Validation of operating rooms
In an environment such as the operating room the possession of appropriate requirements takes an even greater importance in view of the need to ensure high standards of safety for both patients and operators. A preventative maintenance program with regular inspection and maintenance is absolutely essential.
The importance of environmental quality in the hospital sector is an issue now discussed and dealt with for many years, largely regulated by technical standards and especially by increasing the current legislation on workplace safety.
In an environment such as the operating room the possession of appropriate requirements takes an even greater importance in view of the need to ensure high standards of safety for both patients and operators.
The validation of the operating room, therefore, becomes a necessary step in compliance with national and regional legislation.
This validation is configured as Performance-Based Qualification for the existing operating rooms and it has the aim to ascertain the compliance of the system parameters and environmental hygiene required by legislation, technical regulations and industry guidelines in force.
The documents which refer to for the rating of the operating room are represented by the UNI 11425:2011 "Ventilation and air conditioning controlled contamination (VCCC) for the operating theatre design, installation, commissioning, qualification, management and maintenance" and Guidelines ISPESL (published December 2009) "Guidelines on the standards of safety and hygiene in the operating department."
This is an example of the validation protocol in the operating room. Some tests may change depending if the operating room is served by a facility with a turbulent flow or unidirectional mixed.
Intervention protocol for Room with air conditioning (VCCC) with turbulent flow:
- Measurement of the air flow of renewal and calculating air changes / hour
- Measurement of the gradients in environmental pressure
- Particle Classification according to EN ISO 14644-1
- Measurement of the thermo-hygrometric parameters
- Determining the Recovery Time
- Determination of total mesophilic microbial load in air at rest
- Determination of total mesophilic microbial load in the air while operational
- Determination of total mesophilic microbial load on surfaces
- Determination of the average illuminance level of the environment
- Determination of the average illuminance level of the surgical area
- Determination of the level of background sound pressure
- Environmental monitoring of anesthetic gases for the assessment of occupational exposure levels and leak detection circuits of anesthesia in high and low pressure. In the case of unidirectional flow system mixed it is necessary to integrate the controls with the following parameters
- Distribution of air velocity on filtering ceiling
- Verify proper installation and maintenance of filtration systems (leak test)
- Smoke testing (verification unidirectional airflow)
It would be appropriate to provide a measure of the periodic (six-monthly) for the losses of the filtering systems in order to optimize its functionality.
Tags: hospital sector, operating room , validation, UNI 11425:2011 , ISPESL , protocol validation of operating room
