RESUMO
Radiologists are facing ever increasing volumes while trying to provide value-based care. There are several drivers of increasing volumes: increasing population size, aging population, increased utilization, gaps in evidence-based care, changes in the provider workforce, defensive medicine, and increasing case complexity. Higher volumes result in increased cognitive and systemic errors and contribute to radiologist fatigue and burnout. We discuss several strategies for mitigating high volumes including abbreviated MRI protocols, 24/7 radiologist coverage, reading room assistants, and other strategies to tackle radiologist burnout.
Assuntos
Esgotamento Profissional , Radiologistas , Idoso , Humanos , Imageamento por Ressonância Magnética , Recursos HumanosRESUMO
The modern-day radiologist must be adept at image interpretation, and the one who most successfully leverages new technologies may provide the highest value to patients, clinicians, and trainees. Applications of virtual reality (VR) and augmented reality (AR) have the potential to revolutionize how imaging information is applied in clinical practice and how radiologists practice. This review provides an overview of VR and AR, highlights current applications, future developments, and limitations hindering adoption.
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Realidade Aumentada , Radiologia , Realidade Virtual , HumanosRESUMO
Between 2002 and 2016, 806 million medical devices were recalled. When approving a device, the FDA employs advisory boards organized by medical specialty (e.g. cardiovascular) to make approval recommendations. Previous work has demonstrated high numbers of recalled orthopedic and cardiovascular devices; however, no prior studies have controlled for the number of approvals by advisory board. The purpose of this study is to identify device fields at higher risk for safety problems. This study compares specialty-specific, approval-adjusted recall rates of high-risk medical devices from 2002 to 2016 by utilizing publicly available FDA data on recalls and approvals. Devices approved under general hospital (113), anesthesiology (98), and cardiovascular (98) advisory boards constituted 71% of all class I recalls. For devices approved via the more rigorous pre-market approval pathway, those under the purview of the general hospital (0.25 recalls/approval, 95% CI 0.15 - 0.41) advisory board had a significantly higher rate than average (p<0.05). For 510(k) cleared devices, microbiology (6.0 recalls/clearance, 95% CI 3.4 - 10.6), anesthesiology (0.04 recalls/clearance, 95% CI 0.03 - 0.04), general hospital (0.02 recalls/clearance, 95% CI 0.02 - 0.02), and cardiovascular (0.010 recalls/ clearance, 0.009 to 0.015) advisory boards had significantly higher recall rates than average (p<0.05). Future regulatory resources should be directed towards device areas and approval pathways that pose a higher risk for safety problems.
Assuntos
Equipamentos e Provisões/efeitos adversos , Recall de Dispositivo Médico , United States Food and Drug Administration , Estados UnidosRESUMO
OBJECTIVE: To assess recent high-risk ophthalmic medical device recalls. METHODS: The publicly available Food and Drug Administration Center for Devices and Radiological Health database was mined for Class I (high-risk) ophthalmic device recalls from January 1, 2003 to December 31, 2015. The number of Class I ophthalmic device recalls was quantified. Additionally, recall characteristics and market entry data were determined for each device. RESULTS: Twelve Class I ophthalmic device recall events were identified, collectively affecting over 68 million units in distribution. A median of 147,491 units (range 20 to 57,252,581) were recalled per event. 9 out of 12 recalls (75%) had at least one documented occurrence of an adverse event to a patient. Pre-market related issues accounted for one device recall (8%), post-market related issues accounted for nine device recalls (75%), and two device recalls (17%) were indeterminate. 510(k) clearance was the most common pathway to market, accounting for 50% of Class I recalls. Three devices were approved through pre-market approval (PMA) pathway, two devices were exempt from review, and one device failed to register with the FDA. CONCLUSION: Class I recalls surrounding ophthalmology are relatively infrequent compared to other medical specialties. However, given the impact of Class I recalls in the field, ophthalmologists have an impetus to advocate for stronger device regulation particularly in the context of post-marketing surveillance.
