Lack of evidence regarding safety and effectiveness at market entry is driving the need to consider adopting a lifecycle approach to evaluating medical devices, but it is unclear what lifecycle evaluation means. This research sought to explore the tacit meanings of “lifecycle” and “lifecycle evaluation” as embodied within evaluation models/frameworks used for medical devices.

Drawing on qualitative evidence synthesis methods and using an inductive approach, novel methods were developed to identify, appraise, analyze, and synthesize lifecycle evaluation models used for medical devices. Data was extracted (including purpose; audience; characterization; outputs; timing; and type of model) from key texts for coding, categorization, and comparison, exploring embodied meaning across four broad perspectives.

Fifty-two models were included in the synthesis. They demonstrated significant heterogeneity of meaning, form, scope, timing, and purpose. The “lifecycle” may represent a single stage, a series of stages, a cycle of innovation, or a system. “Lifecycle evaluation” focuses on the overarching goal of the stakeholder group, and may use a single or repeated evaluation to inform decision-making regarding the adoption of health technologies (Healthcare), resource allocation (Policymaking), investment in new product development or marketing (Trade and Industry), or market regulation (Regulation). The adoption of a lifecycle approach by regulators has resulted in the deferral of evidence generation to the post-market phase.

Using a “lifecycle evaluation” approach to inform reimbursement decision-making must not be allowed to further jeopardize evidence generation and patient safety by accepting inadequate evidence of safety and effectiveness for reimbursement decisions.

During a medical emergency, the American public often relies on the expertise of emergency medical technicians (EMTs). These professionals face a number of occupational hazards, and the literature suggests that EMTs are at a greater risk of developing physical and mental stress-related disorders. The purpose of this paper is to systematically examine gaps in the extant literature and to present a theoretically driven conceptual model to serve as a basis for future intervention and research efforts.

A systematic review of the literature was conducted utilizing rele-vant databases (e.g., PsychInfo, Medline). All empirical articles regarding emergency medical responders were reviewed, but given the limited research available, relevant theoretical and conceptual literature on the constructs of interest in other, related populations also were included. Based on this extensive review, a modification of the stress process model is suggested to explain the relationships among occupational stress exposure, post-traumatic stress disorder (PTSD), and high-risk alcohol and other drug use.

Exposure to traumatic events was reported to be between 80% and 100% among EMTs, and rates of PTSD are >20%. High-risk alcohol and drug use rates among other emergency response professionals were reported to be as high as 40%. The proposed model suggests direct linkages between occupationally related stress exposure, including chronic and critical incident stress, PTSD, and high-risk alcohol and other drug use. Social support and personal resources (e.g., coping, locus of control) are proposed to have mediating and moderating influences on the three main constructs, and cohesion is introduced as an important, idiosyncratic influence in this population. The moderating influences of gender, age, ethnicity, marital status, and socioeconomic status, level of training, and years of service are included in the proposed model.

High-risk alcohol and other drug use and post-traumatic symptomatology pose substantial risks for EMTs, and consequently, for the patients they serve. It is imperative that researchers develop and test a theoretically grounded model of risk and protective factors that will guide intervention development and future study. The model suggested in this paper, based on a comprehensive literature review and development of theory, represents a critical first step in the intervention research process.