Cause of Device-Related Incident
Device factors; External factors; Support system failures; User errors

Clinical Specialty or Hospital Department
Anesthesia; Clinical/Biomedical Engineering; CSR / Materials Management; Obstetrics and Gynecology; OR / Surgery

Device Factors
Design / labeling error

Document Type
Hazard Reports

External Factors
Medical gas and vacuum supplies

Mechanism of Injury or Death
Burn (electrical, thermal, chemical); Fire

Support System Failures
Failure to train and / or credential; Lack or failure of incoming and pre-use inspections

Tampering and/or Sabotage
*Not stated

User Errors
Failure to perform pre-use inspection; Failure to read label; Improper connection

UMDNS
Medical Gas Cylinders [16-501]; Insufflators, Laparoscopic [16-849]

Use of Wrong Gas in Laparoscopic Insufflator Causes Fire (Update)



Hazard Update [Health Devices Oct-Nov 1994;23(10-11):456-7]

Problem Update

In our original Hazard Report on a fire that occurred during laparoscopic surgery (see Health Devices 23[1-2], Jan-Feb 1994), we noted that pin indexing of medical gas cylinders and yokes can help prevent the use of the wrong gases with laparoscopic insufflators and thus avert risks such as the reported fire. In that incident, a cylinder containing a mixture of carbon dioxide and oxygen in a 20:80 proportion, respectively, was used instead of a cylinder of carbon dioxide only.

We have since learned that the Compressed Gas Association's (CGA) Pamphlet V-1, Compressed Gas Cylinder Valve Outlet and Inlet Connections, defines the same pin-indexing combination (No. 940) for carbon dioxide as for carbon dioxide and oxygen mixtures (with over 7.5% carbon dioxide). This presents an increased risk that a cylinder of oxygen-enriched gas can be connected to an insufflator's gas yoke, possibly leading to a pneumoperitoneal fire during laparoscopic surgery.

Also, some hospitals and suppliers use nonstandard color-marking schemes for their medical gas cylinders; this can lead to confusion and possibly application of the wrong gases.

Discussion

The primary means of identifying which medical gas is contained in a cylinder, and thus of guarding against use of the wrong gas, is reading the cylinder's label; therefore, cylinders with damaged or unreadable labels should not be used. The secondary means of guarding against use of the wrong medical gas cylinder is pin indexing; however, as our original report pointed out, pin indexing should not be relied on as the sole means of identifying the gas. The cylinder color is the tertiary means of identifying the cylinder's contents and also helps with cylinder sorting.

Carbon dioxide–oxygen mixtures of greater than 7.5% carbon dioxide are suffocating gases not typically used for patient administration and therefore have historically been grouped with carbon dioxide in the pin-indexing system. ECRI believes that the standard pin-indexing system should be changed to preclude use of the wrong gas and a potential fire, especially considering the increasing frequency of laparoscopic surgery. We have asked CGA to review this problem, and the association reports that it will be making appropriate changes. Until these changes can be made, which may take as long as five years, users must be careful to ensure that the proper gas (e.g., carbon dioxide) is used for insufflation.

In addition, the lack of a standard universal color-marking scheme for gas cylinders can create confusion. In the United States, most gas suppliers and hospitals follow the standard color-marking scheme defined in CGA Pamphlet C-9, Standard Color Marking of Compressed Gas Containers Intended for Medical Use. This color scheme is used for visual gas identification on most medical devices and is the scheme that the Food and Drug Administration (FDA) suggests be used for medical gas containers in its Good Manufacturing Practices (GMP) guideline, Compressed Medical Gases Guidelines. Other countries use the color markings specified in the International Organization for Standardization's (ISO) Gas Cylinders for Medical Use—Marking for Identification of Contents (ISO 32). In all countries, gray is used to identify carbon dioxide cylinders; in the United States, gray and green are used for carbon dioxide–oxygen mixtures, while gray and white are used in other countries.

Recommendations

  1. Do not use medical gas cylinders with missing, damaged, or obscured labels.
  2. Ensure that insufflator gas cylinder yokes are pin indexed to allow connection of only the proper insufflation gas (e.g., carbon dioxide). Routinely inspect the yokes (e.g., during scheduled inspection and preventive maintenance) for proper and intact indexing pins. Do not remove indexing pins and do not purchase or accept delivery of yokes that have no pins. Label the insufflator with the type of gas with which it is to be used, for example: Insufflation Gas: Carbon Dioxide--Use Gray Tanks Only.
  3. Ensure that all operating room personnel and support technicians who deal with medical gases know and understand the color-marking scheme. All users and suppliers should use the standard color scheme for their country. In all countries, carbon dioxide–only cylinders are gray with no second color.
  4. During the pre-use check, ensure that only the insufflation gas specific for the insufflator and requested by the surgeon is used. Question the use of gases other than carbon dioxide. Note and record on the surgical record the label on and color of the gas cylinder attached to the insufflator.
  5. Store gas cylinders in a manner that will minimize the risk that the gases will be confused (e.g., store special mixed gases separately).

UMDNS Terms

  • Medical Gas Cylinders [16-501]
  • Insufflators, Laparoscopic [16-849]

Cause of Device-Related Incident

Device factor: Design/labeling error

User errors: Failure to perform pre-use inspection; Failure to read label; Improper connection

External factor: Medical gas and vacuum supplies

Support system failures: Failure to train and/or credential; Lack or failure of incoming and pre-use inspection

Mechanism of Injury or Death

Burn (thermal); Fire


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