Margaret Hamburg, the new commissioner of the US Food and Drug Administration, has said that her first priority is to reinvigorate the troubled agency. Doing so, she said, will restore its credibility with the public and policy makers.

In an interview with The Wall Street Journal, the commissioner said that she is taking a “hard look” at the medical device division and a “fresh look” at the abbreviated framework it uses to approve many riskier and implantable products. “This is a high priority,” she said.

Scientists at the FDA’s Center for Devices and Radiological Health have sent letter to Congress and the White House alleging that political and corporate influence have trumped science at the division. The device industry is concerned that the FDA or Congress might toughen standards in applying the abbreviated approval process, called 510(k), to devices that would otherwise go through a lengthy review involving more clinical trials and safety data.

A government report in January said that the 510(k) process has been overused.

Dr. Hamburg said that a new transparency task force at the FDA is weighing the need to transmit emerging data about potential drug side effects against claims by corporations that want to keep commercial information confidential.

A recall has been announced on hand sanitizers made by Clarcon Biological Chemistry Laboratory.  The Food and Drug Administration (FDA) reported that the products being recalled contain high levels of disease-causing bacteria.

“Serious deviations” were found in recent tests dealing with government required practices.  According to the statement the analysis, “revealed high levels of various bacteria, including some associated with unsanitary conditions.  Some of these bacteria can cause opportunistic infections of the skin and underlying tissues.  Such infections may need medical or surgical attention, and may result in permanent damage.”

Some of the products recalled include: Citrushield Lotion, Dermasentials DermaBarrier, Dermassentials by Clarcon Antimicrobial Hand Sanitizer, Iron Fist Barrier Hand Treatment, Skin Shield Restaurant, Skin Shield Industrial, Skin Shield Beauty Salon Lotion, Total Skin Care Beauty, and Total Skin Care Work.

The company located in Roy, Utah, has voluntarily recalled the products.  The FDA advises that anybody with these defective products should throw them away immediately.

Approximately 21,000 Kappa and Sigma pacemakers have been recalled by the FDA due to a wiring defect that could cause a severe heart injury or death.

Medtronic first notified physicians and patients of the pacemaker defects in May, reporting that there had been at least two fatalities potentially connected with the wiring. The FDA has now classified the action as a “Class I” recall, which indicates that the product carries a reasonable probability of adverse health consequences of death.

While the recall only applies to about 21,000 of the more than 1.7 million Kappa or Sigma pacemakers implanted throughout the world, approximately 15,200 patients with Medtronic Kappa pacemakers installed for five years or longer and another 6,100 patients with Medronic Sigma pacemakers installed for more than five years are included in the recall. Medtronic Kappa Series 600/700/900 pacemakers and Sigma Series 100/200/300 pacemakers could be affected by this latest recall. These devices were manufactured primarily between November 2000 and November 2002.

According to a letter sent to healthcare professionals on May 18, 2009, Medtronic did not recommend that physicians consider replacing the device unless a patient is pacemaker dependent or a device is already at the elective replacment time.

Patients experiencing problems with a defective pacemaker may show signs of lightheadedness and fainting, and should contact their doctor if these signs occur.

Hundreds of deaths and thousands of injuries can be traced to defective medical devices each year.