Biosafety and legislative experiences and impact at European and international level Dr. Andreas Wittmann University of Wuppertal Faculty of Safety Engineering

Biosafety and legislative experiences and impact at European and

international level

Dr. Andreas WittmannUniversity of WuppertalFaculty of Safety EngineeringOccupational Phyiology, Occupational Medicine and Infection ControllMadrid, June 1, 2010

Agenda

Identification of the Problem– NSI are not reported– NSI are not seized (during surgical procedures)

Risks involved with NSI– Infections– Others, like shorting of good staff

Technical solutions– Safety devices reduce NSI

Costs Europe´s way out

– European Commission financed „In deep study on socio-economic impact of NSI“

– The Social Partners (HOSPEEM and EPSU) reached consensus– Member states are requested to assure mandatory use of safety devices

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PROBLEM – RISKS INVOLVED – TECHNICAL SOLUTIONS – COSTS – EUROPE´S WAY – DISCUSSION

© A. Wittmann, Madrid 1.6.2010

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Needlestick Injuries Frequency in professional life / German University Hospital

How often did you suffer from a Needlestick-injury during your working life ?



Reporting of Needlestick Injuries

Two Hospitals in Wuppertal Germany (2000)

4

32 7

112

218

0

50

100

150

200

250

300

K1 K2

als geschehen angegebeneNadelstichverletzungen/Jahr

davon gemeldeteNadelstichverletzungen /Jahr

(=14,7%) (=6,25%)

In Questionare admitted Needlestick injuries in 2000

Reported Needlestick injuries in 2000



5

18

4

14

10

21

18

9

8

20

11

9

0

0 5 10 15 20 25

Abdominal

Endoskopie

Gynäkologie

Orthop/Unfallch.

Sonstige

Gefäß/Thorax/Neuroch.

OP-Schwester Chirurg

%

Perception of Needlestick InjuriesUnpercepted needlesticks in gloves after surgical intervention

Nurse Surgeon

Thorax surgery

other

Trauma surgery

Gynaecologic surgery

Endoscopic surgery

Abdominal surgery

WHASSER; Kralj, Beie 1999 (n=1983)



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Perception of Needlestick Injuries 2Unpercepted needlesticks in gloves after surgical intervention

Please recognize that surgeons and nurses have two hands, so that a perforation-rate of 20% indicates one unpercepted Needlestick injurie in 40% of all surgical intervention!



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Bloodborne Pathogens

Hepatitisvirus (HBV, HCV)Human immunodeficiency virus (HIV)Most other pathogens!

…can be transmitted by Needlestick injuries!



Facts on Infections caused by NSI

Estimated 90 % of the work-related HIV infections of health-care-workers in Germany and Europe result from Needlestick-Injuries

Bevore Vaccination against Hepatitis B was established, nearly 1% of the hospital staff got infected each year!

Today Hepatitis C is the most common work related infection in Germany. A vaccination is not available yet.

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Recapping – a high risk procedure

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Strategies for controlling Injury and occupational Disease

Hirarchy of controls (order of preference)

1. Substitution of major Hazards for less hazardous Materials or Processes

2. Technical Solutions to minimize risks

3. Application of engeneering controls to sepatate workers from hazards that remain

4. Use of administrative controls to minimize contact uncontrollable by engeneering

5. Use of personal protective equipment (last line of defence)



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Infection Control

Haz Mat

Exposition/Contact

Infection

• Safety Devices• administrative Control• Personal Protective

Equipment

Substitution ?

Vaccination/ Post Expousure Prophylaxis

Avoiding Blood Contact



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Safety Devices

Safety devices (SD) / safety-engeneered devices (SED) / needle safety devices (NSD) / needle protection devices (NPD)/engineered sharps injury protection (ESIPs)



Obstacles during Implentation of Safety Devices

Typical obstacles– Not necessary („we have no problem on NSI“)– To expensive („NSI create no costs, safety devices do“)– Safety devices are not well engineered yet

Transparency helped to overcome these obstacles– Detailed analyses of NSI, using EPINet™– Follow up cost analyses of NSI – Field tests of safety devices on a large scale (e.g. STOP-

Study, Heidelberg Safety Study)

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Experience with Safety Devices in GermanyManageability / 6 and 12 months (Heidelberg)

