The design of operating rooms is constantly evolving to meet the requirements of the field, drawing on experience and knowledge to address operational needs.
Contamination control, a key concern in healthcare facilities, is governed by the French reference standard NF S 90-351 (April 2013), entitled “Healthcare facilities — Controlled environment zones — Requirements for airborne contamination control.”
This standard defines the health and safety requirements for the design, construction, operation, maintenance, and use of air treatment and air quality control systems in healthcare facilities.
Risk analysis and requirements gathering
The planning of new operating rooms begins with a risk analysis and requirements-gathering process.
The analysis addresses risks related to the site and patient conditions, as well as environmental factors, including technical installations and human factors involving staff.
With regard to requirements gathering, the standard emphasizes a multidisciplinary approach to ensure the most objective and comprehensive assessment possible and to support proper use of the facilities, regardless of the involvement of the personnel concerned (medical team, hygiene department, technical services, project owner, project manager, etc.).
The identification of requirements is complemented by a table included in the standard, covering a number of important elements such as:
- The context of a new technical platform;
- The targeted performance levels;
- The nature of potential contaminants;
- The technical characteristics of the room;
- The nature of the airflow patterns;
- A description of environmental constraints…
A fundamental point is to clearly define the scope of the operating suite along two main lines.
First, identify the filtration zones and transition points between uncontrolled areas and the operating suite:
- Staff airlocks;
- Standing-patient airlocks and stretcher transfer airlocks;
- Unpacking airlocks;
Waste evacuation airlocks, etc.
Next, distribute the aeraulic performance requirements and associated pressure gradients throughout the rooms, applying the principle of forward progression:
Risk class and pressure gradient decreasing from the operating room, from the most critical area toward the least critical area.
Risk level
Depending on the procedures to be performed on the patient, a risk level is identified and corresponds to an appropriate technical level designed to achieve the expected performance objectives. The standard provides examples of activities along with the recommended risk classes.
Performance
The identified risk zone makes it possible to determine the appropriate aeraulic system required to achieve the desired performance.
The standard defines operating room performance and the expected objectives at rest, including particle classification, microbiological classification, and the room’s ability to remove contamination, through particle decontamination kinetics.
Standby mode
Since the latest 2013 version of the standard, and with a focus on ISO 14644 international standard, which serves as a reference for cleanrooms and associated controlled environments, and more specifically Part 1, which addresses classification.
The same standard covers various topics relevant to cleanrooms. Part 4, in particular, deals with cleanroom design.
Modelling
The design is also studied according to industry best practices and makes it possible to model the room according to the identified requirements:
Constituent elements, air treatment, medical equipment, functionality, and even aesthetics, with the integration of customizable panels (colors, landscapes, etc., according to the users’ preferences).
As mentioned above, a multidisciplinary team is assembled to properly assess the proposed design and define the elements and formalize the requirements so that the installation is constructed in accordance with the specifications. These specifications will include, in particular, the characteristics of the walls and the “floor/ceiling/partition” assembly:
- Air tightness;
- Robustness;
- Cleanability;
- Absence of recesses and dead corners;
- Flush integration of fixtures and components.
Client involvement is supported through 3D visualizations, allowing the final result to be visualized as accurately as possible.
Once the design has been approved by all stakeholders, implementation can begin and bring the project to life.
The design must take into account the fact that an operating room is intended to remain in service for many years, and all stages of its lifecycle must be considered in order to maintain the expected performance: cleaning, maintenance, data collection, and monitoring.
Smart / centralized management
Beyond these technical solutions, it is important to create an interface with users for day-to-day operation.
Solutions are available to provide the necessary information while ensuring the essential functionalities required for the operating schedule.
- Adjustment and display of operating parameters (pressure, temperature, humidity, etc.);
- Display of alarms or malfunctions (orange/red criticality levels);
- Display of specific procedures associated with alarms;
- Intercom;
- User-configurable induction scenarios;
- Technical room-opening checklist;
- Emergency calls and pre-programmed calls to the required services (anesthetist, cleaning staff, etc.);
- Music functionality (web radio or Bluetooth) to welcome patients and allow music to be played when required;
- Continuous recording of data and the ability to retrieve information by patient.
The design of operating rooms continues to evolve in order to meet the requirements of the field.
The “box” as it has existed for a very long time — the first operating room dates back to the late 19th century, with Pasteur — has continuously evolved through experience and knowledge to meet its primary objective: contamination control. It is now also part of the effort to improve the patient and user experience in the operating suite.
Regulations, industry best practices, and technological developments make it possible to define processes that will lead to increasingly high-performing and functional operating rooms.
Innovation is at the heart of the concerns of all stakeholders, with the aim of providing medical staff with the most appropriate technical tools to meet patient-care needs under the best possible conditions.