EMERGO - Obblighi normativi sui dispositivi medici e rischi connessi - Webinar

Summary

The transcript discusses the technical and legal aspects of medical device maintenance and safety in Italy. It highlights the importance of following manufacturer's instructions for medical gas systems in ambulances, the necessity of continuous professional development for technicians, and the responsibilities of employers under decree 81/08. The discussion also touches on the application of ISO 13485 and ISO 9001 certifications in ensuring quality service and compliance with regulations.

Takeaways

• 📜 The speaker has over 10 years of experience in technical activities related to medical devices, including checks, maintenance, and verification.
• 🔧 The importance of understanding the technical activities carried out on medical devices and who is authorized to perform them is emphasized due to the lack of clarity among many clients.
• 📈 The webinar involves experts in various fields to discuss reference regulations and the authorization of professionals to perform specific tasks.
• 👨‍💼 The speakers include experts in workplace safety and legal procedures, international experts on medical gas installations, and electrical medical equipment checks.
• 📚 The Medical Device Regulation (MDR) 2017/745 and Legislative Decree 81/2008 are the main legal bases for medical devices and workplace safety.
• 🧪 Medical devices are categorized as products destined for human use for diagnosis, prevention, monitoring, treatment, or alleviation of disease.
• 🔄 The New Approach Directives involve the use of Essential Requirements and Harmonized Standards to ensure the safety and performance of medical devices.
• 🛠️ Manufacturers are responsible for the correct design, production, and maintenance of medical devices, including the creation of a technical file and post-market surveillance.
• 🏥 The use of medical devices spans from domestic settings to healthcare environments, impacting individuals from conception to old age.
• 📝 Documentation and adherence to manufacturer's instructions are crucial for the proper maintenance and safety of medical devices.
• 📈 The speakers stress the importance of continuous training and updating of skills to ensure the safety and efficacy of medical devices and installations.

Q & A

What is the main focus of the webinar?

The main focus of the webinar is to discuss the technical activities related to the checks and maintenance of medical devices, including the legal and technical aspects, and the responsibilities of various professionals involved.

What are the two key regulations mentioned in the transcript?

The two key regulations mentioned are the Medical Devices Regulation (MDR) 2017/745 and the Legislative Decree 81/2008, which cover medical devices and safety and health in the workplace, respectively.

What does the 'new approach' in the context of medical devices refer to?

The 'new approach' refers to a regulatory framework that is based on essential safety and performance requirements for medical devices. It involves the use of harmonized standards to define detailed technical specifications for each type of medical device.

What is the role of notified bodies in the context of medical devices?

Notified bodies are organizations designated by EU member states to assess the conformity of medical devices with the regulations. They play a crucial role in ensuring that products can be freely marketed once they have met the necessary requirements.

What are the responsibilities of a manufacturer under the Medical Devices Regulation?

Manufacturers must design and produce medical devices in accordance with essential safety and performance requirements, create a technical documentation file, and ensure post-market surveillance to monitor and control any risks associated with their devices.

What is the significance of the 'lifespan' of a medical device as mentioned in the transcript?

The 'lifespan' refers to the period during which a medical device is expected to maintain its performance, safety, and compliance with regulatory requirements, provided that all necessary checks, including performance and safety checks, and maintenance are carried out as specified by the manufacturer.

What are the responsibilities of the employer under Legislative Decree 81/2008?

Employers have the responsibility to ensure the safety and health of their workers, including the provision of suitable and correctly maintained medical devices as part of their workplace equipment. They must also ensure that workers are trained and that the equipment is used correctly.

What are the consequences of non-compliance with the maintenance requirements for medical devices?

Non-compliance with maintenance requirements can lead to sanctions, including administrative penalties and fines. In severe cases, it can also lead to criminal liability for the employer or responsible individuals if the device's improper maintenance results in harm or injury.

What is the role of the 'responsible person' in the context of medical devices?

The 'responsible person' is the individual who has the legal relationship with the worker or user of the medical device. They are accountable for ensuring that the device is used correctly and maintained adequately to prevent any harm or damage.

How often should medical gas installations in ambulances be checked according to UNI 11.100?

According to UNI 11.100, medical gas installations in ambulances should be checked for proper functioning semi-annually, while the secondary sources, such as emergency reserves, should be checked quarterly.

What qualifications are required for personnel involved in the maintenance of medical gas installations?

Personnel involved in the maintenance of medical gas installations must be competent, qualified, and adequately trained. They should have technical knowledge, experience, and an understanding of the risks associated with gas medical installations.