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Introduction To Modular Operating Theatres
Introduction To Modular Operating Theatres
Modular operating theatres consist of several key components, each serving a specific function to
enhance the overall performance of the surgical environment:
1. Wall and Ceiling Panels: Made from high-quality, non-porous materials like stainless steel or
antibacterial coated surfaces. They are designed for easy cleaning and resistance to
pathogens, contributing to maintaining a sterile environment.
2. Air Filtration and HVAC System: A critical component that ensures a constant supply of
clean air through HEPA filters, maintaining positive pressure to prevent the ingress of
contaminated air, and controlling temperature and humidity for optimal surgical
conditions.
The design and construction of modular operating theatres must adhere to rigorous specifications
and international standards to ensure safety, efficiency, and compliance with health care
regulations:
Air Quality: ISO 14644 and ASHRAE 170 are two key standards that define the requirements
for air cleanliness in healthcare facilities, including the number of air changes per hour and
the efficiency of HEPA filtration systems.
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HEPA
Infection Control: Guidelines from the Centers for Disease Control and Prevention (CDC)
and the World Health Organization (WHO) offer comprehensive recommendations for
infection prevention in healthcare settings, which influence the design and operation of
modular OTs.
Building and Safety Codes: Local and international building codes, such as those from the
International Building Code (IBC) and the National Fire Protection Association (NFPA),
provide guidelines on construction practices, materials, and safety systems to be used in
modular operating theatres.
Medical Equipment: The performance and safety of medical devices used within modular
OTs are regulated by standards such as those from the International Electrotechnical
Commission (IEC) and the International Organization for Standardization (ISO), specifically
ISO 13485 for quality management systems in medical devices.
Conclusion
Modular operating theatres are at the forefront of surgical innovation, offering a flexible, clean, and
controlled environment that meets the rigorous demands of modern surgery. By adhering to
international standards and employing advanced technology in their components, modular OTs
provide a superior setting for healthcare professionals to perform surgeries, ultimately leading to
better patient outcomes. As technology and healthcare standards evolve, modular operating
theatres will continue to play a pivotal role in shaping the future of surgical care.
Market Players
Several companies were recognized as leading suppliers in the global market for modular operating
theatres. These companies are known for their innovation, quality, and comprehensive services,
including design, manufacturing, installation, and after-sales support. Here are some of the top
global suppliers:
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6. Siemens Healthineers: Siemens Healthineers is a leading provider of healthcare solutions,
including innovative technologies and services for operating theatres that enhance clinical
outcomes.
7. Trumpf Medical (Hill-Rom): Trumpf Medical, part of Hill-Rom, offers a range of products for
the operating room, including modular operating theatres designed for efficiency and
flexibility.
8. Skytron, LLC: Skytron provides clinical solutions to healthcare facilities worldwide, including
modular operating theatre systems that emphasize ergonomics, efficiency, and safety.
9. Grupsa: Grupsa, a company with a strong presence in the healthcare infrastructure sector,
specializes in the design, manufacturing, and installation of hospital doors and modular
operating theatre systems. Their offerings include automatic doors designed with high
standards of hygiene and safety, suitable for operating rooms, intensive care units, and
other critical areas within healthcare facilities. Grupsa's modular operating theatre systems
are designed to provide a sterile environment, optimizing air cleanliness and minimizing the
risk of infection, which are crucial factors in surgical settings. Their products are tailored to
meet the specific requirements of healthcare facilities, ensuring compliance with
international standards and regulations.
These companies are known for their global reach and commitment to innovation in healthcare.
However, the market is dynamic, and new entrants or changes in market positions can occur. It's
always a good idea to conduct current and comprehensive research to identify the best supplier for
specific needs.
International Standards
The standards for modular operating theatres and healthcare facilities vary by region, reflecting
differences in regulatory requirements, healthcare practices, and safety norms. Here’s an overview
of some key standards applicable in the United States, Europe, and Japan:
United States
ASHRAE Standard 170: This standard, "Ventilation of Health Care Facilities," provides
guidelines on ventilation requirements for healthcare facilities to ensure a safe and
comfortable environment.
NFPA 99: The National Fire Protection Association's Health Care Facilities Code sets criteria
for healthcare services or systems based on risk to the patients, staff, or visitors in health
care facilities to minimize fire, explosion, and electricity-related hazards.
ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in
health care facilities, which impacts the design and operation of facilities where surgical
instruments are sterilized.
Europe
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EN 13779: Provides guidelines for ventilation and air-conditioning systems, specifically
addressing indoor environmental input parameters for design and assessment of energy
performance of buildings.
HTM 03-01: Although specifically a UK standard (Health Technical Memoranda), it is widely
respected in Europe for design and management of building engineering services in
healthcare premises.
Japan
JIS T 0913: The Japanese Industrial Standard for the planning, design, construction, and
operation of cleanrooms and associated controlled environments, with applications in
healthcare facilities.
JIS Z 2801: Test for antibacterial activity and efficacy on plastics and other non-porous
surfaces, which would be relevant for materials used in modular operating theatres.
