The Purpose

The purpose of the Unit is to inactivate viruses on medical instruments that cannot be decontaminated at high temperature and exposed to harsh chemical factors, to prevent infection of patients with viral infections – hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) through medical instruments.

The Unit for the inactivation of viruses in the medical instruments (the Unit) is designed for use in health care facilities – both public and private hospitals, clinics and offices of different specialization and levels.

The Unit is protected by a Patent issued by the State Patent Office of the Republic of Uzbekistan, registered in the State Register of Utility Models of the Republic of Uzbekistan in Tashkent under No. FAP 00464 on 04.03.2009.

 

INTRODUCTION

It is alarming to know that there is a growing trend of the intensive spread of viral diseases, which have a high percentage of the formation of a chronic infectious process and pose a threat to the survival of humanity. According to the results of various studies, the frequency of the formation of a chronic infectious process in the outcome of acute viral hepatitis B (HBV) reaches 40-60%, in the outcome of acute viral hepatitis C (HCV) – up to 80%, and with HIV infection (HIV) – up to 100%. Persons infected with HBV, HCV and HIV are sources of infection of healthy people.  These infections lead to disability; patients develop cirrhosis in the outcome of liver disease; hepatocellular carcinoma, Kaposi’s sarcoma, lymphogranulomatosis, deep secondary immunodeficiency and, in a high percentage of cases, result in death.

Today there are no satisfactory solutions to the problem of curing HIV infection, chronic viral hepatitis B (HBV) and chronic viral hepatitis C (HCV). Unlike many infections, the source of HBV, HCV and HIV is only the infected person; therefore, the destruction of the source of infection is not suitable.  Infection with viruses occurs parenterally, mainly during medical procedures. The only way to combat the spread of HBV, HCV and HIV infections is to interrupt the mechanisms and routes of transmission.

Infection of patients in medical institutions with HBV and HCV, and often HIV, is becoming a serious problem, they account for from 3% to 11% of the total number of infected.  Medical and non-medical procedures cause skin cuts and violation of mucous membranes.  In addition, if these procedures are performed with improperly disinfected reusable instruments, they pose a high risk of contracting HBV, HCV and HIV. Infection is possible through the remnants of particles of virus-containing infected blood on common instruments.

A significantly high percentage (from 3% to 11% of the total number of infected) of human infections, especially with HBV and HCV, is observed when reusing virus-infected medical instruments (surgical, dental, ophthalmic, laryngological, gynecological and others).

A reliable method to disinfect medical instruments is to sterilization them in high temperature. However, a significant portion of medical instrument cannot be sterilized at high temperature. Under the influence of high temperatures instruments lose their basic properties such as hardness, elasticity, reflectiveness and others.

Complete removal of viral particles from the surface of medical instruments is not achievable by mechanical means. As a result, viral particles remaining on the instruments are capable of replication (reproduction in the body) and infection of people. To infect a person even a single particle of HBV or HCV is enough if it enters the bloodstream.  This leads to a high risk of infection of patients with viral infections during medical procedures. The massive use of disposable medical instruments for each patient can solve this problem. However, this requires a solution to a number of economic and financial problems.

  1. Advantages and disadvantages of various sterilization methods.
Method Advantages Disadvantages
Steam sterilization The most common method of sterilization in hospitals.

Safe for the environment and medical personnel.

Short exposure.

No toxicity. Low cost.

Does not require aeration.

The quality of sterilization may be impaired by air ingress, reduced material moisture and poor steam quality.

 

Instruments, which are sensitive to high temperature and humidity may be damaged.

Air sterilization Low corrosive properties.

Deep penetration into the material.

Safe for the environment.

Does not require aeration.

Long exposure time

Temperature conditions and sterilization times vary from country to country.

Heat-sensitive products may become damaged.

Sterilization with 100% ethylene oxide Penetrates into packaging and plastic bags. Can be used to sterilize most medical devices. Easy to handle and control. Aeration required.

Small size of sterilization chamber.

Ethylene oxide is toxic, pronounced carcinogen, is highly flammable.

Ethylene oxide packaging should be stored in a fireproof room.

Sterilization with hydrogen peroxide vapor. Low temperature mode.

Method does not require aeration.

Safe for the environment and medical personnel.

The final products are non-toxic.

Easy to handle, operate and control.

Paper products, linens and solutions cannot be sterilized.

Small size sterilization chamber.

Instruments with long and narrow internal channels cannot be sterilized

Synthetic packaging is damaged.

Sterilization with formaldehyde vapors Fire and explosion proof.

Can be used to sterilize most medical instruments.

The surface of the instruments needs to be washed from residues of formaldehyde.

Toxic and allergenic.

Requires Long exposure.

Lengthy formaldehyde removal process after sterilization.

 

Considering the above, a group of specialists of NEW MEDICAL TECHNOLOGIES LLC began to develop a reliable method of inactivation (deprivation of pathogenic properties and replication ability) of viral particles on medical instruments at relatively low temperatures and without the use of potent disinfectant solutions (acids) and to create a unit working on this principle.

Inactivation of viruses in the “Unit for the inactivation of viruses in medical instruments” has several advantages:

  • Reliable neutralization of all types of DNA and RNA viruses;
  • Low temperature inactivation mode;
  • Ability to inactivate viruses on medical instruments made from any material;
  • Absolute safety for personnel and the environment;
  • Absence of toxicity and allergenicity;
  • Safety for medical instruments – hardness, sharpness, elasticity, and reflectiveness is retained.

