Developing a model for consumer product safety evaluation

Safety enforcement practitioners within Europe and marketers, designers or manufacturers of consumer products need to determine compliance with the legal test of "reasonable safety" for consumer goods, to reduce the "risks" of injury to the minimum. To enable freedom of movement of products, a method for safety appraisal is required for use as an "expert" system of hazard analysis by non-experts in safety testing of consumer goods for implementation consistently throughout Europe. Safety testing approaches and the concept of risk assessment and hazard analysis are reviewed in developing a model for appraising consumer product safety which seeks to integrate the human factors contribution of risk assessment, hazard perception, and information processing. The model develops a system of hazard identification, hazard analysis and risk assessment which can be applied to a wide range of consumer products through use of a series of systematic checklists and matrices and applies alternative numerical and graphical methods for calculating a final product safety risk assessment score. It is then applied in its pilot form by selected "volunteer" Trading Standards Departments to a sample of consumer products. A series of questionnaires is used to select participating Trading Standards Departments, to explore the contribution of potential subjective influences, to establish views regarding the usability and reliability of the model and any preferences for the risk assessment scoring system used. The outcome of the two stage hazard analysis and risk assessment process is considered to determine consistency in results of hazard analysis, final decisions regarding the safety of the sample product and to determine any correlation in the decisions made using the model and alternative scoring methods of risk assessment. The research also identifies a number of opportunities for future work, and indicates a number of areas where further work has already begun.

When do firms conform? The effect of regulatory control processes on compliance and opportunism

The authors use social control theory to develop a conceptual model that addresses the effectiveness of regulatory agencies’ (e.g., Food and Drug Administration, Occupational Safety and Health Administration) field-level efforts to obtain conformance with product safety laws. Central to the model are the control processes agencies use when monitoring organizations and enforcing the safety rules. These approaches can be labeled formal control (e.g., rigid enforcement) and informal control (e.g., social instruction). The theoretical framework identifies an important antecedent of control and the relative effectiveness of control’s alternative forms in gaining compliance and reducing opportunism. Furthermore, the model predicts that the regulated firms’ level of agreement with the safety rules moderates the relationships between control and firm responses. A local health department’s administration of state food safety regulations provides the empirical context for testing the hypotheses. The results from a survey of 173 restaurants largely support the proposed model. The study findings inform a discussion of effective methods of administering product safety laws. The authors use social control theory to develop a conceptual model that addresses the effectiveness of regulatory agencies’ (e.g., Food and Drug Administration, Occupational Safety and Health Administration) field-level efforts to obtain conformance with product safety laws. Central to the model are the control processes agencies use when monitoring organizations and enforcing the safety rules. These approaches can be labeled formal control (e.g., rigid enforcement) and informal control (e.g., social instruction). The theoretical framework identifies an important antecedent of control and the relative effectiveness of control’s alternative forms in gaining compliance and reducing opportunism. Furthermore, the model predicts that the regulated firms’ level of agreement with the safety rules moderates the relationships between control and firm responses. A local health department’s administration of state food safety regulations provides the empirical context for testing the hypotheses. The results from a survey of 173 restaurants largely support the proposed model. The study findings inform a discussion of effective methods of administering product safety laws.

Risk assessment applied to comsumer products with reference to CE marking machines for use at work

New Approach’ Directives now govern the health and safety of most products whether destined for workplace or domestic use. These Directives have been enacted into UK law by various specific legislation principally relating to work equipment, machinery and consumer products. This research investigates whether the risk assessment approach used to ensure the safety of machinery may be applied to consumer products. Crucially, consumer products are subject to the Consumer Protection Act (CPA) 1987, where there is no direct reference to “assessing risk”. This contrasts with the law governing the safety of products used in the workplace, where risk assessment underpins the approach. New Approach Directives are supported by European harmonised standards, and in the case of machinery, further supported by the risk assessment standard, EN 1050. The system regulating consumer product safety is discussed, its key elements identified and a graphical model produced. This model incorporates such matters as conformity assessment, the system of regulation, near miss and accident reporting. A key finding of the research is that New Approach Directives have a common feature of specifying essential performance requirements that provide a hazard prompt-list that can form the basis for a risk assessment (the hazard identification stage). Drawing upon 272 prosecution cases, and with thirty examples examined in detail, this research provides evidence that despite the high degree of regulation, unsafe consumer products still find their way onto the market. The research presents a number of risk assessment tools to help Trading Standards Officers (TSOs) prioritise their work at the initial inspection stage when dealing with subsequent enforcement action.

