Needlestick Safety and Prevention Act
Directed OSHA to revise BBP standard
• Effective 4/18/01
– Compliance directive 11/27/01
• Requires use of engineering and work
practice controls
– Sharps safety devices included as engineering controls
– Alternatives to needles are preferable
• Document implementation in written plan
– Review at least annually
• Maintain detailed sharps injury log
– Include device type & brand
• Involve frontline workers
Bloodborne Pathogens
Exposure Control Plan
• Statement of employer
• Implementation
policy
– HB surveillance (optional)
• Designation of responsible
– Post-exposure evaluation
employees
and follow-up
– Housekeeping
• Determination of employee
– Labeling
exposures
• Mandated use of needles
• Implementation
and other sharps with
– Standard (universal)
integrated safety features
precautions
– Engineering controls
• Safety Device Evaluation
– Work practices controls
Committee
– Personal protective
• Documentation of waivers
equipment
• Recordkeeping and
– Training
reporting
– Hepatitis B immunizations
HBV Preexposure Prophylaxis
• Recombinant DNA vaccine available
since 1986
– From yeast cells
– Subunit HBsAg
• 1.0 ml IM given at 0, 1 and 6 months
– Accelerated 0, 1, 2 and 12 months
• For HCWs, document immunity antiHBS 2-6 months post-vaccination
• 6 doses maximum
• Once immune, no boosters
Recordkeeping Rule
• Effective 1/1/02
• New OSHA forms 300 log, 300A summary
and 301 incident report
• Expanded general recordkeeping
requirements
• May use new log for recording
contaminated sharps injuries if
– Record all data required, including brand
– Able to segregate sharps info from log for
privacy concerns
Joint Commission on Accreditation
of Healthcare Organizations
Preventing Needlestick and Sharps Injuries Sentinel Event Alert, Issue 22, August 2001
• Cites and reviews NIOSH Alert and the
Needlestick Safety and Prevention Act.
• “In April 2002, JCAHO will begin assessing
organizational compliance with the new
provisions of the Needlestick Safety and
Prevention Act.”
“The prevention of occupational diseases is
primarily the function of the industrial
management, secondarily, the function of the
plant physician. In an ideal industrial
establishment the two work together; the physician is
conversant with all the processes of manufacture and
is therefore able to link up the disturbances of health
he observes among the workers with the processes in
which they are engaged. He cooperates with
management in the effort to introduce safeguards ....
He is, however, in a subordinate position and
therefore the prime responsibility in the prevention of
occupational disease lies with the management, which
has the last word in regard to methods of work,
substances used, and equipment for the prevention of
disease.”
Alice Hamilton, MD & Harriet L. Hardy, MD
Prevention of Work-related BBP Infection
1. Prevent marshaling of agent
2. Reduce amount of agent
3. Prevent inappropriate release
of agent
4. Modify release of agent
5. Separate host from agent by
time or space
6. Separate host from agent by
physical barriers
7. Modify surfaces and basic
structures
8. Increase host resistance to
injury
9. Improve emergency
responses
10.Improve medical care and
rehabilitation
Haddon, 1970
1. Blood tests only as needed
2. Smaller amounts of blood
needed
3. Safety needle devices
4. Blood collection devices
5. Blood collection devices
6. Sharps containers, goggles
7. Blunt needles
8. Immunization
9. Post exposure prophylaxis
10.Treatment of HBV, HCV and
HIV infections
Controlling Exposures
In order of preference
T
R
A
I
N
I
N
G
•
•
•
•
•
Substitution
Isolation or enclosure
Ventilation (general/dilution & local exhaust)
Work and hygiene practices
Personal protective equipment
(last line of defense)
Types of Safety Features
Chiarello, 1995
Design Features
of a Safer Needle Device
• Barrier between hands and needle after
use
• Allow or require worker’s hands to
remain behind needle at all times
• Integral part of device and not accessory
• Be in effect before disassembly and
remain in effect after disposal
• Be simple, self-evident to operate and
require little or no training
FDA, 1992, 1995
Click for larger picture
MMWR 1/17/97
Recommended Personal Protective Equipment
Task or Activity
Gloves Gown Mask
Bleeding control with spurting blood
Emergency childbirth
Endotracheal intubation, esophageal
obturator use
Oral/nasal suctioning, manually
cleaning airway
Handling and cleaning instruments
with microbial contamination
Bleeding control with minimal blood
Starting an intravenous line
Blood drawing
Measuring blood pressure
Measuring temperature
Giving an injection
CDC 1989
Eyewear
Y
Y
Y
Y
Y
N
Y
M1
M1
Y
M1
M1
Y
N
M1
M1
Y
M2
N
N
Y
Y
M3
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
Y=Yes, N=No, M1=Yes if splashing likely,
M2=Yes if soiling likely, M3=At certain times
Management of Occupational
Blood Exposures
• Provide immediate care to the exposure site
– Wash wounds and skin with soap and water.
