by - dr. sheetal kapse, 2nd year p.g. student, dept. of oral & maxillofacial surgery, RCDSR, Bhilai, C.G. please contact for any question...email id - sheetal.kpse@yahoo.com

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Introduction
History
Sterilization & asepsis
Principles of sterile technique
The hand scrub
Hand towel drying
Gloving
Gowning
Operating room decorum
Operating room procedures
Preparation of surgical site
Draping the patient
The close of operation

3. • Cleanliness of the hospital environment is the best starting
point to achieve the highest patient safety mandate.
• There is a need to decrease the bio-burden present in the
environment in an operating room.
• A systematic method of precautions taken by operating team
leads to a successful procedure.

4. Third book of the Hebrew bible
Book of Leviticus
Chapter 11 – 15
Code of Hygiene

5. • Aristotle recommends
Boiling water to armies.
• Advises the Alexander
• Recommends hygiene
for healthy living

6. •
Hungarian physician of
German extraction now known
as an early pioneer of antiseptic
procedures. Described as the
"savior of mothers"
• Emphasized the importance of
washing hands with chlorinated
water in Obstetrics to reduce
maternal mortality.

7. Beginning of Modern
Nursing
The Very First Requirement in
Hospitals that should do the sick
no harm
Florence Nightingale
( Notes on Nursing 1860 )

8. Starting of Modern Era
Dr. Joseph Lister
• 1867 – Dr. Joseph Lister first identified
airborne bacteria and used Carbolic acid
spray in surgical areas.
• Phenol in Surgery and Decontamination
practices.
• Lister era 1868
• Carbolic Acid in decontamination,
• Reduction of Hospital associated infections
• Mortality reduced
• Morbidity reduced.

9. Beginning of Safe Operation
Theatre Practices
• 1867 – Dr. Joseph Lister first identifies airborne bacteria and
uses Carbolic acid spray in surgical areas.
• 1880 – Johnson and Johnson introduce antiseptic surgical
dressings.

10. STERILIZATION:
The process by which an article is made free of all living organisms either in
vegetative or in spore state.
DISINFECTION:
The destruction or removal of all pathogenic organism / organisms capable of
giving rise to infection.

11. ANTISEPTIC :
A chemical that is applied to living tissue, such as mucous membrane or skin
to reduce the number of organisms present, through inhibition of their
activity or destruction.
DISINFTECTANTS :
A chemical used on non-vital objects to kill surface vegetative pathogenic
organisms but not necessarily spore forms/ viruses.

12. • Spaulding’s classification provides a simplified outline of the
recommended processing methods for items of patient care
equipment, based on the intended use of the item.
• Depending on the intended use of an item, medical and surgical equipment
may be required to undergo the following processes between uses on
different patients:
1.
cleaning, followed by sterilization
2.
cleaning, followed by high, or intermediate level disinfection
3.
cleaning alone

13. Disinfection & sterilization : infection control guidelines

14. • All the materials used as a part of sterile field for an
operation, must be sterile.
• Basic items – linen, instrument set, basin
• Instrument sterilization :
 1 night before
 just before operation
• Once the instrument is removed from sterile wrapper :
use / discard

15. 1.
Linen colour :
Dyed green (reduces glare from light & fatigue and eye
strain).
2.
Use sterile materials only & maintain the sterility
throughout the procedure.
3.
Sterile area are setup just prior to use.
4.
If in doubt : consider the material as unsterile.
5.
Only the top surface of draped table is considered sterile.

16. 6.
Neither the circulator nor the scrub should intrude up on the other’s area at
any time.
• sterile person should touch the sterile materials & unsterile person should touch
the unsterile materials.
• circulator (unsterile person) supplies for the sterile team members.
7.
The scrub should be considered as sterile person.
• gown
• glove
• drapes the table 1st nearest to them
• hand positioning

17. 8.
Sterile team members should keep their contact even with sterile area to a
minimum.
9.
Sterile team members should be within the sterile area & scrub nurse
should allow a wide margin of safety when passing through unsterile area.
Rules :
• Sterile team members should be stand back at a safe
distance from operating table , while draping.
• Pass back to back.
• Unsterile person/ area should be passed by back of
sterile person.
• Face a sterile person/area when passing.
• Stay near the sterile table.
• Used items / soiled sponges are placed into the
basin.
outside of basin : sterilized;
inside of basin : contaminated

