Professional Documents
Culture Documents
Widmer AF 1
Ten Great Public Health Achievements --
United States, 1900-1999
Vaccination
Motor-vehicle safety
Safer workplaces
Control of infectious diseases
Decline in deaths from coronary heart disease and stroke
Safer and healthier foods
Healthier mothers and babies
Family planning
Fluoridation of drinking water
Recognition of tobacco use as a health hazard
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4829a1.htm
Widmer AF 2
Globally important
Infectious diseases
Frequently without
Effective or no treatment
Options
ISOLATION ONLY
www.prweb.com/releases/2005/3/prweb220610.htm
1983 CDC Guideline for Isolation - Provided two systems for isolation: category-specific and
Garner JS, Precautions in Hospitals diseases-pecific
Simmons BP.
HHS - Protective Isolation eliminated; Blood Precautions expanded
publication no. to include Body Fluids
(CDC) 83-8314.
Infect Control
- Categories included Strict, Contact, Respiratory, AFB,
1983;4:245- Enteric, Drainage/Secretion, Blood and Body Fluids
325. - Emphasized decision-making by users
CDC_08
Widmer AF 3
HISTORY OF GUIDELINES FOR ISOLATION
PRECAUTIONS IN HOSPITALS*
Year (Ref.) Document issued Comment
1985-88 Universal - Developed in response to HIV/AIDS epidemic
MMWR Morb Precautions - Dictated application of Blood and Body Fluid precautions to all
Mortal Wkly
Rep 1988; patients, regardless of infection status
37(24):377-82, - Did not apply to feces, nasal secretions, sputum, sweat,
87-8.
Neal JG et al.
tears, urine, or vomitus unless contaminated by visible blood
J Long Term - Added personal protective equipment to protect HCWs from
Eff Med mucous membrane exposures
Implants
1998;8 - Handwashing recommended immediately after glove removal
(3-4):233-40. - Added specific recommendations for handling needles and
other sharp devices; concept became integral to OSHA’s
1991 rule on occupational exposure to blood-borne
pathogens in healthcare settings
1987 Body Substance - Emphasized avoiding contact with all moist and potentially
Lynch P et al. Isolation infectious body substances except sweat even if blood not
Ann Intern
Med 1987; present
107(2):243-6. - Shared some features with Universal Precautions
- Weak on infections transmitted by large droplets or by
contact with dry surfaces
- Did not emphasize need for special ventilation to contain
airborne infections
- Handwashing after glove removal not specified in the
absence of visible soiling
CDC_08
CDC_08
Widmer AF 4
Type of precautions Protection of
HCW Patients
• Standard +++ +++
• Contact + +++
• Droplet +++ +
• Airborne +++ ++
Droplets eg Influenza
Nutrition eg Campylobacter
Widmer AF 5
The Aerobiologic Pathway for the Transmission
of Communicable Respiratory Disease.
Droplets
1m 3m
Widmer AF 6
Tröpfchen (1m)CDC
- 2007 2008 -
1m (3 feet) 3m
2014 1m?
30%
19%
14%
Widmer AF 7
Spatial distribution of the average aerosol
concentrations of Influenza virus, measured over 20
minutes, in patient rooms.
«superspreader»
Widmer AF 8
Respiratory syncytial Virus (RSV)
transmission by aerosol, contact and environment
Widmer AF 9
HICPAC 2007 Guideline for Isolation
Precautions in Healthcare Settings
Two-tier approach:
1. “Standard precautions to reduce to risk of
transmission of bloodborne pathogens ...and from
contact with moist body substances. Designed for the
care of all patients …”
Standard Precautions
Principles
Masks
Gowns
Gloves
Special Situations
• Respiratory Etiquette
Widmer AF 10
Masks to Prevent Droplet/Airborne
Transmission
Wear a facemask:
When there is potential contact with respiratory
secretions and sprays of blood or body fluids (as defined
in Standard Precautions and/or Droplet Precautions)
• May be used in combination with goggles or face shield to
protect the mouth, nose and eyes
Widmer AF 11
Masks
Europe vs US
Surgical Mask
Respirators
Widmer AF 12
Surgical Masks - Premarket
Notification [510(k)] Submissions
8. Filtration Efficiency
For surgical masks that are not NIOSH certified N95 Respirators, we recommend that you evaluate filter
efficiency performance and bacterial filtration efficiency. For surgical masks that are NIOSH certified N95
Respirators, you may submit your NIOSH certification number in lieu of this information.
Particulate Filtration Efficiency
We recommend that you conduct a particle challenge study using 0.1-Micron Polystyrene Latex Spheres.
This in vitro test challenges the mask with unneutralized 0.1-micron polystyrene latex spheres and
measures penetration. The use of latex spheres provides an appropriately rigorous test for evaluating a
submicron efficiency performance (ASTM F 1215-89 Standard Test Method for Determining the Initial
Efficiency of Flatsheet Filter Medium in an Airflow Using Latex Spheres.).
