Tag: medical devices

Bioethics Blogs

A Modest Proposal

FDA should regulate digital games, and potentially other apps, as medical devices.

Why, pray tell?

One doesn’t have to look very hard to find a growing belief (recognition?) that video games are addicting.  CBS has been on the story since at least 2007.  In 2014, “60 minutes” suggested that a violent video game could prompt murder.  Well, they posed it as a question, but to raise it as they did sounds kind of like asking someone, “have you stopped beating your wife?”  And this past April, they did a piece with a former Google employee who suggested that tech companies are designing games, if not apps in general, to draw people into compulsive use.  They revisited the topic, with the same interviewee, in June, using the term “brain hacking.”  Frontline on PBS did a series on the topic in 2010, looking at concerns about internet addiction as well as arguments that some games may hone desirable skills.

Concern about the effect our entertainment media have on us, especially on our kids, is certainly not new.  Remember Tipper Gore, who, among other things, wrote a book about the subject 30 years ago?

The difference comes if our apps and games are not just addictive and self-reinforcing, but if their creators and marketers not only know it but make them that way on purpose.

According to the FDA, a medical device, subject to premarketing and postmarketing regulatory controls by the FDA, is defined in Section 201(h) of the Food, Drug, and Cosmetic Act as (emphasis mine in what follows):

  • “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

FDA recall of pacemaker raises questions about cybersecurity

by Karola Kreitmair, PhD

The FDA has issued a recall of 465,000 pacemakers on the grounds that they are vulnerable to hacking. It was discovered that unauthorized users could remotely access the implanted cardiac device and modify its programming, thereby delivering inappropriate shocks or rapidly draining the battery. In effect, a nefarious actor could hack into the very thing tasked with sustaining someone’s life and turn it into the device that kills them.

Now, luckily, patients with affected pacemakers do not need to have the device removed, an in-office software update suffices, and there have been no reports, so far, of anyone being harmed. But it does provide a poignant reminder that allowing cyber-vulnerable technology into our lives and into our bodies comes with serious risks and drawbacks. Beyond pacemakers, individuals rely on an array of wearable devices to monitor and control their health, such as wearable EMG devices to monitor seizures, or wearable patches to deliver personalized medication transdermally. A much broader group of people uses personal technology to enhance their wellbeing through devices such as fitness trackers, sleep trackers, or mental health apps. Moreover, with the internet of things (IoT), technologies are now more interconnected than ever, with cyber pathways opening up between smart household appliances and personal medical devices, via the central role of the smartphone. This makes us vulnerable not only to hackers interfering with the programming of devices, with the possibility of deadly consequences, but also to the massive theft of highly sensitive data.

We should enter into the personalized health and wellness technology era with eyes wide open.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

These New Devices Promise to Fight Pain without Opioids

Terri Bryant was working at a cheese factory in 2000 when she injured the delicate, rubbery discs between her spinal bones. That was the start of her chronic pain. Two years later, she had back surgery and started regularly taking fentanyl, a powerful prescription opioid medication. Her pain persisted even after a second surgery in 2009.

In 2012, Bryant enrolled in a clinical trial for a device known as a spinal cord stimulator, designed to alleviate back pain. The experimental device was implanted under the skin at the base of her spine. When turned on, it sends pulses of a mild electric current to the nerve fibers in her spinal cord.

The therapy is known as neuromodulation or neurostimulation, and scientists think it works by interrupting the pain signals that are carried from the nerves to the brain. The idea has been around since the 1960s, but in recent years the technology has undergone rapid innovation. While drug developers are trying to discover new nonaddictive medicine to treat pain, medical device manufacturers are racing to develop smaller, more comfortable implants as well as external devices that don’t require surgery. The stimulator Bryant got, called the Senza System, is one of a growing number of medical devices to treat pain.

… Read More

Image: By courtesy of Massachusetts General Hospital and Draper Labs – http://www.darpa.mil/ddm_gallery/SUBNET_Final_1.jpg, Public Domain, https://commons.wikimedia.org/w/index.php?curid=33279426

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Jeremy Howick, The Philosophy of Evidence-Based Medicine, Wiley-Blackwell, 2011

The idea that prescribing physicians should be guided by the most reliable scientific evidence seems obvious, but the actual methodology of evidence-based medicine was only introduced in the early 1990s by an international group of clinicians and researchers led by Gordon Guyatt. Since then it has provided a new paradigm for the scientific foundation of medicine and has influenced other disciplines outside of medicine, for example, evidence-based psychotherapy, science and government. The novel concept of evidence-based medicine is based on hierarchies of evidence from opinions of respected authorities, mechanistic reasoning (pathophysiologic rationale), and reports of expert committees at the bottom to various levels of observational studies and finally to randomized clinical trials (RCTs) at the apex of the pyramid. Since RCTs provide the most rigorous testing of therapies, they are the gold standard. When treatments long believed to be safe and effective are subjected to RCTs, many turn out to be as useless as the quackery of snake oil or as harmful as mercury. So, attention to RCTs as the evidence informing clinical judgment and practice is perhaps analogous to results of rigorous experiments in physics which turn out to be very different from our intuitions. Everyone, it seems, is on the bandwagon, from medical societies and pharmaceutical companies to general practitioners and surgeons, in the quest for an evidence-based practice.

Since evidence-based medicine was conceived with the practical aim of improving the efficacy of medicine, it does not appear that there is much of philosophical interest in the concept until one raises the epistemological question, as Jeremy Howick does in this book: What is the evidence for evidence-based medicine philosophy of evidence (9)?

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Time to Secure Your Implantable Medical Devices from Hackers

by Craig Klugman, Ph.D.

