Medical devices associated adverse events under Materiovigilance Programme of India in a Tertiary Care Hospital of Tribal District of Odisha

ABSTRACT

For definition, a medical device can be an instrument, apparatus, machine, implant, regent, IVD, software, or assisted material intended to be used alone or in combination, for human beings, for one or more medical purposes of diagnosis, prevention, treatment, and monitoring of an injury or a disease or investigation, replacement, modification, treatment, monitoring, and support of an anatomical or physiological condition for supporting and sustaining life, controlling conception by means of in vitro examination, or intending action by pharmacological, immunological, and metabolic in or on of human body. There was no proper system for the regulation, manufacturing, export, import, sale, and distribution of medical devices. [...]the Government of India, in collaboration with the Drugs Technical Advisory Board, recently brought out the Medical Device Rules 2017. [1] The following medical devices and in vitro diagnostics are currently regulated in India Cardiac stents, drug-eluting stents, catheters, heart valves, orthopedic implants, intraocular lenses, intravenous cannulae, bone cements, ablation devices, internal prosthetic replacements, intrauterine contraceptive devices, condoms, tubal rings, umbilical tapes, blood sera, scalp vein sets, ligatures, sutures, staplers, surgical dressings, disposables syringes, hypodermic needles, perfusion sets, and in vitro diagnostic tests for human immunodeficiency virus, hepatitis B surface antigen, and hepatitis C virus. [13] As we are all aware, various medical tools are being used during this coronavirus pandemic, which also gives rise to a number of ADRs related to gloves, masks, sanitizer, swap kits, pulse oximeters, and other equipment. [...]the MvPI-IPC has introduced a specific PPE form for accurate data collection)14 Reports received from hospitals, health-care professionals, and manufacturers are documented.