Bloodborne Pathogens, Sharps Injuries, and Safety Sharps

• Bloodborne Pathogen Statistics

• Federal and state BBP regulations

• Texas sharps injuries

• Safety Sharps

• Recommendations

At the end of 2000-globally

There was an estimated: 36.1 million persons with HIV/AIDS

Adler, Mw, ABC of AIDS development of the epidemic. BMJ. May

19, 2001,322 (7296) 1226-1229

In the U.S. at the end of 2000

• There was an estimated 340,00 persons living with AIDS.

Klevens, RM and Neal, JJ. Update: AIDS United States, CDC MMWR Weekly. July 12, 2002/51(27); 592-595

At the end of 2003

• An estimated 1 million persons are living with HIV infection in U.S.

• Due the highly active antiretroviral therapy (HAART) since 1996, persons with HIV are living longer and the progression to AIDS has lessened.

Espinoza, L. et al. Trends in HIV/AIDS diagnosis—33 states, 2001-2004.

MMWR Weekly. November 18, 2005/54 (45); 1149-1153

CDC Recommendations after a 33 state study

• Adopt confidential, name-based surveillance systems that report HIV infections because AIDS surveillance no longer provides an accurate population-based monitoring of the epidemic.

Espinoza, L. et al. Trends in HIV/AIDS diagnosis—33 states, 2001-2004,

CDC MMWR Weekly. November 18, 2005/54 (45); 1149-1153.

Global BBP Among Health Care Workers

• Reports of global BBP infections among an estimated 35 to 100 million health care workers is fortunately small in comparison to risk:

• 65,000 Hepatitis B infections• 16,400 Hepatitis C infections• 1000 HIV infections

Puro, V. and Shouval, D. Conclusions of the meeting of the Viral Hepatitis B, Hepatitis

C, and other bloodborne infections in health care workers. Rome, Italy, March 17-

18, 2005. Viral Hepatitis. November 2005 14 (1) 1-16.

U.S. Seroconversion of Health Care Workers

• Fifty-seven health personnel in U.S. have been documented to seroconvert to HIV following occupational exposures (with no new cases since 2001)

• One hundred and thirty-nine other cases of HIV or AIDS have occurred among health care workers who have not reported other risk factors

Department of Health and Human Services, CDC Prevention and Surveillance of

healthcare personnel with HIV/AIDS as of December 2002.

BBP Risk With Percutaneous Injury

• .3% risk for contracting HIV with device contaminated with HIV

• 1.8% risk for Hepatitis C if device is contaminated with HCV

• Hepatitis C is the most frequent infection resulting from sharps injuries

Rosenstock, Linda. Statement for the Record on Needlestick Injuries. National Institute For Occupational Safety and Health Centers for Disease Control and Prevention

U.S. Department of Health and Human Services before the House Subcommittee on

Workforce Protection Committee on Education and The Workforce, June 22, 2000.

Hepatitis C

• Called the silent epidemic

70-80% of persons infected will develop active liver disease over a period of years– 10-20% cirrhosis– 1-5% of cirrhosis cases will develop liver cancer

Treatment is about 50% effective

Rosenstock, Linda. Statement For the Record on Needlestick Injuries. NIOSH and Health

Centers for Disease Control and Prevention U.S. DHHS Before the House Subcommittee

on Workforce Protection Committee on Education and the Workforce, June 22, 2000.

Hepatitis B Risk

• 2-40% risk for Hepatitis B with contaminated device

• Unlike HIV and Hepatitis C in which there is no vaccine, Hepatitis B is preventable with vaccine

• Regulations requiring vaccination of health care workers has resulted in the reduction of cases from 17,000 to 400 annually

Source: American Nurses Association. Nursing Facts Needlestick Injury. ANA fact sheet on

Needlestick Injury. Retrieved December 31, 2004 from

http://www.nursingworld.org/readroom/fsneedle.htm

Bloodborne Pathogen Regulations

• Title 29 of the Code of Federal Regulations 1910, 1030– Universal (now Standard) Precautions– Personal Protective Equipment– Engineering Controls– Bloodborne Pathogen Exposure Control Plan

Needlestick Safety and Prevention Act 2000

Revised the previous Bloodborne Pathogen Standard to require:

1. The evaluation and implementation of safer needle devices

2. Documentation of non-managerial staff involvement in selection of safer devices

3. The establishment and maintenance of a sharps injuries log.

U.S. Department of Labor Occupational Safety and Health Administration. 12/18/2001 Compliance Directive for Bloodborne Pathogen Standard Updated-Includes revision

mandated by the Needlestick and Prevention Act.

