Post on 11-Jan-2016
description
US Policies and Legislation on Sharp Instrument Safety: Impact and Lessons
Learned
Janine Jagger, M.P.H., Ph.D.
International Healthcare Worker Safety Center
University of Virginia
European Biosafety Summit
Madrid, June 1, 2010
25 years of progress
1984 present
1985 - USAHepatitis B: 12,000 occupational cases per year – estimated 250 deaths (vaccine available 1981)
HIV: unknown number of occupational cases (CDC started surveillance 1986)
HCV: Hepatitis non-A non-B – unknown number of occupational cases – no test ,no treatment available (identification of HCV 1989)
University Hospital, 1985
Overfilled trash
Needles in IV lines
Inappropriate trash disposal
Update: human immunodeficiency virus infections in health-care workers exposed to blood of infected patients.
MMWR Morb Mortal Wkly Rep 1987; 36(19):285-289.
1987: Panic results from the CDC report:
Six healthcare workers infected with HIV
1 - Pathogen-Specific Hepatitis B vaccine
Effective therapies for HCV
HIV: PEP for HCWs and ARVs for patients
Two Types of Advances:
2 -Exposure Prevention Improved sharps disposal systems
Appropriate personal protective equipment
Safety-engineered sharp devices
universal vaccine
THE
GOOD NEWS . . .
1985 12,500 US HCWs
occupationally infected with HBV
250 deaths
2010
??
HBV
U.S. Health Care Workers with U.S. Health Care Workers with Occupationally Acquired HIV/AIDSOccupationally Acquired HIV/AIDS
80
100
120
140
160
180
200
1992 '93 '94 '95 '96 '97 '98 '99 2000 '01
# o
f c
ase
s
Cumulative Cases*, 1992-2001Cumulative Cases*, 1992-2001
Documented and possible. Source: U.S. Centers for Disease Control and Prevention. For years 1992 through 1999: HIV/AIDS Surveillance Report, year-end reports.For 2000-2001: Fact Sheet: Health Care Workers with HIV/AIDS, pub’d on-line at: www.cdc.gov/hiv/pubs/facts/hcwsurv.htm.
Anti-retrovirals PEP
Giuseppe Ippolito Gabriella de Carli
Vincenzo Puro
Exposure Prevention
Jagger J, Hunt EH, Brand-Elnaggar J, Pearson RD. Rates of needle-stick injury caused by various devices in a university hospital. NEJM 1988; 319(5):284-288.
Jagger J, Hunt EH, Brand-Elnaggar J, Pearson RD. Rates of needle-stick injury caused by various devices in a university hospital. NEJM 1988; 319(5):284-288
27
79
7
8
67
9
3
35
1
9
10
5
4
9
2
0
7
1
3
20
20
Before or during use
After use before disposal
During or after disposal
MECHANISMDISP
SYRINGE
IV TUBE/ NEEDLE
ASSEMBLY
PREFILLED CARTRIDGE
SYRINGE
WINGED NEEDLE IV
SET
VACU TUBE PHLEBOT NEEDLE
IV CATH STYLET OTHER
30% of injuries occurred during recapping
(98/326)
38% of injuries from unnecessary needles
(123/326)
Hollow-bore needles causing needlesticks at UVa Hospital 10 months, 1986 n=326
CDC1987
OSHA1991
state legislatures
1998
FDA19921999
national law2000
Pulling Levers
Universal PrecautionsGuidelines Bloodborne
Pathogens Standard
medical deviceSafety Alerts
California then others
Clinton signsNov 6, 2000
FDA SAFETY ALERT:FDA SAFETY ALERT:Needlestick and Other Risks from Needlestick and Other Risks from
Hypodermic Needles on Secondary I.V. Hypodermic Needles on Secondary I.V. Administration Sets -- Piggyback and Administration Sets -- Piggyback and
Intermittent I.V.Intermittent I.V.April 16, 1992April 16, 1992
Dear Colleague:Dear Colleague:
This is to alert you to the risk of needlestick This is to alert you to the risk of needlestick injuries from the use of hypodermic needles as a injuries from the use of hypodermic needles as a connection between two pieces of intravenous connection between two pieces of intravenous (I.V.) equipment. The use of exposed hypodermic (I.V.) equipment. The use of exposed hypodermic needles on I.V. administration sets or the use of needles on I.V. administration sets or the use of syringes to access I.V. administration set ports or syringes to access I.V. administration set ports or injection sites are unnecessary and should be injection sites are unnecessary and should be avoided. Hypodermic needles should only be avoided. Hypodermic needles should only be used in situations where there is a need to used in situations where there is a need to penetrate the skin.penetrate the skin.
Needleless/Recessed Needleless/Recessed Needle Needle
IV ConnectorsIV Connectors
Glass Capillary Tubes:Glass Capillary Tubes:Joint Safety Advisory About Joint Safety Advisory About
Potential RisksPotential RisksFebruary 1999February 1999
Dear Colleague:Dear Colleague:
The Food and Drug Administration (FDA), the The Food and Drug Administration (FDA), the National Institute for Occupational Safety and National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), and the Occupational and Prevention (CDC), and the Occupational Safety and Health Administration (OSHA) want to Safety and Health Administration (OSHA) want to alert you to the potential risk of injury and/or alert you to the potential risk of injury and/or infection from bloodborne pathogens, including infection from bloodborne pathogens, including human immunodeficiency virus (HIV), hepatitis B human immunodeficiency virus (HIV), hepatitis B and hepatitis C viruses, due to accidental and hepatitis C viruses, due to accidental breakage of glass capillary tubes...breakage of glass capillary tubes...
