Technical Standards: Podiatry-Aesthetics

Technical Standards: Podiatry-Aesthetics

Main standards and regulations applicable to Podiatry and Aesthetics services.

Working in Podiatry and Aesthetics requires much more than technical knowledge and mastery of procedures. Offices, clinics, and specialized centers must follow sanitary standards, biosafety protocols, and good practices to ensure patient safety, professional protection, and service quality.

These regulations establish requirements related to hygiene, instrument processing, sterilization, waste management, use of Personal Protective Equipment (PPE), environmental organization, and infection prevention.

Why Do Standards Exist for Podiatry and Aesthetics?

Regardless of the type of service provided, every Podiatry or Aesthetics service must adopt procedures that ensure:

• Patient safety
• Professional safety
• Prevention of infections and cross-contamination
• Standardization of procedures
• Quality of services provided
• Traceability of sterilization processes
• Compliance with current sanitary legislation

Technical standards serve as a reference for Sanitary Surveillance inspections, audits, quality programs, and for implementing safer routines in the professional environment.

Hierarchy of Standards Applicable to Podiatry

The standards regulating Podiatry and Aesthetics services are not concentrated in a single document. They form a set of federal laws, ANVISA resolutions, Regulatory Standards (NRs), state standards, municipal laws, and technical instructions from manufacturers. Each has a specific function and, together, establish the requirements for the safe operation of establishments, professional protection, and the quality of services provided.

Main Standards and Regulations

How do these standards complement each other?

None of these standards replaces the others. While some establish structural requirements, others regulate instrument processing, waste management, occupational safety, or the operation of health services. Compliance depends on the integrated application of these requirements, also observing state and municipal legislation and the instructions for use (IFU) of the products and equipment used.

Standards by Service Modality

Podiatry Offices

Main references: RDC nº 15/2012 • RDC nº 222/2018 • NR-32 • Local Sanitary Surveillance legislation

Objective: ensure biosafety, adequate processing of instruments, correct waste disposal, and patient protection during podiatric procedures.

Aesthetics Clinics

Main references: RDC nº 222/2018 • NR-32 (when applicable) • State and municipal sanitary legislation • Internal biosafety protocols

Objective: ensure adequate hygiene conditions, environmental organization, prevention of cross-contamination, and safety during aesthetic procedures.

Integrated Health Clinics

Main references: RDC nº 63/2011 • RDC nº 15/2012 • RDC nº 222/2018 • NR-32

Objective: standardize assistance processes, strengthen biosafety practices, and ensure the quality of services offered by multidisciplinary teams.

Educational Institutions

Main references: Institutional biosafety protocols • RDC nº 15/2012 • RDC nº 222/2018 • NR-32

Objective: provide safe training for students, standardize practical procedures, and minimize occupational risks.

Office Infrastructure

In addition to biosafety protocols, Podiatry offices must observe minimum requirements related to physical infrastructure, which may vary according to state and municipal legislation. These include:

• exclusive lavatory for hand hygiene;
• smooth, impermeable, and washable surfaces;
• adequate lighting;
• ventilation compatible with the activity;
• area designated for instrument processing;
• separate storage for clean, sterilized, and contaminated materials;
• operational flow that minimizes cross-contamination.

The Importance of Standard Operating Procedures (SOPs)

Regardless of the service modality, Standard Operating Procedures (SOPs) establish how each activity should be performed, reducing process variability and increasing safety of care. In Podiatry and Aesthetics, SOPs usually cover activities such as:

• Hand hygiene
• Cleaning and disinfection of surfaces
• Cleaning of instruments
• Sterilization
• Storage of sterilized materials
• Use of PPE
• Patient care
• Waste management
• Cleaning and maintenance of equipment

In addition to facilitating team training, SOPs are important documents for sanitary inspections and quality audits.

Manufacturer's Instructions for Use (IFU)

In addition to sanitary standards, all products used in the professional routine must strictly follow the Instructions for Use (IFU) provided by the manufacturers. Autoclaves, enzymatic detergents, disinfectants, sterilization packaging, sealers, chemical indicators, and instruments have specific guidelines for use, cleaning, maintenance, and storage. Non-compliance with these instructions can compromise the effectiveness of biosafety processes and characterize non-conformity during sanitary inspections.

