The IRE Resource Center is a major research library containing more than 27,000 investigative stories.

Most of our stories are not available for download but can be easily ordered by contacting the Resource Center directly at 573-882-3364 or where a researcher can help you pinpoint what you need.

Search results for "medical devices" ...

  • The Implant Files

    For decades, the U.S. Food and Drug Administration’s medical-device approval system has allowed defective implants to spill onto the market, like contaminated water from a broken pipe. Many of those products have remained on hospital shelves, and in patient bodies, long after problems were known. On Sunday, November 25, 2018, the International Consortium of Investigative Journalists, the Associated Press, the NBC News investigative unit and partners around the world published a yearlong investigation that shows regulators bowing to industry pressure to rush approvals, lower safety standards and cloak critical information, and the consequences: a string of grisly accidents that have left hundreds of thousands disfigured, disabled or dead.
  • Question of risk: Medtronic's lost study

    America depends on the timely notification of injuries to protect patients from dangerous medical devices. But as a Star Tribune investigation showed, companies can break injury-reporting laws with impunity. First, the newspaper exposed a long-lost Medtronic study of a controversial bone-surgery product called Infuse. The study documented more than 1,000 serious problems that were not provided to the government during a period of heightened scrutiny of the product’s safety. When Medtronic did report the data to the FDA, more than five years late, the FDA secretly granted Medtronic permission to summarize the data in a file that would be available to the public only under a FOIA request. The Star Tribune went on to document hundreds of these “retrospective summary reports” of long-overdue unreported device reports from two dozen companies.
  • Dangerous Device

    NBC Nightly News’ “Dangerous Device” reports are the product of a yearlong investigation into surgically implanted medical devices that our research linked to at least 39 deaths and hundreds of injuries. Our investigation, which prompted a U.S. Senate inquiry, uncovered a forgery submitted to the federal government, and revealed that the device’s maker knew early on that its product -- and the model that replaced it -- had potentially fatal flaws. Still, the company decided not to recall these devices from the market. [P1:] [P2:] [P3:]
  • How A Recalled Medical Device Killed A Vet At Seattle's VA Hospital

    Thousands of patients are harmed by medical devices in the United States each year. Finding out how or even where those incidents happened can be an uphill climb for people interested in hospital safety, particularly for those whose loved ones are patients at veterans' hospitals. Our two-part investigation reveals systemic problems in the oversight of medical devices as well as the lethal consequences for one Army veteran when a pump that had been recalled the month before flooded his veins with a nearly tenfold overdose of morphine.
  • Left to Their Own Devices

    Medical devices are crucial for the wellbeing of many Americans. They can be as life-sustaining as cardiac pacemakers or as simple as wooden tongue depressors. Regardless of their complexity, all medical devices must go through a clearance process by the Food and Drug Administration (FDA) before they are cleared for market. While the vast majority of these devices are safe and effective, according to the U.S. Government Accountability Office (GAO), hundreds are recalled every year. And the impact of an unsafe medical device can be devastating.
  • A Dangerous Shortcut

    The story details how medical device companies have benefited, and many consumers have been injured, because of a 25-year-old loophole, repeatedly expanded by Congress despite sharp criticism from health safety advocates, that allowed medical devices never tested on humans to be put directly into use. The reporters show that dozens of different devices approved through this loophole have malfunctioned over the years, injuring tens of thousands of patients. Doctors, health advocates and the General Accounting Office have called for changes to the law. But, in part because of heavy donations to members of a key House committee, the loophole remains – and some members of Congress are trying to expand it.
  • Bad to the Bone

    When four executives of a medical-device company called Synthes went to jail for illegally marketing a bone cement—five patients had died after it was injected into their spines—Mina Kimes knew there had to be a compelling saga behind a case that had generated little coverage beyond local news articles. So she began digging, first with FOIA requests for never-before-published government documents, and then assembling hundreds of pages of court transcripts and internal company e-mails and reports. She used that foundation to begin the harder challenge: persuading Synthes employees, many of them terrified by the criminal case and the company’s intimidating chairman, to talk to her. With six months of grueling, old-fashioned reporting, Kimes succeeded, and “Bad to the Bone” is the masterful result. Not only did she persuade more than 20 current and former company employees to speak, but she also revealed a story whose disturbing breadth far exceeded the case presented in court. Her tour de force reporting raises profound new questions about the culpability of a key figure who wasn’t charged: Hansjörg Wyss, the reclusive and controlling Swiss founder and chairman—one of the richest people in the world—who made crucial decisions about how to sell the bone cement. This is a classic tale of corporate malfeasance: Warned by the government not to sell its bone cement for use in the spine, Synthes ignored the admonition despite clear evidence of lethal danger—a pig had died within seconds when the cement was tested on it—and encouraged surgeons to use the cement on people, five of whom died soon afterward. But “Bad to the Bone” isn’t just an exposé. It opens a window into a broader issue: how the medical system actually runs. Readers see how salespeople with no medical training advise surgeons—inside the OR during operations—on how to use their devices. They experience the tale of one surgeon who continues using the cement even after two of his patients died. Oh, and what sort of justice does Synthes itself receive? Wyss sells it, for $20 billion, to health care giant Johnson & Johnson, which praises Synthes’s “culture” and “values.” Corporate crime. Death on the operating room table. Secret e-mails. Surgeons on the edge. An imperious multibillionaire CEO. It’s a mesmerizing article, and Kimes’s reporting takes readers on a deeply unsettling journey that ensures they’ll never look at the medical system the same way again.
  • As Good As New?

    The recycling and re-use of medical devices labeled for one use only is called reprocessing, and is a controversial practice in the medical industry. Thousands of different devices are re-used by hospitals around the country, ranging from simple blood-pressure cuffs to highly-invasive catheters and biopsy tools. The practice saves hospitals millions of dollars, but consumers generally have no idea.
  • Medicine's Middlemen

    An investigation by the New York Times revealed that "just two companies could determine which life-saving drugs and other medical products most of the nation's hospitals bought and at what price. As national gatekeepers for billions of dollars in hospitals supply contracts, these two companies used their unregulated power to enrich themselves through pervasive conflicts of interest and self dealing... Until the Times examined them, these two for-profit companies, Premier and Novation, operated as they wished. They claimed they saved hospitals money by buying in bulk -- but never had to prove it. As private companies with no government oversight, they refused to disclose how they did business, including how much money the makers of the drugs and medical devices were paying them to get supply contracts. In this environment, Premier executives collected millions in personal stock options from the very manufacturers whose company products they were supposed to evaluate objectively. The buying companies steered thousands of hospitals to manufacturers in which the buying companies themselves had a financial interest."
  • Replacement parts

    The News & World Report investigates "how implantable medical devices gain approval from the Food and Drug Administration," according to the contest questionnaire. As the medical devices manufacturing business has grown over the years, so has the number of patients crippled or killed by the implantation of faulty pacemakers, defibrillators, heart valves, knee joints or spinal-fusion screws. The story finds that FDA allows for devices to be marketed before undergoing clinical tests, and is unable to monitor them once the devices are in use.