The BIOPROTECT Us System
HEALTHY MEDICAL DEVICES PROGRAM
“Protecting all medical devices.”
One of the single biggest problems facing the healthcare industry is the battle against Healthcare Acquired Infections (HAIs). This problem effects not only patients, but the insurance industry that for the most part supports the delivery of good medical practices, as well as hospitals that are more than ever focusing their concerns on cost containment measures. HAIs cost the healthcare industry anywhere from $28.5 Billion to over $40Billion yearly and accounts for almost 100,000 deaths out of almost 2 Million infections. HAIs are clearly out of control. One of the primary causes of these HAIs is due to the formation of biofilms on implantable metal-based medical devices of all kinds whether medical, dental or veterinary. Also important is the prevention of harmful bacteria on surgical instruments.
Many methods exist for sterilizing surgical instruments, most of which have their origins in the early to late 1800s in the USA sanitizing medical device tools for surgeries.
These methods include:
- Autoclave Steam Sterilization
- Chlorine Dioxide (CD) Gas Sterilization
- Hydrogen Peroxide Sterilization
- Hydrogen Peroxide Plasma Sterilization
- Gamma Ray Sterilization
- Electron Beam Sterilization
Each of these methods may have a positive sterilizing effect on surgical equipment. However, each method also presents its own set of limitations. And, most importantly, none of the methods of sterilization presently employed uses a technology that attaches to the surgical device to create a covalent bond with that surface resulting in continuous and persistent antimicrobial protection.
Regarding implanted medical devices, biofilms can be formed by as little as a single bacterial species. More often, however, biofilm formation consists of many species of bacteria, as well as fungi, algae, protozoa, debris, and even corrosion products. In addition, a biofilm can form on any surface exposed to bacteria and some amount of water. Staphylococcus aureus (Staph bacterial) is a major cause of HAIs and represents a significant burden on the healthcare system.
Staph bacterial attachment to medical implants and host tissue, and the establishment of a mature biofilm, play an important role in the persistence of chronic infections. The formation of a biofilm, and encasement of cells in a polymer-based matrix, decreases the susceptibility to antimicrobials and immune defenses, making these infections difficult to eradicate. During infection, dispersal of cells from the biofilm can result in spread to secondary sites and worsening of the infection. The virus known as MRSA is a result of a virus building up an immunity to the methods used to eradicate it. The incidence of MRSA in hospitals has risen by 90% in the last 20 years.
MRSA, Staph and other similar viruses are a direct result of a rather poor solution to the problem. The decision to use products whose “kill-field” is created by a chemical-leaching process that adds toxins into the process in order to poison the harmful microbes and render them harmless very often creates toxin-resistant strains (what we know as “Superbugs”). This is due in large part to a process that occurs during the use of these toxic substances to kill the harmful germs. Chemical toxins as they are used up fighting bacteria actually become less concentrated (they get weaker as they get used up), the bacteria can develop an adaptation to the weaker strain of toxin and become immune to it in larger doses when they are administered again. In many ways a straight chemical cure to inhibit the growth of harmful bacteria may do more harm than good.
The BIOPRTOECT Us System™…The Future of Clean™
We employ a non-leaching technology of bound antimicrobials that remain affixed to the medical device or to any porous or nonporous surface and, on a molecular scale, physically pierces the microbe’s membrane rupturing the microorganisms on contact killing them while maintaining efficacy to continue to kill any other microorganisms that come into contact with the treated surface consistently and persistently. This technology is used to treat all types of medical devices and surfaces and is not consumed by the microorganisms as it kills them. Our patented technologies use energy enhanced organophosphorus and benzophenone covalent bonding that produces self-assembling monolayers to form a durable “killing field” and contact for the useful life of the product. These monolayers not only kill microbes on the surface, but protect the device from microbial attachment, colonization, and proliferation without the negative effects on people, the environment or the products.
The BIOPROTECT Us System for Healthy Medical Devices is here to help both hospitals and suppliers of medical devices and equipment remain in compliance with the all EPA, CDC, JCAHO, FDA or additional government requirements. And we can assist and advise on any State and Local Regulations that fall within the guidelines of The BIOPROTECT Us System™.
Our System is the most effective protection that exists in the medical device industry today.
The BIOPROTECT Us System™ is the fastest, safest, and most economical system for helping you with the Federally required, cleaning of equipment and devices that you use daily.
We have a certified 6 step process implemented quarterly for keeping your manufacturing facility safe and persistently and continuously free from harmful bacterial growth. Plus, The BIOPROTECT Us System™ has a 4 process for coating your specific product(s) with our patented and EPA registered antimicrobial protection.
The BIOPROTECT Us System – for Healthy Medical Devices
Our process focuses on the elimination of biofilms that can form on medical devices after insertion, making your medical devices safe and setting your manufacturing process apart from others who may be using less effective methods for antimicrobial protection.
The BIOPROTECT Us System – for Healthy Facilities
Our System for protecting against harmful microorganisms begins with our team of Certified Technicians who know and understand not only how to efficiently and effectively administer The BIOPROTECT Us System™ but also, have been hand-selected as Technicians because they understand your specific industry and the challenges you face in complying with Federal, State and Local regulations.
The BIOPROTECT Us System – for Healthy Medical Devices
IMPORTANT: All antimicrobials must be registered with the EPA, the EU, and often other regulatory bodies for their specific uses. A manufacturers specific use also should be registered (i.e., an antimicrobial that is only EPA registered for use in shoes should not be used for treating socks).
When you enroll for quarterly maintenance using The BIOPROTECT Us System™ Healthy Medical Devices Program, we will do our part to provide you with the assurance that you are compliant with all Regulatory Agencies.
Also, ViaClean Technologies has establish a Device Master File (DMF) at the FDA for companies that want to apply our technology to their medical devices and products. This will help partners expedite the 510(k) premarket submission for safety and effectiveness, or even a de nova process (21 CFR §807.92(a)(3)).
*CERTIFIED INDUSTRIAL SUBMICRON FILTER – BASED UPON OUR SCIENTIFIC TESTING, THE BIOPROTECT US SYSTEM™ HAS CERTIFIED THE SANDERS SUBMICRON FILTER AS THE SUPERIOR INDUSTRIAL FILTER OFFERING THE BEST PROTECTION WHEN USED IN CONJUNCTION WITH THE BIOPROTECT US SYSTEM™.