– Flush mucous membranes with water.
• Determine risk associated with exposure by
– Type of fluid (e.g., blood, visibly bloody fluid,
other potentially infectious fluid or tissue, and
concentrated virus) and
– Type of exposure (i.e., percutaneous injury,
mucous membrane or nonintact skin exposure,
and bites resulting in blood exposure).
Management of Occupational
Blood Exposures
• Evaluate exposure source
– Assess risk of infection using available
information.
– Test known sources for HBsAg, anti-HCV, and HIV
antibody (consider using rapid testing).
– For unknown sources, assess risk of exposure to
HBV, HCV, or HIV infection.
– Do not test discarded needles or syringes for
virus contamination.
Management of Occupational
Blood Exposures
• Evaluate the exposed person
– HBV immune status
– Tetanus prophylaxis
– Baseline lab tests for HCV, HIV, chemistry profile,
complete blood count, urinalysis, pregancy test
PRN
• Give PEP for exposures posing risk of
infection transmission
HBV Postexposure Prophylaxis
Always indicated unless
• Documented immune
• Waiver signed
Hepatitis B Virus Postexposure Prophylaxis
Vaccination and
Ab Response of
Exposed Worker
Unvaccinated
Treatment
Source HbsAg Pos
HBIG x 1 and initiate
HB vaccine series
Previously
Vacccinated
Source HBsAg Neg
Initiate HB vaccine
series
Source Unk or NA
Initiate HB vaccine
series
Click for larger picture
Known
responder
No treatment
No treatment
No treatment
Known
nonresponder
HBIG x 1 and initiate
revac or HBIG x 2
No treatment
Ab response
unknown
Test exposed person
No treatment
for anti-HBs
 If adeq, no Rx
 If inadeq, HBIG x 1
and vaccine booster
If known high risk
source, treat as if
source were HBsAg
pos
Test exposed person
for anti-HBs
 If adeq, no Rx
 If inadeq, vaccine
booster and titer in
1-2 mos
HCV Postexposure Prophylaxis
HIV Postexposure Prophylaxis
Depends on
• Type of exposure
• Severity
• Volume
• Source HIV status
Prophylactic treatment
• May not be
warranted
• Basic regimen
• Expanded regimen
HIV Infection Status
HIV-Positive Class 1
• Asymptomatic
• Known low viral
titer, <1500 RNA
copies/ml
HIV-Positive Class 2
• Symptomatic
• AIDS
• Acute
seroconversion
• Known high viral
load
Selected HIV PEP Regimens
BASIC REGIMEN
 Zidovudine (Retrovir™; ZDV; AZT) +
Lamivudine (Epivir™; 3TC); available as
COMBIVIR™
 ZDV: 600 mg per day, in 2 or 3 divided doses
 3TC: 150 mg twice daily
EXPANDED REGIMEN
Basic regimen plus
 Indinavir (Crixivan™; IDV)
 800 mg every 8 hours, on an empty stomach
Recommended HIV Postexposure
Prophylaxis for Percutaneous Injuries
Infection Status of Source
HIVExposure Positive
Type
Class 1
Less
RecomSevere
mend
basic 2drug PEP
More
Severe
Recommend
expanded
3-drug
PEP
HIVPositive
Class 2
Recommend
expanded
3-drug
PEP
Source of
HIVUnknown
Negative HIV Status
No PEP
Generally,
warranted no PEP
warranted,
consider
basic 2drug PEP
for source
with HIV
risk factors
Unknown Source
Generally, no
PEP warranted,
consider basic 2drug PEP in
setttings where
exposure to HIVinfected persons
is likely
CDC. MMWR 2001.
