Technovigilance keeps hearts at Instituto Nacional de Cardiología Ignacio Chávez beating

At Mexico’s Instituto Nacional de Cardiología Ignacio Chávez (INC), nearly every patient who walks through the door will be treated with a medical device of some kind: a stent threaded into a coronary artery, an injection needle, or an ECG monitor. For the staff working day in and day out with these devices, a troubling question began to surface: when something goes wrong, is the problem with the device itself, or with the way it is being used?

While technovigilance, the systematic monitoring of medical device safety, was already well-established in industry and among marketing authorisation holders in Mexico, hospitals, the very places patients interact with medical devices, had no dedicated system for tracking and evaluating medical device-related incidents. At the same time, Mexico’s federal health regulator, COFEPRIS, was calling on healthcare institutions to maintain both pharmacovigilance and technovigilance systems.

The message was clear: the INC needed to develop a technovigilance system to standardise the detection, analysis, and follow-up of medical device-related incidents. The Institutional Technovigilance Centre (ITC) was formally established within the Clinical Pharmacology Department in 2022, the first of its kind in a hospital setting. It began with a passive model, receiving and managing incident reports as they came in. Before long, it evolved into something far more ambitious: an active, intensive technovigilance programme involving the continuous and standardised collection of information on device performance and related incidents by trained staff. The ITC also led several research initiatives on medical-device safety to identify root causes and contributing factors to device-related incidents. They proved to be valuable in helping us improve the safe use of medical devices at our centre, and the following cases show how.

Finding the root cause of elastomer fragments in adenosine ampoules

One ongoing medical device-related incident at the INC was staff reports of small elastomer fragments in adenosine vials and syringes when preparing adenosine for administration. Although a drug quality problem was suspected, an internal investigation conducted by the ITC found that these fragments were mainly caused by the puncture technique from inserting the needle at the wrong angle into the stopper of the adenosine ampoule, rather than the quality of the drug. Based on these findings, the ITC recommended improving the puncture technique to enhance the safety of this procedure.

Identifying risk factors for pacemaker infection

The ITC also investigated a safety incident related to a very common medical device used at the INC: the pacemaker. It conducted two complementary studies investigating a rise in pacemaker infection, a usually very rare adverse event where an infection in the device pocket leads to skin necrosis and the device pushing through the skin.

The first study used a predictive model combining clinical variables such as patient health condition with device-related factors, such as details of the implant procedure, to identify patterns that could signal a higher risk of complications. The second study focused on clinical biomarkers measured before and after implantation. Taken together, results from both studies revealed consistent clinical patterns linked to pacemaker infection, which could also be used for ongoing monitoring and prevention strategies in the future.

This work has now become an ongoing research initiative at the INC, where efforts are now focused on improving early detection of pacemaker infection and reducing complications related to cardiac implantable devices.

Intensive technovigilance: Strengthening patient safety worldwide

Intensive technovigilance has proven to be a key pillar of patient safety at the INC. Its value has gone beyond detecting safety problems to actively preventing medical device-related harm as we better understand the root causes and risks associated with the most common medical devices we use at the institute. By identifying risks early and improving the management of device performance, this proactive approach supports more efficient operations and stronger response capabilities in our hospital, and we hope that our centre sets a standard that other hospitals could follow.