It's important to note that these standards are complemented by international standards like ISO
13485 for medical devices, which covers the quality management systems for the design and
manufacture of medical devices, including those used in modular operating theatres. Additionally,
facilities must comply with local regulations and building codes, which can vary even within
countries. Compliance with these standards ensures that modular operating theatres meet rigorous
safety, hygiene, and operational efficiency criteria, providing safe environments for both patients
and healthcare professionals.
Model Specification
Creating a model specification for a modular operating theatre involves detailing the requirements
and standards that the theatre must meet, including structural components, environmental
control systems, medical equipment, and safety features. This document serves as a guide for
planners, architects, and medical facilities to ensure that the constructed facility meets the
necessary criteria for functionality, safety, and compliance with healthcare regulations. Here is an
outline of what such a specification might include:
1. General Requirements
Purpose: The modular operating theatre must be designed to accommodate a wide range
of surgical procedures, ensuring patient safety, optimal surgical conditions, and efficient
use of space.
Compliance: Must adhere to relevant local and international standards, including but not
limited to ASHRAE Standard 170, NFPA 99, EN ISO 14644, and JIS T 0913.
2. Structural Components
Wall and Ceiling Panels: Made of high-quality, non-porous materials with antibacterial
coating for easy cleaning and infection control. Must meet fire safety and sound insulation
standards.
Flooring: Non-slip, anti-static, and resistant to chemicals and heavy loads. Should facilitate
easy cleaning and disinfection. (PVC ESD)
Doors: Hermetic sealing capability for maintaining controlled environments, equipped with
automation for hands-free operation.
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3. Environmental Control Systems
Air Filtration and HVAC: HEPA-filtered ventilation system achieving ISO 5 air cleanliness,
with capabilities for temperature and humidity control. System must ensure positive air
pressure relative to adjacent areas.
A Model Installation Method Statement (MIMS) for Modular Operating Theatres outlines the
systematic process for installing a modular operating theatre, ensuring safety, efficiency, and
compliance with applicable standards and regulations. This statement serves as a guideline for
contractors, engineers, and healthcare facility managers to facilitate a smooth installation process.
Lighting: LED surgical lights with adjustable intensity and color temperature, providing
shadow-free illumination. Must include emergency lighting.
Medical Gas Systems: Integrated medical gases (oxygen, nitrous oxide, medical air, vacuum)
with outlets near the surgical table, equipped with alarms for monitoring supply levels.
Central Control Panel: For managing lighting, temperature, humidity, and air quality, with
capabilities for recording and alerting system failures.
Surgical Control Panel: Located within easy reach of the surgical team, allowing control
over medical gases, lighting, and communication systems.
Emergency Systems: Backup power supply, emergency gas shut-off valves, and evacuation
protocols.
Ergonomic Design: Layout and equipment placement must minimize fatigue and physical
strain for the surgical team, ensuring efficient movement and workflow.
Pre-Installation Testing: All systems must be tested prior to installation to verify compliance
with specifications.
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Post-Installation Certification: Upon completion, the modular operating theatre must
undergo a certification process to ensure all components function as intended and meet
the specified standards.
Operator Training: Comprehensive training for staff on the operation of the modular
operating theatre and its components.
Maintenance Manuals: Detailed documentation on maintenance procedures, schedules,
and troubleshooting for all installed systems and equipment.
This model specification serves as a foundational document that can be customized based on the
specific needs of the healthcare facility, technological advancements, and changes in regulatory
requirements.
For constructing the panels of a modular operating theatre, materials should be selected based on
their ability to maintain strict hygiene standards, durability, ease of cleaning, resistance to
chemicals, and ability to support a sterile environment. Here are some of the most suitable
materials:
1. Stainless Steel
Pros: Highly durable, resistant to corrosion, easy to clean, and has a non-porous surface
that does not harbor bacteria. Stainless steel panels can also withstand repeated cleaning
with harsh chemicals without deteriorating.
Cons: Higher cost compared to some other materials and can be susceptible to scratches
and dents if not properly maintained.
Pros: Lower cost compared to stainless steel. Offers good resistance to chemicals, impact,
and moisture. HPL can be manufactured in various colors and patterns, allowing for
aesthetic design flexibility within the operating theatre.
Cons: While durable, it may not match the longevity or antibacterial properties inherent to
metal surfaces like stainless steel.
3. Powder-Coated Aluminum
Pros: Lightweight, corrosion-resistant, and durable. Powder coating can provide a smooth,
easy-to-clean surface that resists microbial growth and withstands cleaning agents.
Cons: Requires high-quality coating to ensure longevity and effectiveness in a sterile
environment.
Pros: Non-porous, easy to clean, and can be treated with antimicrobial coatings. Glass
panels allow for the integration of windows or internal blinds, contributing to a better
working environment.
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Cons: Higher cost compared to stainless steel and HPL. Glass needs to be tempered or
laminated to ensure safety. GRP must be high quality to prevent chipping or cracking over
time.
Pros: Non-porous, can be thermoformed into seamless shapes, reducing crevices where
bacteria might accumulate. Available in a variety of colors and finishes, it supports rigorous
cleaning protocols.
