Biohazard Related to Misuse of Infectious Substance Shippers
Hazard [Health Devices Oct 1993;22(10):500-1]
The clinical laboratory of a member hospital received 10
tubes of frozen hepatitis C virus sera in an infectious substance shipping container sent
from another hospital. On receipt of the frozen sera, laboratory personnel attempted to
open the plastic screw-cap container, but were unable to. They placed the container into
the refrigerator to thaw the 10 frozen sera tubes. Approximately 15 minutes later, the
screw cap blew off the container and broke seven of the plastic tubes, scattering shards
of plastic and frozen sera throughout the refrigerator. Broken plastic and thawed serum
pose a blood-contamination risk to laboratory personnel; fortunately, no one was injured
in this case.
The laboratory later discovered that the hospital sending the specimens
had placed dry ice around the tubes in the screw-cap container and that polycarbonate
plastic tubes, which are inappropriate for low-temperature storage and shipment, were used
to store the sera.
The infectious substance shipper system involved in the
incident consists of a plastic screw-cap vessel for infectious substances, cushioning materials,
absorbent, and an outer box with labels and instructions. It also had a
polystyrene freezer container into which dry ice can be placed to ship frozen substances. The
shipper system includes all hazard labels and instructions for shipping infectious or
diagnostic specimens with dry ice. The screw-cap container itself, which is not designed
for use with dry ice, has no such warnings or instructions.
Most hospitals are familiar with the Occupational Safety and Health
Administration's (OSHA) bloodborne pathogens standard, which describes regulations for
handling bloodborne pathogens in the workplace. (For an in-depth analysis of and
recommendations pertaining to this standard, see our Guidance Article in Health Devices,
22, February 1993.) However, a hospital transporting any infectious substances must be
aware of the regulations involved in packaging, transporting, and shipping these
materials. Any personnel who will be involved with these activities must be properly
trained in procedures for handling, packaging, labeling, and marking, as well as handling
shipping papers and performance tests, according to Department of Transportation (DOT)
regulations effective October 1, 1993. Once employees are trained, they must be retrained
every two years.
According to C.F.R. 49, if dry ice is used, the outer packaging must
permit the release of carbon dioxide. Also, to use dry ice, a Material Safety Data Sheet
(MSDS) that outlines any necessary hazards or precautions should accompany it. Hospitals
and organizations must also follow the International Air Transport Association (IATA)
regulations, which outline appropriate packaging material for various types of dangerous
goods and the shipper's responsibilities; they also specifically address how and when dry
ice is appropriate to use.
Action taken by manufacturer
Other incidents have been reported in which dry ice has been placed in
the screw-cap container, and the manufacturer has now placed a warning label on the
outside of the container. However, a number of the containers already in use do not have
any labeling. The manufacturer states that the user must be properly trained in the
regulations that state the appropriate materials and conditions for shipping dry ice.
Although this incident occurred with a specific manufacturer's product,
ECRI believes that this problem could occur with any screw-cap or sealed container that
may be used to ship or transport infectious substances. An uninformed shipper who
improperly prepares such a container can contribute to serious injuries, not only to
laboratory personnel, but also to the general public if a problem occurs during transit.
Both the hospital (or other organization) and the courier (or carrier service) are liable
for injuries incurred as a result of shipping an improperly labeled or packaged container.
- Never place dry ice in a container, such as the
screw-cap container in the reported incident, that does not allow the gas to
- Ensure that any sealed container being transported
with dry ice is properly labeled.
- Ensure that anyone in the hospital or organization who is shipping
infectious material or any dangerous goods is familiar with the following
agencies and their recommendations for shipping, packaging, or transporting
infectious substances, including:
guidelines for appropriate shipping procedures, which encompass regulations
from the following agencies:
DOT (49 C.F.R. § 172.7 and § 173),
U.S. Public Health Service (42 C.F.R. § 72)
U.S. Postal Service (39 C.F.R §111);
(29 C.F.R. § 1910); other
federal (e.g., Environmental Protection Agency) and state agencies; and
International Civil Aviation Organization (Recommendations
on the Transport of Dangerous Goods. 8th ed., rev.
New York: United Nations, 1993).
Verify that any specimen tubes that are being shipped
are made of appropriate materials conducive to the freezing and thawing of
1993 DOT training requirements specify that hospital or organization
employees responsible for shipping or transporting dangerous goods, such as
dry ice, are properly trained in packaging, shipping, and handling of
dangerous goods and that the training is appropriately
you receive the appropriate shipping papers for packages that you suspect
contain dangerous goods. If you do not receive them, contact the sender
to verify the contents. If the package was improperly shipped, immediately
report this incident to DOT. If an incident occurs that requires cleanup,
also contact the Centers for Disease Control and Prevention (CDC) to
ensure that appropriate cleanup procedures are followed.
- Occupational exposure to bloodborne pathogens; final rule. Fed
Regist 1991 Dec 6 (29
- Research and Special Programs Administration [RSPA],
final rule: Training for safe transportation of hazardous materials. Fed
Regist 1992;May 15 (49 C.F.R. § 172.700 and § 173.1).
- Dangerous goods regulations. 34th ed. Montreal, PQ, Canada,
- Mailers, Specimen Container [15-744]
- Mailers, Specimen Container, Insulated [15-743]
Cause of Device-Related Incident
Device factor: Design/labeling error
User errors: Failure to read label; Incorrect
Mechanism of Injury or Death
Exposure to airborne infectious agents; Exposure to biohazards