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3.
J Clin Sleep Med ; 18(2): 663-667, 2022 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-34705629

RESUMO

As more patients depend upon mechanical or electronic technologies for treatment, medical device recalls-like the recent recall of common positive airway pressure treatment devices-impact millions of patients, often causing significant anxiety, extra costs, and interruption of care for patients. When recalls require health care and/durable medical equipment providers to be part of the solution, the burden on practices and businesses can be significant, creating strains on access for new patients and on limited medical supplies. We have observed that having an established and well-organized medical device recall plan in place allows for a rapid response, decreased practice burden, and reduced provider stress. Coupling the organized response with proactive, empathic, and clear communication with patients reduces their anxiety, provides clear directions for how to address the issue constructively, and reduces reactive communications. We share what we believe are key components of a medical device and produce recall procedure as we describe our institutions response in hopes that others can build on these basics as they design their own response plans. CITATION: Morgenthaler TI, Linginfelter EA, Gay PC, et al. Rapid response to medical device recalls: an organized patient-centered team effort. J Clin Sleep Med. 2022;18(2):663-667.


Assuntos
Recall de Dispositivo Médico , Assistência Centrada no Paciente , Humanos , Assistência Centrada no Paciente/métodos , Estados Unidos , United States Food and Drug Administration
4.
PLoS One ; 16(10): e0258153, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34618861

RESUMO

BACKGROUND: In the United States, medical devices are regulated and subject to review by the Food and Drug Administration (FDA) before they can be marketed. Low-to-medium risk novel medical devices can be reviewed under the De Novo umbrella before they can proceed to market, and this process can be fairly cumbersome, expensive, and time-consuming. An alternate faster and less-expensive pathway to going to market is the 510(k) pathway. In this approach, if the device can be shown to be substantially equivalent in safety and effectiveness to a pre-existing FDA-approved marketed device (or "predicates"), it can be cleared to market. Due to the possibility of daisy-chaining predicate devices, it can very quickly be difficult to unravel the logic and justification of how a particular medical device's equivalence was established. From patients' perspective, this minimizes transparency in the process. From a vendor perspective, it can be difficult to determine the right predicate that applies to their device. METHODS: We map the connectivity of various predicates in the medical device field by applying text mining and natural language processing (NLP) techniques on data publicly made available by the FDA 78000 device summaries were scraped from the US FDA 510(k) database, and a total of 2,721 devices cleared by the 510(k) regulatory pathway in 2020 were used as a specific case study to map the genealogy of medical devices cleared by the FDA. Cosine similarity was used to gauge the degree of substantial equivalence between two medical devices by evaluating their device descriptions and indications for use. Recalls and complaints for predicate devices were extracted from the FDA's Total Product Life Cycle database using html scraping and web page optical character recognition to determine the similarity between class 1 recalled devices (the most severe form of device recall) and other substantially equivalent devices. A specific product code was used to illustrate the mapping of the genealogy from a De Novo device. RESULTS AND DISCUSSION: The ancestral tree for the medical devices cleared in 2020 is vast and sparse, with a large number of devices having only 1-2 predicates. Evaluation of substantial equivalence data from 2003-2020 shows that the standard for substantial equivalence has not changed significantly. Studying the recalls and complaints, shows that the insulin infusion pump had the highest number of complaints, yet none of the recalled devices bore significant degree of text similarity to currently marketed devices. The mapping from the De Novo device case study was used to develop an ancestry map from the recalled predicate (recalled due to design flaws) to current substantially equivalent products in the market. CONCLUSIONS: Besides enabling a better understanding of the risks and benefits of the 510(k) process, mapping of connectivity of various predicates could help increase consumer confidence in the medical devices that are currently in the marketplace.


Assuntos
Equipamentos e Provisões , Bases de Dados como Assunto , Aprovação de Equipamentos , Recall de Dispositivo Médico , Estados Unidos
6.
J Am Acad Orthop Surg ; 29(24): e1362-e1369, 2021 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-34161960