Source: N

übling/FF

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ield

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Sa

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6 month12 month



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Reduction of Risk by using safety devices

The use of Safety Devices decreases the rate of Needlestick injuries from

1,5 NSI/10.000 i. v. treatments to0,2 NSI/10.000 i. v. treatments 1

Sources: 1) Dale J, Pruett S, Maker M. (1998)2) Nübling M, Müller-Barthelmeh R, Buchholz L, Häberle E. (2005)

At Heidelberg University Hospital during a period of one year no NSI with Safety devices happened in wards using Safety Devices only 2



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Strategy for Success by using safety devices

Sources: 2) Nübling M, Müller-Barthelmeh R, Buchholz L, Häberle E. (2005)

At Heidelberg University Hospital during a period of one year no NSI with Safety devices happened in wards using Safety Devices only 2

Wards with „mixed“ Instruments had no signifficant reductions in NSI

Even in the wards using only safety devices nurses were suffering from NSI using „illegal“ conventional Devices



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Nadelstich-verletzung

Empfängergeimpft ?

ErfolgreichAntiHBs positiv?

Auffrischimpfung,Testkosten

KeineMaßnahmen,Testkosten

GeimpftSimultanimpfung

HBV VHBV IV

Meldung; 0,5 h Arbeitsausfall

Nein10 %

Ja90 %

Simultanimpfung647,12 €

+131,32 €1,5h Arbeitsausfall

NormalesImpfschema

196,86 €3x 0,5h Arbeitsausfall

Positiv2,5 %

Negativ97,5 %

KeineMaßnahmen

Auffrischimpfung65,66 €

0,5h Arbeitsausfall

< 5 Jahre85 %

Impfungerfolgreich?

Nein1 %

Ja2 %

> 10 Jahre7,5 %

Anti HBs-TestEmpfänger

47,80€

5-10 Jahre7,5 %

Auffrischimpfungnotwendig

97%

Spenderbekannt ?

Ja90 %



SimultanimpfungAuffrischimpfung

Auffrischimpfungohne Testung

65,66 €0,5h Arbeitsausfall

Nein10 %

HBV VI HBV VII HBV IXHBV VIII HBV X

HBsAg-Test

Spender47,80€

Geimpft

NormalesImpfschema

196,86 €3x 0,5h Arbeitsausfall

Positiv2,5 %

Negativ97,5 %

Ja90 %



Simultanimpfung

Nein10 %

HBV IIHBV I HBV III

HBsAg-Test

Spender47,80€

Spenderbekannt ?



Simultanimpfung

Cost of (reported) NSICalculation using flow-chart-analysis



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Factors of Influenceon the Costs of Needlestick Injuries

Individual Costs Costs of Treatment Infection rate in Population Infection Rate in Health Care Workers possibility to examine the source Patient What is included in „Costs“?

Costs in Common Reporting rate of NSI

Non reported NSI do not need expensive treatment yet

(but perhaps in a few years)



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Costs of a reported NSI in a German Hospital

prevalenceKlinikum Wuppertal

prevalenceGermany

Vaccination rate against HBV

Total Costs Costs for the Hospital

Total Costs Costs for the Hospital

100% 450,57 € 118,80 € 395,48 € 109,84 €

90% 487,48 € 147,78 € 431,71 € 138,90 €

80% 524,39 € 176,76 € 467,94 € 167,95 €

70% 561,30 € 205,74 € 504,17 € 197,01 €

60% 598,20 € 234,72 € 540,39 € 226,06 €

50% 635,11 € 263,69 € 576,62 € 255,12 €

in addiction to the Vaccination Rate against Hepatitis B



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Other Studies on Costs of NSI

Studie Country, (Year) Point of view

Costs [€]

NSI on non infectious Patient (Graf Deuel 2002)

Swizerland (2000-2002)

prospektively 355,87 €

NSI at Patient suffering from HCV (Graf Deuel 2002)


prospektively 682,50 €

NSI at Patient suffering from HIV (Graf Deuel 2002)


prospektively 3.464,64 €

NSI in HIV high prevalence Area (Jagger 1998)

USA (1995-1997)

retrospektively 785,05 €

NSI in HIV low prevalence Area (Jagger 1998)

USA (1995-1997)

retrospektively 629,67 €

NSI In Germany including all administrative Costs (Wagner-Ferrer 2006)

Germany (2006) prospektively 1601 €

NSI in German Hospital (Wittmann 2005) Germany (2005) prospektively 487,48 €



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Economic Costs

Using same flow chart modelizing than for microeconomic costs for reported NSI we tried to find out the costs of non reported NSI.

