Attitudes Toward Medical Device Use Errors and the Prevention of Adverse Events

Johnson, Todd R.; Tang, Xiaozhou; Graham, Mark; Brixey, Juliana J.; Turley, James P.; Zhang, Jiajie; Keselman, Alla; Patel, Vimla L.

doi:10.1016/s1553-7250(07)33079-1

Cited by 28 publications

(15 citation statements)

References 7 publications

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“…Device-use error seems to be more common than malfunction of devices. 18 Distinguishing between the 2 types is not always easy. Poor device design (one form of manufacturer-related error) can contribute directly to use error.…”

Section: Understanding Errors Related To Health Devicesmentioning

confidence: 99%

“…Less obvious are the automated dispensing cabinets, computerized charting systems, medical gas systems, and the additional complex equipment in the laboratory, pharmacy, and other support areas. Additional details about specific device errors and recommendations for improving safety [18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] are presented in Table 1. Manufacturer-related errors occur during design or production of a medical device.…”

Section: Understanding Errors Related To Health Devicesmentioning

confidence: 99%

“…Organizations and leaders similarly tend to blame individual users and focus on encouraging vigilance and retraining of users to prevent further events. 18 Nonetheless, nurses (as users) must break free from the tendency to blame operator error and instead report events. Many patient safety leaders suspect that devicerelated events are significantly underreported.…”

Section: Reducing Risk Related To Medical Devicesmentioning

confidence: 99%

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Medical Devices and Patient Safety

Mattox

2012

Critical Care Nurse

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Section: Understanding Errors Related To Health Devicesmentioning

confidence: 99%

Section: Understanding Errors Related To Health Devicesmentioning

confidence: 99%

Section: Reducing Risk Related To Medical Devicesmentioning

confidence: 99%

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Medical Devices and Patient Safety

Mattox

2012

Critical Care Nurse

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“…A study involving healthcare employees from three hospital systems indicated that a lack of training is associated with most errors. To minimize such errors, user training should focus on more effective error-prevention strategies such as retraining of the user during the NAIMD label review and double checks during critical steps of NAIMD implantation [4]. The three main causes of adverse events have been found to be user challenges, design problems, and lack of effective training; many of these could be minimized with adequate training and more user-friendly medical devices.…”

Section: Safety Evaluation: a Life Cycle Approachmentioning

confidence: 99%

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines

et al. 2016

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Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit–risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.

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“…As Johnson et al (2007) say most errors are attributed solely to the user and that the primary method of error prevention is to retrain the user. Of course this is a cheap option, and one might note that the device manufacturer could also provide the training.…”

Section: Introductionmentioning

confidence: 99%

Avoiding Latent Design Conditions Using UI Discovery Tools

Thimbleby

2010

International Journal of Human-Computer Interaction

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Motivation -Designers make decisions that later influence how users work with the systems that they have designed. When errors occur in use, it is tempting to focus on the active errors rather than on the latent design decisions that framed the context of error, and fixing latent conditions can have a more general (and future) impact than addressing particular active failures. Research approach -A constructive computer science approach is used, and results from a simulation reported. Research limitations -Error is a complex multidisciplinary field; this paper makes a new contribution complimentary to human factors engineering. Take away message -This paper shows that latent design decisions cause serious problems (including fatalities) in safety critical applications; the paper proposes UI discovery tools to identify and manage latent errors. UI discovery enables human factors engineers and programmers to work together to help eliminate broad classes of latent design errors.

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Attitudes Toward Medical Device Use Errors and the Prevention of Adverse Events

Cited by 28 publications

References 7 publications

Medical Devices and Patient Safety

Medical Devices and Patient Safety

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines

Avoiding Latent Design Conditions Using UI Discovery Tools

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