The increase in the complexity of medical devices in the recent past has presented a myriad of challenges for those charged with providing sterile surgical instruments. Particular concerns include narrow bore lumens, multi-component instruments that include electronics or fiber optics, and the reprocessing of single-use devices that contain heat or chemical sensitive polymers. Hospitals are increasingly looking to alternative low-temperature technologies to meet their needs. Currently available low temperature sterilization processes are associated with high capital costs and are out of reach for smaller healthcare facilities. The increase in the number of ambulatory surgical centers and dental clinics and the corresponding increase in the need for sterile instrumentation present a compelling opportunity to provide an economical means of rapidly sterilizing a wide range of devices. This emerging market coupled with increasing environmental regulations enhances the appeal of a process that can meet the outlined needs without creating hazardous waste or potentially dangerous toxins.
AGT's Solution - The Steriglow Sterilization System
Atmospheric Glow Technologies is developing the Steriglow Sterilization System to address the needs of this market. AGT uses its patented OAUGDP® atmospheric plasma process to create short-lived reactive chemical species from air. These chemical species have been proven to neutralize all biocontaminants even in the presence of residual organic debris without inducing damage to sensitive materials as part of research funded by The National Institutes of Health and The Department of Defense.
The Steriglow, illustrated in the concept drawing in Figure 1, will be a standalone device that is compact, economical, and compatible with a multitude of medical or dental device configurations. Once medical or dental devices have been cleaned using standard procedures, they will be placed within the Steriglow. The plasma is initiated and forms the reactive chemical species that will enter the Steriglow's treatment compartment to neutralize all microorganisms present including viruses, bacteria, fungi, and even bacterial endospores (like anthrax).
Figure 1. Conceptual Illustration of the Steriglow Sterilization System.
The Steriglow Sterilization System will offer several advantages that will make it an attractive product:
- Economical - The Steriglow System will be priced within reach for smaller facilities.
- Low Operating Costs - Since OAUGDP® is created using only electricity and air, there will be no costs associated with additional chemicals or gases.
- Fast and Convenient - The ability of ambulatory surgical and dental clinics to return a key instrument to service within 30 minutes is an important criterion for the selection of a sterilization technology. These smaller facilities can reduce their dependence on off-site sterilization contractors, thereby further increasing their savings by being able to reduce instrument inventory.
- Validated Technology - OAUGDP® has been supported by The National Institutes of Health, the U. S. Army, The Technical Support Working Group, and the U. S. Environmental Protection Agency. Vacuum plasma in combination with hydrogen peroxide vapor is already an accepted technology for sterilization. Acceptance of AGT's technology will not be a significant barrier.
- One-step Process - There is no lengthy training process for operators. Cleaned instruments are placed within the chamber and are removed once the process is completed.
- Safe - The end products of the Steriglow process are not hazardous. The benefit of this extends beyond a risk reduction in that financial resources do not have to be committed for hazardous waste disposal or protective garments.
- Compatibility - AGT's atmospheric plasma is exceptionally compatible with a wide range of materials and device configurations, even those that are heat and moisture sensitive.
- Flexible - The Steriglow Sterilization System will be scalable. Systems can be provided that meet the needs of smaller facilities or even regional healthcare centers.
- Easy Installation - Installation will involve only plugging the Steriglow into an electrical outlet. There will be no need for costly renovations for steam lines, exhaust systems, or water like those associated with other sterilization technologies.
Market Opportunity
Total revenues for the disinfection and sterilization market for 2001 were $647 M, with anticipated growth to $928.6 M by 2008. As a sector of the market, plasma sterilization was responsible for $34 M in revenues in 2001. This is expected to increase to $46.2 M by 2008, representing a compound annual growth rate of 4.5% from 2001-2008. Currently, there is only one plasma sterilization system on the market with an average cost of $95 K per system.
There are multiple market drivers that are expected to support the growth of the plasma sterilization market (source: Frost & Sullivan).
- Faster sterilization cycle - An ethylene oxide sterilization cycle requires 12-14 hours. Plasma sterilization occurs in less than one hour. This is a significant driver since the need for rapid instrument turnaround is increasing. This demand is expected to continue to grow.
- Safety concerns - Ethylene oxide (EtO) is a carcinogen. The EtO process has the potential to leave residual toxic compounds on the instrument. Furthermore, the propellants used in this process have been associated with ozone depletion.
- Future ban of HCFC - Hydrochlorofluorocarbons are expected to be banned completely in 2030 with a ban on sales expected in 2015. Hospitals are hesitant to purchase a sterilizer that may be banned in the future. Excise duties are expected to be imposed on HCFC's, increasing cost. Plasma sterilization is environmentally friendly.
- Ease of installation and use - Installation of plasma sterilization systems typically requires only an electrical outlet. They are easy to operate and provide sterile instrumentation in a one-step process.
Technical Verification
Broad spectrum activity
The primary criterion for any sterilization technology to meet is the ability to neutralize all biological contaminants. The traditional benchmark for sterility validation is bacterial endospores given their extreme resistance to heat, chemical disinfectants and radiation. AGT has performed extensive validation studies with several atmospheric plasma device configurations. These studies provide evidence that the reactive chemical species produced by AGT's atmospheric plasma are capable of routinely neutralizing 1,000,000 bacterial endospores per cubic centimeter within minutes at temperatures as low as 25°C. Additional studies with less resistant organisms verify the broad-spectrum efficacy of the Steriglow. Organisms representative of every class of pathogen (bacteria, viruses, molds, yeast, and bacterial endospores) have been rapidly inactivated by OAUGDP®. Upon plasma treatment, the structural integrity of a microorganism is destroyed, leading to death.
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