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Medical devices in dentistry
WFHSS – Prague 16 october 2014
Dr Mikael Zimmerman
DDS, PhD, Associate professor
Sweden
Cross infection control, hygiene and sterilization. Todays most important tasks in all health care
systems.
Modern dentistry perform highly sophisticated
and invasive procedures !
Decontamination,
cleaning and
disinfection
Sterilization and
wrapping
Logistics
and
instruments
Maintaining
fragile
barriers
Maintaining
fragile
barriers
Sterile does not mean ”clean and safe”
If gods not ultra-clean sterilization will
not be successful!
Inadequate methods will destroy delicate
and expensive
instruments
Manual handling of instruments will include hazards
Biological barriers are fragile
Healthcare-associated infections (HCAI):
cause tremendous additional costs,
increase antibiotic resistance
jeopardize treatment outcomes,
prolong patient suffering,
decreases treatment capacity,
creates “bad-will”
A very conservative estimate of healthcare-
associated infections (HCAI) shows each
year approximately :
– 4 million cases
– 37,000 directly attributable deaths
– 16 million extra hospital days
– € 5,5 billion direct costs (average € 334 per day)
Source: ECDC Annual Epidemiological Report 2008
How many cases will be:
• Discovered ?
• Reported ?
• Analyzed and evaluated ?
• Published ?
• Commonly known among dental
professionals ?
How can we gain competence if we don’t no
the real truth ?
To reduce the number of post-operative
infections aseptic techniques are important
not only in surgical procedures.
Antibiotic must never be an alternative
to aseptic techniques, disinfection and
sterilization !
Resistance to beta-lactam antibiotics
Bacteroides, Prevotella 25,0% of strains showed resistance Roda PR., et al. Med Oral Patol Oral Cir Bucal 2007;12:E186-92
Fusiobacterium, Peptostrcc, Prevotella, Streptcc 7,1% of strains
showed resistance Kuriyama T., et al Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2000 Feb;89(2):186-92
High prevalence in subgingival microflora of adult patients with
periodontitis. (Prevotella spp, Actinomyces spp) Herrera D., et al. J Clin Periodontol 2000 Jul;27(7):520-5
van Winkelhoff AJ., et al. J Clin Periodontol 1997 Aug;24(8):538-43
35,6% in anaerobic gr- rods from pus specimens of orofacial
odontogenic infections (Prevotella spp) Kuriyama T., et al. Oral Microbiol Immunol. 2001 Feb;16(1):10-5
Patient-to-patient Hepatitis B virus transmission.
Identical DNA-match between two patientens on the
same day, in the same dental office, treated by the
same dental team – both patients undergoing tooth
extractions.
Redd J.T. Journal of Infectious Diseases, April 2007
The most common risk factor for transmission of HCV (Hepatitis C virus) infection, study from Turkey: history of surgery 98% blood transfusion 39.7% dental procedure 27.5% abortion 21.2% long-term hospitalization 11.6% hemodialysis 10% history of intravenous drug abuse 3.1% history of suspected sexual contact 1.5% Karaca C. et al., Dig Dis Sci. 2006 Feb;51(2):365-9. Department of Gastroenterohepatology, Istanbul Medical Faculty
EU Medical Devices Directives 2007/47
All medical devices must be produced in a
safe environment and all products must be
safe for patients, personell, technicians and
others.
These legal requirements must be fulfiled by
manufacturers and must be maintained and
monitored by the end user during the
entire lifespan of the medical device.
Sterile does not mean ”clean and safe”
If gods not ultra-clean sterilization will not be successful!
Endodontic files cannot be totally cleaned using a washerdisinfector alone.
The instrument holding mechanism within
the machine has a significant effect on the cleanliness of the
files after one intensive cleaning cycle.
Assaf M, et al. Br Dent J. 2008 May24;204(10):E17
Picture showing junction between handle and tip of
instrument.
Instrument which has been in daily use at dental care
clinic.
Adhesive ?
Filling material ?
Colonies of bacteria close to the junction
Manual handling of instruments will include hazards
Drying
blood
causes
corrosion !
Corroded metall – tip of instrument
Corroded metall in larger magnification, gives retention for microorganisms
Corrosion will destroy surface of delicate instruments. Instruments should be of high quality stainless steel.
Disinfection and sterilization
Steam-sterilisers without pre- and post
vacuum process show great variations.
Up to 60% do not result in sterile gods !
Skaug et al., Acta Odont Scand 1999;57:175-180
Coulter WA, et al., J Hosp Infect 2001 Jul;48(3):180-5
Gurevich I., et al. J Hosp Infect 1996 Apr;32(4):295-304
Hirsch A., et al. Med Instrum 1984 Sep-Oct;18(5):272-5
Skaug N, et al., Acta Pathol Microbiol Immunol Scand 1985;93(2):151-6
Hoborn J. Health Lab Sci 1975 Jul;12(3):225-9
Starkey D H. Am J Infect Control 1980 Aug;8(3):79-84
Commonly used items in dental clinics could not be
sterilized in the gravity steam autoclave (type N
process) or unsaturated chemical vapor
sterilizers.
Dental instruments requires high-vacuum steam
autoclave (type B process).
Kolstad RA. J Am Dent Assoc 1998 Jul;129(7):985-91
Palenik C J., et al. Am J Infect Control 1993 Feb;21(1):28-33
Palenik C J., et al. J Indiana Dent Assoc 1997 Spring;76(1):45-50
Sheldrake M A., et al. Quintessence Int 1995 Nov;26(11):771-8
Turbines and handpieces
must be clean before
sterilization.
Hammond L.
Aust Fam Physician 1990 May;19(5):693
Internal axcis from handpiece used for implant surgery!
Turbines and handpieces • External and internal
cleaning and disinfection.
• Lubrication
• Sterilization
• Processtime 12 min
…makes B-class sterilization even safer…
• Dishwashers are not effective for cleaning instruments and they do not disinfect the instruments.
• Dishwashers are not designed by manufactures for processing dental instruments prior to sterilisation.
• The use of dishwashers should not be recommended in dental clinical practice.
O'Connor HJ, et al Ir Dent Assoc. 2014 Apr-May;60(2):84-9.
The most effective stage of any decontamination
procedure is thorough physical cleaning.
Automated processors offer the safest,
most reliable option.
Washer disinfectors must according to European
standard remove all biological material on
instruments. (EN 15883).
Babb JR. Br J Theatre Nurs 1994 Jan;3(10):12-4, 27-9 Chu NS., et al. Am J Infect Control 1999 Aug;27(4):315-9 CDC (Centre for Disease Control, USA) Sterilization or Disinfection of Medical Devices: General Principles
Washer-disinfector was extremely effective in
eliminating microorganisms (>7-log(10) reduction),
including vegetative and spore-forming bacteria from
surgical instruments
Rutala WA, et al. Infect Control Hosp Epidemiol. 2014 Jul;35(7):883-5. doi:
10.1086/676867. Epub 2014 May 20
Tray system and proper
logistics:
• more efficient, save time,
• cleaning and disinfection will
be safer and better,
• instruments will last longer
• better economy
• reduce risks for sharp
injuries
• professionalism
Dental instruments must be recognized as
delicate and sophisticated medical devices.
The dental profession must follow directives
and normes accordingly
“The continues use of old medical
equipment as well as outdated
routines…
…is very difficult to justify on
professional, moral, ethical or
economical grounds.”
“Hygiene in dentistry must include antibiotic
hygiene and infection oriented care.”
Make the world safer !
Thank you for your attention
Dr. Mikael Zimmerman
Contact information:
Mobile: +46-(0)708-49 56 30