Safer Needle Devices: Protecting Health Care Workers

References

Alter, M.J.. "The Detection, Transmission, and Outcome of Hepatitis C Virus Infection." Infectious Agents and Disease. 2(8): 155-166, 1993.

American Hospital Association. Implementing Safer Needle Devices. December, 1992.

Centers for Disease Control and Prevention. "Recommendations for Preventing Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Patients During Exposure-Prone Invasive Procedures." MMWR Recommendations and Reports. 40(RR-8): 1-9, 1991.

Centers for Disease Control and Prevention. "Evaluation of Safety Devices for Preventing Percutaneous Injuries Among Health care Workers During Phlebotomy Procedures - Minneapolis, St. Paul, New York City, and San Francisco, 1993-1995." MMWR. 46(2): 21-29, 1997.

Centers for Disease Control and Prevention. "An Evaluation of Blunt Suture Needles in Preventing Percutaneous Injuries Among Health Care Workers During Gynecological Surgical Procedures - New York City, March 1993-June 1994." MMWR. 46(2): 29-33,1997.

Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report. Atlanta, GA: Division of HIV/AIDS Prevention, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention. Vol. 8. No. 2. 1996.

Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report. Atlanta, Ga: Division of HIV/AIDS Prevention, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention. 9 (1), 1997.

Centers for Disease Control and Prevention. "Recommendations for Prevention of HIV Transmission in Health care Settings." MMWR. 35 ( 2S): 1W-18S, 1987.

Centers for Disease Control and Prevention. Draft Guideline for Infection Control in Health Care Personnel, 1997. Washington, D. C.: GPO, 1997.

Chiarello, L.A. "Selection of Safer Needle Devices: A Conceptual Framework for Approaching Product Evaluation." American Journal of Infection Control. 23( 6):386- 395, 1995.

Chiarello, L.A. Written private communication, to Susan Elliott, September, 1997.

FDA. "Needlestick and Other Risks From Hypodermic Needles on Secondary I.V. Administration Sets-Piggyback and Intermittent I.V." FDA Safety Alert. April 16, 1992.

FDA. Supplementary Guidance on the Content of Premarket Notification (510K) Submissions for Medical Devices with Sharps Injury Prevention Features (Draft). Rockville, MD: General Hospital Devices Branch, Pilot Device Evaluation Division, Office of Device Evaluation, 1995.

Hamory, B.H. "Under Reporting of Needlestick Injuries in a University Hospital." American Journal of Infection Control. 11(5): 174-177, 1983.

Hibberd, P.L. "Patients, Needles, and Health Care Workers: Understanding the Epidemiology, Pathophysiology, and Transmission of the Human Immunodeficiency Virus, Hepatitis B and C, and Cytomegalovirus." Journal of Intravenous Nursing. 18 ( 6S): S22-S31, 1995.

Ippolito, G., Puro, V., Petrosillo, N., Pugliese, G., Wispelwey, B., Tereskerz, P. M., Bentley, M., & Jagger, J. Prevention, Management, and Chemoprophylaxis of Occupational Exposure to HIV. Charlottesville, VA: Advances in Exposure Prevention, International Health Care Worker Safety Center, 1997.

Jagger, J. "Rates of Needlestick Injury Caused by Various Devices in a University Hospital." N England J Med. 319(5): 284-8, 1988.

Jagger, J. (1990). Preventing HIV transmission in health care workers with safer needle devices. Sixth International Conference on AIDS. June 22, 1990: San Francisco, CA.

Kelen, G.D., Green, G.B., Purcell, R.H., Chan, D.W., Qaqish, B.F., Sivertson, K.T., Quinn, T.C. "Hepatitis B and Hepatitis C in Emergency Department Patients." N Engl J Med. 326(21):1399-1404, 1992.

Kroc, K., Pugliese, G. Implementing safer needle devices. Chicago: American Hospital Association, December, 1992.

