Estimates of medical device–associated adverse events from emergency departments

Introduction: Quality and safety is an important challenge in healthcare systems all over the world particularly in developing parts. Objective: This survey aimed to assess patient safety culture (PSC) in emergency departments (EDs) in Yemen and identify its associated factors. Methods: A questionnaire containing the Hospital Survey on Patient Safety Culture (HSOPSC) was distributed to ED physicians, nurses, and clinical, and non-clinical staff at three public teaching general hospitals. The percentages of positive responses on the 12 patient safety dimensions and the summation of PSC and two outcomes (overall patient safety grade and adverse events reported in the past year) were assessed. Factors associated with PSC aggregate score were analyzed. Results: finally, out of 400 questionnaires, 250 (64%) were analyzed. In total, 207 (82.3%) participants were nurses and physicians; 140 (56.0%) were male; 134 (53.6%) were less than 30 years old; and 134 (53.6%) had a university degree. Participants provided the highest ratings for the “teamwork within units” PSC composite (67%). The lowest rating was for “non-punitive response to error” (21.3%). A total of 120 (48.1%) participants did not report any events in the past year and 99 (39.7%) gave their hospital an “excellent/very good” overall patient safety grade. There were signiﬁcant differences between the hospitals’ EDs in the rating of “handoffs and transitions” (p=0.016), “teamwork within units” (p=0.018), and “frequency of adverse events reported” (p=0.016). Staff working in intensive care units (8.4%, n=21) had lower patient safety aggregate scores. Conclusions: PSC ratings appear to be low in Yemen. This study emphasizes the need to create and maintain a PSC in EDs through the implementation of quality improvement strategies and environment of transparency, open communications, and continuous learning.

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An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care ◽

10.1177/2327857920091024 ◽

2020 ◽

Vol 9 (1) ◽

pp. 130-134

Author(s):

Benjamin M. Knisely ◽

Camille Levine ◽

Kush C. Kharod ◽

Monifa Vaughn-Cooke

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Medical Device ◽

Medical Devices ◽

Product Life Cycle ◽

Risk Mitigation ◽

Adverse Event Reporting ◽

Mitigation Strategies ◽

Event Reporting ◽

Device Use

Humans can contribute to error at all stages of the medical device product life-cycle. Use error associated with medical devices can result in catastrophic consequences for end users and inefficient use of healthcare system resources. Industry-wide statistics about medical device use error has the potential to aid in identifying opportunities for human factors intervention, however publicly available statistics are sparse. The Food and Drug Administration (FDA) requires medical device manufactures, importers, and device user facilities to track and report adverse events for post-market surveillance through medical device reports (MDRs). This data is available in an online database: Manufacturer and User Facility Experience (MAUDE). This study provides a comprehensive evaluation of use error adverse events in MAUDE (2010-2018) based on device class, device operator, and event outcome, to address the lack of industry-wide statistics on medical device use error. Results indicate that use error is significantly represented in adverse event reporting, constituting 28.1% of reports labeled with device problem codes. Events associated with patient device operators were predominately associated with diabetes-related medical devices, while provider operators were associated with a wider array of devices. Additionally, it was found that most use error reports were attributed to issues with device output; using the device in accordance with manufacturer expectations; and physically activating, positioning, or separating device components. This work demonstrates the viability of using MAUDE to attain industry wide statistics on medical device use error for later integration in industry-wide or device-specific risk mitigation strategies.

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Estimates of Medical Device-Associated Adverse Events

American Journal of Epidemiology ◽

10.1093/aje/163.suppl_11.s171-c ◽

2006 ◽

Vol 163 (suppl_11) ◽

pp. S171-S171

Author(s):

B Hefflin ◽

T Gross ◽

T Schroeder

Keyword(s):

Adverse Events ◽

Medical Device

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Developing a Smart Infusion Pump Dedicated to Infusion Safety

Ergonomics in Design The Quarterly of Human Factors Applications ◽

10.1177/1064804620944760 ◽

2020 ◽

pp. 106480462094476

Author(s):

Eric A. Smith ◽

George Gray

Keyword(s):

Adverse Events ◽

Medical Device ◽

Large Volume ◽

Infusion Pump ◽

Usability Testing ◽

User Centered Design ◽

Usability Engineering ◽

Engineering Effort ◽

Potential Use ◽

User Centered

A large-volume infusion pump is a medical device with a big job: infuse patients with life-sustaining fluids and medications at a known and controlled rate. And, do it safely. Because infusions are frequently administered therapies, the opportunity for use error–induced adverse events is amplified. To develop a safer infusion pump, Ivenix, Inc., committed to a comprehensive usability engineering effort that included over 400 hours of usability testing. As a result, the pump’s design includes risk controls for mitigating potential use errors not available on today’s pumps. The resulting product was the winner of the 2019 Stanley Caplan User-Centered Design Award.