Assuntos
Recall de Dispositivo Médico , Oftalmologia/instrumentação , United States Food and Drug Administration/estatística & dados numéricos , Bases de Dados Factuais , Segurança de Equipamentos , Humanos , Estudos Retrospectivos , Fatores de Risco , Estados UnidosRESUMO
As radiology is inherently a data-driven specialty, it is especially conducive to utilizing data processing techniques. One such technique, deep learning (DL), has become a remarkably powerful tool for image processing in recent years. In this work, the Association of University Radiologists Radiology Research Alliance Task Force on Deep Learning provides an overview of DL for the radiologist. This article aims to present an overview of DL in a manner that is understandable to radiologists; to examine past, present, and future applications; as well as to evaluate how radiologists may benefit from this remarkable new tool. We describe several areas within radiology in which DL techniques are having the most significant impact: lesion or disease detection, classification, quantification, and segmentation. The legal and ethical hurdles to implementation are also discussed. By taking advantage of this powerful tool, radiologists can become increasingly more accurate in their interpretations with fewer errors and spend more time to focus on patient care.
Assuntos
Aprendizado Profundo , Radiologia , Humanos , Processamento de Imagem Assistida por ComputadorRESUMO
Medical malpractice plaintiff firms play a central role in the prosecution of malpractice claims. There have been limited studies on the online advertising practices of plaintiff medical malpractice firms. The Martindale-Hubbell directory was used to identify all plaintiff medical malpractice firms in Suffolk County, Massachusetts. Each firm's website was individually mined for relevant data. Thirty-one unique medical malpractice law firms were identified. Seventy-seven percent of law firms advertised awards with the Martindale-Hubbell AV rating, AVVO, and Super Lawyer being the three most common. The second most common method of advertising was accomplished through descriptions of successful verdicts and settlements (61%). A total of 408 verdicts, settlements, and arbitrations collectively representing $1.4 billion dollars were advertised by all law firms. Median awarded values for verdicts was advertised as $4.5 million, while the median awarded values for settlements was $1.25 million. Defendants most commonly practiced obstetrics (18%), followed by primary care (14%). Law firms report treatment and diagnosis delay as the most common successful claim (50%), followed much further by misdiagnosis (8%), and communication error (4%). Our sample correlates with larger claims-based studies surrounding the most commonly sued specialties, however, median reported settlement and verdict values were significantly higher in our cohort. Considerations should be made to provide advertising guidelines for medical malpractice plaintiff firms.
Assuntos
Publicidade , Erros de Diagnóstico/legislação & jurisprudência , Imperícia/legislação & jurisprudência , Estudos Transversais , Humanos , MassachusettsRESUMO
IMPORTANCE: The US Food and Drug Administration (FDA) recently issued a safety warning regarding soft-tissue fillers (STFs) based on the risk of blindness and facial necrosis. OBJECTIVE: To examine the quality of evidence leading to FDA approval of STFs. EVIDENCE REVIEW: All original approvals for STFs were mined using the publicly available FDA database. The Cochrane Collaboration's risk of bias assessment tool was applied to all randomized clinical trials (RCTs). FINDINGS: A total of 14 STF approvals were identified. Of those, 10 pivotal studies (71%) were RCTs and 9 (60%) were masked. The median number of patients per trial was 144 (range, 30-439). Eleven of 12 studies (92%) met their primary end point. Ten of 14 trials (71%) involved injections solely of the nasolabial folds or cheeks; only 4 trials involved treatment of other facial regions. All 10 RCTs had an unclear risk of selection bias. Only 2 RCTs reported exclusions and attrition. CONCLUSIONS AND RELEVANCE: Safety warnings relate more to the off-label use of STFs, which has not been sufficiently studied prospectively. Although STFs remain a safe device, with approval based mostly on RCT outcomes, implementation of unique device identifiers and greater use of physician-led registries would ensure physician, consumer, and regulatory confidence in STF safety.
