Événements indésirables graves liés aux soins : déclarations insuffisantes !

The Haute Autorité de Santé (HAS) published its highly anticipated ninth annual report focusing on serious adverse events associated with care, commonly referred to in the French healthcare ecosystem as Événements Indésirables Graves Associés aux Soins (EIGS). Covering a cumulative span of declarations received from March 2017 through December 31, 2025, the comprehensive dataset encompasses a total of 21,636 individual reports. The 2025 reporting cycle specifically registered 5,576 notifications submitted by healthcare practitioners across France, representing a notable 20 percent increase compared to the figures recorded in the preceding year.

Despite this encouraging upward trajectory in notifications, health authorities emphasize that the phenomenon of underreporting remains widespread and problematic. Rather than indicating an actual surge in the frequency of medical mishaps, the yearly rise in declarations is widely attributed by experts to a growing familiarity among medical personnel with the national reporting framework and its digital portals. The report, divided into a summary document known as "les abrEIGÉS" and an extensive technical cahier equipped with statistical breakdowns, underscores a fundamental message: the reporting mechanism is fundamentally designed as an instrument for collective learning and safety enhancement, completely devoid of punitive implications.

Understanding the Landscape of Healthcare Incidents and Reporting Disparities

A granular examination of the aggregate data spanning from 2017 to 2025 reveals distinct patterns regarding the nature of the reported incidents. Errors linked directly to care delivery or the broader organization of healthcare workflows constitute the largest share, accounting for approximately 45 percent of all cases. Incidents involving patients acting against themselves—such as self-harm or unmonitored dangerous behaviors—make up 29 percent of the total, while medication errors and drug-induced iatrogenesis represent 16 percent.

For the specific year 2025, the overarching hierarchy of incident categories remained relatively stable compared to historical baselines. However, notable shifts emerged. Errors related to surgical or interventional procedures climbed to the third position, up from fourth place previously. Concurrently, complications and errors associated with obstetric care moved up to sixth place, shifting from their former seventh rank.

Despite these detailed insights, the persistent underreporting of EIGS remains a major obstacle to achieving optimal patient safety. Independent studies, notably the landmark ENEIS 3 survey referenced by health ministries, indicate that only a fraction of severe medical incidents ultimately find their way into official registries. Industry analysts and healthcare administrators point to several root causes for this deficit: a lingering lack of awareness regarding regulatory reporting requirements, the heavy administrative and analytical workload placed on clinical teams, and a skeptical perception among frontline workers regarding the tangible utility of the reporting process.

To combat these systemic hurdles, the HAS has advocated for a more pragmatic approach centered on risk-based prioritization. Under this strategy, healthcare facilities are encouraged to prioritize the in-depth analysis of specific EIGS based on localized risk profiles and institutional stakes, without ever abandoning the legal obligation to log every identified incident onto the centralized national portal for adverse health events. By refining this feedback loop, the authority hopes to generate more actionable lessons for clinical teams.

The Critical Vulnerability of Medication Prescriptions

Among the various clinical domains scrutinized in the 2025 report, the medication circuit receives intense focus, beginning at its foundational stage: prescription. Because prescribing medication represents the initial step in a complex chain of custody and administration, any error introduced at this juncture inevitably cascades through all subsequent phases, jeopardizing patient safety across hospitals, clinics, and long-term care facilities.

Between March 2017 and December 2024, the HAS collected and evaluated 213 specialized EIGS declarations specifically tied to pharmaceutical prescription errors. The findings of this deep-dive analysis reveal that a staggering 87 percent of these examined incidents stemmed from three primary categories: incorrect dosing, inappropriate drug selection, or complete omission of necessary pharmaceutical interventions.

In response to these findings, the health authority issued eight targeted recommendations aimed at fortifying the medication pathway. Chief among these directives is a stringent reminder to all medical prescribers to strictly adhere to established good practice guidelines and legal regulations. Healthcare institutions are similarly urged to implement double-check mechanisms and leverage computerized physician order entry systems equipped with clinical decision support tools to catch discrepancies before they reach the bedside.

Addressing Systemic Risks in Long-Term Care Facilities and Ehpads

Vulnerabilities in care safety are not confined to acute hospital settings; they are equally prevalent in residential structures for dependent elderly persons, commonly known in France as Ehpads. A dedicated retrospective analysis covering 2,307 EIGS declarations originating from Ehpads between March 2017 and June 2025 sheds light on recurring systemic fragilities within the medico-social sector.

The data highlights systemic challenges in several key areas: the acquisition and continuous maintenance of technical skills and clinical knowledge among staff, the reliability of information transmission during patient transfers between Ehpads and acute care hospitals, diagnostic safety, the formalization of local medication management circuits, and the continuous prevention and mitigation of fall-related risks.

To address these vulnerabilities, the analysis outlines nine priority levers designed to overhaul risk management practices in geriatric facilities. These recommendations stress the importance of bolstering interprofessional communication, investing in continuous staff training, and embedding robust safety protocols into the daily routines of caretakers who manage vulnerable aging populations.

The Mandatory Duty of Disclosing Care-Related Harm to Patients

A critical dimension of the 2025 report centers on the transparent communication of medical errors to affected individuals and their families. The disclosure of a care-related adverse event is framed not merely as an ethical best practice, but as an enforceable legal obligation for healthcare professionals and a fundamental right for patients. This practice is vital for preserving institutional trust and reinforcing an open culture of safety.

Crucially, the HAS insists that the disclosure of harm should never be treated as a single, isolated conversation. Instead, it must be approached as a continuous, transparent process where information is progressively shared with the patient and their loved ones as facts and underlying causes are definitively established through internal investigations.

Despite the clear legal and ethical mandates, the reality on the ground leaves significant room for improvement. Statistics compiled for 2025 reveal that only 77 percent of declared EIGS had actually triggered a formal notification or informational exchange with the patient or their relatives. This gap underscores an urgent need for institutional intervention.

To bridge this divide, health authorities are calling for widespread professional training programs and the institutionalization of dedicated disclosure policies within all healthcare and medico-social establishments. To assist facilities in this mission, the HAS continues to promote its specialized training toolkit, designed to guide clinicians through the delicate process of disclosing medical errors with empathy, accuracy, and adherence to legal standards. Through these combined measures, the French healthcare system aims to transform mandatory reporting from a bureaucratic hurdle into a cornerstone of modern patient safety.