Texas Bloodborne Pathogen Law

– Texas State Legislature passed House Bill 2085 that contained Bloodborne Pathogen regulations effective 2001

1. Law to be analogous to federal mandates

2. Applicable to governmental entities not covered by OSHA– To report sharps injuries to state health department– State required to make an aggregate report of the

injuries

Texas BBP Law cont.

2006 BBP Rules Amended:Cessation of Waivers for Undue Burden and Rural Counties for not using needless devices and safety engineered sharps

Tucked into 2003 federal Medicare law

• Center for Medicare/Medicaid Services requirement for facilities (including governmental entity hospitals and clinics) to comply with BBP standard and that fines will be imposed for those who fail to comply

OSHA Directs Single Use of Blood Tube Holder

Risks to health care worker and to patient

Clinical studies have shown a 50-80% contamination of the blood tube holder after one usage

Perry, J. and Jagger, J. Reuse of blood tube holders, redux. Preventing Occupational

Exposures to Bloodborne Pathogens. Articles from Advances in Exposure

Prevention, 1994-2003 Vol. 6, no.4, 2003; 230-231. The Safety Institute, Premier

Inc. 2004

Implementing Laws and Directives

Changing from Glass:

1. Plastic Blood Tubes

2. Mylar-Wrapped Capillary Tubes with self sealing Tips that require no pressure

3. Plastic Slides

Needleless systems and Safety Sharps

One time use of Blood Tube Holders

Dedicated glucose monitors, insulin vials and lancets

U.S. Sharps Injuries

• CDC estimates that there are 385,000 needle and other sharps-related injuries sustained by hospital-based and other healthcare personnel per year (an average of 1000 injuries per day)

Source: CDC Workbook for Designing, Implementing, and Evaluating a

Sharps Injury Prevention Program

Inconsistency in Reporting and Profound Underreporting

May be as high as 70% in some facilities

Source: DeBraun, B. A Decade of Needlestick Prevention: A California experience. Infection Control Resource, 2001

Texas Governmental Entity Sharps Injuries

Year Number of Injuries

2001 17892002 1622

2003 1779

2004 1686

Type of Facility Reporting Sharps Injuries

• Hospital/Health Centers 71.83%• Colleges/Universities 21.71%• City/County Services 3.62%• State Facilities 1.30%• Schools .77%• Home Health .36%• LTC .18%

Source: 2004 Texas Contaminated Sharps Injuries Report

Job Classification With Greater Number of Sharps Injuries

• R.N. 23.67%

• MD/DO 22.18%

• Intern/Resident 8.66%

• Operating Room staff 6.94%

• Laboratory 6.35%

• LVN 6.23%

2004 Texas Contaminated Sharps Injuries Report

Work Areas with Greatest Number of Injuries

• Operating Room 28.35%• Patient/Resident Room 19.16%• Procedure Room 9.91%• Emergency Dept 9.13%• Laboratory 4.80%• L&D/GYN 4.27%• Medical/Outpatient 3.97%

2004 Texas Contaminated Sharps Injuries Report

Devices Related to Greatest Number of Injuries

• Suture Needle 22.89%• Disposable Syringe 14.23%• Other Syringe 10.97%• Scalpel 7.71%• Surgical Instruments 6.58%• Winged Steel Needle 6.23%• Vacuum Tube Collection 3.32%

