CHICAGO (AP) — A new analysis says most medical devices recalled recently because of deaths or life-threatening problems were approved under rules that don't require human testing.
According to the study authors, these devices include heart defibrillators and brain shunts. Most were approved under regulations for products similar to ones on the market.
Regulations for new devices call for more extensive testing.
The researchers say thousands of deaths or serious medical problems occurred in patients with the recalled devices studied. Their report appears in Monday's Archives of Internal Medicine.
Device makers say the analysis is flawed and conflicts with previous reports.
The report comes as the government is considering changes to the medical device approval process.