BMTS Demolizer technology efficacy testing

Efficacy Testing

Obtaining approval for alternative biomedical waste disposal is a complicated process, sometimes taking more time to complete than gaining approval from the FDA for a new drug. A tremendous amount of testing is required to demonstrate safe and effective treatment of the waste. BMTS has tested the efficacy of Demolizer® technology and either gained formal approval or developed documentation necessary to support use in 47 states, with approvals pending in three additional states.

Bacterial and Viral Efficacy

The Demolizer® technology has been exhaustively tested at Kansas State University, Stanford University and private laboratories in support of state regulatory approvals. Minimum kill criteria of 6 log₁₀ (99.9999%) was demonstrated using the following organisms:¹ B. subtilis (spores), S. aureus, Methicillin resistant S. aureus, E. coli, P. aeruginosa, C. albicans, M. fortuitum, M. bovis, M. phlei, and Giardia spp.

The inactivation of Duck Hepatitis B Virus as a viral indicator organism was demonstrated at a level of at least 2.2 x 10⁵ through efficacy trials conducted at Stanford University.

Demolizer

Emissions Testing

Expanding air from the Demolizer® technology has been tested under challenge conditions using the EPA Test Protocol for Bacterial Emissions. Upon spiking the load with 10⁸ cells of G. stearothermophilus, the emissions were tested to be bacteria-free. A dual filtration system has been incorporated to eliminate odors and to serve in a redundant safety capacity. Absence of bio-aerosols was verified by an independent evaluation at Valley Medical Laboratory (Springfield, MD).

Water condenses from the expanding air during processing and is collected in a jar at the side of the unit. This water was also tested under challenge conditions 10⁸ spores of G. stearothermophilus) by an independent laboratory and demonstrated to be bacteria-free.

Heavy Metal Testing (Sharps)

An independent evaluation demonstrated that Demolizer® processed medical waste meets or exceeds U.S. EPA regulatory requirements regarding acceptable heavy metal levels.² Testing included eight heavy metals all of which tested well within regulatory limits, with six of the eight metals below the detection limit.

¹ “Sterilization Efficacy of the Demolizer® II System for the on-site treatment of sharps and other regulated medical waste against S. aureus, E. coli, C. albicans, M. phlei, and B. subtilis spores”, Kansas State University, July 2006.

Efficacy testing against B. subtilis, S. aureus, C. albicans, M. fortuitum, M. bovis, P. auruginosa, and Giardia, Leberco Testing, Inc., multiple studies, 1992-1994.

“Efficacy of the Demolizer® system on Hepadna Virus (duck hepatitis B virus)”, Stanford University, November 1992.

² Certificates of Analysis for Demolizer® processed red bag and sharps waste, Leberco Testing, Inc., 1993. Heavy metals included: lead, mercury, arsenic, cadmium, barium and chromium.

For more detailed information on our efficacy testing, please contact us.