Source: 2004 Texas Contaminated Sharps Injuries Report

Procedure at Time of Injury

• Injection 18.80%• Suture Skin 13.94%• Draw Venous Blood 11.80%• Suture Deep 9.79%• Cutting 9.13%• Start IV/Heparin Lock 6.67%• Obtain Fluid/Tissue Sample 5.22%

2004 Texas Contaminated Sharps Injuries Report

Cost of Sharps Injuries

• Medical care ranges from $500 to $3,000 depending upon the treatment

• Costs are hard to quantify- Direct and indirect costs such as drug toxicity Cost of emotional trauma to employee Workers comp., burden of medical care Societal cost associated with HIV/Hepatitis Cost of any associated litigation

Source: CDC Workbook

Screening/Testing and Implementing Safety Sharps

• Assess facility needs-which areas are not using safety engineered devices

• Collect baseline data as to employee injuries and type of sharp involved

• Review patient infection rates per type of device

• Develop/use existing team to address safety sharps issue

Safety Sharps Evaluation

• Sharps Evaluation Team 50% frontline staff

• Set criteria for screening and testing

• Use standardized scoring forms

• Seek devices that are rated at least acceptable [Retractable syringes are an improved technology to sliding sheath]

• Team decides which device will be tested

Sharps Evaluation Team Recommends

Safety Device Yes No

BD Sharps Container 5 3

Roche Safe-T-Pro Plus

Lancet 8 1

BD Winged Needle 7 1

Report 2004 Clinical Testing

Vendor Role

1. Demonstrates device at screening workshop

2. Provides staff education 3. Supplies free devices for clinical testing4. Serves in informational/support role if there are problems with the device

5. Has sufficient devices available to meet facility/agency needs

Criteria for Screening/Testing

• Ease of identification and handling of the device• How well the product will work with other devices• Can the product be used with one hand• Does it work for both left and right-handed

persons• Is it easy to use while wearing gloves

Training and Development of Innovative Control Technology Product, Trauma

Foundations,San Francisco,CA Needlestick Prevention Devices ECRI,

Screening/Testing Criteria (cont.)

• Will the healthcare worker know when the safety feature is activated

• Is the exposed sharp covered after use

• Does this device cause more pain or more sticks to the patient

• Does this device cause more risk for patient infection

• Is device better than currently used device

Implementation of Safety Sharps

• Devices that receive the highest scores are recommended by the Sharps Evaluation Team for Implementation

• A plan for implementation includes

-getting staff support

-providing staff education

-Budgeting for the device

-Follow-up

Implementation

Consider using established guidelines for the insertion of central lines that bundles: Aseptic technique (maximal barriers), approved skin antiseptic, type of dressing, monitoring of patient and device, type of device and adherence to approved time frames for device remaining in place

CDC Guidelines

O.R. Work Practice Controls Include:

• Using instruments rather than fingers to grasp needles, retract tissue and load/unload needles and scalpels

• Giving verbal announcements when passing sharps• Avoid hand-to-hand passage of sharps• Use alternative cutting methods blunt

electrocautery, laser• Substitute endoscopic surgery when possible• Use round-tipped bladesSource: CDC Workbook

Follow-up

1. Is the device used-determine how to manage staff resistance

2. Are there fewer injuries-if no, why not

3. Are there more infections-look for the root cause

4. Consider work processes, staffing, worksite climate, device

Healthcare Worker Role

The employer can provide safer devices, but it is up to the staff person to:

1. Know which devices are at higher risk

2. Know how to reduce the risk

3. Know what to do in processes that will always have risks

Source: Perry, Jane et al. How to avoid needlesticks. RNWEB 2004

Effects of Implementing Safety Engineered Devices

• Comparison study showed:

Mean annual Injury Before After Incidence per 1000 FTE 34.08 14.25

(P<.0001)

Source: Sohn, S. et al. Effects of implementing safety-engineered devices on

percutaneous injury epidemiology. Infection Control Hospital

Epidemiology.2004 Jul;25(7):536-42.

Review of Information

• Where we are in Bloodborne Pathogen Statistics

• Current federal and state BBP regulations

• Sharps Injuries Among Texas Govt. entities

• Safety Engineered Sharps Device Use