Marcus, R., Culver, D. H., Bell, D.M., Srivastave, P., Mendelson, M., Zalenski, R., Farber, B., Flinger, D. Hassett, J., Quinn, T., Schable, C.A., Sloan, E. P., Tsui, P., Kelen, G.D. "Risk of Human Immunodeficiency Virus Infection at Sentinel Hospitals in the U.S." American Journal of Medicine. 94(4): 363-370, 1993.

Moyer, L., Hodgson, W. "Hepatitis B Vaccine and Healthcare Workers." Advances in Exposure Prevention. 2 (7):1-10, 1996.

National Institutes of Health. Consensus Development Statement: Management of Hepatitis C. Available online at http://odp.od.nih.gov/consensus/cons/105/105_intro.htm. 1997.

Appendix A: FDA Safety Alert

To Hospital Administrators, Directors of Nursing, Risk Managers, and Infection Control Directors:

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.^(1)(2)(3) 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.

The terms "piggyback" or "intermittent I.V." are commonly associated with this equipment configuration. In these procedures, a hypodermic needle is inserted either into a connecting "Y" site on a primary I.V. line ("piggybacking"), or directly into the I.V. access port ("intermittent I.V.").

Research shows that I.V. tubing-needle assemblies have a higher risk of needlestick injury than any other needle devices; needlestick rates more than six times as high as those from disposable syringes have been documented.⁽²⁾ Although the risk is low, such needlestick injuries have the potential for transmitting bloodborne pathogens such as HIV, hepatitis B virus, and hepatitis C virus. Additionally, health care workers (HCWs) sustain needlesticks from exposed needles dangling from unintentionally disconnected secondary medication sets and from needles that protrude from disposal containers. FDA's Device Experience Network has received at least 24 reports describing hypodermic needles which have broken off inside I.V. administration set ports. Injuries to patients may be incurred if these needles travel directly into the patient's bloodstream.

Although FDA can not recommend use of specific products, we strongly urge that needleless systems or recessed needle systems replace hypodermic needles for accessing I.V. lines. There is no evidence that patient bloodstream infection rates have increased with the implementation of needleless systems that have been cleared for marketing. Patient infection rates, however, should be monitored to ensure appropriate use of these products as well as minimize risks to patients.

For recessed needle systems, we agree with researchers who have stated that devices with the following characteristics have the potential to reduce the risk of needlestick injuries:

• A fixed safety feature to provide a barrier between the hands and the needle after use; the safety feature should allow or require the worker's hands to remain behind the needle at all times.
• The safety feature as an integral part of the device, and not an accessory.
• The safety feature in effect before disassembly and remaining in effect after disposal, to protect users and trash handlers, and for environmental safety.
• The safety feature as simple as possible, and requiring little or no training to use effectively.

Products with these characteristics are currently available on the market. During 1991, some of these products were evaluated as part of a pilot study by the State of New York. Preliminary analysis of these data from hospitals which used a safer technology for I.V. delivery (i.e., recessed needle or needleless systems), alone or in combination with other safety devices, showed a dramatic decline in sharps-related injuries and reductions of up to 93 percent in I.V.-related injuries.⁽⁴⁾

On December 6, 1991, the Occupational Safety and Health Administration (OSHA) promulgated a final rule which is intended to minimize or eliminate the occupational exposure to bloodborne pathogens. In promulgating the standard, which became effective on March 6, 1992, OSHA concluded that exposures can be minimized or eliminated using provisions which include engineering controls (e.g., use of self-sheathing needles), work practices (e.g., universal precautions), and personal protective clothing and equipment.

FDA is interested in information concerning the role of medical devices in the transmission of bloodborne pathogens including HIV. We encourage you to report potential hazards for patients and/or health care professionals to the Product Problem Reporting Program at 1-800-638-6725.

I would appreciate your sharing this Safety Alert with those on your staff who might find it useful, including I.V. teams, nurses, ward supervisors, employee health programs, and product evaluation committees.

If you have questions, please contact: Thomas Arrowsmith-Lowe, DDS, MPH, Deputy Director, Office of Health Affairs, Center for Devices and Radiological Health, FDA at 301-427-1060.

