Technical data

8
Tests were conducted by:
Gayle Macdonald, R.D.H., Ph.D.
University of Southern California School
of Dentistry
Chris H. Miller, Ph.D.
Indiana University
School of Dentistry
John A. Molinari, Ph.D.
University of Detroit Mercy
School of Dentistry
Teresa M. Morton, Ph.D
Eastern Michigan University
Department of Biology
James L. VandenBosch, Ph.D.
Eastern Michigan University
Department of Biology
Leslie B. Heffez, D.M.D., M.S., F.R.C.D.
University of Illinois
School of Dentistry
Eliot I. Sakols, D.M.D., M.S.
Orthodontist
Kenneth W. Stoffers, D.M.D., M.S.
The University of Michigan
School of Dentistry
John M. Young, D.D.S., M.Sc.
The University of Texas at San Antonio
School of Dentistry
All test protocols will be sent upon request.
The investigators above conducted
scientific tests on the G 7781 Dental Thermal
Disinfector. They do not work for Miele, and
hence do not endorse this product. The
investigators above conducted scientific
tests on the Miele G 7781, the predicate
device to the new G 7881.
Special contribution by:
Nancy Andrews, R.D.H.
Consultant
Testing Thermal Disinfection
To prove the disinfection abilities of
the Miele Dental Thermal Disinfector
extensive biological and physical studies
were conducted by renowned institutions
throughout the United States and
Germany. The disinfection parameters
93°C/200°F/10 min. provide high level
disinfection. Although disinfection is not as
absolute as and does not replace
sterilization, it offers a high degre e of
protection against infection for dental
professionals. Th e ar ea s of ef fectiveness
are removal or inactivation of vegetative
bacteria, microbacteria, fungi, fungal spores,
and viruses. Spores are not inactivated.
In all tests conducted by US institutions,
Hu-Friedy scalers and hemostats as
well as A-dec
®
evacuation tips were
contaminated with microorganisms and
blood. In some cases, hydroxyapatite
was added to the contamination to
simulate tooth material.
The microbial challenge was determined
prior to disinfection. Each instrument was
inoculated with up to 500,000,000
microorganisms, usually by submerging
the instruments completely in the
contaminated soil. Up to 12 instruments
constituted a test load, i.e. 6,000,000,000
microorganisms in the wash chamber. To
prove the effectiveness of the machine
when fully loaded, the chamber was then
filled up with uninoculated instruments.
In most cases no microorganisms could
be recultured, indicating that usually
each and every microorganism was
removed or killed.
The Spaulding category high-level
disinfection is the same type of means as
in the sterilant category except that the
use pattern is different. The sterilant is
used as a high-level disinfectant by
e.g. reducing the exposure time within
its effective range of tuberculocidal,
virucidal, and bactericidal action.
The following microorganisms were
used to test the Miele Dental Thermal
Disinfector:
• Mycobacterium tuberculosis
ATCC 25177 (H37Ra)
• Enterococcus faecium ATCC 49224
• Pseudomonas aeruginosa
ATCC 15422
• Salmonella choleraesuis ATCC 10708
• Staphylococcus aureus ATCC 6538
In different models which use the
same thermal disinfection parameters
(93°C/200°F/10 min.) the following
microorganisms were tested for:
• Streptococcus faecium ATCC 6057
• Klebsiella pneumoniae ATCC
• Stophylococcus aureus ATCC 5G511
• Escherichia coli ATCC 11229
• M. terrae ATCC 15755
• Proteus vulgaris ATCC
Thoroughly Tested By Renowned US Institutions
Extensive Biological Testing Conducted to
Prove Cleaning and Disinfection Capabilities