The U.S. Food and Drug Administration (FDA) said it plans on stepping up its prosecutions of pharmaceutical and food industry executives as part of its work to revamp the agency’s criminal division said the Wall Street Journal. It seems the division has been derided by Congress and was recently condemned in a government report, added the Journal.

The FDA recently wrote to Senator Chuck Grassley (Republican-Iowa), saying that an internal committee recommended that the agency and its Office of Criminal Investigations (OCI) “increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool,” quoted the Journal. According to the FDA, it has authority to “prosecute corporate executives for criminal actions” under a provision entitled “strict liability.” Although not enacted to a great extent in recent years, the FDA spokesman said that the government is not required to prove intent to defraud in order to convict. More FDA to Increase Use of Criminal Prosecutions

So called “metal-on-metal” hip replacements may be causing complications for many recipients. According to an article in The New York Times, many orthopedic surgeons have reduced or stopped using such hip implants, and recently The Journal of Arthroplasty, urged doctors to use the metal-on-metal devices only with “great caution, if at all.”

Hip implants should last about 15 years. But in many cases, The New York Times said, recipients of metal-on-metal hip implants require replacement surgery within a year or two. One orthopedic surgeon told the Times that he was now replacing metal-on-metal devices at the rate of one a month. More “Metal-on-Metal” Hip Replacements Linked to Complications

We have written about issues surrounding insulin pump malfunctions and recalls in recent years. Now, Reuters reports that the U.S. Food & Drug Administration (FDA) is working to reduce risks from dangerous problems that affect what it described as tens of thousands of diabetics. While the FDA did not provide specific insulin pump manufacturers names in its report, it is largely known that insulin pump makers include Medtronic Inc, Roche Holding AG, and Johnson & Johnson, said Reuters.

The issue with defective insulin pumps is that the devices, when not operating properly, can result in either high or low blood sugar when appropriate insulin amounts are not delivered, which can result in very dangerous outcomes, including death, explained Reuters. “Device problems critical to insulin pumps exist across manufacturers,” FDA staff said in a report it prepared for an advisory panel that meets tomorrow. More Concerns Raised Over Insulin Pumps

A recall of Baxter International’s HomeChoice and HomeChoice Pro peritoneal dialysis cyclers that was issued last month has been designated a Class I recall by the U.S. Food & Drug Administration (FDA). The recall was given Class I status because of the risk of serious injury or patient death that could be associated with the use of this device. Over the last two years, Baxter has received serious injury reports and at least one patient death report associated with the use of HomeChoice and HomeChoice Pro peritoneal dialysis cyclers.

HomeChoice systems are intended for automatic control of dialysis solutions exchange in the treatment of adult and pediatric renal failure patients undergoing peritoneal dialysis. Model numbers affected by this recall include: 5C4471, 5C4471R, 5C8310, 5C8310R, 5C4474, 5C4474R, R5C8320, R5C8320R, T5C4441, T5C4441R, T5C8300, T5C8300R, 5C4474D and 5C4474DR.
More Baxter Dialysis Machine Recall Deemed Class I

Yesterday we wrote that the Medical Imaging & Technology Alliance, a medical imaging trade group, announced that CT scanner manufacturers will initiate installation of safety controls to better ensure patients do not receive excess radiation, citing the Associated Press (AP). Now, the Wall Street Journal (WSJ) is writing that a movement is gaining speed across the country to lower CT scan radiation exposure in children.

Many are concerned about the cancer risks linked to the use of these devices, especially when children are involved, said the WSJ. About five-to-ten percent of all CT scans performed annually—about 70 million—are conducted on children, said the WSJ, a problem, given their smaller size and longer life span. More Group Wants to Limit CT Scans for Children

Boston Scientific Corp.’s Guidant unit is facing federal criminal charges that it failed to fully disclose problems with its implantable defibrillators to the U.S. Food & Drug Administration (FDA). According to the Associated Press, the charges are part of a previously announced settlement agreement.

The Boston Globe is reporting that Boston Scientific and the U.S. Justice Department have signed a plea agreement that will be filed with the U.S. District Court in St. Paul, Minnesota at a later date. The company agreed in November to plead to the charges and pay $296 million to resolve the investigation. More Boston Scientific Faces Federal Charges over Guidant Defibrillators

The U.S. Food and Drug Administration (FDA) just notified healthcare professionals of a Class I recall of the StatSpin Express 4 Centrifuges, Model #510, Serial Numbers 00100 through 001679, which were manufactured and distributed from November 2007 through January 2010.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. More Class I Recall for Statspin Express 4 Centrifuges

LifeScan, Inc. is conducting a voluntary recall, in the United States, of eight lots of OneTouch® SureStep® Test Strips, used by people with diabetes to measure blood glucose levels at home, the U.S. Food and Drug Administration (FDA) just announced. The OneTouch® SureStep® Test Strips are being recalled because they may provide falsely low glucose results when the glucose level exceeds 400 mg/dL.

The eight lots and sizes of consumer OneTouch SureStep Test Strips being recalled follow. Lot numbers appear on the outer carton and the test strip vial. LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010: More OneTouch® SureStep® Test Strips Recalled for Inaccurate Readings

The Medical Imaging & Technology Alliance, a medical imaging trade group, just announced that CT scanner manufacturers will initiate installation of safety controls to better ensure patients do not receive excess radiation, reported the Associated Press (AP).

In October, the Food & Drug Administration (FDA) announced it was investigating CT scan overdoses. The FDA probe was launched after Cedars-Sinai Medical Center in Los Angeles confirmed that 206 patients mistakenly received eight times the regular dose of radiation during CT brain scans. The machine at Cedars-Sinai had been set at the higher level since February 2008, but the mistake had not been detected for 18 months. According to the Medical Center, the overdoses were discovered in August, when a patient reported hair loss. More CT Scan Makers to Install Safety Controls

Medtronic has been accused of illegally marketing biliary, or bile-duct, stents in a whistleblower lawsuit filed by former employees of the company’s vascular business. According to The Wall Street Journal, the lawsuit appears to parallel a federal investigation by the Department of Justice in Boston into marketing of the biliary stents.

Biliary stents are approved by the Food and Drug Administration (FDA) to keep open bile ducts that have narrowed. According to a report published in The New York Times in January 2008, more than one million patients suffering from clogged arteries and veins in their torsos and legs received biliary stents that had not been approved or tested for this use. Even though they are not approved for this use, physicians can use FDA approved medical devices or drugs in any way they see fit – something known as off-label use. More Medtronic Whistleblowers Claim Biliary Stents Were Marketed Illegally