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