So far this year, the FDA has publicized several incidents involving sterilizer malfunctions. These Manufacturer and User Facility Device Experience (MAUDE) records offer a glimpse into potential problems that can occur when certain devices are used in healthcare settings. SPD departments should watch out for similar problems when using these equipment models. Often MAUDE Adverse Event Reports are simply records of unusual occurrences. However, sometimes glitches can result in serious injury.
In March, an Eagle 3017 ethylene oxide sterilizer put a healthcare professional in the hospital. The operator opened the door of the machine after it had been sitting idle over the weekend. This model typically maintains a temperature of 130 degrees (f) while idling. The employee who opened the chamber was inundated with a rush of hot air. Exposure to the vapor caused eye and throat irritation severe enough to require a trip to the emergency room. The employee was hospitalized for observation and subsequently released.
This sterilizer is a product of STERIS Mexico, a manufacturer based in Nuevo Leon, Mexico. A technician was contacted to inspect the equipment following the accident. An unidentified oily substance with a strong odor was found not only in the malfunctioning unit but in all the other 3017 ETO sterilizers on site. Originally, the compressors were suspected as the potential source of an oil leak. However, these models do not feature compressors that use oil. No source or explanation was found for this contamination. The facility removed the broken sterilizer from service but continued to use the other 3 units.
Other 2009 MAUDE Reports
Sometimes, the equipment is not the problem. Earlier this year, a serious error occurred in a sterilization facility. An employee allegedly poured CIDEX biocide into the water reservoir of an autoclave. This Advanced Sterilization Product solution is not intended for such a use.
The inside of the autoclave chamber was permanently stained by the introduction of the biocide during a cycle. Fortunately, the instruments that were in that load were not distributed for use. No injuries were reported from contact with the residue from the biocide.
In April, a malfunction was reported regarding a Getinge sterilizer. An instrument tray was inside the chamber and the cycle was partly completed when the machine simply quit working. Because the cycle was not finished, the safety lock would not release. A service call was placed to fix the problem.
In the meantime, staff members were faced with a dilemma. The only two remaining trays of instruments were unsterile. Flash sterilization was the only remaining option to get a set ready for the waiting doctor. This incident brings up an interesting point for small clinics and dental offices that have only one autoclave. What happens when it breaks down and traps all your instruments inside?
Do you have a backup plan for what may happen if you experience equipment failure in the middle of a busy day? Request our free report to explore the option of increasing your fleet of sterilizers. A small investment in a benchtop model might pay for itself the next time you have a sterilization emergency.
