysis tubing, resulting in peritonitis, a life-threatening abdominal infection. And a child died when his mother didn’t hear an alarm on his ventilator signaling that the tubing had become disconnected.

FDA is working on ways to help consumers safely operate and maintain home use devices, which include blood glucose monitors, infusion pumps (a device that delivers fluids, including nutrients and medications, into a patient’s body) and respirators. These efforts include issuing a draft guidance document for manufacturers on the design and testing of devices intended for home use, and the development of clearer instructions for use.