Study Examines Microorganism Kill in the Presence of Blood on Surgical Instruments

BioNeutral Group Inc., a specialty life science technology-based company, and Barnabas Health of West Orange, N.J., announce the results of an initial collaborative research program. In this study of about 50 surgical instruments conducted at Saint Barnabas Medical Center, Ygiene 206 Sterilant was shown to effectively remove microorganisms in the presence of blood from contaminated surgical instruments in 90 seconds to two minutes. This use of Ygiene would represent an important preventive step in the reduction of serious occupational exposure to healthcare workers of blood and/or bodily fluids from contaminated surgical instruments.

In the paper, "The Use of Ygiene 206 as a Possible Bloodborne Pathogen Exposure Strategy for Healthcare Workers," study investigator  Nancy Chobin, RN, AAS, ACSP, CSPDM, sought to determine the feasibility of using a disinfectant/sterilant chemical as a pre-treatment for used surgical instruments to protect healthcare workers from exposure to blood and/or body fluids when processing contaminated surgical instruments.  The study included using the chemical in a variety of settings including exposure to human blood that had dried for 12 hours.  The results of the study confirm that the Ygiene 206 chemical may be used to disinfect surgical instruments as a precursor to cleaning and prior to terminal sterilization. 

In early 2012, Barnabas Health became aware of a new chemical that asserts it has a disinfectant as well as a sterilant benefit.  The manufacturer's data revealed that Ygiene 206 eliminated Staphlococcus aureus, Salmonella cholerasius, and methicillin-resistant Staphylococcus aureus (MRSA) in 90 seconds and Pseudomonas aeruginosa, and Aspergillus niger spores in two minutes.

In February 2012, a meeting was held with representatives from the BioNeutral Group, Inc. and Barnabas Health representatives. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) testing as well as technical data for the product were also reviewed. The product is a combination of peracetic acid and hydrogen peroxide with a pH of 4.5-5.0.  There was concern about the effects of the product on surgical instruments.   The EPA and FDA has approved the use of the product for disinfection, killing fungi and as a sporicide (sterilant) but these uses are not approved on any surface or instrument that is introduced on the human body.

Despite the concern, Barnabas Health and BioNeutral believed that it would be prudent to perform a research project to determine the feasibility of using the Product on surgical instruments prior to sterilizing the instruments.  The thought was that if the product does work in the presence of gross soileven with instruments in the closed positionit would be a benefit to healthcare workers handling soiled surgical instruments to reduce or eliminate exposures to blood or bodily fluids from these surgical instruments.  The parties realized that while tests would be performed in a closed environment without actual patient contact, a true test of the product and its capabilities would be required in an actual healthcare setting.

Saint Barnabas Medical Center, one of the Barnabas Health facilities, was selected as the facility to test the effectiveness of the product as a disinfectant on surgical instruments.  All testing was performed by Barnabas Health staff members with technical support provided by BioNeutral.  Only surgical instruments no longer used in patients and/or patient care were utilized for the testing.  Therefore, none of the instruments used during any of the testing were intended for use in patient care. 

In this controlled and limited study, Ygiene 206 was effective as a disinfectant in the presence of blood on surgical instruments even when the surgical instruments were grossly soiled and remained in the closed position. Ygiene 206 is an enhancement to the process and a potential preventative step for healthcare workers in prevention of exposure to blood or bodily fluids from sharps injury when processing surgical instruments. Ygiene 206 could possibly also replace the use of enzymatic detergents for pre-soaking as evidenced by the removal of the soils. The study investigator, Nancy Chobin, does not see Ygiene 206 replacing regular washing (manual, sonic or mechanical), and says that further study is needed.

Source: BioNeutral Group, Inc. and Barnabas Health