18. 9.
Circulator :
•
Unsterile team member
•
Should provide wide margin of safety while passing
•
Away from sterile area
•
Face the sterile area while Passing, but should not touch
•
Should not go within the sterile circle
•
Notify the scrub person while passing behind him
•
Stands at a safe distance while adjusting the light
•
Grasp the table legs well below the table top to move the sterile table

19. 10. Covered sterile materials
•
Edge of cover that encloses the sterile content : sterile.
•
Circulator should lift the cap of solution containing bottles & the caps are
not replaced.
11. Sterile materials / area should be protected form moisture : contaminated
- sterile packages should be laid down in dry area.
- linen package remove from autoclave : wait to become cool & dry
- allow the paint to become dry before draping
- during procedure, any wet area should be covered with dry drape

20. 12. Micro-organisms can not be removed completely, so they should be keep
as minimum as possible
- skin can not be sterilized (staphylococcus)
- skin shaving
- head cap & mask
- hands & arms should be properly scrubbed
- dry the hands with sterile towel
- as much of the operative area is cleansed as feasible
- some area can not be rubbed vigorously
- a sponge is used once only
- sterile area should be separated from other by draping
- after incision of skin, the blade / knife should be isolated from other items

21. 13. Respiratory tract of patient is another source of infection.
14. Team members should not talk except when essential.
15. Bed clothes : should be removed or replaced prior to entry into OT, never
the less the patient should be covered with a coversheet at all times.
16. The doors from corridors into operating room should keep close.
17. Dressing removed from a wound should be placed at once in a bag &
should be discarded.
18. Drain should not be kept open.

22. Good Hand Washing Practices Save many Lives
1. Alcohol with Chlorhexidine.
2.Alchool without Chlorhexidine.
3. Chlorhexidine 2 %
4. Chlorhexidine 4 %
5. Povidone with Iodine 7.5 % - 10%
6. Triclosan 1 %
7. Phenolics
8. quarternary ammonium compound
9. 3 % hexachlorophane
Areas of the harboring dirt and
microorganisms

23. • The scrub area sink should be wide enough to facilitate
easy scrubbing without touching anywhere.
• It should have depth of about 3 feet which prevents
Incorrect
splashing of rebound water onto the clean hands.
• The scrub sinks are fitted with doctors’ taps, rather than
ordinary taps, to facilitate its operation with the help of
arms to prevent contamination of scrubbed hands during
closing the tap.
• The peddle operated taps are ideal in scrub areas as it
permits hand free operations. The cleaned hands are
mopped with sterile towel and disinfected with antiseptic
solution.
Correct
Design of the
washing sink

25. Linen gown
made up of cotton having a
thread count of 240 sq inch
for the reusable stuff .
Paper gown
Plastic gown

27. • The floors and walls should be absolutely smooth and easily cleanable and
should have minimum and neatly made or no joints.
• Flooring should be non porous, scratch proof, anti skid and antistatic
(epoxy resin flooring) .
• The walls should also be covered with smooth material like granite with
minimum joints.
• The ceilings should be painted with oil paints which give smooth finish.
• All the electrical fittings and water pipe lines in the OR must be concealed.
• The OR complex should have only one entry and all the windows should
be air tight in restricted and semi-restricted area.

28. • Avoid contamination of wound.
• Although Unpreventable.
• Chances of cross infection.
• Contamination of surgical wound is mostly from – skin / mucous
membrane being incised.
• Other sources : nose, throat, hand, skin of operating team members.
• Air contamination : omnipresent problem.
• All logical precaution & preparations should be done.

29. Stress must be laid on
1. Temperature
2. Humidity
3. Ventilation
Temperature : 24-270 C
Relative Humidity : 450 – 600 C for adult
550 – 650 C for infants

30. • 1 change / hr : contamination reduced by 60%
• 2 change / hr : contamination reduced by 86%
• 10 change / hr : contamination reduced by 99%
Turbulant / mixing air disritribution
Downword displacement piston system
Unidirectional airflow system / lamellar flow ventilation

31. Zoning :
To ensure the aseptic condition the operating dept is divide into 4 zone :
1. Protective zone
2. Clean zone
3. Sterile zone
4. Disposal zone

32. Advantages of zoning
1. Minimizes risk of hospital infection.
2. Minimizes unproductive movement of staff, supplies &
patient.
3. Increases efficacy of operative team members.
4. Ensures smooth workflow.
5. Deceases hazards in operating room.
6. Ensures proper positioning of equipments.

