With the increase in the number of orthopaedic surgeons and the aggressive marketing by manufacturing companies, high technology orthopaedic surgery is being more frequently carried out in Malaysia. Post-operative sepsis complicating this type of surgery can have disastrous consequences. No data is available in this country on the incidence of post-operative infection in Orthopaedic Surgery. Th...

BACKGROUND Adverse Drug Reactions are one of the leading causes of injury or death among patients undergoing medical treatments. Not all Adverse Drug Reactions are identified before a drug is made available in the market. Current post-marketing drug surveillance methods, which are based purely on voluntary spontaneous reports, are unable to provide the early indications necessary to prevent the...

BACKGROUND Regulatory and economic frameworks stimulated the research and development of orphan drugs, but very little has been done for devices necessary for the in-vivo diagnosis, prevention and treatment of life-threatening conditions with a low prevalence/incidence. DISCUSSION A general public consultation in Europe has shown a positive attitude towards an "orphan device" directive. The U...