RESUMO

BACKGROUND: In the United States, the most overwhelming medical devices, including hip arthroplasty devices, are cleared for human use by demonstration of "substantial equivalence" to a predicate, previously approved marketed device. This study examined the predicate approval lineages of modern hip arthroplasty devices. METHODS: The FDA 510(k) and premarket approval databases were searched to identify all approved hip arthroplasty devices since the database's inception in May 28, 1976. Ancestral predicate lineages were created using approval documentation, and FDA recall data were used to identify recalled devices. RESULTS: Evaluating 2,118 hip arthroplasty devices approved from 1976 to 2020, we found that the number of descendant devices for each approved device varied from 0 to 242. Many descendant devices served as predicates for other devices, leading to frequent indirect connections of equivalency across a wide range of implants. Two hundred forty-six (11.6%) devices were recalled for various reasons, with 34 (1.6%) related to implant design. Evaluating the predicate lineage of 51 hip arthroplasty devices approved between May 1, 2019, and May 1, 2020, 32 of 51 (62.7%) devices were linked, directly or indirectly, to predicates which were recalled for design issues. CONCLUSIONS: The lineage of hip arthroplasty device predicates reflects a complex ancestral web of equivalency across a wide range of implants, although their material and design properties may be different. Several currently approved devices were approved on substantial equivalence claims to products that were subsequently recalled from the market for implant design issues. These findings present several policy considerations for regulators, physicians, and the medical device industry.


Assuntos
Artroplastia de Quadril , Aprovação de Equipamentos , Bases de Dados Factuais , Humanos , Recall de Dispositivo Médico , Estados Unidos , United States Food and Drug Administration
8.
Plast Reconstr Surg ; 147(5S): 39S-43S, 2021 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-33890879

RESUMO

SUMMARY: Textured anatomic silicone gel breast implants have advantages of gel cohesivity and a natural slope between the upper and lower poles of the breast; however, they have fallen out of favor secondary to their risk of breast implant-associated anaplastic large cell lymphoma. For patients who choose to keep their textured devices, there remains controversy over the best long-term follow-up. This article presents an algorithm from plastic surgery, surgical oncology, and radiology at the Massachusetts General Hospital for management of these patients.


Assuntos
Algoritmos , Implante Mamário/métodos , Implantes de Mama , Mamoplastia , Complicações Pós-Operatórias/prevenção & controle , Cirurgia Plástica , Doenças Assintomáticas , Implantes de Mama/efeitos adversos , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/etiologia , Neoplasias da Mama/cirurgia , Procedimentos Cirúrgicos Eletivos , Feminino , Humanos , Linfoma Anaplásico de Células Grandes/diagnóstico , Linfoma Anaplásico de Células Grandes/etiologia , Linfoma Anaplásico de Células Grandes/cirurgia , Recall de Dispositivo Médico , Complicações Pós-Operatórias/cirurgia , Desenho de Prótese , Reoperação , Géis de Silicone , Propriedades de Superfície
9.
Plast Reconstr Surg ; 147(5S): 58S-68S, 2021 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-33890882

RESUMO

SUMMARY: Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance.


Assuntos
Implantes de Mama/efeitos adversos , Remoção de Dispositivo/métodos , Mamoplastia/métodos , Complicações Pós-Operatórias/cirurgia , Implante Mamário/legislação & jurisprudência , Neoplasias da Mama/etiologia , Neoplasias da Mama/cirurgia , Gerenciamento Clínico , Falha de Equipamento , Feminino , Humanos , Linfoma Anaplásico de Células Grandes/etiologia , Linfoma Anaplásico de Células Grandes/cirurgia , Recall de Dispositivo Médico , Educação de Pacientes como Assunto , Desenho de Prótese , Estudos Retrospectivos , Risco , Géis de Silicone , Propriedades de Superfície , Triagem , Revelação da Verdade
10.
J Am Pharm Assoc (2003) ; 61(1): e119-e122, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-32753251

RESUMO

OBJECTIVE: Our objective was to review recent drug and medical device recalls, categorize recall types based on the free text descriptions posted within the recall announcements, and conduct exploratory analyses for researchers interested in pharmaceutical supply chain challenges. METHODS: A cross-sectional study of all current recalls, market withdrawals, and safety alerts published by the United States Food and Drug Administration pertaining to drugs was conducted. A manual review of all the recalls was also conducted to extract additional information including company details, recall type (labeling or quality), and location of failure in the pharmaceutical supply chain (manufacturing or distribution). Descriptive statistics and exploratory bivariate analyses were conducted to test any potential differences between drug and device recalls. RESULTS: Most recalls issued between January 2017 and September 2019 were pharmaceutical drug recalls (85.2%), while 34 (14.8%) medical device recalls were issued for the same period. For drug recalls, 85.1% (166/195) were because of quality, while 14.9% (29/195) were because of labeling issues. Of the quality issues for drug recalls, lack of sterility was the most frequent issue (139/166, 83.7%). There was no difference between drug or device recalls based on recall type (P = 0.16), top 20 pharmaceutical company (P = 0.62), or location of the supply chain failure (P = 0.20). CONCLUSIONS: This study provides a process to categorize and evaluate drug and device recalls by recall type and location of the supply chain. By categorizing the free text provided in public recall data it would be easier to monitor trends over time.


