Human factors perspectives on a systemic approach to ensuring a safer medication delivery process.

The current, prevailing approach to addressing medication delivery safety issues has been to apply solutions at the point of failure with direct, local remediation. These include computerized physician order entry to address transcription and prescribing problems, tall man lettering for label clarity and smart pump systems to address programming use errors. We discuss the lack of a systemic, holistic approach to addressing medication delivery issues that has led to fragmented solutions that do not address the problem as intended and introduce new, unintended patient safety issues. We use recent case studies in addition to our own experimental data from human factors investigations to show how a comprehensive human factors approach can be applied to address systemic error in medication delivery. Only by identifying how (1) subsystems interconnect, (2) information flows, (3) care providers communicate and (4) users are impacted will healthcare organizations and system vendors be able to fully address error in medication delivery. Much of what is required from organizations is to transcend the organizational boundaries of medicine, pharmacy and nursing to produce a delivery system that ensures an integrated approach that addresses all stakeholders' needs.

Designing effective human-automation-plant interfaces: a control-theoretic perspective.

In this article, we propose the application of a control-theoretic framework to human-automation interaction. The framework consists of a set of conceptual distinctions that should be respected in automation research and design. We demonstrate how existing automation interface designs in some nuclear plants fail to recognize these distinctions. We further show the value of the approach by applying it to modes of automation. The design guidelines that have been proposed in the automation literature are evaluated from the perspective of the framework. This comparison shows that the framework reveals insights that are frequently overlooked in this literature. A new set of design guidelines is introduced that builds upon the contributions of previous research and draws complementary insights from the control-theoretic framework. The result is a coherent and systematic approach to the design of human-automation-plant interfaces that will yield more concrete design criteria and a broader set of design tools. Applications of this research include improving the effectiveness of human-automation interaction design and the relevance of human-automation interaction research.

Problems with medical devices may be severely under-reported.

The purposes of this study were to determine whether registered nurses are familiar with the Health Canada Medical Device Problem Report Form, and if so, how often they use it to report problems and concerns compared to how often they experience problems and concerns with medical devices. A survey was mailed to a random sample of 1,000 Ontario nurses to collect demographic information and to determine their familiarity with the aforementioned form, as well as the frequency with which they encounter problems/concerns with medical devices. Seventy-two and a half percent of the nurses reportedly have problems/concerns with medical devices at least yearly, yet 94.2% of them did not know that the Health Canada Medical Device Problem Report Form existed. Therefore, problems/concerns with medical devices encountered by registered nurses may be severely under-reported to Health Canada, contributing to an underestimate of the actual threat that devices pose to patient safety.

Bibliometric analysis of Human Factors (1970-2000): a quantitative description of scientific impact.

Bibliometric analyses use the citation history of scientific articles as data to measure scientific impact. This paper describes a bibliometric analysis of the 1682 papers and 2413 authors published in Human Factors from 1970 to 2000. The results show that Human Factors has substantial relative scientific influence, as measured by impact, immediacy, and half-life, exceeding the influence of comparable journals. Like other scientific disciplines, human factors research is a highly stratified activity. Most authors have published only one paper, and many papers are cited infrequently, if ever. A small number of authors account for a disproportionately large number of the papers published and citations received. However, the degree of stratification is not as extreme as in many other disciplines, possibly reflecting the diversity of the human factors discipline. A consistent trend of more authors per paper parallels a similar trend in other fields and may reflect the increasingly interdisciplinary nature of human factors research and a trend toward addressing human-technology interaction in more complex systems. Ten of the most influential papers from each of the last 3 decades illustrate trends in human factors research. Actual or potential applications of this research include considerations for the publication and distribution policy of Human Factors.

Usability assessment of pacemaker programmers.

There is a perception among clinicians of usability differences in the user interface of pacemaker programmers, but there is an absence of literature in this area. The purpose of this study was to describe usability differences in pacemaker programmers. Forty-two programmer users completed self-administered questionnaires and two usability experts independently performed heuristic evaluation to identify features that violated general usability principles. Programmers from seven manufacturers (coded A-G) were evaluated. There was a balanced representation of users: nurses (58%) versus technologists (40%) who are employed in community (50%) versus academic (45%) hospitals, novice versus expert users based on the median users' programming experience of 60 months (range 1-300 months). Significant differences between programmers were found in overall user satisfaction and ease of programmer use (P < 0.0001) in the display, controls, operation, and physical dimension of the programmers (P < 0.05). Heuristic evaluations showed frequent violations of usability principles in all programmers. Problematic areas include reliance on user recall, inconsistency in operation of critical controls, poor readability, and not anticipating user wants or action. Programmer interface designs do not consistently meet user needs or general usability principles. This impacts on the safe and effective use of programmers. Guidelines in programmer design should be established, particularly with respect to labeling, location, and operation of critical controls.