Sincerely yours,

James S. Benson
Director
Center for Devices and Radiological Health

1. Jagger J. Testimony on preventable needlesticks, preventable HIV infections, preventable deaths among health care workers. Presented before U.S. Congress Committee on Small Business, Subcommittee on Regulation, Business Opportunities, and Energy. Washington D.C., February 7, 1992.

2. Jagger J, Hunt EH, Brand-Elnaggar J, Pearson RD. Rates of needlestick injury caused by various devices in a university hospital. New Engl J Med 1988; 319:284-288.

3. Jagger J. [Letter to James S. Benson, Director, Center for Devices and Radiological Health, Food and Drug Administration]. February 14, 1992.

4. Chiarello L. Testimony on needlestick prevention technology. Presented before U.S. Congress Committee on Small Business, Subcommittee on Regulation, Business Opportunities, and Energy. Washington D.C., February 7, 1992.

Appendix B: Sample Evaluation Form

The attached form is a sample of a form employers may use to evaluate safer syringes. This form was developed by:

For further information or criteria sheets for other types of devices call: (415) 431-4336

Date:__________	Department:___________________	Occupation:________________
Product evaluating:______________________________		Number of times used:________

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Please circle the most appropriate answer for each question. Not applicable (N/A) may be used if the question does not apply to this product.

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DURING USE:	agree..............disagree
1. The safety feature can be activated using a one-handed technique	1	2	3	4	5	N/A
2. The safety feature does not interfere with normal use of this product	1	2	3	4	5	N/A
3. Use of this product requires you to use the safety feature	1	2	3	4	5	N/A
4. This product does not require more time to use than a non-safety device	1	2	3	4	5	N/A
5. The safety feature works well with a wide variety of hand sizes	1	2	3	4	5	N/A
AFTER USE:
6. There is a clear and unmistakable change (either audible or visible) that occurs when the safety feature is activated	1	2	3	4	5	N/A
7. The safety feature operates reliably	1	2	3	4	5	N/A
8. The exposed sharp is blunted or covered after use and prior to disposal	1	2	3	4	5	N/A
TRAINING:
9. The product does not need extensive training to be operated correctly	1	2	3	4	5	N/A

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Of the above questions, which three are the most important to your safety when using this product?

Are there other questions which you feel should be asked regarding the safety/utility of this product?

Appendix C: Additional Resources

Additional resources to assist employers in the areas of needlestick injury analysis, selection of safer needle devices, and in the development of a comprehensive needlestick prevention program are listed below.

American Hospital Association

• Call 1-800-AHA-2626 to order copies of "Implementing Safer Needle Devices" (Item No. 196310). The AHA published this report in December, 1992.

American Nurses Association

• Call 202-651-7130 to obtain ANA position papers on safer needle devices.

EPINet Program

• EPINet includes manuals and software, data collection tools, and tracking and reporting systems for surveillance of bloodborne exposures, tracking device specific injuries, and evaluating the efficacy of safer needle devices.
• To order: Call EPINet Program 1-800-528-9803.

ECRI Health Devices Journal

• ECRI's Health Devices journal features a comprehensive evaluation on safer needle devices.
• To order: Call ECRI circulation department at 215-825-6000.

Internet Websites

• CDC National Prevention Information Network
  http://www.cdcnpin.org
• EPINet
  http://www.med.virginia.edu/~epinet
• CDC Hepatitis Branch
  http://www.cdc.gov/ncidod/diseases/hepatitis/hepatitis.htm
• OSHA's Website
  http://www.osha.gov

SEIU Guide to Preventing Needlestick Injuries

• Developed by Service Employees International Union (SEIU) this 36 page booklet includes a listing of safer needle devices, checklist for compliance with OSHA's bloodborne pathogen standard, safe device feature evaluation checklist, and guide for post-needlestick exposure follow-up. Produced in October 1998, it is available for $5.00 (must be prepaid) by sending a check with your name and mailing address to: SEIU Mailroom, 1313 L Street, NW, Washington, DC 20005. Only single copies are available at this time.