Quite often, medical product manufacturers receive complaints
of device malfunctions, serious injuries or deaths associated
with medical devices. Manufacturers are also required to have
additional post marketing activities, postmarket surveillance
for the monitoring of products after their clearance to market
and device tracking for maintaining
traceability of certain devices to the user level.
Considering the current
healthcare needs of the country, the Government of India has
recently launched Materiovigilance Program to monitor Medical
Devices Associated adverse events (MDAE), create awareness
among healthcare professionals about reporting and monitoring
risk - based profile of Medical Devices. The program will not
only help in ensuring better patient safety but also improve
the standard of industry as well.
The genesis of this soft copy lies in
a series of columns covered in our Medical Device technology
magazine and internet portals over a period of more than 23
years. The soft copy covers a wide range of Devices from simplest
Infusion Devices, Endotracheal / Tracheostomy Tubes,
Catheters, Leukocyte reduction filters, Guide wires, Dialysis
Filters, Vascular Haemostasis Devices, Blood Coating devices
to artificial heart. It also highlights important issues like
safety of healthcare professionals, reuse of single - use
devices, cross-contamination, allergies to use of latex,
sterilization methods, dialysis procedure etc.
Readers would also enjoy and get
enlightened by the quotes given on all the pages which speak
volumes "In A Nutshell".
IN SOFT COPY