ItemProcurement Procedures(EWH, 2012)Procurement is the process of acquiring goods, supplies and services. It includes Equipment, spare parts & supplies for program activities, Equipment, office furniture & supplies for project offices, Drugs and medicines, and Consulting services by individuals or organizations. ItemHTM Guide 2: How to plan and budget your Healthcare Technology(EWH, 2012) Worm, AnnaThis presentation accompanies the book: How to Organize: How to Manage Vol 2, Lenel et. al., (Ziken International: 2005). ItemManagement of Maintenance(VSO, 1995) Skeet, Muriel; Fear, DavidThe breakdown of a piece of equipment is inconvenient to us and can put our patients’ lives at risk. The result is frustration and stress. Sometimes a breakdown is inevitable or a repair is delayed because a spare part is not available or an expert is required to identify and repair the fault. ItemManaging the Lifecycle of Medical Equipment(Tropical Health and Education Trust., 2015)This short article provides a brief overview of major concepts in Healthcare Technology Management such as: the equipment lifecycle, planning, budgeting and financing, assessment and selection, logistics, installation and commissioning, skill development, safety, repair, and decomissioning and disposal. ItemIdentifying Issues and Investigating Incidents Case Study(HumanEra @ UHN & IFMBE Clinical Engineering Division, 2015) Andrea Cassano-Piché, et. alBiomedical technology professionals are often the first people to identify issues with a technology. Sometimes they identify them proactively, during regular inspections, and sometimes they find them retrospectively, when they are contacted by front line staff for assistance. In both of these scenarios, biomedical technology professionals are well positioned to apply human factors methods to identify human factors issues. This chapter will use case studies to showcase two human factors informed methods that can be used to help identify human factors issues with technology either retrospectively (HFRCA), or prospectively (HFFMEA). ItemHuman Factors Informed Procurement and Implementation Process(HumanEra @ UHN & IFMBE Clinical Engineering Division, 2015) Andrea Cassano-Piché, et. alThe human factors informed procurement and implementation process (HFPIP) is a framework that can be followed to support the human factors informed selection of medical technologies in hospital organizations. This framework builds on the traditional procurement process by incorporating human factors methods and standards to help inform a decision, and proactively mitigate residual risk as identified through human factors evaluations. This framework was developed iteratively based on the experience gained during several hospital procurement activities. ItemHuman Factors Informed Root Cause Analysis(HumanEra @ UHN & IFMBE Clinical Engineering Division., 2015) Andrea Cassano-Piché, et. alRoot Cause Analysis (RCA) is a retrospective incident investigation framework, initially developed as a quality management engineering tool, that is now widely used in many industries to support the improved safety of systems following an accident or incident. In healthcare, regulators such as The Joint Commission have mandated immediate investigation and response following a sentinel event, which is “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof” . RCA is a means by which this type of investigation and response can be accomplished. ItemHuman Factors Informed Failure Mode and Effects Analysis Andrea Cassano-Piché, et. al(HumanEra @ UHN & IFMBE Clinical Engineering Division., 2015)Failure Mode and Effects Analysis (FMEA) is an engineering method for proactively assessing vulnerabilities in a system before the risks cause harm. It was first used in the late 1940’s by the US Armed Forces to analyze various flight control systems (Amzen, 1996), as pilot error was leading to crashes and deaths. Since, FMEA has been adapted and used in several industries including military, aerospace, automotive, plastics, food service, and more recently, in healthcare. FMEA has been promoted by several national healthcare quality and safety organizations in Canada and the United States including: the Veterans Health Administration , the Institute for Safe Medication Practices , the Institute for Safe Medication Practices Canada , and the Institute for Healthcare Improvement . Carrying out an FMEA is a means for hospitals to satisfy accreditation standards in the US and Canada including The Joint Commission’s patient safety standard LD.5.2 in the Leadership chapter of the Hospital Accreditation Manual  and Accreditation Canada’s Required Operating Practice that hospitals conduct at least one proactive risk assessment of a high-risk process each year. ItemUsability Testing(HumanEra @ UHN & IFMBE Clinical Engineering Division, 2015) Andrea Cassano-Piché, et. alWhen a technology or system change is evaluated in isolation, the effect of external factors like the environment of use, interfacing technologies and equipment, and team dynamics of multiple care providers are unknown. Putting that same technology in a simulated environment and in the hands of real end users, however, can reveal what problems or unanticipated consequences to expect when the technology or system change is implemented. Whereas during a vendor demonstration of a new technology the technology is shown as a stand-alone device and observers must independently consider as many ‘what- ifs’ as they can think of in the moment, to identify how the technology will fit with its environment and work processes, usability testing allows people to think, and work through tasks and any associated difficulties in a systematic way, without the assistance of highly trained product specialists and within a safe environment. ItemHeuristic analysis(HumanEra @ UHN & IFMBE Clinical Engineering Division, 2015) Andrea Cassano-Piché, et. alWhen a technology is poorly designed, it can lead people to make mistakes while interacting with it. In healthcare, this can be especially serious given the complexity of technology and what we need it to do. Many technologies in healthcare provide support life saving and supporting functions for complex patients with changing medical status. When this technology is poorly designed, it