Technical Standards: Cleaning and Disinfection
Regulatory references and best practices for healthcare services
Introduction
Cleaning and disinfection are essential steps in biosafety programs in healthcare services, contributing to the prevention of Healthcare-Associated Infections (HAIs), the protection of professionals, and patient safety.
The Cleaning and Disinfection category includes various products for sanitizing environments, surfaces, equipment, and skin, including detergents, enzymatic detergents, disinfectants, antiseptics, soaps, 70% alcohol, and other sanitizing agents, each developed for a specific purpose.
Although frequently used together, cleaning, disinfection, and antisepsis are distinct processes, regulated by technical and sanitary standards that establish criteria for product selection, solution preparation, application method, contact time, storage, and safe use.
In addition to ANVISA regulations and the Regulatory Standards applicable to healthcare services, it is crucial to follow the Manufacturer's Instructions for Use (IFU), respecting the recommended concentrations, compatible surfaces, and usage conditions for each product.
Understanding these standards and correctly using sanitizing agents is essential to maintain compliance in healthcare services, reduce the risks of cross-contamination, and ensure the effectiveness of cleaning, disinfection, and antisepsis processes.
Why do standards exist for Cleaning and Disinfection?
Regardless of the size or specialty of the healthcare service, cleaning, disinfection, and antisepsis processes must follow standardized criteria to ensure the effectiveness of sanitizing agents and reduce contamination risks.
The main objectives of technical standards are to:
- Ensure the safety of patients and healthcare professionals.
- Prevent Healthcare-Associated Infections (HAIs).
- Standardize cleaning, disinfection, and antisepsis processes.
- Ensure the correct use of sanitizing agents according to their purpose.
- Guide dilution, contact time, and product compatibility with different materials and surfaces.
- Promote process traceability and compliance with current sanitary legislation.
These regulations serve as a reference for sanitary inspections, audits, quality programs, and accreditation of healthcare services, contributing to safer environments and reducing biological risks.
Main standards and regulations
| Standard | Application | Objective |
|---|---|---|
| RDC ANVISA nº 15/2012 | Healthcare services and CSSD | Defines requirements for cleaning, disinfection, and processing of health products. |
| RDC ANVISA nº 63/2011 | Healthcare services | Establishes good operating practices, including hygiene and cleaning of environments. |
| RDC ANVISA nº 222/2018 | Healthcare services | Regulates waste management during cleaning routines. |
| NR-32 | Healthcare services | Worker protection during cleaning activities and handling of sanitizing agents. |
| ANVISA Manual – Patient Safety: Surface Cleaning and Disinfection | Healthcare services | Guides procedures for surface cleaning and disinfection. |
| IFU (Manufacturer's Instructions for Use) | Sanitizing products | Determines dilution, contact time, compatibility, and application method. |
Standards by environment
Clinics
Main references: RDC nº 63/2011 • RDC nº 15/2012 • NR-32
Standardize the cleaning of clinical areas, equipment, and surfaces between appointments.
Clinics
Main references: RDC nº 63/2011 • RDC nº 15/2012 • NR-32
Ensure standardized protocols for concurrent and terminal cleaning.
Hospitals
Main references: RDC nº 15/2012 • RDC nº 63/2011 • NR-32 • RDC nº 222/2018
Control healthcare-associated infections through systematic cleaning of environments and equipment.
CSSD
Main references: RDC nº 15/2012
Ensure that cleaning correctly precedes disinfection and sterilization processes.
Laboratories
Main references: RDC nº 302/2005 (where applicable) • RDC nº 63/2011 • NR-32
Standardize the cleaning of benches, equipment, and technical areas.
SOPs related to cleaning
Standard Operating Procedures (SOPs) typically include:
- Concurrent cleaning.
- Terminal cleaning.
- Surface cleaning.
- Equipment cleaning.
- Dilution of sanitizing agents.
- Cleaning frequency.
- Use of PPE.
- Waste disposal.
- Process quality control.
Required documentation
- Updated SOPs.
- Cleaning plan.
- Cleaning schedule.
- Training records.
- Technical datasheets for sanitizing agents.
- Manufacturer's IFUs.
- MSDS/SDS for chemical products.
- Dilution records.
- Validity control of sanitizing agents.
- Non-conformity records.
Products that aid in compliance
- Enzymatic detergents.
- Neutral detergents.
- Hospital disinfectants.
- Sodium hypochlorite.
- 70% alcohol.
- Microfiber cloths.
- Mops.
- Wringer buckets.
- Sprayers.
- Dosing bottles.
- PPE for cleaning.
- Dispensers.
- Technical brushes.
Frequently Asked Questions
What is the main standard for cleaning and disinfection in healthcare services?
There isn't a single applicable standard. Depending on the environment and activity performed, prominent standards include RDC ANVISA nº 15/2012, RDC ANVISA nº 63/2011, NR-32, RDC ANVISA nº 222/2018, and ANVISA's technical manuals, which establish requirements for cleaning, disinfection, biosafety, waste management, and professional protection.
Are cleaning and disinfection the same thing?
No. Cleaning involves the removal of dirt and organic matter, reducing the microbial load on surfaces. Disinfection, on the other hand, uses chemical or physical agents to eliminate or inactivate microorganisms present on previously cleaned surfaces and articles.
What is antisepsis?
Antisepsis is a procedure performed on living tissues, such as skin and mucous membranes, using antiseptics to reduce or eliminate microorganisms, helping to prevent infections before healthcare procedures.
Can I use any product for cleaning and disinfection?
No. Products must be used according to their purpose and the manufacturer's recommendations. Where applicable, they must be registered with ANVISA, and comply with the dilution, contact time, material compatibility, and usage conditions described in the Manufacturer's Instructions for Use (IFU).
Should cleaning be performed before disinfection?
Yes. Cleaning is an essential step before disinfection, as the presence of organic matter can reduce the effectiveness of disinfectants and compromise microbiological control.
Do healthcare services need to have SOPs for cleaning and disinfection?
Yes. Standard Operating Procedures (SOPs) are required by various sanitary regulations and must describe cleaning and disinfection routines, products used, frequency, responsible parties, and safety measures adopted by the service.
Are the Manufacturer's Instructions for Use (IFU) mandatory?
Yes. The Manufacturer's Instructions for Use (IFU) are part of the product's technical documentation and must be followed regarding dilution, contact time, application method, surface compatibility, and storage conditions.
What products are included in the Cleaning and Disinfection category?
Depending on the application, this category may include detergents, enzymatic detergents, surface disinfectants, high-level disinfectants, antiseptics, soaps, 70% alcohol, specific cleaners, and other sanitizing agents, always used according to their indication and regulation.
Can all disinfectants be used on any surface?
No. Each disinfectant has a specific indication for use, spectrum of action, and compatibility with certain materials. Before application, it is essential to consult the manufacturer's instructions to avoid damage to surfaces and ensure the effectiveness of the process.
What is the importance of technical standards for cleaning and disinfection?
Technical standards contribute to process standardization, reduce the risks of cross-contamination, promote the safety of patients and professionals, guide the correct use of sanitizing agents, and assist healthcare services in complying with current sanitary legislation.
Conclusion
Compliance with technical standards related to cleaning is fundamental to reduce biological risks, prevent infections, protect professionals, and ensure safe environments for patients and teams. In addition to knowledge of legislation, the use of regulated sanitizing agents, appropriate equipment, and standardized protocols strengthens the biosafety culture and contributes to the compliance of healthcare services.
