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Bloodborne Pathogens and Needlestick Prevention - Possible Solutions |
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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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| April 16, 1992 |
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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.)
equipment1,2,3.
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 documented2.
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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