The principle applied when designing the Unit for the inactivation of viruses on medical instruments.

The principle used to create the Unit was tested in world practice for the inactivation of viruses in freshly frozen blood plasma based on photoactivation of a liquid (photodynamic method). The “Unit for the inactivation of viruses on medical instruments” created at NEW MEDICAL TECHNOLOGIES LLC is a useful model and has no direct analogues.

In the Unit, viruses are inactivated on medical instruments at room temperature in a photoactivated liquid – solution of Methylene Blue. The methylene blue solution is exposed to a monochromatic light flux with a wavelength matching the wavelength of the absorption spectrum of methylene blue. In the Unit, a monochromatic emitter creates a monochromatic light flux.  Under the influence of monochromatic light flux, photo-activation of methylene blue molecules occurs. Photoactivated molecules of methylene blue actively enter into a strong bond with a pair of nucleic acids – guanine and cytosine and block them in the RNA or DNA strands of viruses.  Viruses with such inactivated RNA and DNA, even when they enter the human blood, are not able to infect cells and multiply inside cells (replicate). That is, they completely lose their virulent and pathogenic properties (properties to infect and cause disease).

In addition, photoactivated methylene blue molecules contribute to the formation of active forms of atomic oxygen, enhancing the denaturation of nucleic acids of RNA and DNA viruses.

 

  1. The effectiveness of inactivation of viruses in the Unit for the inactivation of viruses on medical instruments has been proven on:

 

  • Inactivation (loss of cytopathogenic properties) of viruses of vaccine strains of poliomyelitis (Republican Center for State Sanitary and Epidemiological Surveillance of the Ministry of Health of the Republic of Uzbekistan);
  • Inactivation (loss of ability to phage S.typhi) of bacteriophages S.typhi (Republican Center for State Sanitary and Epidemiological Surveillance of the Ministry of Health of the Republic of Uzbekistan);
  • Inactivation (loss of cytopathogenic properties) of influenza viruses (National Influenza Center at the Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan);
  • Inactivation (loss of cytopathogenicity) of Crimean-Congo hemorrhagic fever viruses (Laboratory of especially dangerous viral infections, Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan);
  • Inactivation (loss of lymphotropy) of the human immunodeficiency virus (HIV) (Reference Laboratory of the Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan);
  • Inactivation (loss of lymphotropicity) of the hepatitis C virus (Reference Laboratory of the Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan);
  • Inactivation (loss of lymphotropicity) of the hepatitis B virus (Reference Laboratory of the Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan).

 

  • Operation of the “Unit for the inactivation of viruses on medical instruments”

Medical instruments after use in patients undergo preliminary mechanical cleaning and rinsing in water with detergents. After that, the instruments are thoroughly rinsed in tap water, and then immersed in the cuvette of the Unit with a solution of methylene blue. Instruments are placed at the bottom of the cuvette and must be completely covered with a solution of methylene blue. Next, a cuvette with instruments is placed inside the Unit’s chamber. The Unit’s door closes tightly; the timer is set to the exposure time specified in the instructions – 90 minutes.  When the timer is turned on, the emitter of monochromatic light mounted above the cuvette is switched on in the chamber. The process of photoactivation of methylene blue and the inactivation of viruses present on the surface of medical instruments begins.

After the timer is turned off, the door of the Unit cabinet opens, and a cuvette  with instruments is removed. Instruments are removed with tweezers from a solution of methylene blue and thoroughly rinsed in distilled water.

 

Photoactivated liquid.

Sachets containing 1.0g of dry methylene blue powder are included with the Unit kit. When the content of one sachet is dissolved in 10 liters of distilled water, a 0.01% solution of methylene blue is obtained – a photoactivated liquid. Shelf life of photoactivated liquid in a clean container is 10 days. A serving of 0.01% methylene blue solution is suitable for three uses within one day.  Visually, with the loss of transparency (cloudiness) or the formation of plaque on the surface, a methylene blue solution is considered unsuitable for inactivation of viruses. In this case, the solution is prepared again.

The photoactivated liquid is blue and transparent, odorless and non-toxic. The methylene blue solution is absolutely safe for staff and patients – it does not cause damage if it comes into contact with skin and mucous membranes. The used methylene blue solution is drained into the sewer network.

Methylene blue does not react with inorganic compounds, so it does not affect the materials, which were used to make the medical instruments.

  1. Advantages of “the Unit for the inactivation of viruses on medical instruments” created at NEW MEDICAL TECHNOLOGIES LLC.

 

  1. In the Unit, the process of inactivation of viruses on medical instruments is carried out at room temperature.
  2. The photoactivated liquid used in the Unit is absolutely safe for personnel, does not have a damaging effect on the materials from which medical instruments are made.
  3. In the process of inactivation of viruses in the Unit there is no loss of valuable properties (hardness, elasticity, reflectiveness) and full functionality of medical instruments is maintained.
  4. The Unit is efficient and easy to operate.
  5. In the Unit, the inactivation of viruses present on the surface of medical instruments occurs reliably.

The Unit has an organizational standard and is registered with the Committee for Quality Control of Medicines and Medical Equipment of the Ministry of Health of the Republic of Uzbekistan.  Leading specialists of the republic recommend the Unit for use.

Implementation of the “Unit for the inactivation of viruses on medical instruments” into healthcare practice will significantly reduce the frequency of infection of people with HBV, HCV and HIV during medical manipulations.