-
Integrated Environmental Assessment and... Jan 2017The ecosystem services (ES) concept holds much promise for environmental decision making. Even so, the concept has yet to gain full traction in the decisions and...
The ecosystem services (ES) concept holds much promise for environmental decision making. Even so, the concept has yet to gain full traction in the decisions and policies of environmental agencies in the United States, Europe, and elsewhere. In this paper we examine the opportunities for and implications of including ES in risk assessments and the risk management decisions that they inform. We assert that use of ES will: 1) lead to more comprehensive environmental protection; 2) help to articulate the benefits of environmental decisions, policies, and actions; 3) better inform the derivation of environmental quality standards; 4) enable integration of human health and ecological risk assessment; and 5) facilitate horizontal integration of policies, regulations, and programs. We provide the technical basis and supporting rationale for each assertion, relying on examples taken from experiences in the United States and European Union. Specific recommendations are offered for use of ES in risk assessment and risk management, and issues and challenges to advancing use of ES are described together with some of the science needed to improve the value of the ES concept to environmental protection. Integr Environ Assess Manag 2017;13:62-73. © 2016 SETAC.
Topics: Conservation of Natural Resources; Decision Making; Ecosystem; Environmental Monitoring; European Union; Risk Assessment; Risk Management
PubMed: 27464004
DOI: 10.1002/ieam.1835 -
Medicina (Kaunas, Lithuania) May 2021: Risk management is considered an integral part of laboratory medicine to assure laboratory quality and patient safety. However, the concept of risk management is...
: Risk management is considered an integral part of laboratory medicine to assure laboratory quality and patient safety. However, the concept of risk management is philosophical, so actually performing risk management in a clinical laboratory can be challenging. Therefore, we would like to develop a sustainable, practical system for continuous total laboratory risk management. : This study was composed of two phases: the development phase in 2019 and the application phase in 2020. A concept flow diagram for the computerized risk registry and management tool (RRMT) was designed using the failure mode and effects analysis (FMEA) and the failure reporting, analysis, and corrective action system (FRACAS) methods. The failure stage was divided into six according to the testing sequence. We applied laboratory errors to this system over one year in 2020. The risk priority number (RPN) score was calculated by multiplying the severity of the failure mode, frequency (or probability) of occurrence, and detection difficulty. : 103 cases were reported to RRMT during one year. Among them, 32 cases (31.1%) were summarized using the FMEA method, and the remaining 71 cases (68.9%) were evaluated using the FRACAS method. There was no failure in the patient registration phase. Chemistry units accounted for the highest proportion of failure with 18 cases (17.5%), while urine test units accounted for the lowest portion of failure with two cases (1.9%). : We developed and applied a practical computerized risk-management tool based on FMEA and FRACAS methods for the entire testing process. RRMT was useful to detect, evaluate, and report failures. This system might be a great example of a risk management system optimized for clinical laboratories.
Topics: Humans; Patient Safety; Registries; Risk Assessment; Risk Management
PubMed: 34065022
DOI: 10.3390/medicina57050477 -
BMJ Health & Care Informatics Jan 2023Connecting medical devices to hospital IT networks can create threats that must be covered by IT risk management. In practice, implementing such risk management is not...
OBJECTIVES
Connecting medical devices to hospital IT networks can create threats that must be covered by IT risk management. In practice, implementing such risk management is not trivial because the IEC 80001-1, as the existing state-of-the-art, do not describe sufficiently concrete implementation measures or evaluation indicators. The aim of the present work was to develop and evaluate a catalogue of measures and indicators to help hospitals implement and evaluate risk management in accordance with IEC 80001-1.
METHODS
We conducted a Delphi study with 22 experts. In the first round, we performed interviews to identify implementation measures and evaluation indicators using qualitative content analysis. In the second round, a quantitative experts' survey confirmed the results of the first survey round and identified relationships between the measures and indicators. Based on these results, we then developed a catalogue containing the identified measures and indicators. Finally, we performed a case study to verify the practicability of this catalogue.
