Overview of Class I Device Recalls in Diagnostic Radiology, 2002-2015

Ghobadi, Comeron W.; Hayman, Emily; Xu, Shuai

doi:10.1016/j.jacr.2015.12.025

Cited by 6 publications

(6 citation statements)

References 7 publications

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“…24 The present study excludes such clearances to demonstrate that, unlike high-risk devices, 1 moderate-risk devices used by otolaryngologists are typically cleared without supporting clinical evidence. In contrast to literature examining other specialties, 11,25,26 we found no otolaryngologic devices were subject to recall for life-threatening or serious health hazards. This may reflect the relative safety of otolaryngologic devices or an inability to detect safety concerns for less commonly used devices (compared to automated external defibrillators, joint prostheses, and mechanical ventilators) through passive FDA postmarket surveillance, which is limited by misreporting and underreporting of adverse events by patients, physicians, and manufacturers.…”

Section: Discussioncontrasting

confidence: 99%

US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016

Rathi

Gadkaree

Ross

et al. 2017

Otolaryngol.--head neck surg.

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Objective The US Food and Drug Administration (FDA) clears moderate-risk devices via the 510(k) process based on substantial equivalence to previously cleared devices; evidence of safety and effectiveness is not required. We characterized the premarket evidence supporting FDA clearance of otolaryngologic devices. Study Design Retrospective cross-sectional analysis. Setting Publicly available FDA documents. Subjects and Methods Recently cleared (1997-2016) moderate-risk otolaryngologic devices were categorized by type (diagnostic/therapeutic), subspecialty, implantable designation (yes/no), and recall history (yes/no). Supporting evidence was categorized by type (clinical/nonclinical/none; nonclinical and clinical mutually inclusive) and public availability of nonclinical and clinical performance data (available/not provided/not applicable). Results Between 1997 and 2016, the FDA cleared 377 moderate-risk otolaryngologic devices. The majority were therapeutic (n = 240/377 [63.7%]) and otologic (n = 311/377 [82.5%]); roughly one-third (n = 121/377 [32.1%]) were implantable. Few (n = 10/377 [2.7%]) devices were subject to recall. FDA documents summarizing premarket evidence were accessible for two-thirds (n = 247/377 [65.5%]) of devices. Among these devices, one-quarter (n = 66/247 [26.7%]) were supported by clinical evidence. The majority (n = 177/247 [71.7%]) were supported by nonclinical evidence, although nearly one-quarter (n = 58/247 [23.5%]) were cleared without supporting evidence. Therapeutic devices were more often cleared without supporting evidence (therapeutic: n = 53/170 [31.2%]; diagnostic: n = 5/77 [6.5%]; P < .0001). Nonclinical and clinical performance data were rarely available (nonclinical: n = 49/247 [19.8%]; clinical: n = 32/247 [13.0%]) within public summaries. Conclusion The FDA cleared most moderate-risk otolaryngologic devices for marketing via the 510(k) process without clinical evidence of safety and effectiveness. Otolaryngologists should be aware of limitations in premarket evidence when considering the adoption of new devices into clinical practice.

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Section: Discussioncontrasting

confidence: 99%

US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016

Rathi

Gadkaree

Ross

et al. 2017

Otolaryngol.--head neck surg.

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“…Nonetheless, details of ROD recalls remain poorly characterized. Previous studies have utilized recall data to analyze a variety of safety concerns with medical technologies including orthopedic devices (7), diagnostic radiology devices (8), coronary stents (9), medical software (10), and cardiovascular devices (11). We sought to characterize all recalls involving RODs and to compare these to recalls of other devices.…”

Section: Introductionmentioning

confidence: 99%

Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015

Connor

Tringale

Moiseenko

et al. 2017

International Journal of Radiation Oncology*Biology*Physics

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Purpose Medical devices in radiation oncology have undergone remarkable technological advancement over the last two decades. The U.S. Food and Drug Administration (FDA) administers recalls of medical devices posing safety risks. We analyzed all recalls involving radiation oncology devices (RODs) from the FDA’s recall database, comparing these to non-radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Methods and Materials Recall data on RODs from 2002–2015 were sorted into four product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared to those for other devices by Pearson’s Chi-squared test for categorical data and two-sample Kolmogorov-Smirnov test for distributions. Results There were 502 ROD recalls and 9,534 other class II device recalls from 2002–2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. RODs differed significantly from other devices in all recall outcomes (p≤0.04). Recall cause was commonly software-related (49% vs. 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs. 87.2%) instead of severe (0.2% vs. 4.4%; p<0.001). Time from 510(k) market approval to recall was shorter among RODs (p<0.001), and progressively shortened over time. RODs had fewer recalled devices in commerce than other devices (p<0.001). Conclusions Compared to other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.

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“…Aside from annual postmarket reports required for every PMA submission, additional postmarket surveillance was required for only one radiologic device (4%). Postmarket regulation is an important aspect of device regulation; a small but significant percentage of major recalls (8%) for radiologic devices were attributed to postmarketing issues [5]. In cardiology, two major recalls were attributed to cardiac defibrillator leads approved via the supplement process [21].…”

Section: Discussionmentioning

confidence: 99%

“…Specifically, more details regarding pivotal trials leading to the approval of high-risk radiologic devices should be made available in the SSED. There should be greater involvement of practicing radiologists in the medical device approval, particularly in the postmarketing process [5]. Physician societies in cardiology and gastroenterology lead registries to track device safety and performance in their respective fields [25].…”

Section: Discussionmentioning

confidence: 99%

“…To assess the implications of the proposed legislation for radiology, it is essential to understand the current state of device regulation. Previous work has shown that although major radiologic device recalls are rare, the impact of a single recall can reverberate across thousands of imaging systems [5]. Currently, limited literature is available on the strength of clinical studies, leading to high-risk device approval in the field of radiology.…”

Section: Introductionmentioning

confidence: 99%

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Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015

Ghobadi

Hayman

Finkle

et al. 2017

Journal of the American College of Radiology

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Overview of Class I Device Recalls in Diagnostic Radiology, 2002-2015

Cited by 6 publications

References 7 publications

US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016

US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016

Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015

Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015

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