Assuntos
Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Aprovação de Drogas , Técnicas Cosméticas/normas , Preenchedores Dérmicos/normas , Humanos , Estados Unidos , United States Food and Drug AdministrationRESUMO
The field of women's health has endured numerous recent controversies involving medical devices such as pelvic meshes, laparoscopic morcellators, and a hysteroscopic sterilization device. With the recent passage of the 21st Century Cures Act, new legislation will change how the Food and Drug Administration regulates medical devices. Given these controversies and new changes, we investigated high-risk, class I recalls in women's health from 2002 through 2016. Class I recalls for medical devices are defined by the Food and Drug Administration as the most serious recall events and are designated for situations when there is a reasonable probability of serious adverse health consequences or death. We defined a recall event as a group of unique Food and Drug Administration recalls that share a similar reason for recall and occurred within a 1-month time frame. In total, 7 class I recall events were identified encompassing 83 unique recalls affecting >88,000 medical devices in distribution. Recalls involved a broad range of devices used in women's health including diagnostic assays for chlamydia and gonorrhea, a laparoscopic tissue morcellator, and obstetrical/gynecological surgical kits. Four of 7 (57%) recall events were due to postmarketing problems such as improper packaging and labeling while the remaining 3 (43%) recalls were due to premarketing problems (eg, software issues). Additionally, 3 of 7 (43%) recall events were cleared via the 510(k) pathway, while the remaining were essentially exempt from any form of premarket approval. Two recall events involved sterility concerns of 71 surgical kits used in obstetrics and gynecological surgeries representing the majority of affected devices (78,423) in distribution. Class I medical device recalls are rare but serious events. Most recalled devices in women's health had minimal preapproval regulation and were recalled due to both premarketing and postmarketing reasons. Future regulatory efforts to improve postmarketing surveillance may mitigate the potential impact and frequency of class I recalls, but do not replace the need for a higher burden of proof for both safety and efficacy prior to medical device approval.
Assuntos
Segurança de Equipamentos/estatística & dados numéricos , Ginecologia/instrumentação , Recall de Dispositivo Médico , Obstetrícia/instrumentação , Equipamentos e Provisões/classificação , Feminino , Humanos , Vigilância de Produtos Comercializados/normas , Fatores de Risco , Estados Unidos , United States Food and Drug Administration , Saúde da MulherRESUMO
PURPOSE: The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. METHODS: This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. RESULTS: Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P < .001). CONCLUSIONS: Radiologic devices are largely approved by multireader, multicenter studies, the recommended standard for assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval.
Assuntos
Ensaios Clínicos como Assunto/estatística & dados numéricos , Aprovação de Equipamentos , Diagnóstico por Imagem/instrumentação , Segurança de Equipamentos/estatística & dados numéricos , Radiologia/instrumentação , United States Food and Drug Administration/estatística & dados numéricos , Análise de Falha de Equipamento/estatística & dados numéricos , Estados UnidosRESUMO
Behavioral flexibility is subserved in part by outputs from the cerebral cortex to telencephalic subcortical structures. In our earlier evaluation of the organization of the cortical-subcortical output system (Reynolds and Zahm, J Neurosci 25:11757-11767, 2005), retrograde double-labeling was evaluated in the prefrontal cortex following tracer injections into pairs of the following subcortical telencephalic structures: caudate-putamen, core and shell of the accumbens (Acb), bed nucleus of stria terminalis (BST) and central nucleus of the amygdala (CeA). The present study was done to assess patterns of retrograde labeling in the temporal lobe after similar paired tracer injections into most of the same telencephalic structures plus the lateral septum (LS). In contrast to the modest double-labeling observed in the prefrontal cortex in the previous study, up to 60-80 % of neurons in the basal and accessory basal amygdaloid nuclei and amygdalopiriform transition area exhibited double-labeling in the present study. The most abundant double-labeling was generated by paired injections into structures affiliated with the extended amygdala, including the CeA, BST and Acb shell. Injections pairing the Acb core with the BST or CeA produced significantly fewer double-labeled neurons. The ventral subiculum exhibited modest amounts of double-labeling associated with paired injections into the Acb, BST, CeA and LS. The results raise the issue of how an extraordinarily collateralized output from the temporal lobe may contribute to behavioral flexibility.
Assuntos
Núcleo Central da Amígdala/citologia , Vias Neurais/citologia , Neurônios/citologia , Núcleo Accumbens/citologia , Núcleos Septais/citologia , Lobo Temporal/citologia , Animais , Masculino , Técnicas de Rastreamento Neuroanatômico , Ratos Sprague-DawleyRESUMO
In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk-benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.