RESULTS
We developed and verified a catalogue of 49 measures and 18 indicators to help hospitals implement and evaluate risk management following IEC 80001-1. The case study confirmed the practicability of the catalogue.
DISCUSSION
Compared with IEC 80001-1, our catalogue goes into further detail to offer hospitals a stepwise implementation and evaluation approach. However, the catalogue must be tested in further case studies and evaluated in terms of generalisation.
CONCLUSIONS
The catalogue will enable hospitals to overcome recent difficulties in implementing and evaluating IT risk management for medical devices according to IEC 80001-1.
Topics: Humans; Hospitals; Risk Management
PubMed: 36724909
DOI: 10.1136/bmjhci-2022-100639 -
Acta Bio-medica : Atenei Parmensis Oct 2017The article focuses on the important issue of Risk Management in health. In particular, it describes and critically appraises the new Italian law on patients' safety and...
The article focuses on the important issue of Risk Management in health. In particular, it describes and critically appraises the new Italian law on patients' safety and professional responsibility, and expand on the educational and training needs to implement it on the ground. On the basis of the new law the role of Risk Managers, responsible for quality and safety of healthcare services, becomes of crucial importance in both public and private hospitals in Italy. In such context, education and training of risk managers should be multi disciplinary, ad hoc designed on recent regulations, and, more in general, help to build a new era in healthcare management.
Topics: Humans; Italy; Risk Management
PubMed: 29083345
DOI: 10.23750/abm.v88i3.6747 -
Fertility and Sterility Dec 2013Risk and safety management (RSM) is receiving increasing attention in medicine, with the goals of reducing medical error and increasing quality of care. The principles... (Review)
Review
Risk and safety management (RSM) is receiving increasing attention in medicine, with the goals of reducing medical error and increasing quality of care. The principles and tools of RSM can and should be applied to assisted reproductive technology (ART), a field that has already made significant progress in reducing the undesirable and sometimes dangerous consequences of treatment. ART is a prime area of medicine to contribute and help to lead the application of RSM and patient safety because it has been ahead of many other fields of medicine in standardizing treatment, certifying and auditing practitioners, and reporting standardized outcomes, and because treatments are applied to otherwise healthy individuals where exposure to risk may be less acceptable.
Topics: Female; Humans; Infertility; Male; Medical Errors; Patient Safety; Physicians' Offices; Pregnancy; Reproductive Techniques, Assisted; Risk Management; Safety Management
PubMed: 24200109
DOI: 10.1016/j.fertnstert.2013.10.020 -
British Journal of Anaesthesia Jul 2010
Topics: Humans; Risk Management; Safety Management; State Medicine; United Kingdom; United States; United States National Aeronautics and Space Administration
PubMed: 20551024
DOI: 10.1093/bja/aeq139 -
Critical Reviews in Toxicology Nov 2016When the human health risk assessment/risk management paradigm was developed, it did not explicitly include a "problem formulation" phase. The concept of problem... (Review)
Review
When the human health risk assessment/risk management paradigm was developed, it did not explicitly include a "problem formulation" phase. The concept of problem formulation was first introduced in the context of ecological risk assessment (ERA) for the pragmatic reason to constrain and focus ERAs on the key questions. However, this need also exists for human health risk assessment, particularly for cumulative risk assessment (CRA), because of its complexity. CRA encompasses the combined threats to health from exposure via all relevant routes to multiple stressors, including biological, chemical, physical and psychosocial stressors. As part of the HESI Risk Assessment in the 21st Century (RISK21) Project, a framework for CRA was developed in which problem formulation plays a critical role. The focus of this effort is primarily on a chemical CRA (i.e., two or more chemicals) with subsequent consideration of non-chemical stressors, defined as "modulating factors" (ModFs). Problem formulation is a systematic approach that identifies all factors critical to a specific risk assessment and considers the purpose of the assessment, scope and depth of the necessary analysis, analytical approach, available resources and outcomes, and overall risk management goal. There are numerous considerations that are specific to multiple stressors, and proper problem formulation can help to focus a CRA to the key factors in order to optimize resources. As part of the problem formulation, conceptual models for exposures and responses can be developed that address these factors, such as temporal relationships between stressors and consideration of the appropriate ModFs.
