Imaging equipment such as MRIs, CT scanners and general radiography equipment consume significant amounts of energy while operating. This study describes a series of detailed energy consumption studies on these devices during clinical use at three major health care centres in Canada, one in British Columbia and two in Ontario. The study was conducted by the Canadian Coalition for Green Health Care [1], with funding provided by Natural Resources Canada [2] and BC Hydro [3]. The primary goal of the study was to accelerate the development of ENERGY STAR specifications for medical imaging equipment. Natural Resources Canada is assisting the United States Environmental Protection Agency (US EPA) [4], by collecting these data from the field. Eight testing events were undertaken, providing energy consumption data for low power energy modes, standby/idle power energy modes and active/patient scanning energy modes. Energy consumption was measured over periods ranging from three to eleven days, to provide rich information about when and how frequently the equipment was used and what the associated energy consumption profiles were. Data acquisition rates were varied to gain a detailed understanding of the temporal variations in energy consumption profiles during each use mode. Results from this study showed that there were variations in the low power mode energy consumption of greater than 25% in some cases, and that non-scanning energy consumption, either low power or stand-by modes, in some cases accounted for up to 80% of the total energy consumption of the system at some hospitals. These findings indicate that there is considerable scope for manufacturers to reduce the energy consumption levels of their devices, and for users to reduce energy consumption during clinical use through practices such as placing the system into a lower energy mode or shutting it down while not in use, where possible.

Purpose: Intravenous (IV) compounding safety has garnered recent attention as a result of high-profile incidents, awareness efforts from the safety community, and increasingly stringent practice standards. New research with more-sensitive error detection techniques continues to reinforce that error rates with manual IV compounding are unacceptably high. In 2014, our team published an observational study that described three types of previously unrecognized and potentially catastrophic latent chemotherapy preparation errors in Canadian oncology pharmacies that would otherwise be undetectable. We expand on this research and explore whether additional potential human failures are yet to be addressed by practice standards. Methods: Field observations were conducted in four cancer center pharmacies in four Canadian provinces from January 2013 to February 2015. Human factors specialists observed and interviewed pharmacy managers, oncology pharmacists, pharmacy technicians, and pharmacy assistants as they carried out their work. Emphasis was on latent errors (potential human failures) that could lead to outcomes such as wrong drug, dose, or diluent. Results: Given the relatively short observational period, no active failures or actual errors were observed. However, 11 latent errors in chemotherapy compounding were identified. In terms of severity, all 11 errors create the potential for a patient to receive the wrong drug or dose, which in the context of cancer care, could lead to death or permanent loss of function. Three of the 11 practices were observed in our previous study, but eight were new. Applicable Canadian and international standards and guidelines do not explicitly address many of the potentially error-prone practices observed. Conclusion: We observed a significant degree of risk for error in manual mixing practice. These latent errors may exist in other regions where manual compounding of IV chemotherapy takes place. Continued efforts to advance standards, guidelines, technological innovation, and chemical quality testing are needed.

This paper describes the ways in which human factors methods can help to enhance the work of established clinical engineering teams by placing a new emphasis on error reduction and patient safety. This approach in many ways represents a natural evolution for departments that are looking to enhance their usefulness and relevance to healthcare. Several examples are given of points at which the introduction of human factors methods can reveal issues related to the safe use of medical devices that are not easily accessible by other means. Adoption and implementation of these methods offers the potential for clinical engineering departments to enhance their role of helping to ensure optimal patient safety.