Bacterial Filtration Efficiency
Bacterial Filtration Efficiency (BFE) is a measure of the ability of the mask’s material to prevent the
passage of aerosolized bacteria. BFE is expressed in the percentage of a known quantity that does not
pass the mask material at a given aerosol flow rate. We recommend that you evaluate the BFE of your
device using one of the test methods or standards listed below.
Bacterial Penetration (aerosol filtration) - Mil- M369454C, Military Specifications: Surgical Mask, disposable
(June 12, 1975).
Modified Greene and Vesley Method: Method for evaluation of bacterial filtration efficiency of surgical
masks. J Bacteriol 83:663-667. (1962)..
ASTM F2101-01 Standard Test Method for Evaluating the Bacterial Filtration
Efficiency (BFE) of surgical masks using a Biological Aerosol of S. aureus
Fluid Resistance
Surgical Masks FDA Requirement
• ASTM F 1862: Standard Test Method for Resistance
of Surgical Mask to Penetration by Synthetic Blood
Widmer AF 13
FDA Bacterial Filtration Efficiency
Surgical Masks FDA Requirement
• • ASTM F2101-01 Standard Test Method for Evaluating the Bacterial Filtration
Efficiency (BFE) of surgical masks using a Biological Aerosol of Staphylococcus
aureus.
Masks in the US
Healthcare facilities may find that different types of masks are needed to
meet individual healthcare personnel needs.
Widmer AF 14
The Surgical Mask EN 14683 Typ II
MASK BFE Delta-P Splash-
Resistant (R)
1810 F ≥ 98% < 29,4 Pa No
1810 G ≥ 98% < 29,4 Pa No
1816 / 1826 ≥ 99% < 24,5 Pa No
1818 / 1818FS ≥ 98% = 19,6 Pa No
1819 ≥ 99,3 ≤ 17,6 Pa Yes
1838 ≥ 98% = 19,6 Pa No
Delta-P determines the resistance of the surgical facemask to air flowing
through the mask. Pressure drop also relates to the breathability and comfort of
the surgical mask.
In general, a lower Delta-P translates to increased breathability.
Widmer AF 15
Protective measures reported by
infected vs non-infected staff
NC=not calculatable. *Two-tailed. †Odds ratio of staff with specific protection not getting infected. ‡”Yes” and “most of the time” were grouped
together. §Total cases 254 by forward stepwise (Waldesian) logistic regression using 0·05 as entry probability and 0·10 as removal probability.
Forward and backward stepwise regression result in same model with mask in the model (p=0·011). ¶Comparing proportion of infected over non-
infected staff, with those without mask (11 infected and 72 non-infected).
Widmer AF 16
Respirators
CDC Recommendation 2011: Personal Protective Equipment
http://www.cdc.gov/HAI/settings/outpatient/basic-infection-control-prevention-plan-2011/standard-precautions.html
Widmer AF 17
What is difference between
Type of mask n= Fit-test pass User seal check User seal check User seal check
rate (%) correct (%) incorrectly failed mask incorrectly passed
mask mask
Widmer AF 18
The effectiveness of training and taste
testing when using respirator masks
• FFP 1 80 % 22% 1
• FFP 2 94 % 8% 1
• FFP 3 99 % 2% 1
FFP = Filtering facepiece, NIOSH = National Institute for Occupational Safety & Health
1) Fr FFP-Masken mit NaCl-Aerosol gemäss EN 149 festgelegt
2) NIOSH-N-Masken abgeleitet aus dem von NIOSH angegebenen Assigned Protection Factor (APF) von 10.
Dieser setzt einen bestandenen qualitativen oder quantitativen Fit-Test nach OSHA voraus
Widmer AF 19
Gloves
Gloves
CDC Recommendation 2011: Personal Protective Equipment
http://www.cdc.gov/HAI/settings/outpatient/basic-infection-control-prevention-plan-2011/standard-precautions.html
Widmer AF 20
Gloves
Surgical vs Examination
Leakage Test
EN 355-1
Widmer AF 21
Air Fill check
Widmer AF 22
Isolation Gowns
Gowns
Widmer AF 23
Recognized Consensus Standards by FDA
•AAMI/ANSI PB70:2003/(R)2009
Liquid barrier performance and classification of protective apparel and drapes
intended for use in health care facilities
•ASTM F2407-06
Standard Specification for Surgical Gowns Intended for Use in Healthcare
Facilities
•ASTM F1671-07
Standard Test Method for Resistance of Materials Used in Protective Clothing to
Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage
Penetration as a Test System
•ASTM F1670-08
Standard Test Method for Resistance of Materials Used in Protective Clothing to
Penetration by Synthetic Blood
•AAMI/ANSI ST65:2008
Processing of reusable surgical textiles for use in health care facilities
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=4911
Andreas F. Widmer, MD,MS
ECCMID 2012
Widmer AF 24
Classification of Gowns / Drapes in the US
Level 1 Gowns and Drapes
Describes surgical gowns, other protective apparel, surgical drapes and drape accessories that demonstrate the ability
to resist liquid penetration in a laboratory test,
AATCC 42 (Water resistance: Impact penetration test).
