Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.

Nearly all medical devices reviewed by the U.S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. Established in 1976, this review pathway bases authorizations on the comparability of new devices to previously authorized devices ("predicates"). This evaluation usually does not require clinical evidence of safety and effectiveness. Advocates of the 510(k) clearance process tout its support for device innovation and rapid market access, and critics of the 510(k) clearance process express that it may inadequately protect patient safety. In September 2023, the FDA issued 3 guidance documents that, if finalized, would significantly change medical device regulation. This article provides clinical and regulatory context for the proposed guidance documents, which focus on predicate selection, clinical testing requirements, and implantable devices, and identifies opportunities for further reforms that promote transparency and patient safety.

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.

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.

Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls.

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.

Hospital-at-Home: Multistakeholder Considerations for Program Dissemination and Scale.

Policy Points Hospital-at-Home (HaH) is a home-based alternative for acute care that has expanded significantly under COVID-19 regulatory flexibilities. The post-pandemic policy agenda for HaH will require consideration of multistakeholder perspectives, including patient, caregiver, provider, clinical operations, technology, equity, legal, quality, and payer. Key policy challenges include reaching a consensus on program standards, clarifying caregivers' issues, creating sustainable reimbursement mechanisms, and mitigating potential equity concerns. Key policy prescriptions include creating a national surveillance system for quality and safety, clarifying legal standards for care in the home, and deploying payment reforms through value-based models.

Neutrophils promote tumor resistance to radiation therapy.

Nearly two-thirds of cancer patients are treated with radiation therapy (RT), often with the intent to achieve complete and permanent tumor regression (local control). RT is the primary treatment modality used to achieve local control for many malignancies, including locally advanced cervical cancer, head and neck cancer, and lung cancer. The addition of concurrent platinum-based radiosensitizing chemotherapy improves local control and patient survival. Enhanced outcomes with concurrent chemoradiotherapy may result from increased direct killing of tumor cells and effects on nontumor cell populations. Many patients treated with concurrent chemoradiotherapy exhibit a decline in neutrophil count, but the effects of neutrophils on radiation therapy are controversial. To investigate the clinical significance of neutrophils in the response to RT, we examined patient outcomes and circulating neutrophil counts in cervical cancer patients treated with definitive chemoradiation. Although pretreatment neutrophil count did not correlate with outcome, lower absolute neutrophil count after starting concurrent chemoradiotherapy was associated with higher rates of local control, metastasis-free survival, and overall survival. To define the role of neutrophils in tumor response to RT, we used genetic and pharmacological approaches to deplete neutrophils in an autochthonous mouse model of soft tissue sarcoma. Neutrophil depletion prior to image-guided focal irradiation improved tumor response to RT. Our results indicate that neutrophils promote resistance to radiation therapy. The efficacy of chemoradiotherapy may depend on the impact of treatment on peripheral neutrophil count, which has the potential to serve as an inexpensive and widely available biomarker.

Trends in Labor Unionization Among US Health Care Workers, 2009-2021.

Importance: Labor unionization efforts have resurged in the US, and union membership has been shown to improve worker conditions in some industries. However, little is known about labor unionization membership and its economic effects across the health care workforce. Objectives: To examine the prevalence of labor unionization among health care workers and its associations with pay, noncash benefits, and work hours. Design, Setting, and Participants: This cross-sectional study was conducted using data from the Current Population Survey and Annual Social and Economic Supplement from 2009 through 2021. The US nationally representative, population-based household survey allowed for a sample of 14 298 self-identified health care workers (physicians and dentists, advanced practitioners, nurses, therapists, and technicians and support staff). Exposures: Self-reported membership status or coverage in a labor union. Main Outcomes and Measures: Prevalence and trend in labor unionization. Further comparisons included mean weekly pay, noncash benefits (pension or other retirement benefits; employer-sponsored, full premium-covered health insurance; and employer's contribution to the worker's health insurance plan), and work hours. Results: The 14 298 respondents (81.5% women; 7.1% Asian, 12.0% Black, 8.5% Hispanic, 70.4% White individuals; mean [SD] age, 41.6 [13.4] years) included 1072 physicians and dentists, 981 advanced practitioners, 4931 nurses, 964 therapists, and 6350 technicians and support staff. After weighting, 13.2% (95% CI, 12.5% to 13.8%) of respondents reported union membership or coverage, with no significant trend from 2009 through 2021 (P = .75). Among health care workers, those who were members of a racial or ethnic minority group (Asian, Black, or Hispanic individuals compared with White individuals) and those living in metropolitan areas were more likely to report being labor unionized. Reported unionization was associated with significantly higher reported weekly earnings ($1165 vs $1042; mean difference, $123 [95% CI, $88 to $157]; P < .001) and higher likelihood of having a pension or other retirement benefits at work (57.9% vs 43.4%; risk ratio [RR], 1.33 [95% CI, 1.26 to 1.41]; P < .001) and having employer-sponsored, full premium-covered health insurance (22.2% vs 16.5%; RR, 1.35 [95% CI, 1.17 to 1.53]; P < .001). Union members reported more work hours (37.4 vs 36.3; mean differences, 1.11 [95% CI, 0.46 to 1.75]; P < .001) per week. White workers reported mean weekly earnings that were significantly more than members of racial and ethnic minority groups among nonunionized workers ($1066 vs $1001; mean difference, $65 [95% CI, $40 to $91]; P < .001), but there was no significant difference between the 2 groups among unionized workers ($1157 vs $1170; mean difference, -$13 [95% CI, -$78 to $52]; P = .70). Conclusions and Relevance: From 2009 through 2021, labor unionization among US health care workers remained low. Reported union membership or coverage was significantly associated with higher weekly earnings and better noncash benefits but greater number of weekly work hours.

Comparison of the Financial and Operational Characteristics of For-Profit and Nonprofit Hospitals Receiving Federal Graduate Medical Education Payments, 2011-2020.

This study compares graduate medical education (GME) payments between nonprofit and for-profit hospitals between 2011 and 2020 to assess how hospitals value GME.

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.

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.