Medical Devices

Parents who have been fretting about their kids' junk food consumption, lack of exercise, questionable oral hygiene, astonishing infection risks, poor study habits or excessive social networking need to make way for two more worries -- child-threatening medical devices and drug-resistant lice.  The current issue of the journal Pediatrics  features these gems: "Emergency Department Visits for Medical Device-Associated Adverse Events Among Children" and "Clinical Report -- Head Lice."

The Food and Drug Administration has been allowing medical devices, from hip replacements to external defibrillators, to enter the market under less stringent review processes -- and this may mean potentially unsafe devices are being used by, and even implanted in, unsuspecting patients, a new report finds. According to the report released Wednesday by the Government Accountability Office, medical device makers don't have to go through the FDA's stringent premarket approval process if they can show that their product is roughly equivalent to another device already on the market.

A disproportionate number of medical devices recalled because of possible links to serious health problems or deaths ? including external defibrillators and insulin infusion pumps ? were approved under an abbreviated process that did not require advance testing on patients, according to a five-year study of such recalls. More than 70% of the 113 recalled devices were cleared for market under a shorter Food and Drug Administration review because they were deemed similar to products already on the market, the study found.

A former Hewlett-Packard Co. employee sued the computer giant Thursday, alleging that HP and its spinoff, Agilent Technologies Inc., tried to defraud customers by selling defective medical devices. Robert Hindin's lawsuit seeks damages that could reach the tens of millions of dollars under the California False Claims Act. The suit claims HP engaged in a "scheme to defraud its customers by knowingly selling defective and potentially dangerous medical devices."

Hoping to expand into new markets, Santa Ana-based semiconductor firm Microsemi Corp. said Monday it has joined forces with Advanced Power Technology to build and market devices to the medical community. Microsemi supplies power semiconductors and other products for the electronics, computer, telecommunications, space, defense and medical markets. Advanced Power, based in Bend, Ore., is a research and development engineering firm that builds prototypes of medical devices.

The Food and Drug Administration should stop permitting thousands of medical devices to be marketed and used in patients without proof of safety or effectiveness, the National Academy of Sciences said Friday. The academy's report, coming after a spate of recalls and problems with such devices, pointed up a little-known quirk in the law. In theory, the FDA has broad responsibility to ensure that drugs and medical devices are safe and effective. But thousands of devices go through an expedited review because they are considered similar to older devices that are already on the market.

Despite recalls of defective medical devices that have caused devastating injuries and millions of dollars in medical costs, the Food and Drug Administration is under industry pressure to speed up its approval process. That pressure comes as a new Government Accountability Office report criticized the way the FDA handled approval of high-risk devices, such as defective artificial hips made by Johnson & Johnson that left shredded metal in patients. More than 90,000 artificial hips were recalled last summer after studies showed that about 1 out of 8 recipients needed to have them replaced.

Responding to reports of inadequate regulatory safeguards, Congress took a major step Wednesday toward adopting legislation to strengthen federal oversight of medical devices ranging from pacemakers to pediatric cribs. The House unanimously passed a bill that would require the Food and Drug Administration to conduct timely reviews of the safety and effectiveness of new medical devices coming on the market.

The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates, the agency said Thursday. As it does so, the FDA plans to use data-mining techniques that could give the agency early warning of potential problems. The FDA effort parallels similar efforts underway to improve the agency's response to drug safety concerns.

Interpore Cross International has agreed to acquire American OsteoMedix, a Virginia maker of minimally invasive medical devices, for more than $20 million in cash and stock, the Irvine company announced Thursday. Interpore, a medical-device company, said it will pay about $8 million in cash and roughly 2.4 million shares, subject to adjustment. The shares are worth about $12.6 million, based on Interpore's Thursday closing price of $5.23.