Documentation and Traceability

Compliance with standards also depends on maintaining updated records, such as:

• Standard Operating Procedures (SOPs)
• Team training records
• Sterilization cycle control
• Chemical and biological indicator records
• Equipment calibration certificates
• Preventive maintenance control
• Sterile material validity control
• Cleaning and disinfection records
• Healthcare Waste Management Plan (PGRSS)
• Sanitary Surveillance licenses and documents

Sanitary Licensing

Technical documentation must be complemented by the documents required by competent bodies for the establishment's operation. Depending on local legislation, the following may be required:

• Sanitary License;
• Operating Permit;
• Municipal Registration;
• Healthcare Waste Management Plan (PGRSS);
• equipment maintenance records;
• documentation related to instrument processing;
• proof of team training.

Products that Aid in Compliance

Regulatory compliance also depends on the use of appropriate materials throughout the professional routine. Some products are essential to keep offices and clinics aligned with good practices:

• Personal Protective Equipment (PPE)
• Sterilization packaging
• Chemical indicators for sterilization
• Packaging sealers
• Autoclaves
• Trays for instrument cleaning
• Enzymatic detergents
• Brushes for instrument cleaning
• Sharps disposal containers
• Infectious waste collectors
• Hand hygiene products
• Organizers and trays for instruments
• Biological indicators;
• Bowie & Dick tests (when applicable);
• Neutral detergents;
• Sanitizers regulated by ANVISA;
• Washable furniture;
• Soap and alcohol dispensers.

Which standards deserve greater attention from podiatrists?

Although several standards may be applicable to Podiatry services, some have a direct impact on the professional routine:

• RDC nº 15/2012 — safe processing of reusable instruments;
• RDC nº 222/2018 — adequate waste management;
• NR-32 — protection of professionals against occupational risks;
• NR-6 — correct use of Personal Protective Equipment;
• NR-17 — ergonomics and prevention of occupational diseases;
• Ordinance CVS nº 11/1993 (State of São Paulo) — specific requirements for the operation of Podiatry offices;
• state and municipal sanitary legislation — licensing and complementary requirements.

Frequently Asked Questions

Does Podiatry need to follow sanitary standards?

Yes. Podiatry offices and clinics must meet the requirements of Sanitary Surveillance and adopt biosafety practices, instrument processing, and waste management compatible with the procedures performed.

Does RDC nº 15/2012 apply to Podiatry?

Whenever reusable instruments used in procedures are processed, its principles related to cleaning, disinfection, sterilization, and storage serve as a reference to ensure the safety of the materials used.

Does NR-32 also apply to Podiatry professionals?

When the professional works in health services or is exposed to the occupational risks foreseen in the standard, NR-32 establishes important measures for protection against biological, chemical, and physical risks.

Is PGRSS mandatory?

Whenever waste classified as healthcare waste is generated, its management must follow the requirements of RDC nº 222/2018 and local legislation.

Are SOPs mandatory?

In several regulatory contexts, yes. Furthermore, they are fundamental for standardizing procedures, facilitating training, reducing operational failures, and demonstrating compliance during sanitary inspections.

Technical Basis

This article was prepared based on the main standards and technical references applicable to Podiatry and Aesthetics services, including:

• Law nº 8.080/1990 (Organic Health Law);
• Law nº 9.782/1999 (creation of ANVISA);
• RDC ANVISA nº 50/2002;
• RDC ANVISA nº 63/2011;
• RDC ANVISA nº 15/2012;
• RDC ANVISA nº 222/2018;
• NR-6 – Personal Protective Equipment;
• NR-17 – Ergonomics;
• NR-32 – Safety and Health at Work in Health Services;
• Ordinance CVS nº 11/1993 (State of São Paulo);
• state and municipal sanitary legislation;
• instructions for use (IFU) from manufacturers of health products and sanitizers.

Conclusion

Complying with technical standards is part of the routine of any Podiatry and Aesthetics service committed to safety, quality, and excellence of care.

In addition to knowledge of regulations, having adequate equipment, certified materials, biosafety products, sterilization systems, and solutions for organizing and managing waste contributes to keeping the professional environment aligned with good practices and Sanitary Surveillance requirements.

By investing in standardized processes, updated documentation, and quality products, offices and clinics strengthen patient safety, value professional performance, and promote more efficient and reliable services.

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