Stakeholder challenges in purchasing medical devices for patient safety.

OBJECTIVE: This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. METHODS: Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. RESULTS: The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. CONCLUSIONS: The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.

Initial phase modelling in numerical explosion applied to process safety

The utilisation of computational fluid dynamics (CFD) in process safety has increased significantly in recent years. The modelling of accidental explosion via CFD has in many cases replaced the classical Multi Energy and Brake Strehlow methods. The benefits obtained with CFD modelling can be diminished if proper modelling of the initial phase of explosion is neglected. In the early stages of an explosion, the flame propagates in a quasi-laminar regime. Proper modelling of the initial laminar phase is a key aspect in order to predict the peak pressure and the time to peak pressure. The present work suggests a modelling approach for the initial laminar phase in explosion scenarios. Findings are compared with experimental data for two classical explosion test cases which resemble the common features in chemical process areas (confinement and congestion). A detailed analysis of the threshold for the transition from laminar to turbulent regime is also carried out. The modelling is implemented in a fully 3D Navier-Stokes compressible formulation. Combustion is treated using a laminar flamelet approach based on the Bray, Moss and Libby (BML) formulation. A novel modified porosity approach developed for the unstructured solver is also considered. Results agree satisfactorily with experiments and the modelling is found to be robust. © 2013 The Institution of Chemical Engineers.

Improving the safety and security of the pharmaceutical supply chain

This paper discusses various techniques that may be used to combat counterfeiting in the pharmaceutical supply chain. These include the use of electronic pedigrees (to ensure the integrity of the supply chain), together with mass-serialization (to provide for a unique lifecycle history of each individual package) and authentication of the product (to check for any discrepancies in the various attributes of the product and its packaging are as intended for that individual package). Management of the pedigree process and product authentication is discussed in some detail, together with various other learnings from the Drug Security Network, including identification of some remaining vulnerabilities and suggestions for tightening these loopholes. © 2008 Springer-Verlag Berlin Heidelberg.

Safety of tetanus toxoid in pregnant women: A hospital-based case-control study of congenital anomalies

Reported are the results of the Latin American Collaborative Study of Congenital Malformations (ECLAMC), a hospital-based case-control study of 34 293 malformed and 34 477 matched nonmalformed newborn controls. No statistical differences were found between the malformed and control groups, exposed or not exposed to tetanus toroid.

Effectiveness and safety of cryotherapy after arthroscopic anterior cruciate ligament reconstruction. A systematic review of the literature

Cryotherapy is widely used in rehabilitation; however, its effectiveness after anterior cruciate ligament (ACL) reconstruction remains uncertain. To investigate the effectiveness and safety of cryotherapy following ACL reconstruction through a systematic review, randomized and quasi-randomized clinical trials were searched in the databases: MEDLINE, EMBASE, CENTRAL PEDro, SportDiscus, CINAHL, LILACS (June 2013). the primary outcomes measures were pain, edema and adverse events; the secondary outcomes were knee function, analgesic medication use, range of motion, blood loss, hospital stay, quality of life and patient satisfaction. the methodological quality of studies was evaluated using the Cochrane Collaboration risk-of-bias tool. Ten trials (a total of 573 patients) were included. Results of meta-analysis showed that the use of cold compression devices produced a significant reduction in pain scores 48 h after surgery (p < 0.00001), compared to no cryotherapy. the risk for adverse events did not differ between patients receiving cryotherapy versus no treatment (p = 1.00). the limited evidence currently available is insufficient to draw definitive conclusions on the effectiveness of cryotherapy for other outcomes. There is a need for well designed, good quality randomized trials to answer other questions related to this intervention and increase the precision of future systematic reviews. (C) 2014 Elsevier B.V. All rights reserved.

