4. CME Rules and Regulations

The Material and Sterilization Center (CME) is a technical support unit responsible for cleaning, packaging, sterilization and distribution of medical and hospital supplies. To ensure the safety of patients and healthcare professionals, CME must follow a series of rules and regulations established by different regulatory bodies.

The National Health Surveillance Agency (ANVISA), for example, has a series of regulations that guide the operation of CMEs. Resolution of the Collegiate Board (RDC) No. 15, of March 15, 2012, establishes good practice requirements for the processing of health products and is one of the main regulations that CMEs must follow. This resolution details everything from the physical structure necessary for the CME to the procedures that must be adopted to guarantee the adequate sterilization of the materials.

In addition, Regulatory Norm No. 32 (NR 32), from the Ministry of Labor, also establishes guidelines for the protection of workers in health services, including those who work in CMEs. This standard addresses aspects such as the prevention of accidents with sharps and exposure to biological agents.

The Brazilian Association of Technical Standards (ABNT) also has a series of standards that guide the operation of CMEs. NBR ISO 17665-1, for example, specifies the requirements for the development, validation and routine control of a steam sterilization process for health products. NBR ISO 14971 addresses the application of risk management to health products, a practice that is essential to ensure the safety of patients and health professionals.

In addition to standards and regulations, MSCs must also follow a series of technical and scientific recommendations to ensure proper sterilization of materials. The scientific literature, for example, offers a series of studies and guidelines that can help guide the functioning of CMEs. The World Health Organization (WHO), for example, has a series of guidelines on the prevention of healthcare-associated infections that can be useful to guide the practices of MSCs.

In short, the operation of CMEs must be guided by a series of rules and regulations that aim to guarantee the safety of patients and health professionals. These regulations cover from the physical structure necessary for the CME to the procedures that must be adopted to guarantee the adequate sterilization of the materials. In addition, MSCs must also follow a series of technical and scientific recommendations to ensure proper sterilization of materials. Therefore, knowledge and application of these rules and regulations are fundamental for the professional who works at CME.

Understanding and correctly applying CME rules and regulations is a crucial part of nursing professional education. The CME course - Central of Sterilized Material in Nursing from basic to advanced is an excellent opportunity to acquire this knowledge and skills. This course ranges from the structure and operation of the CME to the rules and regulations that guide its operation, preparing the nursing professional to work safely and effectively in the CME.

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