Assuntos
Recall de Dispositivo Médico , Preparações Farmacêuticas , Estudos Transversais , Humanos , Estados Unidos , United States Food and Drug Administration
11.
Biomed Instrum Technol ; 54(6): 418-426, 2020 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-33339030

RESUMO

BACKGROUND: Medical device recalls have increased in the previous two decades. Orthopedic devices are estimated to constitute 12% of all medical devices recalled. Medical devices enter the market via the Food and Drug Administration's (FDA's) premarket approval (PMA) or 510(k) pathways. This article evaluates orthopedic hip device recalls between Jan. 1, 2007, and Dec. 31, 2017. We hypothesized that the 510(k) approval process would have substantially higher recall rates for defective devices. METHODS: The FDA's device recall database was queried for all orthopedic hip devices from Jan. 1, 2007, to Dec. 31, 2017. Each recall included product description, recall number, device class, date of recall posting, date of recall termination, manufacturer, FDA-determined cause for recall, number of recalled units, distribution, product classification, and method of approval [510(k), PMA, or unspecified]. RESULTS: In total, 774 orthopedic hip devices were recalled between Jan. 1, 2007, and Dec. 31, 2017. The 510(k) approval process constituted 85% of hip device recalls. The most common FDA-determined cause of hip device recalls was device design, which constituted 37% of 510(k)-approved device recalls but only 6% of PMA-approved device recalls. The most recalled hip devices were hip prostheses. Orthopedic hip device recalls have shown a decrease of about 10 recalls per year during the 11-year period of analysis. CONCLUSION: Devices approved through the 510(k) process, compared with the PMA process, were more likely to be recalled for design defects. Although device design is the most common reason for device recall, many recalls are due to suboptimally standardized processes (e.g., packaging, process controls, device labeling). Overall, orthopedic hip device recalls decreased during the period of analysis (2007-17).


Assuntos
Aprovação de Equipamentos , Recall de Dispositivo Médico , Bases de Dados Factuais , Estados Unidos , United States Food and Drug Administration
12.
Brasília, D.F.; OPAS; 2020-12-23. (OPAS-W/BRA/PHE/COVID-19/20-175).
Não convencional em Português | PAHO-IRIS | ID: phr2-53162

RESUMO

O oxigênio é um medicamento essencial para a COVID-19 e, portanto, é muito importante avaliar a disponibilidade de diferentes fontes de oxigênio, bem como dos sistemas de fornecimento e administração ao paciente, para que estes possam ser priorizados, realocados e comparados aos números calculados para a definição de necessidades. Em 4 de abril de 2020, os problemas na cadeia global de abastecimento ainda eram muito relevantes, em decorrência da pandemia de COVID-19. Recomenda-se enfaticamente que os Ministérios da Saúde maximizem o aproveitamento dos insumos e recursos existentes, para permitir uma resposta imediata. Esta é a primeira edição das orientações sobre como conduzir uma avaliação rápida de inventário para determinar a prontidão de uma instituição de saúde, bem como a capacidade de realocação de equipamentos biomédicos para atendimento a casos de COVID-19. Esta ferramenta inclui um questionário (impresso ou digital), juntamente com uma série de cartazes de produtos/dispositivos. Esta ferramenta deve ser usada de acordo com o pacote de materiais sobre doenças (em inglês, disease commodities package, ou DCP) sobre a COVID-19 , a Lista de Prioridades da OMS referente a dispositivos médicos para a COVID-19, e as Especificações Técnicas para sistemas de fornecimento de oxigênio, dispositivos de reanimação e concentradores de oxigênio. Esta ferramenta destina-se a administradores de instituições de saúde, decisores clínicos, gerentes de compras, gerentes de planejamento, engenheiros biomédicos ou engenheiros de infraestrutura para auxiliar na identificação de equipamentos biomédicos prontamente disponíveis para uso imediato e/ou realocação.


