Cause of Device-Related Incident
Device factors; User errors

Clinical Specialty or Hospital Department
Clinical Laboratory; Infection Control; Pharmacy / IV therapy

Device Factors
Design / labeling error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Exposure to airborne infectious agents; Exposure to biohazards

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
Failure to read label; Incorrect clinical use

UMDNS
Mailers [15-742]; Mailers, Specimen Container [15-744]; Mailers, Specimen Container, Insulated [15-743]

Biohazard Related to Misuse of Infectious Substance Shippers



Hazard [Health Devices Oct 1993;22(10):500-1]

Problem

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.

Discussion

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[2], 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.

Conclusions

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.

Recommendations

  1. Never place dry ice in a container, such as the screw-cap container in the reported incident, that does not allow the gas to escape.
  2. Ensure that any sealed container being transported with dry ice is properly labeled.
  3. 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: IATA guidelines for appropriate shipping procedures, which encompass regulations from the following agencies: U.S. 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); OSHA (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).
  4. Verify that any specimen tubes that are being shipped are made of appropriate materials conducive to the freezing and thawing of specimens.
  5. The 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 documented.
  6. Ensure that 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.

Notes

  1. Occupational exposure to bloodborne pathogens; final rule. Fed Regist 1991 Dec 6 (29 C.F.R.§ 1910.1030).
  2. 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).
  3. Dangerous goods regulations. 34th ed. Montreal, PQ, Canada, 1993.

UMDNS Terms

  • Mailers [15-742]
  • 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 clinical use

Mechanism of Injury or Death

Exposure to airborne infectious agents; Exposure to biohazards


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