33. Protective
zone
Clean zone
1. Pre-operating
Sterile zone
Disposal zone
1. Operating room
1. Dirty wash room
2. Scrub room
2. Disposal corridor
1.
Reception
2.
Waiting room
3.
Changing room
2. Recovery room
3. Anesthesia room
4.
Autoclave
3. Theatre work
4. Instrument
5.
Trolley bay
6.
Control area of
4. Plaster room
electricity
5. Blood storage &
room
room
frozen section
room
6. Doctor’s work
room
7. Anesthesia store
sterilization
5. Trolley area

34. Equipment planning
1.
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12.
Operating table & transfer trolley system
Operating light system
Fixed services system (medical gases, vacuum, surgical diathermy, cold light)
Anesthesia equipment
Patient monitoring & resuscitation equipment
Operating radiography system
Operating microscopic equipment
Extracorporeal circulation system
Patient heating & cooling equipment
Laboratory support equipment
Bedpan washer / disinfector
Furniture & fixtures

35. Equipments for oral & maxillofacial surgery
1.
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Operating table & transfer trolley system
Operating light system
Suction apparatus
Radiograph viewing box
Dental motor (drill)
Anesthesia equipment
Diathermy
Laser
Cryotherapy
Operating microscope (up to 40X magnification)
Instruments pertaining to surgery

36. Handling of the Sterilized Instruments

38. Need for fumigation
Surveillance studies of different zones in operation theatre showed that the
isolates were
• Staphylococcus aureus (16%)
• Coagulase negative staphylococcus aureus (26.7%)
• Acinobacter species (2.03%)
• Klebsiella (0.3%)
• E.coli, Pseudomonas species, Proteus species were also found in majority

39. Owens C.D., Stoessel K. Surgical site infections: Epidemiology, microbiology and
prevention. Journal of Hospital Infection . 2008.70;S2:3–10

40. •
Daily cleaning should be carried out after the operating sessions are over.
•
All the surfaces should be cleaned with detergent and water and may be
wiped over with a phenol if any spills with blood / body fluid are present.
•
All the walls must be wiped down to hand height everyday.
•
The floors should be scrubbed with warm water and detergent and dried. No
disinfectant is necessary.
•
The O.T. table and other non clinical equipments must be wiped to remove all
visible dirt and left to dry.
•
Weakly cleaning of all the areas inside the operating theatre complex should
be done thoroughly with warm water and detergent and dried.
•
The storage shelves must be emptied and wiped over, allowed to dry and
restacked.

41. Procedure for fumigation:
• The windows should be sealed and
formaldehyde should be generated either by
boiling a solution of formalin 40% or by
adding it to potassium permanganate, in a
metal vessel on the floor, since heat is also
generated. The door is than closed and
sealed.
• For a 10 x 10 x 10 ft room - 150 gm
potassium permanganate and 280 ml of
formalin are used

42. Duration:
• In case of any construction in O.T.
• In case of infected cases
• For routine clean cases
48 hrs
24hr
12 hrs.
• Alternatively 250 ml of formalin and 3000 ml of tap water are put into a
machine (auto mist) and time is set for 2 hrs. The mist is circulated for 2hrs
inside the closed room.
• Room is kept sealed for another 2 hrs for action of vapor. Ventilate for
suitable time for vapor to dissipate. Room then can be used.
• Three swabs are taken from walls, all equipments, floor or O.T. table at
intervals.
• 1st swab - 48 hrs after fumigation
• 2nd swab- 24 hrs after 1st swab
• 3rd swab - 12 hrs after 2nd swab

43. • All three consecutive swabs should come negative.
• In some centers, Bacillocid is being used for fumigation. It is
combination of chemically bound formaldehyde and
glutaraldehyde.
• Ideally all O.T. rooms should be fumigated once a week

44. Fumigation to be neutralized
• Neutralize Residual
formalin gas with Ammonia
by exposing 250 ml of
Ammonia per liter of
Formaldehyde used.
• Place the ammonia solution
in the centre of the room
and leave it for 3 hours to
neutralize the formalin
vapour

