RESUMEN
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.
RESUMEN
In this Viewpoint, the accuracy, usefulness, and marketing of at-home rape kits is explored.
Asunto(s)
Alta del Paciente , Embolia Pulmonar , Triaje , Humanos , Embolia Pulmonar/terapia , Embolia Pulmonar/diagnóstico , Triaje/métodosRESUMEN
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.
Asunto(s)
Glutaminasa , Glutamina , Sarcoma , Animales , Glutamina/metabolismo , Ratones , Glutaminasa/metabolismo , Glutaminasa/genética , Glutaminasa/antagonistas & inhibidores , Sarcoma/metabolismo , Sarcoma/radioterapia , Sarcoma/genética , Glucosa/metabolismo , Modelos Animales de Enfermedad , Tolerancia a RadiaciónRESUMEN
This essay compares Medicare Advantage's claim denials and reversals with traditional Medicare and questions whether coverage obligations are being met.
Asunto(s)
Medicare Part C , Estados UnidosAsunto(s)
Tecnología Biomédica , Aprobación de Recursos , Accesibilidad a los Servicios de Salud , Cobertura del Seguro , Humanos , Aprobación de Recursos/legislación & jurisprudencia , Accesibilidad a los Servicios de Salud/economía , Accesibilidad a los Servicios de Salud/legislación & jurisprudencia , Cobertura del Seguro/economía , Estados Unidos , United States Food and Drug Administration/legislación & jurisprudencia , Tecnología Biomédica/economía , Tecnología Biomédica/legislación & jurisprudenciaRESUMEN
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.
Asunto(s)
Atención a la Salud , Cirugía General , Mecanismo de Reembolso , Especialización , Maryland , Atención a la Salud/economíaRESUMEN
This cross-sectional study describes the inclusion of unique device identifier in recall notices for moderate- and high-risk medical devices in the US.
Asunto(s)
Aprobación de Recursos , Recall de Suministro Médico , Humanos , Estados Unidos , Factores de Riesgo , United States Food and Drug Administration , Vigilancia de Productos ComercializadosRESUMEN
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.
RESUMEN
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.
Asunto(s)
COVID-19 , Reforma de la Atención de Salud , Humanos , Salud Pública , Sistemas de Datos , Política de SaludRESUMEN
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.
Asunto(s)
Atención a la Salud , Salud Poblacional , Humanos , Estados Unidos , Planes de Aranceles por Servicios , Calidad de la Atención de SaludRESUMEN
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.
Asunto(s)
Salud Urbana , Urbanización , Humanos , Población Urbana , Demografía , CiudadesRESUMEN
Importance: In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. Current regulations permit manufacturers to use devices subject to a Class I recall-the FDA's most serious designation indicating a high probability of adverse health consequences or death-as predicates for new devices. The consequences for patient safety are not known. Objective: To determine the risk of a future Class I recall associated with using a recalled device as a predicate device in the 510(k) pathway. Design and Setting: In this cross-sectional study, all 510(k) devices subject to Class I recalls from January 2017 through December 2021 (index devices) were identified from the FDA's annual recall listings. Information about predicate devices was extracted from the Devices@FDA database. Devices authorized using index devices as predicates (descendants) were identified using a regulatory intelligence platform. A matched cohort of predicates was constructed to assess the future recall risk from using a predicate device with a Class I recall. Main Outcomes and Measures: Devices were characterized by their regulatory history and recall history. Risk ratios (RRs) were calculated to compare the risk of future Class I recalls between devices descended from predicates with matched controls. Results: Of 156 index devices subject to Class I recall from 2017 through 2021, 44 (28.2%) had prior Class I recalls. Predicates were identified for 127 index devices, with 56 (44.1%) using predicates with a Class I recall. One hundred four index devices were also used as predicates to support the authorization of 265 descendant devices, with 50 index devices (48.1%) authorizing a descendant with a Class I recall. Compared with matched controls, devices authorized using predicates with Class I recalls had a higher risk of subsequent Class I recall (6.40 [95% CI, 3.59-11.40]; P<.001). Conclusions and Relevance: Many 510(k) devices subjected to Class I recalls in the US use predicates with a known history of Class I recalls. These devices have substantially higher risk of a subsequent Class I recall. Safeguards for the 510(k) pathway are needed to prevent problematic predicate selection and ensure patient safety.