News from here and there - Faulty medical devices

摘要

Medical devices, which are intended to heal and cure, may contribute to morbidity and mortality. A medical device is an 'instrument, apparatus, appliance, software, material, or other article' used for 'diagnostic or therapeutic purposes', as per the Medical Devices Rules, 2017. The medical devices industry in India accounts for 4%-5% of the total national US$ 96.7 billion healthcare market. In 2010, Johnson and Johnson's Acetabular Hip Resurfacing System (ASR) implant was recalled globally because of metal poisoning, which resulted in a high rate of revision hip surgeries. Despite the global recall of this implant, the Central Drugs Standard Control Organization (CDSCO) in India cancelled its licence after 2 years in 2012, and a medical device alert was issued on the Johnson and Johnson ASR implants only in 2013. Moreover, only about 1200 of the 4700 people who had received the hip implant in India have been tracked so far.