45. An example is set as..
• Operation Theatre Volume = L×B×H = 20 × 15 × 10 = 3000 cubic feet
• Formaldehyde required for fumigation = 500 ml for 1000 cubic feet
= So 1500 ml of formaldehyde required
• Ammonia required for neutralization = 150ml of 10% ammonia for 500 ml
of formaldehyde
= So 450 ml of 10% ammonia require

46. • NPO for 6 hrs : food
• NPO for 3 hrs : clear fluid
Avoid excessive starvation
• Shaving
• Lipstick, nail varnish & other cosmetics should be removed
• Patient should not be shifted in operating room with full bladder

47. • Hospitalization 2 – 3 days prior to surgery
• A good bath to clean all the dirt from the body
• Outside clothing should be discarded and the patient should be provided
clean hospital clothing
Preparation of Part:
• The part to be operated should be washed thoroughly with soap and water.
• The hair should be removed by shaving at least 12 hours prior to the
surgery .
• The clean and shaved part is vigorously scrubbed with antiseptic solution
like savlon, chlorhexidine or povidon iodine and mopped with sterile
gauge.
• The cleaned part is painted with solution like mercury chrome or 2% picric
acid, covered with sterile pad and sealed with adhesive taps.

48. • The oral cavity should be thoroughly inspected for any septic foci;
calculus, tarter, infected carious teeth, infected periodontal pockets etc. and
they should be treated/ removed.
• Antiseptic mouth washes should be prescribed (Chlorhexidine, Povidon
iodine etc.) for periodic mouth rinsing to reduce the count of
microorganism.
• Loose teeth should be extracted as they may come in the way of intubations
of patient and may get knocked out and aspirated during the intubation.

49. SURGICAL TEAM
•
Chief surgeon, who directs the surgery
•
One or more assistant surgeons, who help
the chief surgeon
•
Anesthesiologist, who controls the supply of
anesthetic and monitors the person closely
•
Scrub nurse, who passes instruments to the
surgeon
•
Circulating nurse, who provides extra
equipment to the operating team

50. Assisting the surgeon – Floor nurse
• Receive the patient from the ward, from the staff nurse. Details obtained
are Particulars of the patient
Elective/Emergency
Diagnosis
Procedure planned
Consent obtained
Pre-medications administered
Whether pre-operative instructions have been followed and patient is prepared
Confirm removal of jewellery/ornaments
Patency of IV Canula
Patient records – files, X-rays, investigation reports.
OT dress has been changed
http://www.grh.gov.mv/images/OPERATION%20THEATRE%20ASSISTING%20DU
RING%20OPERATIONS.pdf

51. - Make patient wear the OT cap.
- Transfer the patient form the wheel chair/trolley to the operation table .
- After anesthesia induction, clear the operative site .
-
Remove the patient’s gown and keep it in the un-sterile zone.
- Scrub nurse, scrubs, gowns and opens the set .
- Scrub nurse arranges the set and checks instrument.
- Back out form the Sterile zone and circulate in semi-sterile zone .
http://www.grh.gov.mv/images/OPERATION%20THEATRE%20ASSISTING%20DU
RING%20OPERATIONS.pdf

52. - Handing over of linen/instruments to the operating staff.
- Being prepared to scrub if needed .
- On the completion of operation, counting the
instruments, sponges, needles .
- Assist to shift the patient from the operating table to the trolley.
- Shifting the trolley to the operating theatre door.
http://www.grh.gov.mv/images/OPERATION%20THEATRE%20ASSISTING%20DU
RING%20OPERATIONS.pdf

53. Assisting the surgeon - Scrub Nurse
- Bringing the instruments trolley and paint the trolley with betadine
- Remove the drape/rubber sheet from the container and spread it on the
trolley (instrument/linen), using cheattle forceps
- Transfer the linens from the bin to the trolley
- Arrange to instruments in a designated fashion in the trolley and count them
- Drape the two trolleys with small drapes
- Pass the gown, gloves to the surgeon.
http://www.grh.gov.mv/images/OPERATION%20THEATRE%20ASSISTING%20DU
RING%20OPERATIONS.pdf