Background: Little research has examined how physicians choose medical devices for treating individual patients to reveal if interventions are needed to support decision-making and reduce device-associated morbidity and mortality. This study explored factors that influence choice of implantable device from among available options. Methods: A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites. They were asked how they decided what device to use in a given patient, sources of information they consulted, and how patients were engaged in decision-making. Sampling was concurrent with data collection and analysis to achieve thematic saturation. Data were analyzed using constant comparative technique by all members of the research team. Results: Twenty-two physicians from five Canadian provinces (10 cardiovascular, 12 orthopedic; 8, 10 and 4 early, mid and late career, respectively) were interviewed. Responses did not differ by specialty, geographic region or career stage. Five major categories of themes emerged that all influence decision-making about a range of devices, and often compromise choice of the most suitable device for a given patient, potentially leading to sub-optimal clinical outcomes: lack of evidence on device performance, patient factors, physician factors, organizational and health system factors, and device and device market factors. In the absence of evidence from research or device registries, tacit knowledge from trusted colleagues and less-trusted industry representatives informed device choice. Patients were rarely engaged in decision-making. Physician preference for particular devices was a barrier to acquiring competency in devices potentially more suitable for patients. Access to suitable devices was further limited to the number of comparable devices on the market, local inventory and purchasing contract specifications. Conclusions: This study revealed that decision-making about devices is complex, cognitively challenging and constrained by several factors limiting access to and use of devices that could optimize patient outcomes. Further research is needed to assess the impact of these constraints on clinical outcomes, and develop interventions that optimize decision-making about device choice for treating given patients.

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OBJECTIVE:Interruptions to secondary tasks resulting in multiple tasks to resume may tax working memory. The objective of this research is to study such interruptions experienced by intensive care unit (ICU) nurses.BACKGROUND:ICU nurses are frequently interrupted, resulting in a switch from primary to secondary tasks. In two recent studies, we observed that some of these secondary tasks also get interrupted, resulting in multiple tasks that have to be resumed, a phenomenon we refer to as nested interruptions. Although completing multiple secondary tasks in a serial fashion during an interruption period can create context-switching costs, we hypothesize that nested interruptions tax the working memory even more than just performing multiple secondary tasks sequentially because the nurse would have to encode in working memory the resumption goals for both the primary and the interrupted secondary tasks.METHOD:We conducted a laboratory study with 30 ICU nurses, who performed an electronic order-entry task under three interruption conditions: (a) baseline-no secondary task during the interruption period; (2) serial-performance of two tasks one after the other during the interruption period; and (3) nested-performance of two tasks during the interruption period, one of which was also interrupted.RESULTS:Nested interruptions resulted in significantly longer primary-task resumption lag and less accurate task resumption compared with both the serial interruption and baseline conditions.CONCLUSION:The nested nature of interruptions adds to the resumption lag and diminishes resumption accuracy by likely populating the working memory with goals associated with interrupted secondary tasks.

Although the high quality of medical images is strictly controlled during acquisition, it is often not adequately maintained during image review. This is due to the lack of a published process and information on optimal monitor settings for medical image viewing. Other complications include large differences between various types, applications, and vendors, and scarce literature describing monitor quality control protocols. Guidelines and recommendations also vary between countries and are sometimes conflicting . The University Health Network (UHN) is comprised of the Toronto General, Toronto Western, and Princess Margaret Hospitals. The UHN Medical Imaging Department also manages medical imaging at the Mount Sinai Hospital (MSH). Approximately 450 computers at UHN and 200 computers at Mount Sinai Hospital are able to review medical images through the PACS (Picture Archiving and Communication System) using the eFilm Workstation application. The majority of PACS clinical review workstations are located in clinics and physicians’ offices. A smaller number of the PACS workstations are used by radiologists in reading rooms. The PACS monitors are heterogeneous with respect to manufacturer, type (CRT versus LCD, colour versus greyscale, etc.), age, size, and image quality. This initiative is the first comprehensive monitor quality assurance program at UHN and MSH.

OBJECTIVES:Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed.DESIGN:A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team.RESULTS:Twenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as "symbiotic", but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness.CONCLUSIONS:Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how hospitals do and should govern interaction with representatives, or support their staff in this regard.

