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:

mz@admodum.se

Mobile: +46-(0)708-49 56 30