Assuntos
COVID-19 , Coronavirus , Infecções por Coronavirus , Controle de Infecções , Equipamento de Proteção Individual , Utilização de Equipamentos e Suprimentos , Recall de Dispositivo Médico , Hospitais , Almoxarifado Central Hospitalar
13.
Heart Rhythm ; 17(11): 1909-1916, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32512178

RESUMO

BACKGROUND: No comparative study of outcomes in Riata and Sprint Fidelis leads undergoing lead extraction (LE), lead abandonment (LA), and generator change only (GC) has been published. OBJECTIVES: Determine outcomes (major complications [MC]; death, extended hospitalization, or rehospitalization within 60 days [RH]; lead malfunction) of LE, LA, and GC for recalled leads. METHODS: Retrospective, multicenter, comparative study. RESULTS: A total of 298 LE, 85 LA, and 310 GC were performed. In the clinical setting of a lead intervention, there was no difference in a composite of MC, death, RH, lead revision, inappropriate shocks, or device infection between LE and LA groups (15% vs 22%, P = .140). In the clinical setting of a device at elective replacement interval (ERI), there were significantly more acute events at 60 days (MC, death, and RH) in the LE and LA groups at 15.4% (4) and 15.4% (4), and this was significantly (P = .017) higher than the GC group at 5.1% (16). There was no difference (P = 1.000) in the composite of MC, death, RH, lead malfunction, lead revisions, device infections, or inappropriate shocks between LE, LA, and GC groups at 15.4% (4), 15.4% (4), and 17.4% (54), respectively. Following generator change, 14 of 175 Fidelis leads and 3 of 135 Riata leads failed over a total of 12,714 months of follow-up. CONCLUSIONS: The failure rate of recalled leads was substantially lower compared to previous reports. It may be prudent to perform generator change only when the device is at ERI, especially when the recalled lead has historical performance that likely outweighs the risks of extraction/abandonment.


Assuntos
Desfibriladores Implantáveis/efeitos adversos , Remoção de Dispositivo/métodos , Gerenciamento Clínico , Recall de Dispositivo Médico , Idoso , Desenho de Equipamento , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Tempo
14.
Biomed Instrum Technol ; 54(3): 178-188, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32442013

RESUMO

This article provides recommendations to manufacturers on using the Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) and Medical Device Recall databases to identify unknown use issues, discover design opportunities, and improve one's risk management file. These recommendations are based on the experiences of researchers who have spent time analyzing and working with both database systems and have developed a methodology for each. Manufacturers can leverage the suggested practices described in this article to address regulatory requirements.


Assuntos
Recall de Dispositivo Médico , Bases de Dados Factuais , Estados Unidos , United States Food and Drug Administration
15.
J Arthroplasty ; 35(8): 2259-2266, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32279947

RESUMO

BACKGROUND: Medical device recalls have the potential to affect patient outcomes in orthopedic surgery. We assessed high-risk orthopedic medical device recalls in the recent past. METHODS: The publicly available Food and Drug Administration medical device recall database was mined for information on class 1 and class 2 recalls of orthopedic implants or medical devices related to orthopedic surgery from January 1, 2015 to December 31, 2019. Recall details, including reason for recall, class of recall, and the recalling company, were recorded. The data were quantified and analyzed in Excel. RESULTS: The results of this study showed that orthopedic device recalls constitute a significant percentage of total medical device recalls, ranging from 11.8% to 21.5%. In the last 5 years, 2018 was the busiest year for all medical and orthopedic device recalls. Packaging errors were the most common reasons for orthopedic device recalls, followed by design flaws and manufacturing issues. Marketing and software issues were uncommon reasons for orthopedic device recalls. Zimmer Biomet, Johnson & Johnson (parent company of DePuy Synthes), and Stryker had the highest number of orthopedic device recalls over the last 5 years and also constitute the top 3 orthopedic companies with the largest market share of orthopedic implants. CONCLUSION: Orthopedic device recalls remain a significant concern and constitute, on average, 16.6% of all class II medical device recalls from 2015 to 2019. Manufacturing companies can reduce the number of orthopedic device recalls by improving their device design, manufacturing, and packaging stages of the production cycle. LEVEL OF EVIDENCE: III.


