Health & Medicine6 Nov 2026 · about 6 min

Nearly 3-fold jump in serious adverse events caused by medical devices: New data

The brief

A serious adverse event, or SAE, is a harmful medical event associated with a medical device that can create a life-threatening condition or prolong a patient’s hospital stay. Global reporting norms also classify events involving death or disability as serious. The classification describes the seriousness of the outcome, not automatically proof that the device caused it. A medical device adverse event, or MDAE, is the broader category tracked through India’s Materiovigilance Programme. The suspected devices listed in recent reports included surgical gloves, syringes, urine bags, pregnancy-test kits, catheters, and blood-pressure monitors. Some events may therefore be less severe than SAEs. The key difference is the patient’s outcome and its severity. The IPC’s SAE figures cover events it received and reviewed, while its annual reports give broader MDAE totals without separately identifying serious cases. The article also notes that an event may arise from a procedural lapse rather than the device itself.

What is a serious adverse event caused by a medical device, and how is it different from a less serious medical device adverse event?

A medical device adverse event, or MDAE, is the broader category tracked through India’s Materiovigilance Programme. The suspected devices listed in recent reports included surgical gloves, syringes, urine bags, pregnancy-test kits, catheters, and blood-pressure monitors. Some events may therefore be less severe than SAEs.

The key difference is the patient’s outcome and its severity. The IPC’s SAE figures cover events it received and reviewed, while its annual reports give broader MDAE totals without separately identifying serious cases. The article also notes that an event may arise from a procedural lapse rather than the device itself.

How many serious adverse events did the Indian Pharmacopoeia Commission record from 2020 through 2025, and how did the annual total change?

The Indian Pharmacopoeia Commission recorded 9,373 SAEs from 2020 through 2025. These were cases received and reviewed by the IPC, the Central body responsible for publishing official drug standards. The disclosure was obtained after an RTI appeal and a Central Information Commission order.

The annual total increased from 808 in 2020 to 2,176 in 2025. That is a nearly three-fold rise across six years. The article does not provide every annual figure in the text, but it identifies the starting and ending totals and the six-year aggregate.

These numbers are separate from the much larger MDAE counts published in recent annual reports. For example, the IPC logged 14,584 MDAEs in financial year 2024-2025. SAEs had previously been kept as restricted information, so the released series provides a clearer view of the severe-event category for the first time.

Why is the nearly three-fold increase in reported serious adverse events important for patients and medical-device safety in India?

The rise matters because SAEs involve outcomes such as life-threatening conditions, prolonged hospitalisation, death, or disability. More reported serious events mean the safety system is recording a substantially larger severe-event burden than at the start of the period. Patients, clinicians, regulators, and manufacturers therefore have more reason to examine patterns in device-related harm.

The increase went from 808 SAEs in 2020 to 2,176 in 2025, while the six-year total reached 9,373. However, the figures alone do not prove that devices became less safe. The IPC told the CIC that an event might result from a procedural lapse or from the device itself.

The disclosure is important because serious-event figures had previously been restricted, even though broader MDAE totals appeared in annual reports. Without device categories, brands, manufacturers, or case descriptions, the public cannot assess which products or procedures may be associated with the increase.

How are serious adverse events related to the much larger number of medical device adverse events reported through India’s monitoring system?

India’s Materiovigilance Programme records medical device adverse events through 775 monitoring centres nationwide. MDAE is the broad reporting category, while SAE identifies events with severe outcomes such as death, disability, life-threatening conditions, or extended hospitalisation. The IPC’s newly disclosed SAE figures add severity detail that the annual MDAE reports did not separate.

The scale difference is substantial. The IPC logged 14,584 MDAEs in financial year 2024-2025, while the released SAE series recorded 2,176 cases in calendar year 2025. The periods are not identical, so these figures should not be treated as a precise same-period ratio. They show that serious cases form a more specific category within a much larger reporting system.

The broader totals include suspected products ranging from surgical gloves and syringes to stents and ventilators. Reports are reviewed, and selected cases may be forwarded to CDSCO. The article does not explain whether every MDAE is assessed for SAE status in the same way.

Why has the Indian Pharmacopoeia Commission withheld details such as the device category, brand, and manufacturer, and what does that make difficult to determine?

The IPC argued that manufacturer names and related details were exempt under Section 8(1)(d) of the RTI Act. It described them as commercial-confidence and third-party information. The IPC said disclosure could harm the concerned entity’s competitive position. It also argued that compiling every category and manufacturer would be too voluminous and consume public-authority resources.

The Central Information Commission order said brand details and device descriptions could not be disclosed because it was not conclusively established whether events arose from procedural lapses or from the devices themselves. That distinction matters: a report records a suspected association, not a final finding of product failure.

With those details withheld, patients and researchers cannot readily determine whether particular device types, brands, or manufacturers appear repeatedly. The public also cannot compare the disclosed SAE total with specific products. The restriction limits accountability and makes it harder to investigate patterns, while the IPC continues reviewing reports through its monitoring system.

What happens after a suspected medical device problem is reported, and why were only a small number of reported cases forwarded to the drug regulator?

A suspected device problem is reported through the Materiovigilance Programme and reviewed by the IPC. The programme requires SAEs to be reported within 15 days. After review, cases considered to require further action may be forwarded to the Central Drugs Standard Control Organisation, or CDSCO, the drug regulator named in the article.

The numbers show a sharp filtering point. In 2024-2025, the IPC logged 14,584 MDAEs but forwarded only 22 cases to CDSCO. In 2023-2024, it logged 10,269 MDAEs and forwarded 16 cases. The forwarded lists included suspected items such as gloves, syringes, urine bags, pregnancy-test kits, catheters, and BP monitors.

The article does not state why only a small number were forwarded. It says the lists represented suspected devices requiring necessary or further action. Therefore, the figures show the difference between reports received and cases escalated, but they do not establish how many reports were confirmed device failures.

How do medical-device surveillance systems work, and why are public databases with details about device failures important for identifying unsafe products?

Medical-device surveillance collects reports from monitoring centres, records suspected devices and patient outcomes, and reviews the information for possible safety concerns. India’s IPC runs this process under the Materiovigilance Programme through 775 centres. Its ADRMS online portal is designed to streamline reporting, and SAEs must be submitted within 15 days.

The review can lead to selected cases being forwarded to CDSCO for necessary action. The IPC’s reports show this process: 14,584 MDAEs were logged in 2024-2025, but 22 cases were sent onward. The article also notes the US MAUDE database, a public repository of adverse-event and device-problem reports across device categories.

Public product-level data can help connect repeated events with device types, brands, or manufacturers and support closer investigation. In India, withheld details make those patterns harder to see. The article does not state that a particular product was declared unsafe, but it shows why transparent, detailed reporting matters for identifying possible risks.

This brief was written by AI from the original reporting and checked by other models. Names, figures and quotes come from the source; read it for full context.