In Ireland, 11 incidents which included the death of patients are being investigated, as medical devices are being suspected as the cause of death. However, there is no certainty as to when the investigations on the 11 deaths between 2015 and 2017 would finish as per the Health Products Regulatory Authority (HPRA). Incubators, hip implants, and coronary pacemakers are some of the devices linked to these deaths. Others include plasters, bandages, wheelchairs, contact lenses, blood pressure monitors, and even pregnancy test kits. Other investigations during the three-year period related to 19 deaths where medical devices were suspected were initiated, but none ended with any substantial evidence. When there is a malfunction of equipment or inadequacy in the instructions for use, which could lead to death directly or indirectly, an incident report is filed. The HPRA then ensures that an investigation is conducted to establish if the manufacturer was able to communicate the outcome of the inquiry to the end-user in Ireland.
According to an HPRA spokesperson, due to the corrective action, 41 percent led to product removals, 14 percent pointed to software upgrades, and 15 percent led to field modifications. Design errors, manufacturing errors, inadequate pre-market testing, and quality system failures are a few of the several reasons behind the removal of products. A medical device is defined as “a health product that a patient uses for medical reasons.” The ability of devices to diagnose, monitor, or treat illnesses and assist people with physical impairments makes them beneficial.
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