Level 2 Gowns and Drapes
Describes surgical gowns, other protective apparel, surgical drapes and drape accessories that demonstrate the ability
to resist liquid penetration in two laboratory tests, AATCC 42 (Water resistance: Impact penetration test) andAATCC
127 (Water resistance: Hydrostatic pressure test).
Level 3 Gowns and Drapes
Describes surgical gowns, other protective apparel, surgical drapes and drape accessories that demonstrate the ability
to resist liquid penetration in two laboratory tests, AATCC 42 (Water resistance: Impact penetration test) and AATCC
127 (Water resistance: Hydrostatic pressure test). For Level 3, the test criterion for AATCC 127 performance is set at a
higher value than for Level 2.
Level 4 Gowns
Describes surgical gowns and protective apparel that demonstrate the
ability to resist liquid and viral penetration in a laboratory test, ASTM
F1671 (Standard test method for resistance of materials used in
protective clothing to penetration by blood-borne pathogens using
Phi-X174 bacteriophage penetration as a test system).
Level 4 Drapes
Describes surgical drapes and drape accessories that demonstrate the ability to resist liquid penetration in a laboratory
test, ASTM F1670 (Standard test method for resistance of materials used in protective clothing to penetration by
synthetic blood).
Widmer AF 25
Quality of Gowns: Test procedures
Gowns
CDC Recommendation 2011: Personal Protective Equipment
http://www.cdc.gov/HAI/settings/outpatient/basic-infection-control-prevention-plan-2011/standard-precautions.html
Widmer AF 26
Goggles, Face Shields
CDC Recommendation 2011: Personal Protective Equipment
http://www.cdc.gov/HAI/settings/outpatient/basic-infection-control-prevention-plan-2011/standard-precautions.html
Clinical approach
Widmer AF 27
Respiratory Hygiene and Cough Etiquette
http://www.cdc.gov/flu/professionals/infectioncontrol/resphygiene.htm
http://www.cdc.gov/flu/professionals/infectioncontrol/resphygiene.htm
Widmer AF 28
HICPAC Guideline for Isolation
Contact Precautions
www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf
58
Widmer AF 29
Conditions Warranting
Contact Precautions
Colonization with multi-resistant bacteria (MDROs)
Major abcess, cellulitis or bedsore
Clostridium difficile infection
Acute diarrhea in an incontinent patient
RSV infection, croup or bronchiolitis in young infants
isseminated herpes simplex skin lesions
Scabies norwegica
HightRisk of MDROs: transfer from endemic healthcare
facility
www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf
59
www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf 60
Widmer AF 30
Multiple Modes of transmission of human
respiratory viruses
Primary mode(s) of respiratory
Virus Family
transmission
Contact, possibly droplet spray and/or
Adenoviruses Adenoviridae
aerosol (limited data) [2, 3 and 4]
Contact, droplet spray and/or aerosol
Influenza viruses Orthomyxoviridae
(conflicting data) [5•, 6, 7•, 8 and 9••]
Parainfluenza
Paramyxoviridae Uncertain (limited data) [10, 11 and 12]
viruses (HPIV)
Metapneumovirus Paramyxoviridae Uncertain (limited data) [2]
Respiratory
Direct and indirect contact [7• and 13], possibly
syncytial virus Paramyxoviridae
droplet spray [14]
(RSV)
Contact, droplet spray and/or aerosol
Rhinoviruses Picornaviridae
(conflicting data) [7• and 15]
Droplet spray and aerosol [2, 4 and 16],
SARS coronavirus Coronaviridae
possibly contact [17
Pica N Current Opinion in Virology, Volume 2, Issue 1, 2012, 90 - 95
Widmer AF 31
Physical interventions to interrupt or
reduce the spread of respiratory viruses N=
1225
7 Allinterventions
1482
9 Nose wash
5 Wearing gloves
1836
Widmer AF 32
Contact Precautions: how long?
CDC_08
07_CDC_Isolation_Guidelines
Widmer AF 33
CLINICAL SYNDROMES OR CONDITIONS WARRANTING EMPIRIC
TRANSMISSION-BASED PRECAUTIONS IN ADDITION TO STAN-
DARD PRECAUTIONS PENDING CONFIRMATION OF DIAGNOSIS*
CDC_08
07_CDC_Isolation_Guidelines
CDC_08
Widmer AF 34
Not covered, but important
standard precaution
Handhygiene Technique
old 6 steps / new 3
/
http://www.who.int/patientsafety/en
Widmer AF 35
Compliance with standard
precautions in patients in Isolation
Widmer AF 36
Impact of burden of isolation on contact
isolation precautions (CIP) compliance
Widmer AF 37
CONCLUSIONS
Widmer AF 38