Safety interventions

Laitinen, H. and Keijo Paivarinta, K. 2010. A new-generation safety contest in the constraction industry - A long-term evaluation of a real-life intervention, Safety Science, 48(5), 68086, http //dx.doi.Org/10.1016/j.ssci.2010.01.018. 

Pedersen, L.M., Nielsen, K.J. Kines, P. 2011. Realistic Evaluation as a New Way to Design and to Evaluate Occupational Safety Interventions. Safety Science 50(1) 48 54. 

Where a specific incident leading to safety, quality or production problems has occurred, the plant management may wish to perform a very focused intervention. This will be directed at identifying the direct and underlying causes of the problem, and developing an appropriate remedial strategy. The process for performing an analysis of this type is described in the incident analysis section of Chapter 6. 

A All managers will continue to be held accountable for the safety and environmental performance of their departments. Indeed, part of their annual f>erformance review depends on meeting specific safety and environmental objectives. But, the processes will be redesigned so that they require as little management intervention as possible. Based on our... 

The definition of an automatic burner is A burner where, when starting from the completely shut-down condition, the start-gas flame is established and the main gas safety shut-off valves are activated without manual intervention. This means that a burner is only automatic if it is ignited by means of a remote interlock (e.g. thermostat, timeswitch, etc.) closing. A burner is not automatic if it has a pilot burner that remains ignited in the off condition. Nor is a burner strictly automatic if a start button needs to be pushed, even though the controls may comply with all requirements for automatic burners. 

The amount of process plant that can be defined accurately as automatic is relatively small, and manual intervention is often involved at some stage. The relevant design criteria are therefore often IM/12 or IM/18. In practice, fully automatic burner controllers tested and certified by British Gas are available that comply with the requirements of BS 5885. Although these have features which may not be applicable to non-automatic plant, it may be more appropriate to use such a controller, particularly as its safety is well proven. It may also be less expensive than buying and installing separate timers, relays, etc. For some processes (for example, those that do not need and cannot tolerate a long purge) such controllers may not be appropriate. 

The effectiveness of catheter-based intra-arterial therapy to remove residual thrombus after IV rt-PA treatment is being tested in the Interventional Management of Stroke study (IMS-Ill). This study will randomize patients to 0.6 mg/kg IV rt-PA, followed by angiography with additional intra-arterial therapy as indicated, or IV full-dose rt-PA (0.9 mg/kg). A nonrandomized safety study suggested that intraarterial therapy, after 0.6 mg/kg IV rt-PA, could be accomphshed with acceptable rates of sICH. ° ... 

The abciximab in Acute Ischemic Stroke trial was a randomized, placebo-controlled dose-escalation study to examine the safety of abciximab in acute stroke. It randomized 74 patients within 24 hours of stroke onset to receive one of four doses of abciximab (by bolus with or without additional infusion, 54 patients) or placebo (20 patients). The median baseline National Institute of Health Stroke Scale (NIHSS) score was 15. The rates of asymptomatic ICH were 19% in the intervention group compared to 5% in the placebo group p = 0.07). Most (9 of 11) of the asymptomatic ICH patients had more severe stroke (NIHSS >14). No cases of symptomatic ICH or major systemic bleeding occurred. There was a trend toward a lower rate of stroke recurrence (2% vs. 5%) and a higher rate of functional recovery at 3 months in the group treated with abciximab than with placebo. 

For any intervention intended to impact favorably upon human health, it is important to evaluate its safety and efficacy in order to demonstrate that it does not cause harm and it does provide the expected benefit. The gold standard method for evaluating any intervention, whether it be a botanical product, dietary supplement, drug, medical device or medical procedure, is the randomized, clinical trial (RCT). A clinical trial is a type of experiment conducted in human subjects where the effects of at least two interventions are compared. Often, the clinical trial takes the form of an active treatment compared to an inactive control or placebo. 

Concomitant or prior medications may be used in either safety or efficacy analyses. The presence of specific medications may be used as covariates for inferential analyses. Also, medications are often summarized to show that the therapies under study come from medically comparable populations. Medications may be used to determine protocol compliance and to help define a protocol-compliant study population. Concomitant medications may be examined to determine whether they interact with study therapy or whether they can explain the presence of certain adverse events. From a CDISC perspective, prior medications would be considered a finding while concomitant medications would be considered an intervention. 

It is widely recognised that food safety depends on effective intervention at all stages in the food chain, including the production of raw materials. This book provides an authoritative summary of the wealth of research on reducing microbial and other hazards in raw and fresh red meat. 

Clinical trials serve to assess the safety and efficacy of any potential new therapeutic intervention in its intended target species. In our context, an intervention represents the use of a new biopharmaceutical. Examples of other interventions could be, for example, a new surgical procedure or a novel medical device. Veterinary clinical trials are based upon the same principles, but this discussion is restricted to investigations in humans. Clinical trials are also prospective rather than retrospective in nature, i.e. participants receiving the intervention are followed forward with time. 

LOPA is a semi-quantitative tool for analyzing and assessing risk. This method includes simplified methods to characterize the consequences and estimate the frequencies. Various layers of protection are added to a process, for example, to lower the frequency of the undesired consequences. The protection layers may include inherently safer concepts the basic process control system safety instrumented functions passive devices, such as dikes or blast walls active devices, such as relief valves and human intervention. This concept of layers of protection is illustrated in Figure 11-16. The combined effects of the protection layers and the consequences are then compared against some risk tolerance criteria. 

By explicitly showing the cause-effect relationships from precursor via control to the latent conditions, recommendations for all three ways of intervention principles can be made. The next sub-Section will therefore discuss an approach where the concepts discussed in this Chapter can be used to display the working and influence of a control process on the safety of an organization. 

The precursor was identified in the maintenance sub-process. In practice, the operators from technical support observed the presence of substances inside the packaging machines. Subsequently, they consulted the chief operator on how to remove the substances from the machines and perform the most suitable intervention. These actions correspond with the control elements on the operational control level. The actions were performed in order to resume production quickly, and adhere to planned schedules. Additionally, experience and training provided the operators with guidelines on how to perform the maintenance effectively. In practice the production manager, responsible for any preventive solutions was not aware of the existence of this precursor and consequently had no overview of these deviations even though the company s quality and safety standards required an overview of all deviations and... 

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