Questioning quality of FDA approved cardiovascular devices a study released on Tuesday said several Americans receive implanted cardiovascular devices that are approved but many of the devices have not undergone rigorous safety and effectiveness research before being approved.

Journal of the American Medical Assn however on Wednesday said that

The findings don't mean cardiovascular devices are universally unsafe.

Agency-sponsored report concluded that the FDA had approved cardiovascular devices based on data that lacked adequate strength.

Dr Sanket Dhruva, a co-author of the paper and a medical resident at UC San Francisco said that, “The FDA has subjected drugs to tougher scrutiny before deciding whether to approve them. But far less attention has been given to medical devices.”

For reaching a conclusion the researchers reviewed the pre-market approval paperwork for 78 high-risk cardiovascular devices were FDA approved from January 2000 through December 2007.

The study found that a single study supported 65 per cent of the pre-market approval applications for high-risk devices. Only 27 per cent of the studies were randomized and only 14 per cent were blinded.

Another study found that more than 40 per cent of the studies used to approve cardiovascular devices had lacked high-quality data.