Non-Non-Breakable Breakable
Plastic Plastic Hematocrit Hematocrit
TubesTubes
safety-engineered devices conventional devices
A New Generation of Protective Devices
illegal
International Healthcare Worker Safety Center, University of Virginia
The Needlestick Safety and Prevention ActNovember 6, 2000
NO DATA
NO PROBLEM
Exposure Prevention
International Healthcare Worker Safety Center, University of Virginia
Multi-hospital surveillance in
U.S. begins 1993
Sharps Injury Rates per 100 Occupied Beds
Teaching Hospitals 1986 - 2007
01020304050
60708090
100
1986 1993 1999 2007
Inju
ries
per
100
occu
pied
bed
s
1 hosp
1 hosp
11 hosp
7 hosp
OSHA 1991 FDA 1992
Law 2000
Exposure Prevention Information Network (EPINet) - International Healthcare Worker Safety Center, University of Virginia
0
2
4
6
8
10
12
14
16
18
1986 1993 1999
Injury Rates from Needles on IV Lines Before & After the 1992 FDA Safety Alert
EPINet hospitals, International Healthcare Worker Safety CenterIn
jurie
s pe
r 10
0 ho
spita
l bed
s
85%
1 teaching hospital
1 teaching hospital
99.9%
FDA alert
9 teaching hospitals
14/550
84/513
17/4,454
02468
101214161820
1986conventional
1993conventional
1993safety
IV catheter injury rates per 100,000 devices
Inju
ries
per
100,
00 d
evic
es18.4
7.5
1.2
1 hospital 3 hospitals 3 hospitals
International Healthcare Worker Safety Center, University of Virginia**Jagger J. Bentley M. J Intraven Nurs 1997;20(6):S33-S39
* ** **
*Jagger J, Hunt EH, Brand-Elnaggar J, Pearson RD.. NEJM 1988; 319(5):284-288.
Safety IV Catheters/Infusion Sets
A misconception about safety- engineered
sharp devices
Question: What is the best safety device?
The answer is . . . . .
Wrong question
The correct question is . . . . .
What is the appropriate safety device for the procedure being performed?
Appropriate applications for syringes with different safety features
Hinged Cap/Retracting Hinged Cap/Retracting Safety SyringesSafety Syringes
Retracting/Sliding Retracting/Sliding Sheath Safety SyringesSheath Safety Syringes
0
1
2
3
4
5
6
Blood DrawA/V
VascularAccess
Injection S/Q Prefill
Sliding shield
Hinged capSpring retract
Passive
Inju
ries
per
100
,000
dev
ices
Injury Rates from Safety-engineered Needles with Different Safety Features
(denominator = 22 million safety devices, numerator = 453 needlesticks
GERES Research Group. Tosini W et al. Infect Control and Hosp Epidem 2010;31:402-407.
Passive Devices
Increase in Percent Market ShareIncrease in Percent Market Shareof 3 Safety Devices, U.S., 1998-2003of 3 Safety Devices, U.S., 1998-2003
(1998-2005 applies to all US hospitals; 1998, 2001 also includes clinics, offices, labs)(1998-2005 applies to all US hospitals; 1998, 2001 also includes clinics, offices, labs)
14
52
6362
78
92
0
10
20
30
40
50
60
70
80
90
100
disposable syringes phlebotomysets/needles
I.V. catheters
%
1998 *
2001**
2003***
2005***
•*Source: Advances in Exposure Prevention • * * Source: Healthcare Products Information Services, Philadelphia•*** Amber Hogan, Materials Management Magazine, Nov 29, 2005, Vol 14, No 11
<10 <10
28
% U
S M
arke
t S
hare
Figure 1
7983
95
Injury Rates from Hollow-bore Needles: Safety versus Conventional,
U.S. EPINet 1995-2006
0
5
10
15
20
25
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
87 hospitals; total injuries = 24,440 (excludes injuries occurring before use of device)
International Healthcare Worker Safety Center, University of Virginia
Inju
ries
per
100
occ
upie
d be
ds
law
ConventionalSafety
Device Specific Injury Rates Before (1993-2000) versus After (2001-2004)
0
1
2
3
4
5
6
7
8
9
before after before after before after before after
US EPINet 1993-2004: 87 hospitals; total injuries = 10,778. Excludes injuries occurring before use of device
International Healthcare Worker Safety Center, University of Virginia
Rat
e pe
r 10
0 oc
cupi
ed b
eds
Figure 3
Conventional
Safety
syringe phlebotomy butterfly IV catheter
-22%
-59%
-23%
-53%
Relative Bloodborne Pathogen Risk to Healthcare Workers
blood drawing needles blood specimen
containers (glass)
vascular access needles
mucocutaneous contact, specimen aspiration needles
injection needles
International Healthcare Worker Safety Center, University of Virginia
Two areas where progress lags:
Operating Room
Non-hospital settings
OR versus Non-OR Injury RatesEPINet 1993-2003: 87 hospitals; total injuries = 28,895. Excludes injuries occurring before use of device
0
5
10
15
20
25
30
35
Rat
e p
er
100 o
ccu
pie
d b
ed
s
Non-OR rateOR Rate
International Healthcare Worker Safety Center, University of Virginia
law
A Global Standard A Global Standard for Healthcare Worker for Healthcare Worker
ProtectionProtection
Goal: To provide basic protection to all Goal: To provide basic protection to all healthcare workershealthcare workers
- - free hepatitis B vaccination free hepatitis B vaccination
- elimination of unnecessary sharps - elimination of unnecessary sharps
- legislation requiring safety-engineered sharp - legislation requiring safety-engineered sharp devicesdevices
- appropriate personal protective equipment (PPE)- appropriate personal protective equipment (PPE)
- HIV post-exposure prophylaxis (PEP)- HIV post-exposure prophylaxis (PEP)
- Hepatitis C treatment- Hepatitis C treatment