can be responsible for errors leading to patient safety events. Identifying technology designs, or aspects of design, that violate best practices for designing Human-tech systems is a potentially life-saving undertaking. Heuristic analysis is one method by which technology design can be evaluated to determine whether users will find it challenging to operate. ItemTask Analysis(HumanEra @ UHN & IFMBE Clinical Engineering Division, 2015) Andrea Cassano-Piché, et. alOnce data have been collected in the field, you will need a way to make sense of the data, and to share it in a meaningful way with others. Completing a task analysis can be extremely helpful in accomplishing both of these goals. Taking the time to package your data into a task analysis format is an effective way of systematically identifying any assumptions being held, or any gaps in your own understanding. ItemInterviews, Focus Groups, and Surveys(HumanEra @ UHN & IFMBE Clinical Engineering Division, 2015) Andrea Cassano-Piché, et. alData collection through observation yields rich information about how people do things, but this insight only provides part of the story. It is also important to understand why a system has been set up, or things are being done, in a particular way. Understanding why from the subject’s perspective helps to prevent you, the observer, from introducing bias by assigning your own assumptions to something you have observed. It is also important to help you learn about people’s mental models, preferences, and knowledge, in the context of technology use. Sometimes observations do result in an understanding of why the system functions as it does; namely, if you have the time and freedom to talk with, and ask questions of the people you are shadowing. However, in reality this is usually difficult because those being observed are busy, with little time to answer questions at length. This is why it is a good idea to plan to collect data in a number of ways, from multiple subjects, including using methods like interviews, focus groups, and surveys. ItemObservation for HTM(HumanEra @ UHN & IFMBE Clinical Engineering Division, 2015) Andrea Cassano-Piché, et. alWhen people with similar training and experience are presented with a particular situation, it is not uncommon to find that they take fairly different approaches to managing the situation. This is not necessarily because one person has a better approach or more information than another, but because there are many factors that influence how people perform their work. In healthcare, we believe people inherently want to do their work safely and effectively, and that when their performance is unsafe or ineffective, there are factors, which they may or may not be aware of, that influence their performance. These factors come from a combination of internal and external sources that can vary over time. Examples of external factors that can impact work include equipment design, the physical layout of a workspace, expected workflow and work practices, organizational policies, team dynamics, and organizational culture. Internal factors, or natural human limitations (Chapter 3), that can affect our work include our ability to remember multiple units of information, or to pay attention to many things that are happening at the same time. People also vary in terms of their skill level and ability to perform certain tasks based on factors like age, level of training, and experience. ItemThe Need for Human Factors in Health Technology Management(HumanEra @ UHN & IFMBE Clinical Engineering Division, 2015) Andrea Cassano-Piché, et. alAll people, no matter how careful, have the potential to make mistakes. Healthcare professionals enter the field out of a desire to help others, but because all humans have certain known strengths and limitations, people can often find themselves in situations where the systems in which they work lead them to make mistakes. In 1999, the Institute of Medicine’s publication To Err is Human  revealed that approximately 44,000 to 98,000 preventable deaths take place each year in the United States, making it the 8th leading cause of death. A similar study in Canada showed even worse outcomes on a per capita basis, with between 9,000 and 24,000 preventable deaths occurring each year . Other studies in the United Kingdom , New Zealand , and Australia  found that 8.7%, 12.9% and 16.6% of hospital admissions, respectively, were associated with an adverse event. In 2013, fourteen years after To Err is Human was published, an updated review of the literature provided higher estimates still, with between 210,000 and 400,000 preventable adverse events occurring in the United States annually. Errors leading to adverse events and preventable patient deaths remain a serious, global issue. ItemHow to Manage the Finances of Your Healthcare Technology Management Teams(Ziken International, 2018)The operational budget refers to the planned engineering activities (operations) that the HTM Team carries out for its customers. In other words it allocates funds against the activities in the operational plan (Section 4). It is a recurrent budget – all capital needs are contained in a separate capital budget. The quality and usefulness of an operational budget for healthcare technology management depends to a large degree upon the professional skills and experience of the people who prepare it. Some might argue that budgeting takes a lot of time, increases paperwork, and contributes to inflexible working practices. However, experience shows that the time and effort invested in preparing a realistic budget pays off during the course of the year ItemHow to Organize the Maintenance of Your Healthcare Technology(Ziken International, 2018)The system introduced in this Guide provides a solid approach to managing maintenance. However, we recognize that there are other ways of organizing the maintenance services which may be more appropriate for your administrative system. The important thing is to implement a well-functioning system. 11 1.2 Introduction to this specific guide ￼As you read through the recommendations in this Guide, you may find it useful to refer to advice in other Guides in the Series, as indicated in the text. Additional useful reference materials and contacts are given in Annex 2.