An evaluation of certain aspects of an occupational health service

This thesis has been concerned with obtaining evidence to explore the proposition that the provision of occupational health services as arranged at the present time represents a misallocation of resources. The research has been undertaken within the occupational health service of a large Midlands food factory. As the research progressed it became evident that questions were being raised about the nature and scope of occupational health as well as the contribution, in combating danger at work, that occupational health services can make to the health and safety team. These questions have been scrutinized in depth, as they are clearly important, and a resolution of the problem of the definition of occupational health has been proposed. I have taken the approach of attempting to identify specific objectives or benefits of occupational health activities so that it is possible to assess how far these objectives are being achieved. I have looked at three aspects of occupational health; audiometry, physiotherapy and pre-employment medical examinations as these activities embody crucial concepts which are common to all activities in an occupational health programme. A three category classification of occupational health activities is proposed such that the three activities provide examples within each category. These are called personnel therapy, personnel input screening and personnel throughput screening. I conclude that I have not shown audiometry to be cost-effective. My observations of the physiotherapy service lead me to support the suggestion that there is a decline in sickness absence rates due to physiotherapy in industry. With pre-employment medical examinations I have shown that the service is product safety oriented and that benefits are extremely difficult to identify. In regard to the three services studied, in the one factory investigated, and because of the immeasurability of certain activities, I find support for the proposition that the mix of occupational health services as provided at the present time represents a misallocation of resources.

An investigation into the impact of safety features on the ergonomics of surgical scalpels

In the case of surgical scalpels, blade retraction and disposability have been incorporated into a number of commercial designs to address sharps injury and infection transmission issues. Despite these new designs, the traditional metal reusable scalpel is still extensively used and this paper attempts to determine whether the introduction of safety features has compromised the ergonomics and so potentially the take-up of the newer designs. Examples of scalpels have been analysed to determine the ergonomic impact of these design changes. Trials and questionnaires were carried out using both clinical and non-clinical user groups, with the trials making use of assessment of incision quality, cutting force, electromyography and video monitoring. The results showed that ergonomic performance was altered by the design changes and that while these could be for the worse, the introduction of safety features could act as a catalyst to encourage re-evaluation of the ergonomic demands of a highly traditional product.

The SECURE study:long-term safety of Ranibizumab 0.5 mg in neovascular age-related macular degeneration

Objective - To evaluate long-term safety of intravitreal ranibizumab 0.5-mg injections in neovascular age-related macular degeneration (nAMD). Design - Twenty-four–month, open-label, multicenter, phase IV extension study. Participants - Two hundred thirty-four patients previously treated with ranibizumab for 12 months in the EXCITE/SUSTAIN study. Methods - Ranibizumab 0.5 mg administered at the investigator's discretion as per the European summary of product characteristics 2007 (SmPC, i.e., ranibizumab was administered if a patient experienced a best-corrected visual acuity [BCVA] loss of >5 Early Treatment Diabetic Retinopathy Study letters measured against the highest visual acuity [VA] value obtained in SECURE or previous studies [EXCITE and SUSTAIN], attributable to the presence or progression of active nAMD in the investigator's opinion). Main Outcome Measures - Incidence of ocular or nonocular adverse events (AEs) and serious AEs, mean change in BCVA from baseline over time, and the number of injections. Results - Of 234 enrolled patients, 210 (89.7%) completed the study. Patients received 6.1 (mean) ranibizumab injections over 24 months. Approximately 42% of patients had 7 or more visits at which ranibizumab was not administered, although they had experienced a VA loss of more than 5 letters, indicating either an undertreatment or that factors other than VA loss were considered for retreatment decision by the investigator. The most frequent ocular AEs (study eye) were retinal hemorrhage (12.8%; 1 event related to study drug), cataract (11.5%; 1 event related to treatment procedure), and increased intraocular pressure (6.4%; 1 event related to study drug). Cataract reported as serious due to hospitalization for cataract surgery occurred in 2.6% of patients; none was suspected to be related to study drug or procedure. Main nonocular AEs were hypertension and nasopharyngitis (9.0% each). Arterial thromboembolic events were reported in 5.6% of the patients. Five (2.1%) deaths occurred during the study, none related to the study drug or procedure. At month 24, mean BCVA declined by 4.3 letters from the SECURE baseline. Conclusions - The SECURE study showed that ranibizumab administered as per a VA-guided flexible dosing regimen recommended in the European ranibizumab SmPC at the investigator's discretion was well tolerated over 2 years. No new safety signals were identified in patients who received ranibizumab for a total of 3 years. On average, patients lost BCVA from the SECURE study baseline, which may be the result of disease progression or possible undertreatment.