From the Guidelines
When a problem is discovered in a medical energy device that is also found in other hospitals, the manufacturing company (MC) should be reported to first. This is based on the recommendation that consumers of medical technology, such as patients or healthcare providers, should report device errors and malfunctions to the manufacturers and appropriate regulatory agencies 1. The manufacturing company needs to be informed promptly so they can investigate the issue, provide technical guidance, and potentially issue a recall or corrective action to prevent further incidents. After notifying the MC, it is also crucial to inform the maintenance administrator (MA) as they are responsible for the facility's equipment safety and can take immediate action to remove the device from service if necessary. Lastly, the Ministry of Health (MOH) should be notified, especially if the issue represents a significant safety concern that could affect multiple healthcare facilities. Key steps to take include:
- Notifying the manufacturing company (MC) about the device malfunction
- Informing the maintenance administrator (MA) for immediate action within the facility
- Notifying the Ministry of Health (MOH) for broader safety concerns This sequence ensures both a rapid local response to protect patients and staff and the initiation of a broader investigation and potential corrective actions by the manufacturer and regulatory bodies.
From the Research
Reporting Requirements for Medical Energy Devices
To address the issue of a problem discovered in a medical energy device, also found in other hospitals, it is essential to understand the reporting requirements. The following options are available:
- Ministry of Health (MOH)
- Manufacturing company (MC)
- Maintenance administrator (MA)
Relevant Studies
Studies have shown that reporting adverse events and device-related problems is crucial for ensuring patient safety. According to 2, the European Directive 98/79/EC regulates the marketing and post-marketing surveillance of in vitro diagnostic medical devices, requiring manufacturers to report incidents and corrective measures to the national competent authority. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) are responsible for receiving these reports.
Reporting Responsibilities
The Safe Medical Devices Act of 1990, as discussed in 3, requires hospitals, health professionals, and users of medical devices to report patient incidents involving medical devices to the manufacturer and the FDA. This law gives the FDA the authority to directly regulate the use of medical devices in healthcare facilities. Similarly, 4 states that in France, the manufacturer, user, and anyone informed of an event or risk caused by a medical device must declare the event to the appropriate administrative authority.
Recommended Course of Action
Based on the studies, it is recommended that the problem be reported to:
- The manufacturing company (MC), as they are responsible for ensuring the safety and efficacy of their devices, as stated in 2 and 3.
- The Ministry of Health (MOH), as they are the national competent authority responsible for regulating medical devices and ensuring patient safety, as mentioned in 2 and 4. The maintenance administrator (MA) may also be informed, but they are not the primary point of contact for reporting adverse events or device-related problems, as seen in 5 and 6.