Individual medical practices: which disinfectants are approved by the Ministry of Health and how do you check the label?

If you manage a private medical practice, you already know that choosing disinfectants is not just a matter of preference or price. You need products approved by the Ministry of Health, correctly classified, and used according to instructions. Otherwise, you risk sanctions during DSP (Public Health Directorate) inspections and, more importantly, you expose patients and staff to avoidable risks.

To make the right decisions, check three things before purchasing:

1. the existence of an approval number issued by the National Commission for Biocidal Products (CNPB);
2. classification into the appropriate product type (TP1, TP2);
3. the field of use and spectrum of activity clearly stated on the label.

What should medical staff check on the product label?

1. Administrative data and traceability (Product identification)

- The approval/authorization number issued by the Ministry of Health.

- Product type (e.g., TP2) and field of use (medical/hospital).

- Names of active substances and their exact concentration.

- Batch number (Lot) and expiration date (Exp).

2. Technical parameters (Instructions for use)

- Preparation method and dilution tables (if concentrated).

- Demonstrated spectrum of efficacy (bactericidal, virucidal, etc.).

- Mandatory contact time for each individual spectrum.

- User category (must state "professional use").

3. Safety and chemical risk elements

- Hazard pictograms (graphic symbols in red rhombuses).

- Risk and precautionary phrases (H and P statements).

- First aid measures.

- UFI code (a mandatory 16-character European code used by poison control centers for the instant identification of chemical composition and first-aid measures in case of accidental exposure).

What does "disinfectant approved by the Ministry of Health" mean?

A disinfectant used in medical spaces falls under the category of biocidal products and must comply with EU Regulation 528/2012. In Romania, the CNPB within the Ministry of Health analyzes the documentation and issues an approval number. Without this approval, the product cannot be legally used in healthcare facilities.

Each product falls into a specific type:

• TP1 – hand hygiene;
• TP2 – surfaces and equipment.

Types of disinfectants needed in your practice

In most cases, a medical practice needs at least three categories of products: for hands, for surfaces, and for instruments.

Hand disinfectants (TP1)

For staff and patient hygiene, choose disinfectants from the TP1 category with bactericidal, yeasticidal, and virucidal (limited or full spectrum) activity. For practices with high respiratory or epidemiological risk, the spectrum also extends to mycobactericidal activity. In practice, many formulas use ethanol in effective concentrations.

On the label, check the contact time for hygienic disinfection and, if applicable, for surgical disinfection. Respect the recommended quantity and frequency of application. In high-patient-flow practices, these details make the difference between a correct procedure and one that is merely formal.

You can consult the complete range of Klintensiv professional disinfectants to select products adapted to your type of activity.

Surface disinfectants (TP2)

For examination tables, handles, non-invasive equipment, or hard surfaces, use products classified as TP2. For example, a product like Klintensiv ready-to-use surface disinfectant simplifies application and reduces the risk of incorrect dosage.

Check the activity spectrum (bactericidal, yeasticidal/fungicidal, virucidal, and even mycobactericidal or sporicidal in high epidemiological risk areas) and the contact time. If you work in practices with a high risk of contamination, carefully analyze the specific requirements of your specialty.

Disinfectants for instruments and medical devices

Semi-critical instruments (those that come into contact with intact mucous membranes or damaged skin) mandatorily require high-level disinfection, while devices that penetrate sterile tissues must be sterilized. For heat-sensitive items (which cannot withstand high temperatures), sterilization is performed via cold chemical immersion with products like Oxoklin, while the rest of the critical instruments require mandatory autoclaving.

An example of a ready-to-use product for decontaminating surfaces and non-critical/semi-critical medical devices is Sterisol, a high-level RTU disinfectant, used by strictly adhering to the contact time recommended by the manufacturer.

Read carefully the immersion time, compatibility with materials (stainless steel, medical plastic, silicone), and the rinsing procedure. If you skip these steps, you compromise the process.

To check the mandatory European standards and log reductions required for each type of microorganism in medical facilities, consult the SR EN 14885:2022 Guide on the antimicrobial spectrum.

How to properly check a disinfectant label?

Follow these steps every time you introduce a new product into the practice:

1. Check the CNPB approval number. Look on the label for a code in the format "XXXX BIO/XX/XX.XX". Write it down and check its validity in the official register or request a copy of the approval from the distributor.

2. Identify the product type (TP). Ensure the product matches your usage: TP1 for hands, TP2 for surfaces.

3. Read the field and area of application: the label must explicitly mention the instructions for use in healthcare facilities / medical field for the decontamination of hard, non-porous surfaces. Find out the user category: the product must be approved for "professional use". If the label states it is intended for household use (for the general public), it does not meet efficacy standards and has no legal basis to be introduced into the practice.

4. Analyze the microbiological spectrum and contact time

• In healthcare facilities (according to Order 1761/2021), mycobactericidal/tuberculocidal and sometimes sporicidal activity are often required, depending on the risk.

5. Check safety instructions Consult hazard pictograms and recommendations regarding protective equipment. In spaces such as schools, kindergartens, or offices, manage the storage of and access to concentrated products carefully.

Select disinfectants based on the type of space, frequency of use, and the risk associated with your activity. Keep approvals, technical sheets, safety data sheets, and purchase invoices on file. This demonstrates compliance and protects your business.

Periodically analyze the products you use and ensure they meet all legal and technical requirements. If you have doubts, request additional information from the supplier before introducing them into your daily protocol.