2023-06-15 04:00:25
- The new indications of Cofepris and Conamed are mandatory for all medical personnel.
- The legal acquisition of medicines guarantees strict controls of good manufacturing practices that make them safe, effective and of quality.
- Only health professionals with specialty accreditation can supply anesthetics.
The Federal Commission for the Protection against Sanitary Risks (Cofepris) and the National Commission of Medical Arbitration (Conamed) They released a new statement. The main objective is to encourage health professionals to purchase anesthetics from legally constituted distributors, which helps prevent possible health risks due to the supply of irregular products.
The legal acquisition of this type of product extends the guarantee that the strict controls of good manufacturing and distribution practices are met, as well as the safety, quality and efficacy of drugs used in surgical or obstetric procedures.
cofepris recommends to purchasers of health supplies, verify that the distributors from whom they purchase supplies and products have a health license and/or notice of operation, as well as a notice from the health officer.
Once the inputs are received, it should be reviewed in detail that they correspond to what is described in the entry document regarding the description, expiration date and lot number. In addition to the above, they must make sure that the medication packaging does not show alterations or damage.
Refering to preservation and storage of anesthetics, the indications contained in the labeling of each product must be followed. In addition, each establishment must register the control and recording of temperatures. Also have calibration instruments and action protocols when medicines are exposed to temperatures outside the limits specified in the cold chain.
Likewise, it is of vital importance that health professionals have the accreditation of the specialty necessary for the use of anesthetics.
Likewise, health professionals must indicate in the clinical record all the interventions of the personnel involved in the treatment and care of patients, and each one of the prescribed medications must be recorded in the medical, nursing, and post-anesthetic notes.
Recommendations of the National Medical Arbitration Commission
In turn, Conamed informs that professionals duly authorized to practice anesthesiology who perform surgical procedures on patients on an outpatient basis or those who require hospitalization must clinically support the need for the use of anesthetic drugs; evaluate the risk-benefit of the procedures to be performed, as well as obtain informed consent.
Each procedure will necessarily have to be documented in the clinical file, in strict adherence to the precepts established by the Constitution in its articles 1, 4 and 6, as well as in the General Health Law in its articles 32, 51 bis 1 and 77. encore 37.
Health professionals are obliged to report all adverse events that occur during the performance of any anesthetic event, in order to comply with the provisions of the General Health Law, in its articles 194 subsection III, as well as the 195.
In addition to the above, the professional who practices anesthesiology must comply with the provisions of the General Health Law in relation to the use and acquisition of medicines, in its articles 233, 234, 236, 237, 245 (sections I, II and III). , 247, 248 and 464 (sections I, II, III and IV) and the Federal Penal Code in its article 193.
Cofepris endorses the commitment to place patients at the center of health regulation, for which reason in December 2022 it published the Senior Health Directive for Medical Care Establishments with Aesthetic, Obstetric and/or Surgical Procedures in which the sanitary measures that must be complied with are reiterated, as stipulated by the current sanitary legislation.
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