Topics: Environmental Exposure; Environmental Pollutants; Humans; Public Health; Risk Assessment; Risk Management
PubMed: 27685317
DOI: 10.1080/10408444.2016.1211617 -
Applied Ergonomics Sep 2022Effects of psychosocial hazards on risk of musculoskeletal disorders (MSDs) are often very substantial, but workplace risk management practices focus largely on...
Effects of psychosocial hazards on risk of musculoskeletal disorders (MSDs) are often very substantial, but workplace risk management practices focus largely on biomechanical hazards, as do the risk assessment methods used by ergonomists. Translation of research evidence into more effective workplace practices demands a more holistic risk management framework that encompasses both types of hazard. In this context, we evaluate the validity of different MSD risk assessment methods for different purposes, focusing particularly on requirements for routine workplace risk management. These include choice of fit-for-purpose assessment methods, prioritisation of hazards that are most affecting risk, and control actions as high as possible in the risk control hierarchy. Ergonomists could facilitate more effective workplace risk management by promoting: awareness of the need for change; improvements to guidance from OHS regulators; research on MSD-related workplace management issues; and professional development programs on this topic for ergonomists and other OHS practitioners.
Topics: Ergonomics; Humans; Musculoskeletal Diseases; Occupational Diseases; Risk Management; Workplace
PubMed: 35512433
DOI: 10.1016/j.apergo.2022.103774 -
Transfusion Dec 2018Wild poliovirus (WPV) is nearing eradication, and only three countries have never interrupted WPV transmission (Pakistan, Afghanistan, and Nigeria). WPV2 was last... (Review)
Review
Wild poliovirus (WPV) is nearing eradication, and only three countries have never interrupted WPV transmission (Pakistan, Afghanistan, and Nigeria). WPV2 was last detected in 1999, and it was declared eradicated in 2015. WPV3 has not been detected since 2012. Since 2016, WPV1 has been detected in only two countries (Afghanistan and Pakistan), with only 22 cases reported in 2017 and 12 cases reported in 2018 (as of July 10). Because of WPV2 eradication and the risk of emergence of type 2 vaccine-derived polioviruses from continued use of trivalent oral polio vaccine (OPV), trivalent OPV was replaced by bivalent OPV (types 1 and 3) in a globally coordinated effort in 2016. WPV2 eradication and trivalent OPV cessation also mean that breach of containment in a facility working with type 2 poliovirus is now a major risk to reseed type 2 circulation in the community. As a result, the World Health Organization has developed a "Global Action Plan to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use." Because poliovirus has long been used as a standard for qualification of intravenous immunoglobulin, disinfectant products, and sanitation methods, poliovirus containment has implications far beyond poliovirus laboratories.
Topics: Containment of Biohazards; Disease Eradication; Emergency Medical Services; Health Facilities; Humans; Poliomyelitis; Poliovirus Vaccines; Risk Management
PubMed: 30536438
DOI: 10.1111/trf.15018 -
Naunyn-Schmiedeberg's Archives of... Apr 2016In spite of tremendous advances in biopharmaceutical science and technology, the productivity of pharmaceutical research and development has been steadily declining over... (Review)
Review
In spite of tremendous advances in biopharmaceutical science and technology, the productivity of pharmaceutical research and development has been steadily declining over the last decades. The reasons for this decline are manifold and range from improved standard of care that is more and more difficult to top to inappropriate management of technical and translational risks along the R&D value chain. In this short review, major types of risks in biopharmaceutical R&D and means to address them will be described. A special focus will be on a risk, i.e., the lack of reproducibility of published information, that has so far not been fully appreciated and systematically analyzed. Measures to improve reproducibility and trust in published information will be discussed.
Topics: Animals; Drug Discovery; Drug-Related Side Effects and Adverse Reactions; Efficiency; Humans; Reproducibility of Results; Risk Assessment; Risk Factors; Risk Management; Time Factors; Translational Research, Biomedical; Workflow
PubMed: 26883784
DOI: 10.1007/s00210-016-1216-8