Cons: Can be more expensive than some alternatives and may require professional
installation to ensure seamless joints.
Infection Control: Materials must support strict infection control protocols, minimizing the
risk of harboring bacteria or mold.
Maintenance and Durability: Consider the life cycle cost, including maintenance
requirements, durability, and resistance to damage from cleaning agents and equipment.
Regulatory Compliance: Materials must comply with local and international standards for
fire safety, air quality, and health care facility construction.
Environmental Impact: Sustainable materials or those with a lower environmental impact
may be preferred for green building certifications.
Choosing the right material for modular operating theatre panels requires balancing cost,
functionality, and compliance with health and safety standards.
Powder coating stainless steel panels is not a common practice for several reasons, particularly in
environments like modular operating theatres where hygiene and corrosion resistance are
paramount. Here are some considerations regarding the use of powder-coated stainless steel:
Aesthetic Choices: Powder coating can be used to add color or texture to stainless steel,
which might be desired for design reasons. However, in a modular operating theatre,
aesthetic considerations are usually secondary to functional and hygienic concerns.
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Insulation Properties: Powder coating can provide some level of thermal insulation.
However, this is typically not a necessary feature for stainless steel panels in an operating
theatre.
Protection in Less Aggressive Environments : In environments where the chemical and
biological exposure is less aggressive than in an operating theatre, powder-coated
stainless steel might be used for its aesthetic value or minor additional protection against
wear. However, this is more common in architectural applications than in critical
healthcare environments.
Potential Disadvantages
Risk of Damage: If the powder coating on stainless steel panels is chipped or cracked, it can
create niches for bacteria to grow, away from the reach of cleaning agents. This is a
significant concern in an environment where sterility is crucial.
Compromised Stainless Steel Properties : The protective oxide layer of stainless steel that
provides its corrosion resistance can be compromised if the surface is improperly prepared
for powder coating, leading to potential corrosion spots where the coating might be
breached.
Stainless steel
Conclusion
For modular operating theatres, the inherent properties of stainless steel typically make powder
coating unnecessary and potentially undesirable. The priority in these settings is to maintain the
highest standards of cleanliness, infection control, and durability. Stainless steel's natural finish
usually provides the best balance of these requirements without the need for additional coatings.
Installation Method
A Model Installation Method Statement (MIMS) for Modular Operating Theatres outlines the
systematic process for installing a modular operating theatre, ensuring safety, efficiency, and
compliance with applicable standards and regulations. This statement serves as a guideline for
contractors, engineers, and healthcare facility managers to facilitate a smooth installation process.
1. Introduction
Objective: To detail the process for the safe and efficient installation of a modular operating
theatre.
Scope: Includes delivery, handling, installation of structural components, environmental
control systems, medical gas systems, electrical systems, and final testing.
Standards Compliance: Adheres to relevant local and international standards, including but
not limited to ASHRAE Standard 170, NFPA 99, EN ISO 14644, and JIS T 0913.
2. Pre-Installation Requirements
Site Assessment: Conduct a thorough assessment of the installation site to identify any
potential challenges or requirements for preparation.
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Utilities Preparation: Ensure all necessary utilities (electrical, plumbing, HVAC connections)
are available and meet the specifications for the modular operating theatre.
Delivery Coordination: Schedule delivery of modular components, ensuring the site is ready
for receipt and storage of materials.
3. Installation Team
Roles and Responsibilities: Define the roles and responsibilities of the installation team,
including project manager, engineers, technicians, and support staff.
Safety Training: Provide comprehensive safety training, focusing on personal protective
equipment (PPE), handling of materials, and emergency procedures.
4. Installation Process
Unpacking and Inspection: Carefully unpack and inspect all structural components for
damage.
Assembly: Follow manufacturer’s instructions for the assembly of wall and ceiling panels,
ensuring all components fit accurately and securely.
HVAC and Air Filtration: Install the HVAC system, including air handlers and HEPA filtration
units, according to the design specifications to ensure optimal air quality and flow.
Temperature and Humidity Control: Integrate temperature and humidity control systems
with the central HVAC system.
Installation: Install medical gas pipelines, outlets, and alarm systems, ensuring they are
properly labeled and tested for leaks.
Wiring: Install electrical wiring, following all safety standards and regulations.
Lighting: Install surgical and ambient lighting fixtures, ensuring they are correctly
positioned and functional.
Central Control Panel: Install and configure the central control panel for environmental
monitoring and control.
System Testing: Perform comprehensive testing of all systems (HVAC, medical gases,
electrical, lighting) to ensure they operate according to specifications.
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Safety Checks: Conduct safety checks, including emergency lighting and power systems.
Commissioning: Officially commission the theatre for use after successful testing and
inspection by relevant authorities.
Staff Training: Provide training for hospital staff on the operation and maintenance of the
modular operating theatre.
Documentation: Hand over all relevant documentation, including installation manuals,
maintenance guides, and warranty information.
7. Conclusion
This Model Installation Method Statement provides a framework for the safe and efficient
installation of a modular operating theatre. Adherence to this statement and collaboration among all
stakeholders is crucial for the successful implementation of the project.
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