Patient engagement (PE) is warranted when treatment risks and outcomes are uncertain, as is the case for higher risk medical devices. Previous research found that patients were not engaged in discussions or decisions about implantable medical devices. This study explored physician views about engaging patients in such discussions.Qualitative interviews using a basic descriptive approach.Canada.Practicing cardiovascular and orthopaedic physicians.Level, processes and determinants of PE in medical device discussions and decisions.Views were largely similar among 10 cardiovascular and 12 orthopaedic physicians interviewed. Most said that it was feasible to inform and sometimes involve patients in discussions, but not to partner with them in medical device decision-making. PE was constrained by patient (comfort with PE, technical understanding, physiologic/demographic characteristics, prognosis), physician (device preferences, time), health system (purchasing contracts) and device factors (number of devices on market, comparative advantage). A framework was generated to help physicians engage patients in discussions about medical devices, even when decisions may not be preference sensitive due to multiple constraints on choice.This study identified that patients are not engaged in discussions or decisions about implantable medical devices. This may be due to multiple constraints. Further research should establish the legitimacy, prevalence and impact of constraining factors, and examine whether and how different levels and forms of PE are needed and feasible.

Objectives: Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace. Methods: We used data from Health Canada to study medical device recalls in Canada from 2005 to 2015. We analyzed the risks of medical device recalls according to the risk class of the device (I lowest; IV highest) and the hazard priority of the recall (Type I highest potential harm; Type III lowest potential harm). Results: During a 10-year period, there were 7,226 medical device recalls. Most recalls were for intermediate risk class (Class II, 40.1 percent; Class III, 38.7 percent) medical devices. Among recalled devices, 5.0 percent were judged to have a reasonable probability of serious adverse health consequences or death (Type I recall Hazard Priority classification). While the number of medical devices marketed in Canada is not known, over a similar 10-year period, 24,849 new Class II, II, and IV medical device licenses were issued by Health Canada. Conclusions: Several hundred medical device recalls occur in Canada each year. Further research is needed to characterize the nature of medical device recalls, and to explore how consumers use information about recalls.

Background Postmarket surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Little is known about factors that influence whether and how physicians report AMDEs, an essential step in developing behaviour change interventions. This study explored factors that influence AMDE reporting. Methods Qualitative interviews were conducted with physicians who differed by specialties that implant cardiovascular and orthopaedic devices prone to AMDEs, geography and years in practice. Participants were asked if and how they reported AMDEs, and the influencing factors. Themes were identified inductively using constant comparative technique, and reviewed and discussed by the research team on four occasions. Results Twenty-two physicians of varying specialty, region, organisation and career stage perceived AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Physician beliefs and behaviour were reinforced by limited healthcare system capacity and industry responsiveness. The healthcare system lacked processes and infrastructure to detect, capture, share and act on information about AMDEs, and constrained device choice through purchasing contracts. The device industry did not respond to reports of AMDEs from physicians or improve their products based on such reports. As a result, participants said they used devices that were less than ideal for a given patient, leading to suboptimal patient outcomes. Conclusions There may be little point in solely educating or incentivising individual physicians to report AMDEs unless environmental conditions are conducive to doing so. Future research should explore policies that govern AMDEs and investigate how to design and implement postmarket surveillance systems.

Introduction Some cardiovascular devices are licensed based on limited evidence, potentially exposing patients to devices that are not safe or effective. Research is needed to ascertain if the same is true of other types of medical devices. Knee arthroplasty is a widely-used surgical procedure yet implant failures are not uncommon. The purpose of this study was to characterize available evidence on the safety and effectiveness of knee implants. Methods A review of primary studies included in health technology assessments (HTA) on total (TKA) and unicompartmental knee arthroplasty (UKA) was conducted. MEDLINE, EMBASE, CINAHL, Cochrane Library and Biotechnology & BioEngineering Abstracts were searched from 2005 to 2014, plus journal tables of contents and 32 HTA web sites. Patients were aged 18 and older who underwent primary TKA or UKA assessed in cohort or randomized controlled studies. Summary statistics were used to report study characteristics. Results A total of 265 eligible primary studies published between 1986 and 2014 involving 59,217 patients were identified in 10 HTAs (2 low, 7 moderate, 1 high risk of bias). Most evaluated TKA (198, 74.5%). The quality of evidence in primary studies was limited. Most studies were industry-funded (23.8%) or offered no declaration of funding or conflict of interest (44.9%); based on uncontrolled single cohorts (58.5%), enrolled fewer than 100 patients (66.4%), and followed patients for 2 years or less (UKA: single cohort 29.8%, comparative cohort 16.7%, randomized trial 25.0%; TKA: single cohort 25.0%, comparative cohort 31.4%, randomized trial 48.6%). Furthermore, most devices were evaluated in only one study (55.3% TKA implants, 61.1% UKA implants). Conclusions Patients, physicians, hospitals and payers rely on poor-quality evidence to support decisions about knee implants. Further research is needed to explore how decisions about the use of devices are currently made, and how the evidence base for device safety and effectiveness can be strengthened.