Assuntos
Procedimentos Ortopédicos , Ortopedia , Bases de Dados Factuais , Humanos , Recall de Dispositivo Médico , Estados Unidos , United States Food and Drug Administration
16.
Lasers Surg Med ; 52(9): 837-841, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32221981

RESUMO

BACKGROUND AND OBJECTIVES: Device innovation in dermatology is increasing. Medical devices identified as "substantially equivalent" to predicate ones by the United States Food and Drug Administration (FDA) may be exempt from premarket approval through the 510(k) pathway. The 510(k) pathway has been criticized for having less stringent clinical data requirements, and implications of dermatologic device clearance via this pathway are incompletely described. The objective of this study is to characterize dermatologic device clearance via the 510(k) pathway. STUDY DESIGN/MATERIALS AND METHODS: We performed a retrospective review of the FDA's 510(k) database between January 1, 1996 and December 31, 2018. Dermatologic devices were included based on product code and classified by the application. Approval pathways and decision characteristics were compared among dermatologic device categories. RESULTS: Of the 76,607 records screened, 4,637 met inclusion criteria. Laser/thermal devices comprised the largest category (64.2%), followed by wound (24.0%) and light-based devices (5.8%). The majority of 510(k) pathway submissions were traditional (89.2%) compared with alternative (10.8%) submission types (P = 0.003). Devices that were deemed substantially equivalent without limitations (98.5%) were the most common among all device categories. Rates of device clearance over the study period increased for all categories except laser/thermal devices. CONCLUSIONS: Dermatologic devices are increasingly cleared via the FDA's 510(k) pathway through "substantial equivalence" with minimal requirements for premarket clinical data. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.


Assuntos
Aprovação de Equipamentos , Preparações Farmacêuticas , Recall de Dispositivo Médico , Estudos Retrospectivos , Estados Unidos , United States Food and Drug Administration
18.
JAMA Intern Med ; 180(2): 198-205, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-31860011

RESUMO

Importance: Timely and complete disclosure of medical device defects is necessary to manage patient care safely and effectively. Objectives: To determine if the manufacturer's recommendations following the recall of a medical device were timely and complete, the follow-up information and data provided to patients and physicians were adequate for managing patient care, and the actions taken by the US Food and Drug Administration (FDA) regarding the recall were appropriate. Design, Setting, and Participants: This single-center retrospective case series included 90 of 448 patients who were implanted with a cardiac resynchronization therapy pacemaker at the Minneapolis Heart Institute from May 2003 through January 2011; this pacemaker was recalled in November 2015. In addition, returned product reports submitted by the manufacturer to the FDA via the Manufacturer and User Facility Device Experience (MAUDE) database from January 2008 through December 2018 were analyzed. Main Outcomes and Measures: Clinical outcomes were serious adverse clinical events that occurred before and after the November 2015 recall notifying physicians and patients that the device's battery could fail unexpectedly because of high internal impedance. Technical outcomes were signs and causes of failure. Results: Five of 90 patients observed during 2015 experienced syncope when their pacemakers stopped pacing owing to battery or wire connection defects prior to the recall. Of the 90 patients, 37 (41%) were men, and the median (interquartile range) age at implantation was 71.3 (66.1-78.2) years. Analysis of the MAUDE data revealed that battery failures prior to the recall were associated with serious adverse events that included 1 death, 1 cardiac arrest, 5 syncopal attacks, and 6 heart failure exacerbations; 3 additional prerecall syncopal events were caused by wire connection defects. The manufacturer and the FDA were aware of the battery and wire connection defects for 19 months before issuing the recall, yet the wire connection problem was not included in the advisory and physicians were not informed that interrogating the pacemaker could result in loss of pacing. The FDA classified the recall as class II rather than the more critical class I. Conclusions and Relevance: This case series study of patients implanted with a defective pacemaker found that the pacemaker recall was delayed and that subsequent communications did not include all critical information needed for safe and effective patient care. These findings should prompt reforms in how the medical device industry and the FDA manage future medical device recalls.


Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca , Revelação , Falha de Equipamento , Insuficiência Cardíaca/terapia , Disseminação de Informação , Recall de Dispositivo Médico , Idoso , Progressão da Doença , Feminino , Parada Cardíaca , Humanos , Masculino , Mortalidade , Estudos Retrospectivos , Síncope/etiologia , Fatores de Tempo , Estados Unidos , United States Food and Drug Administration
19.
J Surg Res ; 247: 445-452, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31668430

RESUMO

BACKGROUND: Medical devices introduced to market through the 510K process often have limited research of low quality and substantial conflict of interest (COI). By the time high-quality safety and effectiveness research is performed, thousands of patients may have already been treated by the device. Our aim was to systematically review the trends of outcomes, research quality, and financial relationships of published studies related to de-adopted meshes for ventral hernia repair. MATERIALS AND METHODS: Literature was systematically reviewed using PubMed to obtain all published studies related to three de-adopted meshes: C-QUR, Physiomesh, and meshes with polytetrafluoroethylene. Primary outcome was change in cumulative percentage of subjects with positive published outcomes. Secondary outcome was percentage of published manuscript with COI. RESULTS: A total of 723 articles were screened, of which, 129 were analyzed and included a total of 8081 subjects. Percentage of subjects with positive outcomes decreased over time for all groups: (1) C-QUR from 100% in 2009 to 22% in 2018, (2) Physiomesh from 100% in 2011 to 20% in 2018, and (3) polytetrafluoroethylene from 100% in 1979 to 49% in 2018. Authors of only 20% of articles self-reported no COI, most representing later publications and were more likely to show neutral or negative results. CONCLUSIONS: Among three de-adopted meshes, early publications demonstrated overly optimistic results followed by disappointing outcomes. Skepticism over newly introduced, poorly proven therapies is essential to prevent adoption of misleading practices and products. Devices currently approved under the 510K processes should undergo blinded, randomized controlled trials before introduction to the market.


Assuntos
Ensaios Clínicos como Assunto/normas , Conflito de Interesses/economia , Aprovação de Equipamentos/normas , Herniorrafia/instrumentação , Telas Cirúrgicas/efeitos adversos , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/ética , Aprovação de Equipamentos/legislação & jurisprudência , Herniorrafia/efeitos adversos , Humanos , Recall de Dispositivo Médico/legislação & jurisprudência , Recall de Dispositivo Médico/normas , Retirada de Dispositivo Médico Baseada em Segurança/legislação & jurisprudência , Retirada de Dispositivo Médico Baseada em Segurança/normas , Telas Cirúrgicas/economia
20.
Pract Radiat Oncol ; 10(1): e8-e15, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31408733

RESUMO

PURPOSE: Medical devices in radiation therapy undergo a complex process of Food and Drug Administration (FDA) approval. Little is known about which processes within the radiation therapy medical device industry are most prone to events involving wrong dose, volume, or targeting in radiation therapy treatment. METHODS AND MATERIALS: We carried out a retrospective analysis of the United States FDA Medical Device Recalls database for recalls of products classified as "Accelerator, Linear, Medical" from 2010 to 2016. Each recall event was classified using a modified Delphi method among 3 experts in safety according to product type, error category, and severity score. Error categories included inconvenience; suboptimal plan or treatment; incorrect dose, volume, or targeting; and nonradiation injury risk. Variables investigated were product type, recall year, FDA-determined cause, and quantity of units recalled. Univariate and multivariate logistic regression were used to identify factors prognostic of incorrect dose, volume, or targeting. RESULTS: We identified a total of 250 recall events between 2010 and 2016, with 165 eligible for analysis. Linear accelerators (LINACs) (28%) and LINAC control software (19%) were the most frequently recalled products. The most common FDA-determined causes for recalls were software design (42%) and device design (26%). On univariate analysis (P < .05), LINAC control software (odds ratio [OR] 5.4) and oncology information system or treatment management system (OR 3.9) versus LINACs and software design (OR 3.4) versus device design were associated with wrong dose, volume, or targeting events. On multivariate analysis, only the association with LINAC control software (OR 3.7) persisted for wrong dose, volume, or targeting events. CONCLUSIONS: Review of these data shows that problems with LINAC control software were associated with incorrect dose delivery at a 4-fold higher rate than errors with LINACs. Manufacturers should focus on improvements in software design to minimize dose- and targeting-related errors to patients.


Assuntos
Recall de Dispositivo Médico , Erros Médicos/estatística & dados numéricos , Aceleradores de Partículas/estatística & dados numéricos , Lesões por Radiação/prevenção & controle , Radioterapia (Especialidade)/instrumentação , Bases de Dados Factuais/estatística & dados numéricos , Desenho de Equipamento , Humanos , Neoplasias/radioterapia , Doses de Radiação , Lesões por Radiação/epidemiologia , Lesões por Radiação/etiologia , Estudos Retrospectivos , Software , Estados Unidos , United States Food and Drug Administration
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