Assuntos
Histeroscopia/efeitos adversos , Vigilância de Produtos Comercializados , Esterilização Reprodutiva/efeitos adversos , Esterilização Reprodutiva/instrumentação , Feminino , Política de Saúde , Humanos , Histeroscopia/instrumentação , Rotulagem de Produtos , Vigilância de Produtos Comercializados/métodos , Esterilização Reprodutiva/métodos , Estados Unidos , United States Food and Drug AdministrationRESUMO
Recent controversies surrounding obstetrics and gynecology devices, including a permanent sterilization device, pelvic meshes, and laparoscopic morcellators, highlight the need for deeper understanding of obstetrics and gynecology medical device regulation. The U.S. Food and Drug Administration premarket approval database was queried for approvals assigned to the obstetrics and gynecology advisory committee from January 2000 to December 2015. Eighteen device approvals occurred in the time period studied. The most common clinical indications included endometrial ablation (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days). Regarding the pivotal trials leading to approval, there were 11 randomized controlled trials, one randomized crossover study, five nonrandomized prospective studies, and two human factor studies. Fourteen devices (78%) met their primary clinical efficacy endpoint. Only 12 of 18 devices were required to conduct postmarket surveillance. A significant proportion of devices (42%) were approved on the basis of nonrandomized controlled trials. Three devices have been withdrawn after approval, all of which were either not referred or not recommended for approval by the obstetrics and gynecology advisory committee. Of the three devices withdrawn from the market, two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns. Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices.
Assuntos
Aprovação de Equipamentos , Vigilância de Produtos Comercializados , Bases de Dados Factuais , Feminino , Ginecologia , Humanos , Obstetrícia , Ensaios Clínicos Controlados Aleatórios como Assunto , Estados Unidos , United States Food and Drug AdministrationRESUMO
PURPOSE: To assess class I radiological device recalls using the FDA medical device recall database and provide a detailed analysis, including recall trends, regulatory changes, and policy implications for the future. METHODS: This institutional review board-exempt study utilized the FDA Center for Devices and Radiological Health database for class I diagnostic radiological device recalls from November 1, 2002 to July 12, 2015. Recall characteristics, as well as market entry data, were collected for each device. RESULTS: Thirteen class I radiological device recalls were identified, with 12 of them occurring after 2011. SPECT nuclear medicine systems were the most common, followed by fluoroscopic x-ray and MRI systems. Eleven of the recalls were attributed to premarket-related issues. One recall event occurred in response to the death of a patient during a nuclear scan. Twelve of the devices were cleared under the 510(k) pathway. A median of 213 devices (range: 2 to 12,968) were recalled per event, and all but two devices had a worldwide distribution at the time of recall. CONCLUSIONS: We found that policy changes to the FDA were temporally related to class I radiological recall events. Additionally, class I radiological device recalls share characteristics: device modality, reason for recall, market entry, and product distribution. These recalls have broad implications and highlight the need for continued regulatory oversight as imaging technologies continue to advance.
Assuntos
Recall de Dispositivo Médico , Radiologia , Humanos , Estados Unidos , United States Food and Drug AdministrationRESUMO
The midbrain dopaminergic neuronal groups A8, A9, A10, and A10dc occupy, respectively, the retrorubral field (RRF), substantia nigra compacta (SNc), ventral tegmental area (VTA), and ventrolateral periaqueductal gray (PAGvl). Collectively, these structures give rise to a mixed dopaminergic and nondopaminergic projection system that essentially permits adaptive behavior. However, knowledge is incomplete regarding how the afferents of these structures are organized. Although the VTA is known to receive numerous afferents from cortex, basal forebrain, and brainstem and the SNc is widely perceived as receiving inputs mainly from the striatum, the afferents of the RRF and PAGvl have yet to be assessed comprehensively. This study was performed to provide an account of those connections and to seek a better understanding of how afferents might contribute to the functional interrelatedness of the VTA, SNc, RRF, and PAGvl. Ventral midbrain structures received injections of retrograde tracer, and the resulting retrogradely labeled structures were targeted with injections of anterogradely transported Phaseolus vulgaris leucoagglutinin. Whereas all injections of retrograde tracer into the VTA, SNc, RRF, or PAGvl produced labeling in many structures extending from the cortex to caudal brainstem, pronounced labeling of structures making up the central division of the extended amygdala occurred following injections that involved the RRF and PAGvl. The anterograde tracing supported this finding, and the combination of retrograde and anterograde labeling data also confirmed reports from other groups indicating that the SNc receives robust input from many of the same structures that innervate the VTA, RRF, and PAGvl.