Recommended HIV Postexposure
Prophylaxis for Mucous Membrane
and Non-intact Skin Exposures
Infection Status of Source
HIVExposure Positive
Type
Class 1
Small
Consider
Volume
basic 2drug PEP
Large
Volume
HIVPositive
Class 2
Recommend
basic 2drug PEP
Source of
HIVUnknown
Negative HIV Status Unknown Source
No PEP
Generally, Generally, no
warranted no PEP
PEP warranted,
warranted, consider basic 2consider
drug PEP in
basic 2setttings where
drug PEP exposure to HIVRecomRecomfor source infected persons
mend
mend
with HIV
is likely
basic 2expanded
risk factors
drug PEP 3-drug
PEP
CDC. MMWR 2001.
Reported Failure of Combination Drug
PEP to Prevent HIV Infection in HCWs
Exposed to HIV-Infected Blood
Source
of Injury
Biopsy
needle
Hollow
needle
Large
bore
hollow
needle
Hollow
needle
Unknown
sharp
Rx
Hours to Days to Days to Source
st
1 Dose Illness Seroconv Pt on Rx
ZDV,ddI
.5
23
23
Yes
ZDV,ddI
1.5
45
97
No
ZDV/d4T,
3TC,IDV
1.5
40
55
Yes
(sens)
ZDV,3TC,
ddI,IDV
ddI,d4T,
NVP
0.67
70
83
Yes (res)
2.0
42
100
Yes (res)
Management of Occupational
Blood Exposures
• Initiate HIV PEP as soon as possible,
preferably within 2 hours of exposure
• Offer pregnancy testing to all women of
childbearing age not known to be pregnant
• Seek expert consultation if viral resistance
suspected
• HIV PEP for 4 weeks if tolerated
Management of Occupational
Blood Exposures
• Provide counseling
– Emotional effects
– Risks of transmission
– Medications, including adherence
– Advise exposed persons to seek medical
evaluation for any acute illness occurring during
follow-up
• Perform follow-up testing
– Monitor for adverse effects
– Seroconversion
Sample Protocol for Follow-up
if on HIV PEP Medications
Follow-up
Time
Tests
Baseline
Chem, incl amylase, CBC, U/A, HIV, HCV,
HBV panel (PRN), RPR, pregnancy (PRN)
2 & 4 weeks
Chem, incl amylase, CBC, U/A
6-8 weeks
Chem, incl amylase, CBC, U/A, HIV, HCV,
anti-HBs (PRN), RPR
3 months
PRN: HIV, HCV, Anti-HBs, RPR
6 & 12 months HIV, HCV, anti-HBs (PRN), RPR
Primary Side Effects of
Antiretroviral Agents
Antiretroviral
Agent
Primary Side Effects
and Toxicities
Zidovudine
Anemia, neutropenia, nausea,
headache, insominia, myalgia,
weakness
Lamivudine
Abdominal pain, nausea, diarrhea,
rash, pancreatitis
Indinavir
Nausea, abdominal pain,
nephrolithiasis, indirect
hyperbilirubinemia
Compliance with HIV PEP
43%
44%
9% 4%
Completed as
prescribed
Completed with
modified dose
Discontinued at
least 1 drug
Discontinued all
drugs
N=449 subjects with follow-up at 4-6 weeks
HIV PEP Registry, 3/31/99
Reasons HIV PEP Discontinued
No.
Symptoms
99
Lab test results
4
Source HIV negative
95
Subject choice
62
Health care provider judgement 25
Other
9
%
50
2
48
31
13
5
N=197
HIV PEP Registry, 3/31/99
Management of Occupational
Blood & Body Fluids Exposures
Summary
• Provide immediate care to the exposure site.
• Determine risk associated with exposure.
• Evaluate the exposed person.
• Give PEP for exposures posing risk of
infection transmission.
• Provide counseling.
• Perform follow-up testing.
Natl Clinician’s
PEP Hotline
(PEPLine)
Needlestick!
(UCLA)
Hepatitis Hotline
Resources
UCSF
888.448.4911
ucsf.edu/hivcntr
UCLA
needlestick.mednet.ucla.edu
CDC
888.443.7232
cdc.gov/hepatitis
HIV Antiretroviral
Consortium 800.258.4263
Pregnancy Registry
glaxowelcom.com/
preg_reg/antiretroviral
MedWatch
FDA
800-332-1088
fda.gov/medwatch
HIV/AIDS TreatConsortium hivatis.org
ment Info Service
International Health UVa
med.virginia.edu/~epinet
Care Worker Safety
Center