Hospital protocols for high-risk areas: ICU, ER, and isolation – what needs to be updated annually

Critical areas within a hospital (ICU, ER, and isolation wards) operate under constant pressure. These areas treat hemodynamically unstable patients, perform high-risk invasive maneuvers, and manage biological agents with epidemic potential. If protocols lag behind clinical reality or the current legal framework, inconsistencies arise that increase the risk of healthcare-associated infections (HAIs), expose the facility to sanctions, and, in extreme cases, generate legal consequences.

This guide is addressed to hospital managers, medical directors, ICU and ER heads of department, coordinating nurses, epidemiologists, infection prevention and control officers (CPPIAAM), and cleaning companies serving medical units. The information is also applicable to private clinics, laboratories, dialysis centers, or any facility that manages high-biological-risk areas.

The legal and regulatory framework: what to check annually before anything else

Any protocol revision starts with alignment to the legislation in force. Mandatory national legislation for critical areas:

• Ministry of Health Order no. 1761/2021 for the approval of Technical Norms regarding cleaning, disinfection, and sterilization in public and private sanitary units.
• Ministry of Health Order no. 1101/2016 regarding the approval of Norms for the surveillance, prevention, and limitation of healthcare-associated infections in sanitary units.
• Ministry of Health Order no. 914/2006 regarding the structure and organization of hospitals.
• Standard NP 015 regarding the design of hospital buildings.
• Ministry of Health Order no. 1226/2012 regarding the management of waste resulting from medical activities.
• Government Emergency Ordinance no. 41/2019 and Government Decision no. 617/2014.
• The hospital's White Plan: management of emergency situations and mass casualty incidents; it must be reviewed annually and correlated with actual capacities (functional ICU beds, available ventilators, PPE stocks, biocidal solution stocks).

European legislation:

• Regulation (EU) no. 528/2012 concerning biocidal products.
• SR EN 14885:2022.
• Decision 2012/506/EU, updated by Implementing Decision (EU) 2018/945: standardized case definitions used for HAI surveillance (adopted in the methodological guides of the INSP/CNSCBT), mandatory according to Ministry of Health Order 1101/2016.

CPPIAAM obligations: what must be documented in any healthcare unit with beds

According to Ministry of Health Order no. 1101/2016, every healthcare unit with beds has the legal obligation to develop an annual program for the surveillance, prevention, and limitation of HAIs, which includes:

• case definitions used for HAI surveillance (according to Decision 2012/506/EU);
• the methodology for detecting, recording, and reporting HAIs;
• procedures for monitoring staff accidental exposure to biological products (Annex no. 2 of Order 1101/2016);
• standard precautions: the mandatory minimum for preventing HAI transmission (Annex no. 2 of Order 1101/2016, correlated with Annex no. 4 for the isolation guide);
• the duties of each employee regarding HAI prevention, as stated in their job description.

The absence of any of these documents constitutes a major non-compliance during a Public Health Directorate (DSP) inspection.

Infection control in the ICU: biocidal products and specific procedures

Hand hygiene is the most important factor in reducing HAI transmission in the ICU. Update the protocol according to the 5 WHO moments:

• Before patient contact.
• Before aseptic procedures.
• After exposure to biological fluids.
• After patient contact.
• After contact with the patient's surroundings.

Specify in the protocol:

• the product used for hygienic/surgical hand disinfection by rubbing (Alchosept or Klintensiv Disinfectant Gel — 3 ml, 30 seconds/90 seconds according to EN 1500/EN 12791);
• situations where handwashing with soap and water is mandatory instead of rubbing;
• the product for surgical hand disinfection by washing (CHDG Soap — 2×4 ml, 2×2 minutes);
• the prohibition of jewelry, watches, and long/painted/artificial nails.

Surface disinfection in the ICU

Surfaces in the ICU are classified into high-risk areas (patient unit, monitors, infusion pumps, bed rails, side rails) requiring high-level disinfection after every invasive procedure and at least 3 times/day, and medium-low risk areas (offices, access hallways) with daily disinfection.

Recommended products for ICU surfaces:

• Klintensiv Surface Disinfectant RTU - high level;
• Klinomed Wipes (medium-level disinfectant wipes), suitable for small devices, monitors, protected keyboards, infusion pumps;
• Desogen Aero for terminal disinfection of the ICU room upon patient transfer/death or after a confirmed HAI case.

Mandatory annual verification of the biocidal product portfolio:

• Confirm that each product used is approved by the Ministry of Health and listed in the National Register of Biocidal Products (according to GEO no. 41/2019).
• Verify that the declared activity spectrum (bactericidal, levuricidal, fungicidal, mycobactericidal, virucidal, sporicidal) covers the needs of the area, tested by applicable EN standards (EN 13727, EN 13624, EN 14476, EN 14348, EN 17126, etc.).
• Update technical datasheets and safety data sheets (SDS) in the department's biocidal products folder.