Development of process control methodology for tracking the quality and safety of pain, agitation and sedation management in critical care units

Objective: To develop sedation, pain, and agitation quality measures using process control methodology and evaluate their properties in clinical practice. Design: A Sedation Quality Assessment Tool was developed and validated to capture data for 12-hour periods of nursing care. Domains included pain/discomfort and sedation-agitation behaviors; sedative, analgesic, and neuromuscular blocking drug administration; ventilation status; and conditions potentially justifying deep sedation. Predefined sedation-related adverse events were recorded daily. Using an iterative process, algorithms were developed to describe the proportion of care periods with poor limb relaxation, poor ventilator synchronization, unnecessary deep sedation, agitation, and an overall optimum sedation metric. Proportion charts described processes over time (2 monthly intervals) for each ICU. The numbers of patients treated between sedation-related adverse events were described with G charts. Automated algorithms generated charts for 12 months of sequential data. Mean values for each process were calculated, and variation within and between ICUs explored qualitatively. Setting: Eight Scottish ICUs over a 12-month period. Patients: Mechanically ventilated patients. Interventions: None. Measurements and Main Results: The Sedation Quality Assessment Tool agitation-sedation domains correlated with the Richmond Sedation Agitation Scale score (Spearman [rho] = 0.75) and were reliable in clinician-clinician (weighted kappa; [kappa] = 0.66) and clinician-researcher ([kappa] = 0.82) comparisons. The limb movement domain had fair correlation with Behavioral Pain Scale ([rho] = 0.24) and was reliable in clinician-clinician ([kappa] = 0.58) and clinician-researcher ([kappa] = 0.45) comparisons. Ventilator synchronization correlated with Behavioral Pain Scale ([rho] = 0.54), and reliability in clinician-clinician ([kappa] = 0.29) and clinician-researcher ([kappa] = 0.42) comparisons was fair-moderate. Eight hundred twenty-five patients were enrolled (range, 59-235 across ICUs), providing 12,385 care periods for evaluation (range 655-3,481 across ICUs). The mean proportion of care periods with each quality metric varied between ICUs: excessive sedation 12-38%; agitation 4-17%; poor relaxation 13-21%; poor ventilator synchronization 8-17%; and overall optimum sedation 45-70%. Mean adverse event intervals ranged from 1.5 to 10.3 patients treated. The quality measures appeared relatively stable during the observation period. Conclusions: Process control methodology can be used to simultaneously monitor multiple aspects of pain-sedation-agitation management within ICUs. Variation within and between ICUs could be used as triggers to explore practice variation, improve quality, and monitor this over time

Combining Functional and Structural Reasoning for Safety Analysis of Electrical Designs

C.J.Price, D.R.Pugh, N.A.Snooke, J.E.Hunt, M.S.Wilson, Combining Functional and Structural Reasoning for Safety Analysis of Electrical Designs, Knowledge Engineering Review, vol 12:3, pp.271-287, 1997.

A European Perspective on the Precautionary Principle, Food Safety and the Free Trade Imperative of the WTO

A European Perspective on the Precautionary Principle, Food Safety and the Free Trade Imperative of the WTO. European Law Review, Vol.27, No.2. April 2002, pp.138-155. RAE2008

Systematic Verification of Safety Properties of Arbitrary Network Protocol Compositions Using CHAIN

Formal correctness of complex multi-party network protocols can be difficult to verify. While models of specific fixed compositions of agents can be checked against design constraints, protocols which lend themselves to arbitrarily many compositions of agents-such as the chaining of proxies or the peering of routers-are more difficult to verify because they represent potentially infinite state spaces and may exhibit emergent behaviors which may not materialize under particular fixed compositions. We address this challenge by developing an algebraic approach that enables us to reduce arbitrary compositions of network agents into a behaviorally-equivalent (with respect to some correctness property) compact, canonical representation, which is amenable to mechanical verification. Our approach consists of an algebra and a set of property-preserving rewrite rules for the Canonical Homomorphic Abstraction of Infinite Network protocol compositions (CHAIN). Using CHAIN, an expression over our algebra (i.e., a set of configurations of network protocol agents) can be reduced to another behaviorally-equivalent expression (i.e., a smaller set of configurations). Repeated applications of such rewrite rules produces a canonical expression which can be checked mechanically. We demonstrate our approach by characterizing deadlock-prone configurations of HTTP agents, as well as establishing useful properties of an overlay protocol for scheduling MPEG frames, and of a protocol for Web intra-cache consistency.