Needlestick Safety and Prevention Act of 2000: Impact and Limitations

Janine Jagger, M.P.H., Ph.D.

International Healthcare Worker Safety Center

University of Virginia

GERES 21eme Journee Annuelle Paris, December 9, 2011

CDC1987

OSHA1991

state legislatures

1998

FDA19921999

national law2000

Pulling Levers

Universal PrecautionsGuidelines

Bloodborne Pathogens Standard

medical deviceSafety Alerts

California then others

Clinton signsNov 6, 2000guidelines, regulations, legislation

FDA SAFETY ALERT:Needlestick and Other Risks from Hypodermic

Needles on Secondary I.V. Administration Sets --Piggyback and Intermittent I.V.

April 16, 1992

Dear Colleague:

This is to alert you to the risk of needlestick injuries from the use of hypodermic needles as a connection between two pieces of intravenous (I.V.) equipment. The use of exposed hypodermic needles on I.V. administration sets or the use of syringes to access I.V. administration set ports or injection sites are unnecessary and should be avoided. Hypodermic needles should only be used in situations where there is a need to penetrate the skin.

0

2

46

8

10

1214

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 Center

Inju

ries

per

100

hosp

ital b

eds

85%

1 teaching hospital

1 teaching hospital

99.9%

FDAalert

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.

The Needlestick Safety and Prevention ActNovember 6, 2000

U.S. Estimated percent market share* of safety compared to conventional devices, 1998 – 2009

7

needles & syringes

IV catheters

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

occu

pied

bed

s

lawConventionalSafety

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%

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

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

Rat

e p

er 1

00 o

ccu

pie

d b

eds

Non-OR rateOR Rate

International Healthcare Worker Safety Center, University of Virginia

law

National Market Share of Safety Phlebotomy Needles, U.S. Compared to the Increasing Proportion of Injuries from

Safety Phlebotomy Needles 1997-2007

U.S. law

% o

f inj

urie

s/m

arke

t sha

re

Conventional phlebotomy needle injuries = 425 Safety phlebotomy needle injuries = 253

Figure 2

Syringes Used for Venous Blood Drawing: Percent of Injuries from Safety Syringes

U.S. law

% o

f inj

urie

s

syringe injuries (venous blood draw), U.S. = 1,038 syringe injuries (venous blood draw), Italy = 554

Figure 3

Syringes Used for Arterial Blood Drawing: Percent of Injuries from Safety Syringes

% o

f inj

urie

s

syringe injuries (arterial blood draw), U.S. = 220 syringe injuries (arterial blood draw), Italy = 179

Figure 4

Winged Steel Needles: Percent of Injuries from Safety Winged Steel Needles

U.S. law

% o

f inj

urie

s

winged steel needle injuries, U.S. = 1165 winged steel needle injuries, Italy = 899

Figure 5

Phlebotomy Needle Injuries: Percent of Injuries from Safety Phlebotomy Needles

U.S. law

% o

f inj

urie

s

phlebotomy needle injuries, U.S. = 681 phlebotomy needle injuries, Italy = 193

Figure 6

Lancet Injuries: Percent of Injuries from Safety Lancets

U.S. law

lancet injuries, U.S. = 335 lancet injuries, Italy = 439

Figure 7

U.S. – Italy: Needlestick Rates for Five Blood-Drawing Devices Before and After 2000

syringes (venous blood draw), syringes (arterial blood draw), winged steel needles, phlebotomy needles, lancets

occupied beds, U.S. = 67,573 occupied beds, Italy = 85,409 injuries, U.S. = 3,439 injuries, Italy = 2,264

- 46.4%

6.9%

Figure 9

Distance traveled

Look behind you to see how far you have come.