Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.

BACKGROUND: Cardiovascular devices account for one third of all Class I recalls, the U.S. Food and Drug Administration's (FDA) most severe designation, indicating a reasonable probability of "serious adverse health consequences or death." Understanding recalls and their causes is important for patient safety. OBJECTIVE: To characterize Class I recalls of cardiovascular devices and the clinical evidence supporting authorization. DESIGN: In this cross-sectional study, cardiovascular device recalls from 1 January 2013 through 31 December 2022 were identified using the FDA's annual log. Information about devices was extracted from publicly available FDA decision summaries. SETTING: The FDA Medical Device Recalls database. PARTICIPANTS: Cardiovascular devices with Class I recalls. MEASUREMENTS: Recalls were characterized by their causes and scope. Devices were characterized by their regulatory history (product code, special designations) and clinical evidence (premarket testing, postmarket surveillance). Clinical studies were analyzed for quality, including end point selection (clinical vs. surrogate, use of composites). RESULTS: From 2013 to 2022, there were 137 Class I recall events affecting 157 unique cardiovascular devices, of which 112 (71.3%) were moderate-risk 510(k) devices and 45 (28.7%) were high-risk premarket approval (PMA) devices. Recalls affected a median of 7649 units (IQR, 953 to 28 446) and were most commonly attributed to device design (43 [31.4%]). Forty-two (26.8%) devices had multiple Class I recalls. Thirty (19.1%) devices underwent premarket clinical testing (7 [6.2%] 510(k) devices, 17 [85.0%] PMA devices, and 6 [24.0%] PMA supplement devices). Most studies used surrogate (27 [79.4%]) and composite (24 [70.6%]) measures as primary end points. Twenty-two (48.9%) PMA devices had required postapproval studies, with 14 reporting delays. No 510(k) devices were subject to postmarket surveillance. LIMITATION: Details about clinical testing may be missing from FDA summaries. CONCLUSION: Cardiovascular devices with Class I recalls were infrequently subjected to premarket or postmarket testing, with recalls affecting thousands of patients annually. PRIMARY FUNDING SOURCE: None.

At-Home Testing for Survivors of Sexual Assault-Empowerment or Exploitation?

In this Viewpoint, the accuracy, usefulness, and marketing of at-home rape kits is explored.

Targeting glutamine metabolism improves sarcoma response to radiation therapy in vivo.

Diverse tumor metabolic phenotypes are influenced by the environment and genetic lesions. Whether these phenotypes extend to rhabdomyosarcoma (RMS) and how they might be leveraged to design new therapeutic approaches remains an open question. Thus, we utilized a Pax7Cre-ER-T2/+; NrasLSL-G12D/+; p53fl/fl (P7NP) murine model of sarcoma with mutations that most frequently occur in human embryonal RMS. To study metabolism, we infuse 13C-labeled glucose or glutamine into mice with sarcomas and show that sarcomas consume more glucose and glutamine than healthy muscle tissue. However, we reveal a marked shift from glucose consumption to glutamine metabolism after radiation therapy (RT). In addition, we show that inhibiting glutamine, either through genetic deletion of glutaminase (Gls1) or through pharmacological inhibition of glutaminase, leads to significant radiosensitization in vivo. This causes a significant increase in overall survival for mice with Gls1-deficient compared to Gls1-proficient sarcomas. Finally, Gls1-deficient sarcomas post-RT elevate levels of proteins involved in natural killer cell and interferon alpha/gamma responses, suggesting a possible role of innate immunity in the radiosensitization of Gls1-deficient sarcomas. Thus, our results indicate that glutamine contributes to radiation response in a mouse model of RMS.

A Patient-Centered Documentation Skills Curriculum for Preclerkship Medical Students in an Open Notes Era.

Introduction: New legislation allows patients (with permitted exceptions) to read their clinical notes, leading to both benefits and ethical dilemmas. Medical students need a robust curriculum to learn documentation skills within this challenging context. We aimed to teach note-writing skills through a patient-centered lens with special consideration for the impact on patients and providers. We developed this session for first-year medical students within their foundational clinical skills course to place bias-free language at the forefront of how they learn to construct a medical note. Methods: One hundred seventy-three first-year medical and dental students participated in this curriculum. They completed an asynchronous presession module first, followed by a 2-hour synchronous workshop including a didactic, student-led discussion and sample patient note exercise. Students were subsequently responsible throughout the year for constructing patient-centered notes, graded by faculty with a newly developed rubric and checklist of best practices. Results: On postworkshop surveys, learners reported increased preparedness in their ability to document in a patient-centered manner (presession M = 2.2, midyear M = 3.9, p < .001), as rated on a 5-point Likert scale (1 = not prepared at all, 5 = very prepared), and also found this topic valuable to learn early in their training. Discussion: This curriculum utilizes a multipart approach to prepare learners to employ clinical notes to communicate with patients and providers, with special attention to how patients and their care partners receive a note. Future directions include expanding the curriculum to higher levels of learning and validating the developed materials.

