The FDA’s NEST Initiative and Women’s Health

The history of medical device regulation in the United States has been shaped by the prominent failure of individual devices, many of which were indicated for women.

The Dalkon Shield intrauterine device infamously ushered in the 1976 amendments to the Federal Food, Drug, and Cosmetics Act, establishing the first pre-market notification and approval process for medical devices in the United States. Similarly, a series of failures among devices designed for women’s health—including the power morcellator, the Essure System, and pelvic mesh—has recently invigorated the FDA’s focus on its post-market regime. Read More

Report: Maternal Mental Health Must be a Top Priority

The U.S. Preventive Services Task Force (USPSTF), published recommendations recently urging clinicians to refer pregnant and postpartum women to counseling if they are at risk of depression.

The recommendations respond to the prevalence of perinatal depression, which is considered to be the most common pregnancy complication. Perinatal depression, affects up to one in seven women and can develop at any time after a woman becomes pregnant, immediately following the brith of a child, or even up to a year after.

Among the many concerning potential consequences of maternal depression are premature births and low birth weights, as well as neglect and inattentiveness from mothers after the baby is born, which can subject infants to risk of additional problems, according to Karina Davidson, a USPSTF member who helped write the recent recommendations. Read More

NHS logo on the side of a building

Update on the Future Direction of Patient Safety in the National Health Service

Matt Hancock, the Secretary of State for Health and Social Care on February 6 gave a wide-ranging speech on the future direction of patient safety in the NHS. The speech is important as it gives key insights into government priorities for patient safety policy development in the NHS.He stated that we all trust nurses and doctors more than any other profession. He spoke about the importance of a “just culture” in the NHS and openness, honesty, and trustworthiness. Read More

Image of a pile of gold coins on top of a map showing African continent

Repayment for Training as an Optimal Solution to Medical Brain Drain

In an earlier post I offered two arguments for why wealthy nations have a moral obligation to address medical professional brain drain from resource-scarce developing nations. But once one acknowledges that wealthy nations have this obligation, a question remains as to what the best way to fulfill that obligation is.

Some have suggested that the solution is for wealthy nations to train an ample amount of doctors in their home countries so that they no longer need to take talent from developing nations to make up for the gap. This idea has intuitive appeal. After all, it allows more medical doctors to be trained in wealthy nations like the U.S. and results in more doctors being trained overall (assuming that developing nations would continue to train the same amount of doctors under such a model). Read More

Machine Learning in Medicine: Addressing Ethical Challenges

Machine learning in medicine is accelerating at an incredible rate, bringing a new era of ethical and regulatory challenges to the clinic.

In a new paper published in PLOS Medicine, Effy Vayena, Alessandro Blasimme, and I. Glenn Cohen spell out these ethical challenges and offer suggestions for how Institutional Review Boards (IRBs), medical practitioners, and developers can ethically deploy machine learning in medicine (MLm). Read More

group of nurses walking in hospital hallway

Burnout and Moral Distress in Nurses: Can Staffing Numbers Increase Patient Safety?

I know Nurse X only by her failures the night a young woman with asthma died gasping for breath just steps from the emergency entrance of Somerville Hospital. The preventable nature of the woman’s death, and the discovery of that hard truth by her husband, are described thoroughly and compellingly in Sunday’s Boston Globe magazine.

This death was the result of medical error, estimated to be the third leading cause of death behind heart disease and cancer.

But the blurry image of Nurse X, standing in the ER doorway and failing to see the dying woman in the shadows steps away, is for me a snapshot of burnout. I’ll carry it with me to the voting booth on Tuesday when I stare at Question 1, the ballot measure in Massachusetts that could determine and lock into place nurse-to-patient staffing levels. Read More

health secretary matt hancock leaves 10 downing street

No room for complacency in patient safety in the NHS

Matt Hancock, the recently appointed Government, Health and Social Care Secretary, made a keynote speech on patient safety in London recently. The speech spelled out the future direction of NHS (National Health Service) patient safety policy development in England and also contained some very useful observations and policy which have relevance to patient safety policy developers globally, as well as in England.

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millennial man at home sick with scarf and thermometer talking on the phone

The Millennial Need for Speed in Healthcare

According to a recent Kaiser Family Foundation (KFF) poll, shockingly large swaths of Americans have reported that they don’t have a primary care provider.

The July 2018 report found that 45 percent of 18-29 year olds, as well as 28 and 18 percent of 30-49 and 50-64 year olds, respectively, also lack designated primary care.

Kaiser Health News (KHN) explained that the price transparency, convenience, and speed of alternatives to office-based primary care physician (PCP) visits appear to be some of the preferences driving these patterns. Retail clinics, urgent care centers, and telemedicine websites satisfy many of these preferences, and are therefore appealing alternatives to scheduled appointments with a PCP. For example, extended hours and shorter wait times at increasingly widespread retail clinics have attracted young patients who want to avoid the hassle and wait times involved in scheduling and attending a traditional doctors office.

A 2015 PNC Healthcare survey similarly found that millennials saw their PCP significantly less (61 percent) than baby boomers and seniors (80 and 85 percent, respectively). The study emphasized the effects of technology on millennials’ trends in healthcare acquisition, such as higher utilization of online reviews to shop for doctors (such as Yelp). It also found that millennials are much more likely to prefer retail and acute care clinics, and are more likely to postpone treatment due to high costs than older generations.

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Adverse Health Event Reporting in Minnesota a Valuable Tool

By John Tingle

doctors performing surgery
Medical errors are a common cause of death globally. (thinkpanama/flickr)

“Medical errors are the third leading cause of death in the United States,” says a new report by the World Health Organization. And in the United Kingdom, “recent estimations show that on average, one incident of patient harm is reported every 35 seconds.”

Patient safety remains an issue of concern for all countries across the globe. But by observing what other countries do and report about patient safety we can avoid the costly mistake of trying to reinvent the wheel when information is already available about important trends.

The Minnesota Department of Health (MDH) have recently published their 14th Annual Public Report on Adverse Health Events in Minnesota. The report contains a lot of detailed patient safety information, analysis, and trends which will be of use to health carers and patient safety policy developers everywhere.

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From bioethics to medical anthropology to humanities and back: A year in review

I thought I would take this opportunity to reflect on the past year, where I will be in the future, and how the student fellowship has impacted me. I still hope to contribute to the Bill of Health blog going forward, but as my last official post as a Petrie-Flom Student Fellow, I would be remiss if I did not express my sincere gratitude to everyone at the Petrie-Flom Center, the faculty and staff, the other student fellows, and especially my mentors: Professors I. Glenn Cohen, Carmel Shachar, and Intisar A. Rabb.

My own project took a few different turns this year. My original proposal was to explore the ways in which bioethics and biomedical issues will play a significant role in reviving the dialectic between secular scholars and religious authority. Ayman Shabana rightly argues that respect for Islamic religious norms is essential for the legitimacy of bioethical standards in the Muslim context, wherein he attributes the legitimating power of these norms—as well as their religious and spiritual underpinnings—to their moral, legal, and communal dimensions. Building off of Shabana’s work, my initial argument held that the relationship between the secular and religious worlds is important because the discourse between the two, although often presumed to be dichotomous, is not necessarily antithetical nor is it impassable. This led me back to the arguments of the venerable philosophers Alasdair MacIntyre and Charles Taylor whereby, in critiquing the concept of secularism itself along with its historical contexts, furthered my argument and helped me to clarify the significant role that religion plays vis-à-vis categorical issues such as fundamental beliefs and metaphysics. I still maintain this, and it is something I continue to work on, although I decided to take my project in another direction.

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