The first step to add “Santa Fe” to control medical equipment

The House of Representatives voted unanimously, turning to the Senate for review, on the county’s compliance with National Act 26906, a regulation that defines a system for tracking and verifying the technical competence of active medical health products in use. Half the punishment was greeted by a group of CSE managers who waited for approval from the can bar.

It is an initiative of the Equality Caucus which obtained the opinion of three committees before arriving at the venue where it was supported by the plenary. “It is a law designed to save lives and improve the quality of care for patients in Santa Fe,” said Augustina Donnett, who did not fail to note that her partner on the bench, Robin Giustiniani, worked to pass national standards during his time as a Senator for the Nation.

The national law was ratified at the end of 2013 and there are already seven provinces that have joined: La Rioja, Mendoza, Buenos Aires, Chaco, Corrientes, Tierra del Fuego and Entre Ríos. The objective of the standard is “to establish a traceability system for active medicinal products, their metrological traceability, and to establish or enhance biomedical technology services throughout the national territory.”

“On the other hand, traceability allows us to know the path of medicines to ensure that they are monitored from their manufacture and distribution to their sale, avoiding the circulation and consumption of illegal medicines; on the other hand, the biomedical technology enterprise services allow us to ensure technical verification of the adequacy of facilities, physical facilities and equipment,” Dunnett explained. , as well as corresponding repairs and maintenance of health medical products in technology parks for public and private beneficiaries.

The Syndicate of Professional Engineers has raised the necessity of adhering to the national standard to address the problem of non-licensing and oversight by authorities of medical equipment and operational maintenance by qualified specialists.

The legislator did not hesitate to stress that “the establishment of bioengineering services in health institutions, both public and private, has become necessary in view of the increasing integration of technology related to systems for medical diagnosis, treatment and rehabilitation of patients, the technical complexity of medical equipment and associated facilities, as well as the need for Provide health care providers with corresponding professional controls over such equipment and facilities that provide health workers and patients with certainty that they are operating properly in order to sustain life.” According to Donnet, “In order to provide adequate and safe health care, and to ensure compliance with current regulations, health providers should encourage the integration of bioengineering professionals, who are responsible for ensuring the safe and effective operation of equipment and facilities for diagnosis, treatment, and rehabilitation.”

In the project’s foundations, he notes that the World Health Organization (WHO) has determined that effective policies on health technologies combat inequality and address the accessibility, affordability, and availability of medical devices, both innovative and essential, needed to respond to health needs. . He states that these policies should cover the four phases of medical devices: research and innovation, safety regulation, decision-making evaluation, and overall management. WHO has also developed a set of technical and reference documents, aimed at bioengineers, medical engineers, health managers, NGOs and academic institutions where recommendations for the assessment and management of medical devices, the aspects to be covered and the qualifications necessary for those responsible for carrying out these activities are outlined.

Meanwhile, Santa Fe County, in April 1993, included bioengineering professionals in the statute and order of university health professionals set forth in Law No. 9282. “From then until now, these professionals have been performing jobs in both public and private institutions. In the province without a regulatory framework that would lead to a significant improvement in technological processes in health,” Dunnett said.

The bill submitted to the Senate states that the Ministry of Health is the executive branch and at the request of the radical Silvia Ciancio, chairperson of the Health Committee, it is established that in December of each year, health institutions, both public and private, must send to the Ministry of Health a list of active medicinal products Used together with the name, its use, the date of incorporation into the enterprise, the manufacturer’s warranty period, the valid National Administration of Medicines, Food and Technology (ANMAT.) Medicinal Product Certification, the authorization certificate for the company selling the equipment and any other data deemed relevant.

The House of Representatives also handed over to the Senate two other bills with half a penalty related to health. One declares May every year as “Willian-Buren Syndrome Month” in the county territory, and on the other hand, training in comprehensive mental health is guaranteed to all persons working in the public service at all levels and hierarchies in the executive, legislative and judicial branches.

The first initiative is from the radical Marcelo Gonzalez who explained that Williams-Buren syndrome is a rare genetic condition, caused by a loss of genetic material on chromosome 7, which was first described by New Zealand cardiologist John Williams and in parallel with German pediatrician Alois Buren. This condition occurs in one in every 7,500 live births and it is estimated that there are 6,000 cases in Argentina.

Mental health training is authored by Judge Leandro Busatto and it is decided that persons included in the base will implement integrated mental health training in a planned, systematic, up-to-date and mandatory manner. “Comprehensive mental health training is understood as a set of activities, tasks and programs aimed at providing content aimed at recognizing mental health as a process determined by historical, socio-economic, cultural, biological and psychological components, the maintenance and improvement of which involves social dynamics and construction linked to the realization of the human and social rights of each person. The state is the guarantor of these rights,” as stated in another article.