What Are Cleanroom Ceiling Systems?

How Clean is The Air in The Operating Room?

According to guidelines published in the Journal of the American College of Surgeons, surgical site infections (SSIs) affect as many as 300,000 patients per year in the United States. SSIs are the most common and costly of all hospital-acquired infections (HAIs), accounting for 20 percent of all HAIs. The estimated annual cost ranges from $3.5 billion to $10 billion.¹ Additionally, SSIs can affect countless patient-centered outcomes including financial burdens, quality of life, and satisfaction with treatment. Patients who develop SSIs following a surgical procedure may be impacted over periods of several months to several years, and may experience severe pain, insecurity and isolation as a result.

One of the factors impacting the rate of post-operative infection is the level of airborne bacteria in the Operating Room. Airborne bacteria can be diluted and removed using an appropriate ventilation system, preserving Operating Room air quality. Operating room ceiling ventilation systems, specifically with a single large diffuser design (SLD), originated from cleanroom technologies originally developed for computer chip and pharmaceutical manufacturing.

What is Cleanroom Technology?

Advances over the past several years can be associated with the reduction of SSIs. Ultra-clean air systems in the Operating Room improved during the 1960s and 1970s. Additionally, more effective surgical sterilization procedures, laminar flow, high-efficiency particulate absorbing (HEPA) filtration, ultraviolet radiation, air renewal, and humidity control in the Operating Room have influenced the rate of SSI following surgical procedures. Since the development of laminar airflow ventilation systems in ORs, ventilation and ultra-clean air and laminar airflow are standard practice.

HEPA filters are designed to filter out airborne particles. Multiple studies conclude that ORs with HEPA filtration systems have lower levels of microbial and Aspergillus contamination² and reduced levels of particulate matter in the air.³

Manufacturers of pharmaceutical, semiconductors and other sensitive products must adhere to strict standards on airflow requirements that limit the level of particle contaminants. These industries, by complying with ISO 14644 cleanroom standards, decreased product loss as a result of a failure to meet air quality standards in sensitive environments.⁴ Cleanroom technology helps to mitigate the risk of airborne particles and prevent gaps within the Operating Room air.

What is the CLEANSUITE^® Operating Room Ceiling System?

The CLEANSUITE Operating Room Ceiling System* is a single-diffuser, cleanroom ceiling system for hospitals that directs airborne particles and contaminants away from the patient and OR staff while encompassing the room with HEPA-filtered air.

At 100 particles per cubic foot, the CLEANSUITE System is the only solution to achieve the ISO Class 5 Cleanroom specification, surpassing the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) 170 standard for patient safety. The CLEANSUITE System removes airborne particles and contaminants away from the area of the patient on the operating table, bathing the patient in HEPA-filtered air, while at the same time preventing entrapment of airborne particles around the surgical site. The CLEANSUITE Ceiling System integrates structure, air delivery, and room lighting.

CLEANSUITE Operating Room Ceiling System Features

Air Delivery and Air Exchange in the Operating Room

• Single large diffuser (SLD)
• Cleanroom Technology for unidirectional airflow (ISO Class 5 Cleanroom specification)
• Equalizer balancing dampers
• CleanScreen™ Diffuser

Modular Structure for the Operating Room of the Future

• Integrated boom and imaging rail mounting
• Internal and external truss systems to support various mount locations
• Fully welded modules
• Module anchoring locations

The CLEANSUITE Ceiling System also offers optional accessories such as:

• Touch screen control panels
• Equipment and lighting boom mounts
• Imaging rail hookup
• Gel-seal HEPA filters (bottom load)
• Hinged access panels
• Audio system components

Benefits of the CLEANSUITE Operating Room Ceiling System

The CLEANSUITE System directs airborne contaminants away from the operating room staff and patients, minimizing the risk of SSI from airborne bacteria in the OR. The CLEANSUITE laminar airflow system provides contamination control with the CleanScreen diffuser that optimizes airflow to a unidirectional movement with minimal turbulence, creating a cleanroom environment for the Operating Room.

Because the CLEANSUITE System is a single-source solution for ceiling design and helps future proof OR infrastructure with the ability to easily move ceiling-mounted equipment in the future. The integrated lighting system creates a uniform brightness over the patient during surgical procedures, dimmable lights give surgeons control of lighting levels and green lights help reduce surgeon eye fatigue during long surgical procedures.

Operating Rooms equipped with the CLEANSUITE Ceiling System are suitable for various types of procedures including orthopedics, trauma, neuro, cardio, and hybrid.

How Does the CLEANSUITE Operating Room Ceiling System Work?

The CLEANSUITE Ceiling System uses a true gapless laminar flow ceiling system to minimize turbulence and gently guide particles away from the surgical site, bathing the patient and staff in ultra-clean air. Laminar airflow systems such as the one employed by the CLEANSUITE System are designed to provide highly filtered air with continuous air exchanges to reduce airborne particles in the Operating Room. HEPA-filtered air minimizes the re-circulation of contaminants in the surgical suite, reducing air microbial loads.5 The CLEANSUITE System uses HEPA filters designed to significantly reduce levels of particulate matter in the air, bathing the patient and surgical area with lower levels of contaminants and ultra-clean air.

Learn more about the CLEANSUITE Ceiling System

*CLEANSUITE is a registered trademark of NORTEK AIR SOLUTIONS, LLC.

References

1 Kristen A. Ban, Joseph P. Minei, Christine Laronga, Brian G. Harbrecht, Eric H. Jensen, Donald E. Fry, Kamal M.F. Itani, E Patchen Dellinger, Clifford Y. Ko, Therese M. Duane. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. Journal of the American College of Surgeons, 2017; 224 (1): 59 DOI: 10.1016/j.jamcollsurg.2016.10.029
2 Crimi, P. Valgiusti, M. Macrine, G. et al. (2009). Evaluation of microbial contamination of air in two hematology departments equipped with ventilation systems with different filtration devices. Journal of Preventative Medicine Hygiene. 50, 33-36.
3 Wan G. H., Chung, F. F., Tang, C. S. (2011). Long-term surveillance of air quality in medical center operating rooms. Am J Infect Control. 39(4), 302-308
4 Eichelberger, D. (2018). Clean Air in the Operating Room [White paper]. Retrieved from https://ww1.steris.com/onbDocs/V436/0/1267691.pdf
5 Aydin, C. N., Ucar, F. B., Haliki Uztan, A., Corbaci, C., Akpinar, O. (2013). Determination and comparison of microbial loads in atmospheres of two hospitals in Izmir, Turkey. Ann Agric Environment Medicine. 20, 106-110.