High-level disinfection of semi-critical instruments in the ICU (reusable laryngoscopes, ventilation circuits, reusable suction catheters):

• Dezicon (concentrated product);
• Peroklin (ready-to-use), high level, no risk of dilution errors;
• Oxoklin for cold chemical sterilization for heat-sensitive devices, with mandatory rinsing in sterile water.

Learn more about the impact of nosocomial infections on healthcare units!

Disinfection in the ER

Define separately in the protocol:

Routine disinfection between patients (interval 5–10 minutes):

• Examination stretcher, armrests, equipment handles.
• Recommended product: Klinomed Wipes or Klintensiv Alchosafe.
• Mandatory specification in the protocol: who performs the disinfection (the nurse or dedicated cleaning staff), with what product, and in what timeframe. Ambiguity of responsibility leads to omissions.

Intermediate disinfection (at the end of each shift):

• Treatment of all surfaces in examination cubicles, including equipment.
• Completion of the disinfection schedule.

Terminal disinfection (after a case with high biological risk: C. difficile, MRSA, patient with a communicable infectious disease):

• Complete evacuation of the space.
• Manual disinfection of all surfaces with a high-level product (Surface Disinfectant RTU or Dezicon 2%).
• Disinfection by nebulization with Desogen Aero (10 ml/m³, 30 minutes) after manual cleaning and disinfection.
• Re-entry only after complete ventilation and expiration of the safety time from the technical datasheet.
• Mandatory documentation of the intervention.

Decontamination after exposure to C. difficile: alcohol is not effective against C. difficile spores. The protocol must explicitly specify the use of sodium hypochlorite (1000 ppm minimum, 10 minutes contact) or a sporicidal product approved for this indication.

Disinfection in isolation wards

Alcohol-based products, including routine ones, are not effective against Clostridioides difficile spores, and their use as the sole method is strictly prohibited. The mandatory procedure consists of prior washing of surfaces to remove organic matter, followed by the mandatory application of sodium hypochlorite with a concentration of at least 1000 ppm active chlorine or a specialized product with approved sporicidal action, according to standard EN 17126. The mandatory contact time on surfaces before wiping or drying is at least 10 minutes.

Current disinfection (at least once per shift):

• Patient unit surfaces: Surface Disinfectant RTU or Dezicon, 60 minutes.
• Floors: Deziamino, 60 minutes.

Terminal disinfection (upon discharge/transfer/death of the isolated patient):

• Removal of all reusable materials before disinfection.
• Manual disinfection of all surfaces, including walls and ceilings (at accessible levels).
• Disinfection by nebulization with Desogen Aero (10 ml/m³, 30 minutes) after manual cleaning and disinfection.
• Re-entry according to instructions in the technical datasheet.
• Complete documentation of terminal disinfection.

Correct use of PPE: order of donning and doffing

Errors in doffing PPE are one of the most frequent causes of staff self-contamination. Describe step-by-step in the written procedure and display at the entrance to the isolation area:

Donning order:

• Hand hygiene.
• Isolation gown.
• Sterile/clean gloves over the gown cuffs.
• Mask (surgical or FFP2/FFP3 according to isolation type).
• Eye protection (face shield or goggles).

Doffing order (in an anteroom or dedicated space, not in the room):

• Removal of gloves (technique: "inside out").
• Hand hygiene.
• Removal of eye protection (grabbing by the elastic/sides, without touching the face).
• Untying/opening the gown (grabbing from the back), rolling outward.
• Hand hygiene.
• Removal of the mask (grabbing by the elastic/ties, without touching the face).
• Hand hygiene.

Organize annual practical training with simulation and document participation. Periodically verify through direct observation that the procedure is respected, not just that staff signed that they have read the document.

Standardization of biocidal products: mandatory annual review

Review annually the technical datasheets, approvals, and area of use for every biocidal product used in the ICU, ER, and isolation wards. Products with expired approvals, formula modifications, or those withdrawn from the National Register can no longer be legally used.

Non-negotiable operational rules:

• Clean before disinfecting: organic matter inactivates disinfecting substances; disinfection on dirty surfaces is ineffective and, legally, non-compliant.
• Respect the correct concentration: under-concentration reduces efficacy and may favor the selection of resistant strains; over-concentration generates toxicity, corrosion, and unjustified costs.
• Ensure full contact time: do not wipe prematurely; if the surface dries before the contact time expires, reapply the product.
• Use controlled dosing systems for concentrates: automatic dilutors or dedicated graduated syringes eliminate human variability.
• Label any container of prepared solution with name, concentration, date, and time of preparation.
• Never mix different disinfectant products.

Klintensiv product portfolio recommended for critical areas:

For more valuable information about disinfection, download the Klintensiv guides!

Klintensiv disinfectants are approved by the Ministry of Health and tested according to current EN standards.

Use biocidal products safely. Always read the label and product information before use.