NEW DELHI, Sept 22: The government has directed hospitals to strengthen monitoring of medical devices by reporting serious adverse events linked to such equipment within 15 days.
The move is aimed at improving patient safety and ensuring that problems involving medical equipment are identified and addressed promptly. The reporting system covers incidents involving devices such as insulin pumps, infusion pumps, pulse oximeters and defibrillators.
Hospitals will be required to document serious incidents in which faulty or malfunctioning equipment causes or could cause harm to patients. The information can help authorities identify recurring problems and assess the safety of medical devices being used in healthcare facilities.
The initiative is part of efforts to strengthen India’s medical device surveillance framework and improve accountability across the healthcare system.
Systematic reporting of adverse events can also provide regulators with important safety information for taking corrective measures and monitoring device performance.