Industries such as aviation and nuclear power have greatly improved their safety performance through the application of human factors methods to the design, development, selection and deployment of a range of technologies and work processes. Health care safety performance generally lags behind these industries and would benefit from a similar application of human factors methods. Clinical engineers are in an ideal position to acquire and apply this human factors knowledge, and lead its adoption in health care. This paper describes a text that has been written specifically for clinical engineers and others who design, develop, select and support the use of health care technologies, to enable them to learn the key methods of human factors and adopt them as part of their ongoing work. Early indications are that these approaches help to ensure that health care technologies are used more safely and effectively, and it is hoped that large-scale adoption will result in a noticeable and worthwhile improvement in overall health care safety. The described text is now ready and has been published in English on the IFMBE website. It is available as a free download in PDF format. Clinical engineers and others working around the world in the area of health technology are encouraged to learn and adopt these methods, and use them as appropriate in their local setting. At time of writing, plans are underway for a translation of this book into Spanish. Once completed, this version will also be made available online at no charge. The authors encourage readers to contact them with their experiences, and the aim is to build a worldwide community that gradually adopts these methods and helps to drive safety improvements in health care.

PURPOSE:In a previous study of interruptions to intensive care unit (ICU) nurses, we found that other personnel tend to regulate their interruptions based on nurses' tasks. However, nurses' tasks are not always immediately visible to an interrupter. This article evaluates a task-severity awareness tool (TAT) designed for nurses to inform others when they are performing high-severity tasks. When a nurse engages the tool within an ICU room, a "do not disturb please!" message is displayed outside the room. METHODS:Task-severity awareness tool was installed in a cardiovascular ICU room at a Canadian hospital. Fifteen nurses assigned to the TAT room and 13 nurses assigned to 11 other rooms were observed, approximately 2 hours each, over a 3-week period. Data were collected in real time, using a tablet computer. RESULTS:Interruption rate during high-severity tasks in the TAT room was significantly lower than in other rooms; interruptions with personal content were entirely mitigated during high-severity tasks. Furthermore, interruptions from nurses and medical doctors were also entirely mitigated during high-severity tasks but happened more frequently during non-high-severity tasks compared with rooms with no TAT. CONCLUSIONS:Task-severity awareness tool proved to be effective in mitigating unnecessary interruptions to critical tasks. Future research should assess its long-term effectiveness.

The evolution of clinical engineering certification in Canada started in 1980 with the development of a Canadian Board of Examiners, which used both written and oral examination methods to determine candidates' eligibility for certification. After an initial burst of activity, the number of applicants coming to the Board slowed down, to the point where the Board effectively ceased to function for an extended period. Renewed interest in the first decade of this century led to a fresh initiative to re-establish the Board. This time, it was decided to twin the activities of the Canadian Board with its United States counterpart, to the extent possible, to try to ensure the sustainability of the Canadian Board. Thanks to support from US colleagues, the new Canadian Board is in place, with a process that is closely aligned with that of the US. The main differences are the need to examine Canadian candidates on codes, standards and regulations that are Canada-specific, and the requirement in each Canadian province or territory for licensure as a professional engineer if the title engineer is to be used. The Canadian and US Boards are both accountable to the Healthcare Technology Certification Commission.