In the last few weeks, a major malware attack (WannaCry) paralyzed computers around the world, including electronic health records at the UK’s National Health Service and at hospitals throughout the world. Hacking is a growing problem that can cripple computer systems and even household appliances. Consider that in October 2016, an internet attack came from web-enabled residential devices (cameras, refrigerators, virtual assistants, thermostats, all of which are part of the internet of things) that crippled major websites.…

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Medicine Is Going Digital. The FDA Is Racing to Catch Up

When Bakul Patel started as a policy advisor in the US Food and Drug Administration in 2008, he could pretty much pinpoint when a product was going to land in front of the reviewers in his division. Back when medical devices were heavy on the hardware—your pacemakers and your IUDs—it would take manufacturers years to get them ready for regulatory approval. FDA reviewers could keep up pretty well

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

In the Journals–March 2017, Part I by Julia Kowalski

Here is Part I of our March article round-up.

American Anthropologist

A Dog’s Life: Suffering Humanitarianism in Port-au-Prince, Haiti

Greg Beckett

In the Bel Air neighborhood of Port-au-Prince, Haiti, most residents are dependent on humanitarian and foreign assistance for food, services, aid, and jobs. Yet, some residents feel that the conditions under which such aid is provided actively blocks their ability to live a life they find meaningful. In this article, I explore how some Haitians theorize this humanitarian condition through the figure of the dog, an animal that exemplifies, for Haitians, the deep history of violence, dehumanization, and degradation associated with foreign rule. I then contrast this with how foreign aid workers invoke the figure of the dog to illustrate their compassionate care for suffering others. Drawing on research among Bel Air residents and foreign aid workers in the years after a devastating earthquake destroyed much of Port-au-Prince, I show how the figure of the dog is central both to Haitian critiques of humanitarian aid and to the international humanitarian imaginary that responds to forms of suffering it deems cruel.

Biosocieties

“Let’s pull these technologies out of the ivory tower”: The politics, ethos, and ironies of participant-driven genomic research

Michelle L. McGowan, Suparna Choudhury, Eric T. Juengst, Marcie Lambrix, Richard A. Settersten Jr., Jennifer R. Fishman

This paper investigates how groups of ‘citizen scientists’ in non-traditional settings and primarily online networks claim to be challenging conventional genomic research processes and norms. Although these groups are highly diverse, they all distinguish their efforts from traditional university- or industry-based genomic research as being ‘participant-driven’ in one way or another.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

The Value of Oversight in a Century of Promise & ‘Cures’

This post, by CEC member Paul McLean, originally appeared on WBUR’s CommonHealth blog.
The blood-thinner heparin is not a 21st-century cure. It was discovered 100 years ago by a scientist looking for something else entirely, and is one of the oldest drugs still in regular use.
After my daughter was diagnosed with a potentially fatal blood disorder, heparin played a key daily role in her treatment. We’d wash our hands meticulously, lay out gloves and antiseptic wipes, saline flushes for the access lines to her fragile immune system, and finally the sealed heparin syringe.
For many months, we went through boxes of heparin and never questioned its safety. Never had reason to.
But in 2008, after my daughter was officially declared cured and we’d used heparin for the last time, contamination in the supply from China killed 19 Americans and harmed many others. Writing that sentence still gives me the chills. My daughter survived thanks to medicine, but it also could have killed her.
So you can understand why, as the 21st Century Cures Act sailed to passage, I experienced both excitement and dread.
That heparin contamination was in part due to lax oversight of the drug supply chain. It reminds me why I do not want to see the work of the Food and Drug Administration compromised by overeager drug companies taking advantage of the hopes of desperate patients, and taking shortcuts on safety.
The “giant piñata” of a bill, as science blogger Derek Lowe aptly described the 21st Century Cures Act, is destined to explode in unexpected ways.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Integrated Plans Fertile for Real-World Evidence

January 25, 2017

(Managed Care Magazine) – Real-world evidence (RWE) is the hot topic this year, a way to evaluate treatments—and make changes on the fly, if necessary—under a new president who thinks the FDA moves too slowly. Put simply, RWE looks at how well new medications and medical devices do after they’ve hit the market, relying on data collected outside of traditional clinical studies. Many drugs often don’t do well, said Shalilja Dixit, one of the presenters at a recent conference in Philadelphia by EyeforPharma, a worldwide company that seeks to keep the pharmaceutical industry relevant by tracking shifting trends. Dixit, who studies health outcomes for Intercept Pharmaceuticals, said that 49% of drugs do not have the same impact on outcomes that they had in clinical trials.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

A New Edition of International Journal of Technology Assessment in Health Care Is Now Available

January 18, 2017

International Journal of Technology Assessment in Health Care (vol. 32, no. 4, 2016) is available online by subscription only.

Articles include:

  • “Changing Health Technology Assessment Paradigms?” by Don Husereau, Chris Henshall, Laura Sampietro-Colom, and Sarah Thomas
  • “Scientific and Social Value Judgments for Orphan Drugs in Health Technology Assessment” by Elena Nicod and Panos Kanavos
  • “Cost of Intensive Care in India” by John Victor Peter, Kurien Thomas, Lakshmanan Jeyaseelan, Bijesh Yadav, Thomas Isiah Sudarsan, Jony Christina, Anna Revathi, K R John, and Thambu David Sudarsanam
  • “Health Technology Assessment of Medical Devices in Europe: Processes, Practices, and Methods” by Sabine Fuchs, Britta Olberg, Dimitra Panteli, and Reinhard Busse
  • “Public and Patient Involvement in Health Technology Assessment: A Framework for Action” by Julia Abelson, Frank Wagner, Deirdre DeJean, Sarah Boesveld, Fran?ois-Pierre Gauvin, Sally Bean, Renata Axler, Stephen Petersen, Shamara Baidoobonso, Gaylene Pron, Mita Giacomini, and John Lavis

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.