In April 2013, ANVISA published Ordinance No. 529, which inserts in Brazilian healthcare the concern with Patient Safety.

The ordinance had a great value even 14 years after the publication of the report “To Err is human”, considered the first milestone of Patient Safety in the world, because it was from there that this issue gained prominence.

This standard defined by ANVISA regulates the beginning of Patient Safety care in Brazil.

For this decision to launch the National Patient Safety Program (PNSP) different aspects were taken into account: the WHO recommendation, the high number of Adverse Events (AE) in the country and the multidisciplinary approach to the subject, which directly encompasses issues related to Quality and Risk Management.

The general objective of the ordinance is to improve the quality of care in all healthcare facilities in Brazil.

The specific objectives of the ordinance are summarized as follows:

  • Involve patients and their families in Patient Safety actions.
  • To produce, organize and disseminate knowledge to society about Patient Safety
  • Promote the culture of Safety, in healthcare education, on Patient Safety.

In July 2013 ANVISA defined, through RDC No. 36/2013, actions for the promotion of Patient Safety and quality improvement in healthcare services.

The first action was the creation of the Patient Safety Core (NSP) to implement the actions of the Patient Safety Plan in healthcare services.

Role of the Patient Safety Center

The NSP should be formed by members with capacity and power to execute the actions of the Patient Safety Plan in the Health Services.

Its main guidelines should be:

  • Continuous improvement of care processes and the use of healthcare technology.
  • Systematic dissemination of the safety culture by all sectors of the healthcare facility.
  • Articulation and integration of risk management processes.
  • Ensuring good operating practices in the health service.

Its main actions are:

  1. Developing, implementing and monitoring employee training programs.
  2. Establish barriers for the prevention of incidents to patients.
  3. Implement patient safety protocols and monitor their indicators.
  4. Analyze and evaluate data on incidents that have occurred.
  5. Disseminate and share the results of the analysis and evaluation of incidents.
  6. Notifying the National Health Surveillance System of AE’s arising from healthcare.
  7. Monitor and disseminate health alerts and other notifications issued by the authorities.



The publication by ANVISA of this standard, which involves attention to Patient Safety, is very important, because through it, even small institutions must include in their priorities the need for quality and safety, which go together.

Lack of attention to AE’s allows them to become major problems that increase the chances of process failures.

Unfortunately, even today, in 2021, many hospitals throughout Brazil still do not recognize the importance of Patient Safety Centers, and therefore, in many of them, the implementation of safety protocols and AE notifications, for example, are not yet part of the routine of multidisciplinary teams.

The actions of the PSNs, when well executed throughout the country, will save lives and generate real data on the AE situation in Brazil.

Below is a video, provided by EAD ANVISA, which helps on how to notify Health Surveillance of adverse events occurring during assistance in health services:

Pharmacist Daniela Faria