The Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the Center for Devices and Radiological Health of the Food and Drug Administration (FDA) have produced a joint advisory notice on the use of glass capillary tubes. This document, "Glass Capillary Tubes: Joint Safety Alert about Potential Risks", is designed to inform readers of the potential hazards associated with these devices. An OSHA News Release will be published to notify the public of the safety advisory. FDA and NIOSH will also be disseminating the advisory to the public through their respective agency procedures.

Safer alternatives to conventional glass capillary tubes are described in this advisory. Breakage of glass capillary tubes during use may result in a penetrating wound and blood inoculation to the user. With such an injury comes a risk of acquiring a bloodborne pathogen infection, such as human immunodeficiency virus (HIV), hepatitis B, and hepatitis C. Surveillance studies of health care workers indicate that hundreds of these exposures occur, sometimes requiring expensive and lengthy treatment as well as tremendous mental anguish for injured workers.

According to the Directorate of Compliance Programs, employers using [glass] capillary tubes may be cited under the bloodborne pathogen's standard (29 CFR 1910.1030) under certain circumstances, e.g., improper housekeeping (i.e., picking up broken, contaminated capillary tubes with the hands) [paragraph (d)(4)(ii)(D)]; improper handling of regulated waste (i.e., improperly disposing of contaminated capillary tubes) [paragraph (d)(4)(iii)], or lack of personal protective equipment (i.e., not using gloves when handling contaminated capillary tubes) [(d)(3)(ix)]; or failure to provide post-exposure evaluation and follow-up of exposure incidents [paragraph (f)(3)]. Additionally, 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).

Please use this information as an outreach and training tool. We hope this information will be useful to you and your staff. Please circulate this memorandum and the attached document to others in your region as appropriate.

For further information or comments, you may contact the Office of Health Compliance Assistance (202-693-2190) or the Office of Occupational Health Nursing (202-693-2120).

Related: February 22, 1999; Trade Press Release

Attachment

Glass Capillary Tubes:
Joint Safety Advisory About Potential Risks
(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. ⁽¹⁾ 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).⁽²⁾ 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.⁽³⁾ 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.⁽³⁾ 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⁽⁴⁾

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:

1. Capillary tubes that are not made of glass⁽⁵⁾,


2. Glass capillary tubes wrapped in puncture-resistant film,


3. Products that use a method of sealing that does not require manually pushing one end of the tube into putty to form a plug, or


4. Products that allow the blood hematocrit to be measured without centrifugation.

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:

• FDA: Office of Surveillance and Biometrics, FAX at (301) 594-2968 (attn: Carol L. Herman, Public Health Analyst, by e-mail at czh@cdrh.fda.gov);


• CDC: National Institute for Occupational Safety and Health, 1-800-35-NIOSH (1-800-356-4674); or


• OSHA: Directorate of Technical Support, Office of Occupational Health Nursing, at (202) 693-2120 (attn: Elise Handelman).

Copies of this Safety Advisory and additional relevant information can be found on the following webpages:

• http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM062285


• www.cdc.gov/niosh/homepage.html

Signed:

Charles N. Jeffress
Assistant Secretary
OSHA

Linda Rosenstock
Director
NIOSH

D. Bruce Burlington, M.D.
Director
CDRH, FDA

References

1. Jagger, J., Hunt, E.H., and Pearson, R.D.: Sharp object injuries in the hospital; causes and strategies for prevention. Am J Infec Control 18(4):227-231, 1990. (Back to Text)

2. Aoun, H.: When a house officer gets AIDS. N Eng J Med 321(10):693-696, 1989. (Back to Text)

3. Jagger, J., Bentley, M., and Perry, J.: Glass capillary tubes: eliminating an unnecessary risk to healthcare workers. Adv Exp Prev 3(5):49-55, 1998. (Back to Text)

4. Jagger, J. and Deitchman, S.: Hazards of glass capillary tubes to healthcare workers. JAMA 280(1):31, 1998. (Back to Text)

5. Hudson, M., Morgan-Capner, P., and Wilson, M.: Potential hazards with fine bore capillary tubes used by non-pathology staff. J Hosp Infec 28(4):323-324, 1994. (Back to Text)

[Corrections 6/10/02]