Needlestick Safety and Prevention ActDirected 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 PathogensExposure Control Plan

• Statement of employer policy

• Designation of responsible employees

• Determination of employee exposures

• Implementation– Standard (universal) precautions– Engineering controls– Work practices controls– Personal protective equipment– Training– Hepatitis B immunizations

• Implementation– HB surveillance (optional)– Post-exposure evaluation and

follow-up– Housekeeping– Labeling

• Mandated use of needles and other sharps with integrated safety features

• Safety Device Evaluation Committee

• Documentation of waivers• Recordkeeping and reporting

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 anti-HBS 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

Industrial Toxicology, 1949

Prevention of Work-related BBP Infection1. Prevent marshaling of agent 1. Blood tests only as needed

2. Reduce amount of agent 2. Smaller amounts of bloodneeded

3. Prevent inappropriate releaseof agent

3. Safety needle devices

4. Modify release of agent 4. Blood collection devices

5. Separate host from agent bytime or space

5. Blood collection devices

6. Separate host from agent byphysical barriers

6. Sharps containers, goggles

7. Modify surfaces and basicstructures

7. Blunt needles

8. Increase host resistance toinjury

8. Immunization

9. Improve emergencyresponses

9. Post exposure prophylaxis

10. Improve medical care andrehabilitation

10. Treatment of HBV, HCV andHIV infections

Haddon, 1970

Controlling Exposures

• Substitution• Isolation or enclosure• Ventilation (general/dilution & local exhaust)• Work and hygiene practices• Personal protective equipment

(last line of defense)

TRAINING

In order of preference

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.gif

MMWR 1/17/97

Recommended Personal Protective EquipmentTask or Activity Gloves Gown Mask EyewearBleeding control with spurting blood Y Y Y Y

Emergency childbirth Y Y M1 M1

Endotracheal intubation, esophagealobturator use

Y N M1 M1

Oral/nasal suctioning, manuallycleaning airway

Y N M1 M1

Handling and cleaning instrumentswith microbial contamination

Y M2 N N

Bleeding control with minimal blood Y N N N

Starting an intravenous line Y N N N

Blood drawing M3 N N N

Measuring blood pressure N N N N

Measuring temperature N N N N

Giving an injection N N N N

CDC 1989Y=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 ProphylaxisVaccination andAb Response ofExposed Worker Source HbsAg Pos

Treatment

Source HBsAg Neg Source Unk or NA

Unvaccinated HBIG x 1 and initiateHB vaccine series

Initiate HB vaccineseries

Initiate HB vaccineseries

PreviouslyVacccinated

Known responder

No treatment No treatment No treatment

Known nonresponder

HBIG x 1 and initiaterevac or HBIG x 2

No treatment If known high risksource, treat as ifsource were HBsAgpos

Ab response unknown

Test exposed personfor anti-HBs If adeq, no Rx If inadeq, HBIG x 1

and vaccine booster

No treatment Test exposed personfor anti-HBs If adeq, no Rx If inadeq, vaccine

booster and titer in1-2 mos

Click for larger picture

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 REGIMENBasic 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

ExposureType

HIV-PositiveClass 1

HIV-PositiveClass 2

HIV-Negative

Source ofUnknownHIV Status Unknown Source

LessSevere

Recom-mendbasic 2-drug PEP

MoreSevere

Recom-mendexpanded3-drugPEP

Recom-mendexpanded3-drugPEP

No PEPwarranted

Generally,no PEPwarranted,considerbasic 2-drug PEPfor sourcewith HIVrisk factors

Generally, noPEP warranted,consider basic 2-drug PEP insetttings whereexposure to HIV-infected personsis likely

CDC. MMWR 2001.

Recommended HIV Postexposure Prophylaxis for Mucous Membrane

and Non-intact Skin ExposuresInfection Status of Source

ExposureType

HIV-PositiveClass 1

HIV-PositiveClass 2

HIV-Negative

Source ofUnknownHIV Status Unknown Source

SmallVolume

Considerbasic 2-drug PEP

Recom-mendbasic 2-drug PEP

LargeVolume

Recom-mendbasic 2-drug PEP

Recom-mendexpanded3-drugPEP

No PEPwarranted

Generally,no PEPwarranted,considerbasic 2-drug PEPfor sourcewith HIVrisk factors

Generally, noPEP warranted,consider basic 2-drug PEP insetttings whereexposure to HIV-infected personsis likely

CDC. MMWR 2001.

Reported Failure of Combination Drug PEP to Prevent HIV Infection in HCWs

Exposed to HIV-Infected BloodSourceof Injury Rx

Hours to1st Dose

Days toIllness

Days toSeroconv

SourcePt on Rx

Biopsyneedle

ZDV,ddI .5 23 23 Yes

Hollowneedle

ZDV,ddI 1.5 45 97 No

Largeborehollowneedle

ZDV/d4T,3TC,IDV

1.5 40 55 Yes(sens)

Hollowneedle

ZDV,3TC,ddI,IDV

0.67 70 83 Yes (res)

Unknownsharp

ddI,d4T,NVP

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

AntiretroviralAgent

Primary Side Effectsand Toxicities

Zidovudine Anemia, neutropenia, nausea,headache, insominia, myalgia,weakness

Lamivudine Abdominal pain, nausea, diarrhea,rash, pancreatitis

Indinavir Nausea, abdominal pain,nephrolithiasis, indirecthyperbilirubinemia

Compliance with HIV PEP

43%44%

9% 4%

Completed asprescribed

Completed withmodified dose

Discontinued atleast 1 drug

Discontinued alldrugs

N=449 subjects with follow-up at 4-6 weeksHIV PEP Registry, 3/31/99

Reasons HIV PEP Discontinued

No. % Symptoms 99 50Lab test results 4 2Source HIV negative 95 48Subject choice 62 31Health care provider judgement 25 13Other 9 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.

ResourcesNatl Clinician’sPEP Hotline(PEPLine)

UCSF 888.448.4911ucsf.edu/hivcntr

Needlestick!(UCLA)

UCLA needlestick.mednet.ucla.edu

Hepatitis Hotline CDC 888.443.7232cdc.gov/hepatitis

HIV AntiretroviralPregnancy Registry

Consortium 800.258.4263glaxowelcom.com/preg_reg/antiretroviral

MedWatch FDA 800-332-1088fda.gov/medwatch

HIV/AIDS Treat-ment Info Service

Consortium hivatis.org

International HealthCare Worker SafetyCenter

UVa med.virginia.edu/~epinet