Coverage Denials in Medicare Advantage-Balancing Access and Efficiency.

This essay compares Medicare Advantage's claim denials and reversals with traditional Medicare and questions whether coverage obligations are being met.

Transforming Value-Based Dementia Care-Implications for the GUIDE Model.

This Viewpoint reviews the Guiding an Improved Dementia Experience (GUIDE) Model to assess its suitability in providing equitable and cost-effective dementia care and to compare it with previously introduced specialty care payment models to identify opportunities for refining payment innovation in dementia care.

Transforming Specialty Care Delivery and Payment Under Global Budgets-Insights from the Provision of Surgical Services in Maryland.

This Viewpoint discusses Maryland's global budget revenue model, which centrally regulates reimbursement rates for all payers via a hospital-specific, prospectively set cap on total annual revenue across all care sites.

Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022.

This cross-sectional study describes the inclusion of unique device identifier in recall notices for moderate- and high-risk medical devices in the US.

Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study.

Background: Medical device recalls are initiated in response to safety concerns. Class I (highest severity) recalls imply a reasonable likelihood of serious adverse events or death associated with device use. Recalled devices must be identified, assessed, and corrected or removed, upon which a recall can be terminated. Objective: To characterize Class I medical device recalls and corresponding recalled devices. Methods: This was a cross-sectional study of Class I recalls posted on the Food and Drug Administration's annual log from January 1, 2018 to June 30, 2022 for moderate-risk and high-risk medical devices. Devices were categorized by therapeutic use, need for implantation, and life-sustaining designation; recalls were categorized by reason, status, and time elapsed. Results: There were 189 unique Class I medical device recalls, including 151 (79.9%) for moderate-risk and 34 (18.0%) for high-risk devices. Sixty-five (34.4%) recalls were for cardiovascular devices, 36 (19.0%) for implanted devices, and 37 (19.6%) for life-sustaining devices. The median number of device units recalled in the US per recall notice was 4620 (interquartile range [IQR], 578-42,591), with 11 (5.8%) recalls associated with more than 1 million device units. Overall, 125 (66.1%) devices had multiple recalls, with a median of 4 (IQR, 3-11) recalls issued per recalled device. As of September 15, 2022, 50 (26.5%) recalls were terminated, with a median of 24 (IQR, 17.3-30.8) months elapsed between recall initiation and termination. Recalls were terminated more commonly among devices recalled once compared to those recalled multiple times (36.2% vs 19.2%; p=0.02) and for recalls that recommended discontinuing further use of affected devices compared to those that recommended device assessment and/or education of affected population (31.8% vs 18.2%; p=0.04). Conclusion: High-severity medical device recalls are common and affect millions of device units annually in the US. Recall termination takes a significant amount of time, putting patients at risk for serious safety concerns.

Transforming Public Health Data Systems to Advance the Population's Health.

Policy Points Accurate and reliable data systems are critical for delivering the essential services and foundational capabilities of public health for a 21st -century public health infrastructure. Chronic underfunding, workforce shortages, and operational silos limit the effectiveness of America's public health data systems, with the country's anemic response to COVID-19 highlighting the results of long-standing infrastructure gaps. As the public health sector begins an unprecedented data modernization effort, scholars and policymakers should ensure ongoing reforms are aligned with the five components of an ideal public health data system: outcomes and equity oriented, actionable, interoperable, collaborative, and grounded in a robust public health system.

The Next Generation of Payment Reforms for Population Health - An Actionable Agenda for 2035 Informed by Past Gains and Ongoing Lessons.

Policy Points The predominantly fee-for-service reimbursement architecture of the US health care system contributes to waste and excess spending. While the past decade of payment reforms has galvanized the adoption of alternative payment models and generated moderate savings, uptake of truly population-based payment systems continues to lag, and interventions to date have had limited impact on care quality, outcomes, and health equity. To realize the promise of payment reforms as instruments for delivery system transformation, future policies for health care financing must focus on accelerating the diffusion of value-based payment, leveraging payments to redress inequities, and incentivizing partnerships with cross-sector entities to invest in the upstream drivers of health.

Urbanization and the Future of Population Health.

Policy Points Cities, which are where the majority of the world's population lives today, directly and indirectly shape human health and well-being. Urban health research, policy, and practice are increasingly using a systems science approach to address the upstream and downstream drivers of health in cities, which include social and environmental factors, features of the built environment, conditions of living, and health care resources. To guide future scholarship and policy, we propose an urban health agenda for 2050 focused on revitalizing the sanitation movement, integrating data, scaling best practices, adopting the Health in All Policies approach, and addressing intraurban health inequities.