54. - Handover the paint and drapes to the surgeon
- Coordinate with the floor nurse for passing consumables
- Connect various tubes and wires as required
- Pass the instruments to the surgeon as required
- Instrument count at the end of the procedure
- Cleaning the stains from the operation site
- Assist in Surgical site dressing
- Re-gowning the patient
- De-scrubbing
http://www.grh.gov.mv/images/OPERATION%20THEATRE%20ASSISTING%20DU
RING%20OPERATIONS.pdf

55. PURPOSE:
• To reduce the resident and transient microbial counts at the
surgical site immediately prior to making the surgical incision.
• To minimize rebound microbial growth during the
intraoperative and postoperative period.
• To reduce the risk of post surgical site infection.
• To prevent injury to the patient during surgical skin
preparation.

56. Hair removal
• 1 night before or just prior to skin preparation
• Close shave is not necessary
•
Stroke against the direction that the hair is growing using
short strokes. Short hair stubble will still be evident after
clipping.

57. Management of hair
• Hair removal may or may not occur;
• Long hair may be parted along the incision line and hair secured away from
the incision with elastic bands; or short hair may have a thin strip of hair
clipped along the incision line.

58. 1.
4% Chlorhexidine Gluconate (Betasept, Hibiclens, Dyna-Hex4)
2.
Hexachlorophene 3% (Phisohex)
3.
Iodine Scrub/Soap 7.5% (Wet skin with water, apply enough iodine
scrub to create lather and scrub for 5 minutes. Blot or rinse off using
sterile towel or gauze).
4.
Iodine Paint 10% (Paint area to be prepped with solution and allow to
dry prior to starting procedure).
5.
Duraprep/Chloroprep
6.
Betadine Gel
"Recommended Practices for Skin Preparation of Patients", AORN Standards and
Recommended Practices for Perioperative Nursing, 2002 (Denver, Assoc. of Operating
Room Nursing, Inc., 2002) Meeker Ruth, M., Rothrock, J.C. Alexander's Care of the Patient
in Surgery, II tll edition, (St. Louis: Mosby Year Book, 1999)

59. 5 min.
1.
Extraoral scrub procedure (circumoral preparation
should be done prior to intraoral procedure) .
2.
Scrub should begin in the center of the area to be
prepared & then move outwards concentrically is
possibly (minimizes the contamination from
unscrubbed area).
3.
Once central part is prepared, then it should not be
touched again with same sponge.
4.
Start in middle & extend towards periphery.
Best Practice Guidelines, Surgical
Skin Preparation

60. Purpose
I.
II.
•
•
•
Isolate the surgical area from other parts of body that have not been
prepared for surgery.
Isolate from nonsterile operating room equipments & personnel.
A double layer drape is effective.
2,3,4, drapes can be placed over the endotracheal tube.
For isolation of mouth : clear plastic drape with an adhesive side
(vidrape)

61. Patient’s head is
placed on sterile
sheets covered by 2
towels. Towels are
used to drape
patient’s head.
Additional towels
may then be added to
isolate surgical area.

62. Clear drape is placed with
adhesive surface contacting
skin just below the
mouth, which effectively
isolates it from surgical site.
Moth or nasal area may be
entered by pulling drape
toward & then reisolated by
returning drape to its original
position.

63. 2 towels with edges
folded to outside are
then joined together
with towel clips &
then unfolded to
create opening
through which
operate can enter
into oral cavity.

64. • Confirm the completion of all the surgical plan.
• Report the anesthetist regarding completion of procedure.
• Check for satisfactory wound closure & cessation of
hemorrhage.
•
-
Mouth should be checked for –
Clot
Debris
Swabs
Extracted teeth
• Make a count of them.

65. • Throat pack removal.
• Write the operative notes.
• Shift the patient on a trolley equipped with oxygen cylinder &
mask, assisted by 2 persons (one should be trained nurse).

66. • Keep the patient in recovery room & in recovery position.
(under observation of anesthetist.)
• Emergency situations can be managed by surgeon/anesthetist/both.

67. • “Precautions to protect against exposure must be taken when there is
any potential for exposure to bodily fluids. It is assumed that all bodily
fluids have the potential to transmit disease”
• The Universal Precaution Rule:
Treat all human blood, bodily fluids and other potentially infectious
materials as if they are infectious.