What does it take? A case study of radical change toward patient safety.

BACKGROUND: Adopting a human factors engineering approach to patient safety requires a radical behavioral shift from "blame and shame," which emphasizes further training, to systems thinking, which also emphasizes improved system design. A medical device manufacturer appeared to initiate this radical shift after exhibiting the traditional approach for years. METHODOLOGY: The research focused on a patient-controlled analgesia device. A qualitative case study methodology was used to study events in the period from the device's introduction (1988) until the start of the behavioral change (May 2001). Data on 50 relevant events were analyzed. The tabular summary was analyzed for evidence of the prerequisites predicted by punctuated equilibrium theory, and the graphical time line was analyzed for evidence of vertical alignment across levels. RESULTS: Radical behavioral change was preceded by a critical 9.5-month period with three characteristics: new corporate leadership, perceived poor corporate performance, and aligned disruptions occurring within a relatively short time at almost every level in the external environment in which the company operated. DISCUSSION: These findings are consistent with punctuated equilibrium theory, according to which organizations can experience long periods of resistance to change followed by fast revolutionary change (approximately two years). The findings also have implications for when and how to introduce patient safety policy interventions to "tilt the playing field" and thereby increase the likelihood that such reforms will succeed.

Programming errors contribute to death from patient-controlled analgesia: case report and estimate of probability.

PURPOSE: To identify the factors that threaten patient safety when using patient-controlled analgesia (PCA) and to obtain an evidence-based estimate of the probability of death from user programming errors associated with PCA. CLINICAL FEATURES: A 19-yr-old woman underwent Cesarean section and delivered a healthy infant. Postoperatively, morphine sulfate (2 mg bolus, lockout interval of six minutes, four-hour limit of 30 mg) was ordered, to be delivered by an Abbott Lifecare 4100 Plus II Infusion Pump. A drug cassette containing 1 mg.mL(-1) solution of morphine was unavailable, so the nurse used a cassette that contained a more concentrated solution (5 mg.mL(-1)). 7.5 hr after the PCA was started, the patient was pronounced dead. Blood samples were obtained and autopsy showed a toxic concentration of morphine. The available evidence is consistent with a concentration programming error where morphine 1 mg.mL(-1) was entered instead of 5 mg.mL(-1). Based on a search of such incidents in the Food and Drug Administration MDR database and other sources and on a denominator of 22,000,000 provided by the device manufacturer, mortality from user programming errors with this device was estimated to be a low likelihood event (ranging from 1 in 33,000 to 1 in 338,800), but relatively numerous in absolute terms (ranging from 65-667 deaths). CONCLUSION: Anesthesiologists, nurses, human factors engineers, and device manufacturers can work together to enhance the safety of PCA pumps by redesigning user interfaces, drug cassettes, and hospital operating procedures to minimize programming errors and to enhance their detection before patients are harmed.

Ecological interface design: progress and challenges.

Ecological interface design (EID) is a theoretical framework for designing human-computer interfaces for complex sociotechnical systems. Its primary aim is to support knowledge workers in adapting to change and novelty. This literature review shows that in situations requiring problem solving, EID improves performance when compared with current design approaches in industry. EID has been applied to industry-scale problems in a broad variety of application domains (e.g., process control, aviation, computer network management, software engineering, medicine, command and control, and information retrieval) and has consistently led to the identification of new information requirements. An experimental evaluation of EID using a full-fidelity simulator with professional workers has yet to be conducted, although some are planned. Several significant challenges remain as obstacles to the confident use of EID in industry. Promising paths for addressing these outstanding issues are identified. Actual or potential applications of this research include improving the safety and productivity of complex sociotechnical systems.

Designing for adaptation to novelty and change: functional information, emergent feature graphics, and higher-level control.

Ecological interface design (EID) is a theoretical framework that aims to support worker adaptation to change and novelty in complex systems. Previous evaluations of EID have emphasized representativeness to enhance generalizability of results to operational settings. The research presented here is complementary, emphasizing experimental control to enhance theory building. Two experiments were conducted to test the impact of functional information and emergent feature graphics on adaptation to novelty and change in a thermal-hydraulic process control microworld. Presenting functional information in an interface using emergent features encouraged experienced participants to become perceptually coupled to the interface and thereby to exhibit higher-level control and more successful adaptation to unanticipated events. The absence of functional information or of emergent features generally led to lower-level control and less success at adaptation, the exception being a minority of participants who compensated by relying on analytical reasoning. These findings may have practical implications for shaping coordination in complex systems and fundamental implications for the development of a general unified theory of coordination for the technical, human, and social sciences. Actual or potential applications of this research include the design of human-computer interfaces that improve safety in complex sociotechnical systems.