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Medical devices have historically been less regulated than their drug and biologic counterparts. A benefit of this less demanding regulatory regime is facilitating innovation by making new devices available to consumers in a timely fashion. Nevertheless, there is increasing concern that this approach raises serious public health and safety concerns. The Institute of Medicine in 2011 published a critique of the American pathway allowing moderate-risk devices to be brought to the market through the less-rigorous 501(k) pathway,1 flagging a need for increased postmarket review and surveillance. High-profile recalls of medical devices, such as vaginal mesh products, along with reports globally of nearly two million injuries and more than 80,000 deaths linked to faulty medical devices,2 have raised public health critiques regarding the oversight of these products. Should we follow the recommendation of the Institute of Medicine to reduce the use of the 510(k) pathway, and, if so, what should replace it? What would an ideal regulatory pathway, reflecting the twin goals of innovation and patient protection, look like in the twenty-first century? These questions are complicated by new tools and mechanisms that can be used to achieve our goals. For example, in an era of big data, where we have the capabilities to better follow postmarket incidents, what should postmarket review look like?
Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core.
The criteria for objective memory impairment in mild cognitive impairment (MCI) are vaguely defined. Aggregating the number of abnormal memory scores (NAMS) is one way to operationalise memory impairment, which we hypothesised would predict progression to Alzheimer’s disease (AD) dementia.
As part of the Australian Imaging, Biomarkers and Lifestyle Flagship Study of Ageing, 896 older adults who did not have dementia were administered a psychometric battery including three neuropsychological tests of memory, yielding 10 indices of memory. We calculated the number of memory scores corresponding to z ≤ −1.5 (i.e., NAMS) for each participant. Incident diagnosis of AD dementia was established by consensus of an expert panel after 3 years.
Of the 722 (80.6%) participants who were followed up, 54 (7.5%) developed AD dementia. There was a strong correlation between NAMS and probability of developing AD dementia (r = .91, p = .0003). Each abnormal memory score conferred an additional 9.8% risk of progressing to AD dementia. The area under the receiver operating characteristic curve for NAMS was 0.87 [95% confidence interval (CI) .81–.93, p < .01]. The odds ratio for NAMS was 1.67 (95% CI 1.40–2.01, p < .01) after correcting for age, sex, education, estimated intelligence quotient, subjective memory complaint, Mini-Mental State Exam (MMSE) score and apolipoprotein E ϵ4 status.
Aggregation of abnormal memory scores may be a useful way of operationalising objective memory impairment, predicting incident AD dementia and providing prognostic stratification for individuals with MCI.
Telehealth continues to experience substantial investment, innovation, and unprecedented growth. However, telehealth has been slow to transform healthcare. Recent developments in telehealth technologies suggest great potential for chronic care management, mental health services, and care delivery in the home—all of which should be particularly impactful for an aging population with physical and cognitive limitations. While this alignment of technological capacity and market demand is promising, legal barriers remain for telehealth operators to scale up across large geographic areas. To better understand how federal and state law can be reformed to enable greater telehealth utilization, we review and extract lessons from (1) establishment of a healthcare relationship, (2) state licensure laws, and (3) reimbursement. We analyze these areas because of the legal ambiguities or inconsistencies they raise depending on the state, which seem to be hampering telehealth growth without necessarily improving quality of care. We propose several solutions for a more unified approach to telehealth regulation that incorporate core bioethics principles of doctor-patient relationship, competence, patient autonomy, as well as population-wide questions of resource allocation and access. Lawmakers should clarify that healthcare relationships may be established outside of in-person meetings, align licensure laws via an interstate compact or federal preemption, and expand Centers for Medicare and Medicaid plans to reimburse telehealth delivery in the home.
World War II was a global war. It was a war of transport, mobility, and speed, fought in the far corners of the planet, across four continents and four oceans. It was also a gross national product war, fought with huge armies equipped with the fruits of modern industry – guns, artillery, tanks, trucks, airplanes, and thousands of other tools and supplies. To fight a war of men and material simultaneously on opposite sides of the earth, the United States needed weapons of speed and distance, such as the airplane, but also tools of mobile transport, such as heavy trucks – and they needed them in record numbers. The United States also required a transportation infrastructure at home (and abroad) that could deliver people and resources where needed for production and warfare.
Studies have shown that US college and university professors are disproportionately left-leaning and Democratic and these tendencies are especially pronounced in the social sciences. Critics of this ideological homogeneity have leveled a wide range of charges in light of these findings: that these political orientations seep into research and teaching, that it affects accumulated knowledge, policymaking, student attitudes, American political culture, and that it promotes motivated reasoning, bias, and groupthink. This chapter reviews the most credible of the arguments for greater ideological diversity and attempts to move beyond applied concerns by asking whether and how discussion of political diversity and bias in academia might be reconceptualized to form the basis for meaningful empirical studies.
Pain may be asked as part of a viva topic or candidates may be lucky or unlucky enough to have a full 5-minute viva devoted to the topic. It is an important part of orthopaedic practice which is often neglected, but more important now with the push towards day-case surgery and even day-case arthroplasty. Pain is well known to appear as questions in the Part I MCQ/SBA exam.
This viva can be awkward, as bits and pieces such as pain assessment can appear fluffy to orthopods and in real life is best left to the anaesthetists.
The 21st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), i.e., groups of primary care clinicians and practices in all 50 states working to improve clinical care and translate research findings into practice. This symposium contribution seeks to (1) describe some of the common shortcomings of clinical trials, (2) explore the opportunities and challenges posed by use of real-world evidence as a basis for drug and device regulation, (3) briefly describe the history and evolution of PBRNs, and (4) articulate the challenges and opportunities for using PBRNs to fulfill the 21st Century Cures Act mandate for real-world evidence.
Discovery of strongly-lensed gravitational wave (GW) sources will unveil binary compact objects at higher redshifts and lower intrinsic luminosities than is possible without lensing. Such systems will yield unprecedented constraints on the mass distribution in galaxy clusters, measurements of the polarization of GWs, tests of General Relativity, and constraints on the Hubble parameter. Excited by these prospects, and intrigued by the presence of so-called “heavy black holes” in the early detections by LIGO-Virgo, we commenced a search for strongly-lensed GWs and possible electromagnetic counterparts in the latter stages of the second LIGO observing run (O2). Here, we summarise our calculation of the detection rate of strongly-lensed GWs, describe our review of BBH detections from O1, outline our observing strategy in O2, summarize our follow-up observations of GW170814, and discuss the future prospects of detection.
Medical and public health research includes surveys, interviews, and biospecimens — techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this system, but has not yet specified the form that it will use instead. By examining the policies of the top 50 research institutions, this article assesses institutional practices surrounding exempt research, quantifies the extent of exempt-research review requirements, documents a problem of “over-compliance,” and makes recommendations for reform.
This Article explores two ways in which airline travel is an important vector for the spread of infectious disease, and argues that airlines have market-based and liability-based reasons to require that passengers be vaccinated. Going further, the Article explores whether the federal government has the legal and constitutional authority—especially under the Commerce Clause—to encourage or mandate that airlines implement such a vaccine screen. By disrupting the spread of disease at key network nodes where individuals interact and then connect with other geographic regions, and by creating another incentive for adult vaccination, an airline vaccine screen could be an effective and legally viable tool for the protection of public health.