68. Transmission of blood-borne viruses
Transmission of HBV is approximately 100 times more efficient than
transmission of HIV and approximately 10 times more efficient than HCV.

69. • In the case of HCV, patient-to-patient transmission has been associated
with endoscopic procedures.
• The risk of transmission of HIV is estimated to be approximately 0.3%
after a percutaneous needlestick injury with HIV-infected blood and 0.09%
after a mucous membrane exposure.
• Transmission of HBV in the health care setting can be prevented through
health care worker, patient and community hepatitis B vaccination
programs.

71. • Depending on the nature of the exposure, PEP is available to health care
workers to prevent infection with HIV and HBV.
• The sooner PEP is administered, the more likely it is to be effective in
preventing infection.
• Clinicians should always refer to the most recent protocols and seek
appropriate advice about administration of PEP because the area is
constantly changing.
• Blood should be taken prior to or shortly after administration of PEP to
check for prior exposure or infection.

72. HIV PEP should be
started between one and
two hours after an
exposure.
Medication
2-drug
regimen
3-drug regimen
Zidovudine (AZT)
300 mg twice a day
300 mg twice a day
Stavudine (d4T)
30 mg twice a day
30 mg twice a day
Lamivudine (3TC)
150 mg twice a day
150 mg twice a day
Protease Inhibitors
1st choice
Lopinavir/ritonavir (LPV/r)
400/100 mg twice a day or
800/200 mg once daily with meals
2nd choice
Nelfinavir (NLF)
1250 mg twice a day or
750 mg three times a day with empty stomach
3rd choice
Indinavir ()
800 mg every 8 hours and drink 8–10 glasses (1.5 litres) of water
daily

73. • If the exposed person is not immune to HBV, or is unaware of their
immune status, then HBIG should be given within 48–72 hours of
exposure.
For example
• If the exposed person is not immune to HBV, or is of unknown immune
status, HBIG should be administered within 72 hours of exposure
• If the exposed person is a non-responder to the HBV vaccine, HBIG should
be given within 72 hours
• There is currently no PEP available to prevent HCV infection. In 1994, the
Advisory Committee on Immunization Practices (ACIP) reviewed available
data regarding the prevention of HCV infection with IG and concluded that
using IG as PEP for hepatitis C was not supported.
Alter MJ. Occupational exposure to hepatitis C virus: a dilemma. Infect Control Hosp Epidemiol
1994;15:742--4

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2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Chandrakant P.Taware. Oral and Maxillofacial Surgery: Hospital Management Protocol. 2009. Ed. 1.
U. J. Moore. Principles of Oral and Maxillofacial Surgery. 2011. ed. 6.
Chris H. Miller , Charles John Palenik. 2010. ed. 4.
Maxine A. Goldman. Pocket Guide to theOperating Room . 2008. Ed. 3.
Sapna, Majumdar S., Venkatesh P. The Operation Theatre : Basic Architecture . Delhi Journal of
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Berkelman R L, Holland B W, Anderson R L . J. Clin. Microbiol. 1982, 15(4):635.
Owens C.D., Stoessel K. Surgical site infections: epidemiology, microbiology and prevention. Journal of
Hospital Infection (2008) 70(S2) 3–10.
Best Practice Protocols Clinical Procedures Safety. WHO/EHT/CPR 2004 reformatted. 2007 WHO
Surgical Care at the District Hospital 2003.
Mangram AJ, Horan TC, Pearson ML. Guideline for Prevention of Surgical Site Infection. Guideline for
Prevention of Surgical Site Infection, 1999. Instrument Processing, Work Flow and Sterility Assurance. A
Peer-Reviewed Publication by Eve Cuny, MS and Fiona M. Collins. www.ineedce.com.
GAYATHRI M., KAARTHIC S., KALAISELVAM S. Operation Theatre Sterilization And Efficacy
Comparison Of Superoxidized Water With Various Disinfectants.PROJECT REPORT.
The Prevention of Transmission of Blood-Borne Diseases in the Health-Care Setting. 2005. I SBN 07557-1735-X.
Alter MJ. Occupational exposure to hepatitis C virus: a dilemma. Infect Control Hosp Epidemiol
1994;15:742—4.
Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to
HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. Recommendations and
Reports. June 29, 2001 / 50(RR11);1-42