PRE-QUALIFICATION OF MEDICAL-HOSPITAL SUPPLIES AS A RISK MANAGEMENT MEASURE TO AVOID ADVERSE SELECTIONS
Posted: Wed Feb 19, 2025 5:44 am
Before we delve into the subject of prequalification of medical-hospital materials specifically, it is important to highlight that health is constitutionally based, so it is necessary for the reader to be aware that health supplies, even under the strict control of the National Health Surveillance Agency (Anvisa), may present quality deviations and, consequently, pose risks to the health of the community. Let us see what is provided for in the Federal Constitution of 1988:
Art. 196. Health is a right of all and a duty of the State, guaranteed through social and economic policies that aim to reduce the risk of disease and other harm and to provide universal and equal access to actions and services for its promotion, protection and recovery. (Our emphasis)
Aiming to reduce health risks to the population, especially users of the public health system, the National Health Surveillance Agency (Anvisa), established by Law No. 9,782/1999, aims to promote the protection of the population's health through sanitary control of the production and marketing of products and services subject to sanitary lebanon telegram data surveillance. In this sense, it has excellent work on the post-marketing of medical-hospital products, in order to monitor them.
2. Notification System
Thus, the Agency issued Ordinance No. 1,660/2009, which established the Health Surveillance Notification and Investigation System (Vigipós), within the scope of the National Health Surveillance System, as an integral part of the Unified Health System. The ordinance establishes:
Art. 1º To establish the Health Surveillance Notification and Investigation System, within the scope of the National Health Surveillance System, for the monitoring, analysis and investigation of adverse events and technical complaints related to services and products under health surveillance in the post-marketing/post-use phase. (Our emphasis)
Through the Notivisa notification system, the quality and safety of products available on the market are monitored, appropriate control measures are adopted, safety alerts are issued, health legislation is updated, among other actions to protect the health of the population – in Notivisa, for example, data is entered on:
Adverse events (any undesirable effect, in humans, resulting from the use of a product under health surveillance, such as: death, disability, prolonged hospitalization of the patient);
Technical complaints (any notification of suspected change or irregularity in a product or company, related to technical or legal aspects that may or may not cause harm to individual or collective health).
Most of the time, these notifications are made by the Sentinel Network, regulated by Resolution No. 51/2014, which defines it as: “a group of health institutions that work in conjunction with entities of the National Health Surveillance System, in the surveillance of adverse events and technical complaints related to products subject to health surveillance”. The network currently consists of 272 health services, most of which are hospitals covered by the SUS, in all regions of the country. The network also includes blood banks, specialized institutes and emergency care units. To join the Sentinel Network, health services must comply with the provisions of Normative Instruction No. 8/2014.
All entities of the National Health Surveillance Service (SNVS), member institutions of the Sentinel Network, healthcare professionals and companies that manufacture products under the Health Surveillance Agency (all previously registered) can notify. Ordinary citizens do not yet have access to the system, but they can notify through the “Individual Notification” form available on the Anvisa website or directly to SNVS entities, by email , ombudsman, etc.
Art. 196. Health is a right of all and a duty of the State, guaranteed through social and economic policies that aim to reduce the risk of disease and other harm and to provide universal and equal access to actions and services for its promotion, protection and recovery. (Our emphasis)
Aiming to reduce health risks to the population, especially users of the public health system, the National Health Surveillance Agency (Anvisa), established by Law No. 9,782/1999, aims to promote the protection of the population's health through sanitary control of the production and marketing of products and services subject to sanitary lebanon telegram data surveillance. In this sense, it has excellent work on the post-marketing of medical-hospital products, in order to monitor them.
2. Notification System
Thus, the Agency issued Ordinance No. 1,660/2009, which established the Health Surveillance Notification and Investigation System (Vigipós), within the scope of the National Health Surveillance System, as an integral part of the Unified Health System. The ordinance establishes:
Art. 1º To establish the Health Surveillance Notification and Investigation System, within the scope of the National Health Surveillance System, for the monitoring, analysis and investigation of adverse events and technical complaints related to services and products under health surveillance in the post-marketing/post-use phase. (Our emphasis)
Through the Notivisa notification system, the quality and safety of products available on the market are monitored, appropriate control measures are adopted, safety alerts are issued, health legislation is updated, among other actions to protect the health of the population – in Notivisa, for example, data is entered on:
Adverse events (any undesirable effect, in humans, resulting from the use of a product under health surveillance, such as: death, disability, prolonged hospitalization of the patient);
Technical complaints (any notification of suspected change or irregularity in a product or company, related to technical or legal aspects that may or may not cause harm to individual or collective health).
Most of the time, these notifications are made by the Sentinel Network, regulated by Resolution No. 51/2014, which defines it as: “a group of health institutions that work in conjunction with entities of the National Health Surveillance System, in the surveillance of adverse events and technical complaints related to products subject to health surveillance”. The network currently consists of 272 health services, most of which are hospitals covered by the SUS, in all regions of the country. The network also includes blood banks, specialized institutes and emergency care units. To join the Sentinel Network, health services must comply with the provisions of Normative Instruction No. 8/2014.
All entities of the National Health Surveillance Service (SNVS), member institutions of the Sentinel Network, healthcare professionals and companies that manufacture products under the Health Surveillance Agency (all previously registered) can notify. Ordinary citizens do not yet have access to the system, but they can notify through the “Individual Notification” form available on the Anvisa website or directly to SNVS entities, by email , ombudsman, etc.