In U.S. hospitals pathogen transfer from patient to patient by various pathways
causes 2.5 to 3 million infections annually out of 30 million patients, over 100,000
resulting deaths, and $30 billion in associated medical costs. The numbers are
growing rapidly as a result of antibiotic resistant bacteria.
The current state of the art for infection control for patients in a hospital
environment is sanitizing healthcare worker's and doctor's bare hands between
patient visits using hand washing and alcohol rubs. Sanitation of surfaces in
the patient's room and healthcare worker clothing changes are not often done.
Germgard Lighting LLC has identified and maintains that the current technology does not
work because it does not deal with the main source of infections, which is transfer
in both directions of pathogens from surfaces in the patient's room, healthcare
worker's clothing and instruments to the hands, usually gloved. Once on the surface
of the gloved hand it is transferred to the patient. This view is support by experts.
The recognized solution based on our initiative is a device allowing the doctors
and healthcare workers to sanitize their hands each time the patient is about to be
touched. However that approach is viewed as currently not possible because of the
time required, the inconvenience, and the irritation of the hands associated with
the sanitation process.
Germgard has developed a rapid, conveniently placed sanitation device for the
gloved hand, based on Germgard Lighting LLC's proprietary UV-C light technology. This allows
hand sanitation just as the patient is about to be touched.
The UV-C based device is a shoe box sized unit; the gloved hands are inserted into the unit and in 3 seconds of exposure, greater than 99.999% of vegetative pathogens on the entire external surface of the gloves including between fingers are inactivated. This applies to all pathogens; however spores take longer. In contrast spores are not inactivated at all with alcohol rubs on bare hands only, and non-enveloped virus are difficult; alcohol rubs typically do not achieve as much as 99.99% removal of pathogens. The time for the process is 3 seconds for each hand in series for a single unit for a total of 6 seconds or 3 seconds total for two single hand units side by side. The gloves are opaque and no UV-C reaches the skin. The process is entirely safe. The UV-C does not compromise the integrity of the glove.
The application of the Germgard product is for use in civilian hospitals, VA hospitals, military field hospitals, surgical centers, emergency services, restaurants and other food handling organizations, to reduce transfer of pathogens that could cause infection. There are 900,000 hospital beds in 6000 registered U.S. hospitals. The cumulative U.S. market is for about 1 million units in hospitals (and a potentially much greater market in restaurants, banquet halls, and food preparation establishments). There is greater demand for such products internationally. The selling price per unit is expected to be less than the annual cost of alcohol rubs per hospital bed.
The technical approach is indisputably safe and according to FDA requires only an efficacy prove-in for premarket clearance. The physical inactivation mechanism is scientifically sound, well established, and completely characterized: inactivation studies for Germgard Lighting LLC's device are currently underway.
Sterilization of surgical instruments for manufacturers or reuse by hospitals,
surgical centers and other large volume users is generally performed centrally.
Several gas based technologies are available as well as radiation. Users of smaller
numbers of surgical instruments who typically sterilize instruments for their own
reuse invariably use high pressure steam autoclaves. The autoclave dominates the
market for local instrument sterilization. Autoclaves require instrument prewrapping
and post sterilization handling water, and significant electric power. Since
instruments need to be dried the full process takes several hours. The high
temperature steam degrades instruments and limits choice of materials.
Germgard Lighting LLC's patented (pending) approach utilizes ozone, a proven sterilant for
centralized instrument sterilization, in a unique way. The instrument or instruments
to be sterilized are placed in a pouch or multi instrument kit, which is then sealed
and is impervious to pathogens or gas flow. Using a unique, patented approach, ozone
at very high concentration is continuously created from dry oxygen and maintained
within the single instrument pouch or kit. No ozone leaves the sealed pouch or kit
and the ozone is destroyed before the pouch or kit is opened.
The surgical instrument or set of instruments remains sealed in the pouch or kit
until used and there is no handling or instrument exposure until used. Ozone can
damage instruments but not to the same extent as high pressure steam. The total
time for the process is much shorter than for steam sterilization; well under 30
minutes. The unit is smaller and overall less expensive. The sterilized instrument
is available immediately upon finishing the sterilization process or can remain in
the sterile pouch or kit until needed.
Germgard Lighting LLC's Ozone Sterilizer device is targeting 99.9999% inactivation of pathogens on external and externally connected internal surfaces. This applies to all pathogens including spores and possibly prions.
The application of Germgard Lighting LLC's surgical instrument sterilization system is for
use in doctors and dentists offices, small surgical centers, military field hospitals
and emergency services. The annual U.S market for autoclaves is about $450 million for
about 100,000 units. The annual U.S. market for related sterile consumables is about
$700 million. Germgard Lighting LLC will capture market share in both of these growth market
segments. The actual sales price of the unit and the disposable are not finally set.
However, the sterilization cost per tool will be an order of magnitude less than
current approaches.
Autoclaves used by the military are obsolete and in need of replacement by equipment
that is faster, smaller, lighter, does not require water and not power hungry. Our
approach should be ideal for military applications.
The technical approach is indisputably safe and according to FDA requires only an efficacy prove-in for premarket clearance. The physical mechanism is well established: inactivation studies will be underway shortly. We plan to partner with a medical device manufacturer for validating the technique.