– probable Seroconversions, – resulting Infections, – Illnesses and – the lifetime costs of these illnesseswere considered.

Costs (and also savings) of early demise were not considered.



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Economic Costs 2

Economic Costs of each unreported NSI

non negotiated/disconted 79 € for each NSI negotiated (30 years) 52 € for each NSI



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Calculation of additional Costs for the Implementation of Safety Devices

Discovery of yearly usage of Sharps in an 1000 Bed hospital

Identification of Sharps that could be replaced by Safety Devices

Survey at Manufacturers of Safety Devices in 2002 and in 2006; Costs for complete conversion to safety devices were calculated.



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Cost-Benefit Equation

Maximum Level Treatment 2.477 Employers 1.006 Beds „Cases“ (2001): 38.175

Number of NSI

reported2000: 1802001: 1852002: 1722003: 127

Our Hospital



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Additional Costs of the Substitution

Ø Total Substitution 2002: 156.000 €Ø Total Substitution 2006: 116.000 €

Replacement of: Veincatheters (peripher), Canulas for Blood Drawing, Butterflycanulas, Canulas for Injektion, and Lancets for peripheral blooddrawing



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Cost-Benefit Calculation

Number of NSI

Number of NSI after

Conversion

Economised Costs for Hospital

Economised Costs for Insurance Company

Economised Costs in total

Economised Costs for Insurance Company

Additional Costs Hospital

500 75 62.000 € 207.000€ 269.000€ 207.000 € 54.000 €

400 60 50.000 € 166.000€ 216.000€ 166.000 €66.000 €

300 45 38.000 € 124.000€ 162.000€ 124.000 €78.000 €

200 30 25.000 € 83.000 € 108.000€ 83.000 €91.000 €

166 25 21.000 € 69.000 € 90.000 € 69.000 €95.000 €

100 15 13.000 € 42.000 € 54.000 € 42.000 €

103.000 €



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Costs of NSI in Germany

50.000 reported NSI = 24 Mio € 450.000 unreported NSI = 23 Mio €

Additional Costs for Safety Devices (530.000 Hospital Beds in Germany) = 61 Mio €

Balance: 14 Mio. €;



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History of NSI Prevention in Germany

70s: First vaccinations in Freiburg University Hospital against Hepatitis B (Tomsson Vaccine)Early 80s: Working Group of Prof. Hofmann started routine Vaccination against Hepatitis B for healthcare WorkersSince 1982: registration of all NSI (at Freiburg University Hospital)1999: German version of EPINet



History of NSI Prevention in Germany 2

1996: New german safety law, for the prevention of danger at work technical solutions must conform to the „state-of-the-art“.

1999: Biological Safety Act (Biostoffverordnung) binds employers to operate a risk assessment process for all biological hazards

1998: First safety devices available in Germany 2003-2007: Special „technical rule“ (TRBA 250) was

implemented. The use of safety devices as „state-of-the-art“ was made mandatory within three steps (shall be used to have to be used)

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History of NSI Prevention in Europe

Embedded into European Safety Laws promoted by the European Healthcare Workers

Association a legislative invite by the European Parliament was

initiated. The European Comission set of a in deep Study of the

socio-economic and environmental impact of NSI. Social Partners agreed in an european guideline for

national safety legislation to avoid NSI Guideline is the base for national laws in Europe

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Discussion I

Risk assesment has to be done, but surgical NSI often not recognized by staff and underreporting is one mayor Problem in

identification of NSI as a Problem

Major risks are Bloodborne infections Costs involved due to analytics, treatment and

loss of work

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Discussion II

Reducing NSI ist possible using Technical solutions, such as safety devices Administrative strategies, such as strict

banning of recapping and mandatory use of Sharps Containers

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Reducing NSI is a long-winded process, even in Germany and Europe it took more than one decade from the identification of the Problem to accepted standards in safety.



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Needlestick Injuries

Are Common,Dangerous,Expensive andPreventable!



Documents

Biosafety and legislative experiences and impact at European and international level Dr. Andreas Wittmann University of Wuppertal Faculty of Safety Engineering