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FDA Highlights Pediatric Medical Device Adverse Events, Encourages Reporting

Biomedical Instrumentation & Technology ◽

10.2345/0899-8205-44.s1.4b ◽

2010 ◽

Vol 44 (s1) ◽

pp. 4-4

Keyword(s):

Adverse Events ◽

Medical Device

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Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases

Journal of Korean Medical Science ◽

10.3346/jkms.2019.34.e255 ◽

2019 ◽

Vol 34 (39) ◽

Author(s):

Chiho Yoon ◽

Ki Chang Nam ◽

You Kyoung Lee ◽

Youngjoon Kang ◽

Soo Jeong Choi ◽

...

Keyword(s):

Adverse Events ◽

Training Program ◽

Medical Device

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Medical device safety: Investigating contributions of human factors

10.7287/peerj.preprints.1840 ◽

2016 ◽

Author(s):

Kathrin Lange

Keyword(s):

Adverse Events ◽

Human Factors ◽

Medical Device ◽

Medical Devices ◽

Human Error ◽

Long Term Memory ◽

Serious Adverse Events ◽

True Value ◽

Federal Institute ◽

Medical Device Safety

The core tasks of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM]) with respect to medical device safety include evaluating risks arising from the use or application of medical devices (based on incident reports), assessing and coordinating the counter-measures to be taken (i.e. corrective actions), and authorizing clinical trials of medical devices and evaluating the corresponding serious adverse events. Additionally, the BfArM also conducts research on medical device safety, specifically on the possibilities and challenges of data-driven approaches to detect and evaluate risk and on the contribution of human factors to device safety – i.e. factors that may have an impact on how users interact with a device. The present talk focuses on this latter issue. The significance of addressing human factors relating to the use of medical devices results from the contribution of human error to adverse events. For instance, an involvement of human error could be identified in a good 10% of the reports of suspected device-related incidents evaluated by the BfArM between 2005 and 2014. For several reasons, it may be assumed that the true value of device-related incidents involving human error is even larger and that the potential for human error is likely to increase in the future. To effectively reduce the risk for human error – or block its negative outcome - it is imperative to not only identify human error as a significant cause of adverse events, but rather understand the causation of the error, including the conditions under which errors are likely to occur. This requires the analysis of the perceptual, cognitive (e.g. attention, working memory, long term memory), motor or motivational processes involved and the identification of relevant factors at the various levels of the socio-technical system. In our research, we currently pursue two selected human factors issues, selected based on the incident-data collected at the BfArM and on the current literature: Insufficient device knowledge and the multi-faceted issue of device alarms, the latter including both the users’ interactions with alarming devices and their perceptual, cognitive, or motor responses to the devices’ alarms.

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Use of a new transanal irrigation device for bowel disorder management by patients familiar with the irrigation technique: a prospective, interventional, multicenter pilot study

Techniques in Coloproctology ◽

10.1007/s10151-020-02212-x ◽

2020 ◽

Vol 24 (7) ◽

pp. 731-740

Author(s):

K. Charvier ◽

V. Bonniaud ◽

D. Waz ◽

C. Desprez ◽

A.-M. Leroi

Keyword(s):

Pilot Study ◽

Adverse Events ◽

Medical Device ◽

Bowel Dysfunction ◽

Secondary Outcome ◽

Electric Pump ◽

Open Label ◽

Serious Adverse Events ◽

New Device ◽

Transanal Irrigation

Abstract Background The aim of this study was to evaluate the feasibility of transanal irrigation (TAI) with a new medical device incorporating an electric pump, the IryPump®R Set. Methods An interventional, prospective, open-label, non-comparative, multicenter pilot study on TAI was conducted at three French university hospitals. Patients with experience of TAI were enrolled for a 1-month period during which 5 consecutive TAIs were performed using the IryPump®R Set (B.Braun Melsungen AG Melsungen, Germany). The study’s primary efficacy criterion was successful TAI, defined as (i) use of the patient’s usual irrigation volume of water, (ii) stool evacuation, and (iii) the absence of leakage between TAIs. The first two TAIs were not taken into account in the main analysis. The secondary outcome measures were device acceptability, bowel dysfunction scores, tolerability, and safety. Results Fifteen patients were included between November 2016 and May 2017, and 14 were assessed in the main analysis. The TAI success rate was 72.4% (21 out of 29 procedures). The bowel dysfunction scores at the end of the study did not differ significantly from those recorded on inclusion. A high proportion of patients (> 70%) reported that TAI was feasible with the new medical device. There were no serious adverse events or device-related adverse events. At the end of the study, 50% of the participants were willing to consider further use of the new device. Conclusions In patients familiar with TAI, using a new medical device incorporating an electric pump was feasible. Levels of patient satisfaction were high, especially with regard to comfort of use and a feeling of security during TAI.

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