Hospitals told to report serious medical device events within 15 days
NEW DELHI: A faulty insulin pump that delivers too much insulin, an infusion pump that gives medicines too quickly, a pulse oximeter showing incorrect oxygen levels or a defibrillator failing during a cardiac emergency will now come under a more systematic hospital safety-monitoring system.
The Indian Pharmacopoeia Commission (IPC) has issued a new guidance document asking hospitals to strengthen monitoring and reporting of adverse events linked to medical devices. Serious adverse events have to be reported to the Materiovigilance Programme of India (MvPI) within 15 days, while non-serious adverse events and certain potentially harmful near-miss incidents have to be reported within 30 days.
Patients too have a direct role. Those who notice that a medical device is not functioning properly or experience an adverse event can inform the treating hospital or healthcare professional and directly report suspected device-related events to IPC.
IPC has provided a toll-free helpline, 1800-180-3024, for consumers and other stakeholders. It supports reporting in 10 languages, including Hindi, Bengali, Tamil, Telugu and Malayalam.
Importantly, the system is not limited to cases in which a patient is actually injured. A device malfunction or quality problem detected before use can be treated as a near miss. If it could potentially cause harm during future use, it is reportable within 30 days even when no patient has been harmed.
The guidance also says suspected device-related events should be reported even when it has not yet been established that the device caused the problem, allowing the event to be assessed and investigated further.
The guidance, prepared by IPC in collaboration with the World Health Organization India and other stakeholders, covers medical devices including in-vitro diagnostic devices, implants, life-support equipment and newer artificial intelligence-enabled and software-based devices.
Hospitals have been asked to actively monitor critical devices, including invasive, implantable and life-supporting equipment. Their performance, malfunctions, complaints and near misses should be reviewed weekly or monthly based on usage and risk, with heightened monitoring of devices under IPC safety alerts or advisories.
Each department should have a designated nodal person for monitoring, staff sensitisation and timely reporting. Lists of monitored devices should be displayed in intensive care units, operation theatres, catheterisation laboratories and specialty wards.
The guidance was unveiled on Monday by Union Minister of State for Health and Family Welfare Anupriya Patel during National Pharmacovigilance Week. The government also announced approval of the Biovigilance Programme of India, under which IPC will lead monitoring of adverse events associated with medicines and biological products used in organ and tissue transplantation.
The Indian Pharmacopoeia Commission (IPC) has issued a new guidance document asking hospitals to strengthen monitoring and reporting of adverse events linked to medical devices. Serious adverse events have to be reported to the Materiovigilance Programme of India (MvPI) within 15 days, while non-serious adverse events and certain potentially harmful near-miss incidents have to be reported within 30 days.
Patients too have a direct role. Those who notice that a medical device is not functioning properly or experience an adverse event can inform the treating hospital or healthcare professional and directly report suspected device-related events to IPC.
IPC has provided a toll-free helpline, 1800-180-3024, for consumers and other stakeholders. It supports reporting in 10 languages, including Hindi, Bengali, Tamil, Telugu and Malayalam.
Importantly, the system is not limited to cases in which a patient is actually injured. A device malfunction or quality problem detected before use can be treated as a near miss. If it could potentially cause harm during future use, it is reportable within 30 days even when no patient has been harmed.
The guidance also says suspected device-related events should be reported even when it has not yet been established that the device caused the problem, allowing the event to be assessed and investigated further.
The guidance, prepared by IPC in collaboration with the World Health Organization India and other stakeholders, covers medical devices including in-vitro diagnostic devices, implants, life-support equipment and newer artificial intelligence-enabled and software-based devices.
Hospitals have been asked to actively monitor critical devices, including invasive, implantable and life-supporting equipment. Their performance, malfunctions, complaints and near misses should be reviewed weekly or monthly based on usage and risk, with heightened monitoring of devices under IPC safety alerts or advisories.
Each department should have a designated nodal person for monitoring, staff sensitisation and timely reporting. Lists of monitored devices should be displayed in intensive care units, operation theatres, catheterisation laboratories and specialty wards.
The guidance was unveiled on Monday by Union Minister of State for Health and Family Welfare Anupriya Patel during National Pharmacovigilance Week. The government also announced approval of the Biovigilance Programme of India, under which IPC will lead monitoring of adverse events associated with medicines and biological products used in organ and tissue transplantation.
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