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Biomedical subjects

S J Ellis

Publications and source records attributed to S J Ellis.

79 records · Page 5Linked to original sources
PubMedDate not supplied

An essential 'health check' for all medical devices.

In order to safeguard patient safety, all new or modified medical devices must be assessed for their safety and performance before they are used routinely in clinical practice. Most devices will carry a CE (Confirmity European) mark to demonstrate their safety, but many devices will require an alternative method of assessment. In this article, we discuss the procedures already in place, the significant gaps that exist in the system and the risk management issues. We consider the impact on research and clinical practice, and describe our comprehensive risk management system for objectively assessing the safety of any medical device.

Equipment Safety↗
PubMedDate not supplied

Extrapontine myelinolysis after correction of chronic hyponatraemia with isotonic saline.

Rapid correction of severe chronic hyponatraemia with hypertonic saline can cause central pontine myelinolysis. Less well appreciated are the dangers of rapid correction with isotonic saline. A case is reported in which correction of severe hyponatraemia by 11 mmol/l in 24 hours with isotonic saline produced extensive extrapontine myelinolysis, one of the manifestations of the osmotic demyelination syndrome.

Aged↗
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Brain stem death.

Explore the source record for details and available documents.

Brain Death↗
PubMedDate not supplied

The cult of the double-blind placebo-controlled trial.

The double-blind, placebo-controlled trial is held as the gold standard in medical knowledge, but this tool of investigation has its weaknesses. These include ethical limitations on the types of comparison that can be undertaken, the central conflict between best practice for an individual and trial protocols, problems of applicability to the general population and applicability of work done on one population to another, type II errors, publication bias, misuse and limitation of statistics, fraud, maintenance of blinding, asking the wrong question, and a simplistic, reductionist view of clinical management. The concentration on the randomised, controlled trial devalues information from other sources, such as natural history studies, clinical experience and case reports. The randomised, controlled trial is an important source of information and as physicians we should welcome more well-crafted trials, but they are not the only source of information.

Controlled Clinical Trials as Topic↗