(You are encouraged to copy and distribute this
Advisory)
February 1999
Dear Colleague:
The Food and Drug
Administration (FDA), the National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC), and the
Occupational Safety and Health Administration (OSHA) want to alert you to the
potential risk of injury and/or infection from bloodborne pathogens, including
human immunodeficiency virus (HIV), hepatitis B and hepatitis C viruses, due to
accidental breakage of glass capillary tubes, and to recommend certain steps
that can minimize the risk.
Background
Glass capillary tubes are
used for the collection of blood in a variety of healthcare settings, including
hospitals, ambulatory care facilities, physicians’ offices, blood donation
facilities, and blood testing centers. Accidental breakage of these slender,
fragile tubes has been reported when the tubes are inserted into putty to be
sealed and during centrifugation. Breakage of the tubes during putty insertion
may result in a penetrating wound and blood inoculation to the user. One such
injury resulted in the transmission of human immunodeficiency virus (HIV) to a
physician who has since died of acquired immunodeficiency syndrome (AIDS). Glass
capillary tubes can break during centrifugation and cause blood to splatter,
potentially exposing personnel to bloodborne pathogens. The broken glass
fragments can injure the user, resulting in a percutaneous exposure to blood.
At one acute care facility,
the injury rate associated with glass capillary tubes was 2.6 per 100,000 tubes
purchased in 1992. Approximately 108 million glass capillary tubes are sold
each year in the United States, suggesting that approximately 2,800 injuries
may occur nationwide if a similar injury rate occurs at other healthcare
facilities. Two systems for surveillance of hospital-based healthcare worker
injuries have reported injuries from glass capillary tubes, some of which caused
blood exposure and resulted in the need for antiretroviral post-exposure
prophylactic therapy.
Recommendations
To reduce the risk of
injury due to breakage of capillary tubes, FDA, NIOSH, and OSHA recommend that
users consider blood collection devices less prone to accidental
breakage, including:
Although FDA, NIOSH, and
OSHA cannot recommend specific products, blood-collection devices with these
characteristics are currently available, and their use may reduce the risk of
injury and blood exposure.
Reporting and Recordkeeping
The Safe Medical Devices
Act (SMDA) of 1990 requires hospitals and other user facilities to report
deaths, serious illnesses, and injuries associated with the use of medical
devices, including capillary tubes. Readers should follow procedures
established by their own facilities for such mandatory reporting of adverse
events. Practitioners who become aware of any medical device-related adverse
event or product problem/malfunction should report to their designated Medical
Device User Facility Reporting contact person. Even if a medical device-related
incident or product quality problem is not required to be reported under the
SMDA, health professionals are encouraged to report any medical device related
concerns to MedWatch, the FDA’s voluntary reporting program. Submit reports to
MedWatch by phone at 1-800-FDA-1088, by FAX at 1-800-FDA-0178, via the MedWatch
website at www.fda.gov/medwatch, or mail to MedWatch, FDA, HF-2, 5600 Fishers
Lane, Rockville, Maryland 20852-9787.
Occupational illnesses and
injuries sustained from capillary tubes may be recordable under OSHA’s
recordkeeping requirements (see 29 CFR Part 1904: Recording and Reporting
Occupational Injuries and Illnesses). Additionally, post-exposure follow-up for
employees may be indicated [see OSHA’s Instruction CPL 2-2.44C (March 6, 1992):
Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens
Standard, 29 CFR 1910.1030 ].
Getting More Information
If you have any questions
on this Advisory, please contact:
Copies of this Safety
Advisory and additional relevant information can be found on the following
webpages:
Signed:
|
Charles
N. Jeffress |
Linda
Rosenstock, M.D. |
D.
Bruce Burlington, M.D. |