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30 June 2025

Medical Negligence Patient Safety 1.6A

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MEDICAL NEGLIGENCE PATIENT SAFETY 1.6A

UNDEFINED NOTIFABLE INCIDENT

John Whelan with Specialist expertise in Medical Negligence and Patient Safety gives an example of a case which falls outside of the definition of a Notifiable Incident as envisaged by item 1.6 of the Patient Safety Act 2023.      This example involves similar mistakes to that envisaged by item 1.6 of the Act but yet since it doesn’t lead to the death of the Patient it is not a Notifiable Incident as defined by Item 1.6.    This example is one of many cases which should fall within the ambit of the Patient Safety Act and can be introduced by a Ministerial regulation under Section 8.

Item 1.6A

A Notifiable Medical Incident involving an unintended and unanticipated injury

An example of a Notifiable Incident involving an unintended and unanticipated injury occurring in any place or premises in which a health service provider provides the health service that is directly related to any medical treatment and the injury did not arise or was a consequence of the illness of the Patient or the underlying condition of the Patient.

Example: Medication Error Resulting in Severe Anaphylaxis

A Patient is administered an intravenous antibiotic in a hospital setting by a nurse. Due to a failure in checking the Patient’s documented allergy history, the Patient receives a medication they are allergic to (e.g., ceftriaxone). Within minutes, the Patient experiences a severe anaphylactic reaction requiring emergency resuscitation and admission to the intensive care unit (ICU).

  • Unintended and unanticipated injury: Severe anaphylaxis requiring ICU admission.

  • Location: Occurred in a hospital, a health service premises.

  • Directly related to medical treatment: The injury occurred as a result of drug administration.

  • Not due to the Patient's underlying condition: The reaction was caused by a preventable medical error, not by the illness the Patient was being treated for.

Although the Patient did not suffer permanent damage or die, the negligence in medication administration posed a serious risk to the Patient’s life and caused additional medical intervention, longer hospital stays, and psychological distress.

For more detailed insights into how the Patient Safety Act 2023 impacts you and how Whelan Law can support you, please visit our Patient Safety Rights Legal Advice https://www.whelanlaw.ie/news/medical-negligence-and-patient-safety/

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