BACKGROUND:In a previous study, we observed that the majority of interruptions experienced by nurses in a cardiovascular intensive care unit (CVICU) carried information directly related to their patient or other aspects of work affecting other patients or indirectly affecting their patient. Further, the proportion of interruptions with personal content was significantly higher during low-severity (in case of an error as defined by nurses) tasks compared to medium- and high-severity tasks suggesting that other personnel may have evaluated the criticality of the nurses' tasks before interrupting. However, this earlier study only collected data when an interruption happened and thus could not investigate interruption rate as a function of primary task type and severity while controlling for primary task duration as an exposure variable. OBJECTIVES:We addressed this methodological limitation in a second observational study that was conducted to further study interruptions and also to evaluate an interruption mitigation tool. The data from the baseline condition (i.e., no tool) is analyzed in this paper to validate the results of our previous study and to report interruption rates observed during tasks of varying severities (low, medium, high), with a particular focus on comparing different interruption contents. DESIGN AND SETTING:The study was conducted in a 24-bed closed CVICU at a Canadian hospital, during day shifts. PARTICIPANTS:The baseline condition involved thirteen nurses. METHODS:Over a 3-week period, three researchers observed these nurses 46-120 min each, with an average of 89 min. Data were collected in real time, using a tablet computer and software designed for this purpose. The rate of interruptions with different content was compared across varying task severity levels as defined by CVICU nurses. RESULTS:Nurses spent about 50% of their time conducting medium-severity tasks (e.g., documentation), 35% conducting high-severity tasks (e.g., procedure), and 14% conducting low-severity tasks (e.g., general care). The rate of interruptions with personal content observed during low-severity tasks was 1.97 (95% confidence interval, CI: 1.04, 3.74) and 3.23 (95% CI: 1.51, 6.89) times the rate of interruptions with personal content observed during high- and medium-severity tasks, respectively. CONCLUSIONS:Interrupters might have evaluated task severity before interrupting. Increasing the transparency of the nature and severity of the task being performed may help others further modulate when and how they interrupt a nurse. Overall, rather than try to eliminate all interruptions, mitigation strategies should consider the relevance of interruptions to a task or patient as well as their urgency.

Palliative care clients with complex needs are increasingly choosing to remain at home for their care. Home represents familiarity, presence of supportive family and friends, potential for normalcy and, a safe haven. The palliative care literature although robust is hardly ever linked with safety and home care. Patient safety has been focused predominantly on institutions without a corresponding level of research or safety initiatives in the home care sector. Although a growing body of research has begun to highlight the complexity and multidimensionality of home care safety there is a dearth of understanding of safety issues from the perspectives of clients, caregivers, and paid providers who are responsible for managing and coordinating palliative home care. The aim of this study was to describe the experiences, challenges, and insights regarding safety for adults receiving and providing palliative home care services.

Background: This evidence-based practice guideline was developed to update and address new issues in the handling of cytotoxics, including the use of oral cytotoxics; the selection and use of personal protective equipment; and treatment in diverse settings, including the home setting. Methods: The guideline was developed primarily from an adaptation and endorsement of an existing guideline and from three systematic reviews. Before publication, the guideline underwent a series of peer and external reviews to gather feedback. All comments were addressed, and the guideline was amended when required. The guideline applies to health care workers who could come into contact with cytotoxic drugs at any point in the medication circuit. The intended users are hospital administrators, educators, and managers; occupational health and safety services; and pharmacy and health care workers. Results: The recommendations represent a reasonable and practical set of procedures that the intended users of this guideline should implement to minimize opportunities for accidental exposure. They are not limited to just the point of care; they cover the entire chain of cytotoxics handling from the time such agents enter the institution until they leave in the patient or as waste. Conclusions: Reducing the likelihood of accidental exposure to cytotoxic agents within the medication circuit is the main objective of this evidenced-based guideline. The recommendations differ slightly from earlier guidelines because of the availability of new evidence.