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FDA SAFETY ALERT:
Needlestick and Other Risks from Hypodermic Needles on Secondary I.V. Administration Sets -
Piggyback and Intermittent I.V.


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This is not DOL or OSHA controlled material and is provided here for reference only. We take no responsibility for the views, content or accuracy of this information.

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 which 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 which 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 DC, (1992, February 7).

2 Jagger J., et al. "Rates of needlestick injury caused by various devices in a university hospital."New Engl J Med 319.5(1988, August 4): 284-288.

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

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 DC, (1992, February 7).

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