Tag Archives: patient safety

FDA warns that breast implants are not “lifetime devices”: Tips for covering this story

Photo by Docteur Spitalier Philippe via Flickr

The Food and Drug Administration (FDA) announced last week a series of steps meant to address long-standing concerns about breast implants. These include new labeling with a boxed warning about risks, a patient decision checklist and updated silicone gel-filled breast implant rupture screening recommendations.

These actions follow years of efforts by patient advocates and journalists to make public information about risks associated with breast implants, including a rare form of cancer of the immune system.

Laurie McGinley of the Washington Post offered a broad overview of the issue in her 2019 story about an earlier step the FDA took that helped pave the way for last week’s announcement. The FDA in 2019 issued a draft guidance document that offered recommendations for makers of breast implants about addressing potential risks. In 2020, the FDA issued a final version of this guidance document, a tool the FDA often uses to tell companies what it expects of them in terms of manufacturing, testing and promoting their products.

Last week, the FDA leveraged its authority over the regulation of medical devices to ensure that doctors discuss risks associated with breast implants with patients seeking them.

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Where have all the patient safety activists gone? … Answer: They’re still around, just a bit quieter

Today, Sept. 17, is the first World Patient Safety Day, declared by the World Health Organization to draw attention to ever-present need – still – to reduce avoidable patient harm in health care settings.

And November marks the 20th anniversary of “To Err is Human,” the National Academy of Medicine’s 1999 report that estimated as many as 98,000 people die a year in United States hospitals. That widely publicized report called for a national agenda to improve patient care processes to make it easier for honest providers to safely treat patients and harder for them to cause harm. Continue reading

Conference among many efforts to reduce diagnostic errors

Photo: Matthew Hadley via Flickr

Every nine minutes, someone in a U.S. hospital dies due to a medical diagnosis that was wrong or delayed. This jarring fact is front and center on the home page of the Society to Improve Diagnosis in Medicine (SIDM). Reducing this number to zero is why some 400 physicians, nurses, patients, health institutions, nonprofits, and policymakers gathered in New Orleans this week for the 11th annual Diagnostic Error in Medicine Annual International Conference. Continue reading

Moore Foundation awards $500,000-plus grant to AHCJ

The Center for Excellence in Health Care Journalism, the educational arm of the Association of Health Care Journalists, has been awarded a grant of more than half a million dollars to strengthen the knowledge and skills of health care journalists.

The Gordon and Betty Moore Foundation made the three-year grant of $509,400 to the Missouri-based center to assist in educating journalists in building their knowledge base in several areas.

Along with continuing the foundation’s support of a web-based core curriculum on health information technology, the grant will support a new curriculum on patient safety, curated resources for freelance journalists and an endowing sponsorship of the annual conference of AHCJ.

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Weaving data, human stories into compelling series on dental deaths

Brooks Egerton

Brooks Egerton

In early 2014, a 4-year-old Dallas boy named Salomon Barahona Jr. died after undergoing sedation for a dental procedure.

The child’s death spurred Dallas Morning News reporter Brooks Egerton to embark upon what turned out to be a major reporting project – an 18-month investigation of dental safety in the United States.

Egerton sifted through thousands of records detailing patient harm and endangerment drawn from many sources: state and federal regulators, police, coroners, academic researchers, courts, litigators, insurers, dental schools and dentists themselves. Continue reading