2023-08-11 04:00:17
The new document is made up of 17 points that must be compulsorily complied with for organ procurement and transplantation.
One of the provisions indicates that the Internal Transplant Committee must confirm that there is no profit in the process.
In the case of imported corneas, the reasons why they cannot be obtained in the country and the clinical and epidemiological background on the risks of infectious diseases must be explained.
The Federal Commission for the Protection against Sanitary Risks (Cofepris) and the National Transplant Center (Cenatra) issued a High Health Directive aimed at establishments dedicated to the work of saving lives through the procurement and transplantation of organs, tissues and cells. The objective is that they comply with current regulations and guarantee safe procedures for patients.
The technical document is made up of 17 points that this type of establishment must comply with to safeguard the quality of transplants with standards of equity, altruism and transparency.
New mandatory provisions
Among the provisions, the process that must be followed by the Internal Donation Coordination Committee and Internal Transplant Committeewith the preparation of a report for each procedure, where the criteria for distribution of an organ or tissue to an establishment are specified, as well as the assignment to the patient based on ethical, medical, scientific and legal reasons.
To carry out transplants in national and foreign patients, the Internal Transplant Committee must carry out an exhaustive investigation to corroborate that there is no profit or coercion in the process.
Therefore, the relationship between donor and recipient will be described in detail in the minutes of said committee with the evidence established in article 26 of the Regulations of the General law of health in the field of transplants.
The establishments that carry out the procurement and transplantation of organs, tissues and cells must report in the Computer System of the National Transplant Registrythe survival of the transplanted patient and the graft, the constant updating of data on the patients waiting for a transplant, among others.
Regarding the health professionals involved in donation and transplantation processes, the High Health Directive indicates that they must be registered in the Information System of the National Transplant Registry of the health facility. In addition, there should be no conflict of interest on the part of the health personnel involved simultaneously in a distribution and assignment process.
Indications for transplantation of imported corneas
He High Health Directive informs that, in the case of transplantation of imported corneas, in addition to the corresponding health authorization, the establishment and the ID of the recipient to whom they will be addressed must be specified. Also the reasons why they cannot be obtained in the country, and the clinical and epidemiological background on the risks of infectious diseases.
To guarantee that these types of establishments comply with the necessary sanitary conditions, Cofepris will carry out sanitary surveillance, which may be carried out at any time. In case of finding any health risk, security measures will be applied. For example, the assurance of products and the suspension of work or services, among others.
Cenatra and Cofepris continue to work in coordination to ensure that the noble work of saving lives through organ, tissue and cell donation and transplantation is carried out in accordance with ethical, medical, scientific and legal criteria, in establishments free of health risks.
Also read:
Hospital General de México, a pillar in organ procurement and transplantation
Graphic of the day: Celebrities who have received organ transplants
New method for organ transplantation reduces patient harm
#Cofepris #Cenatra #publish #guide #organ #transplantation