Ear syringes for community-based physician offices and medical reprocessing requirements

There are two types of ear syringes commonly used in community-based physician offices: reusable and disposable ear syringes.

According to Spaulding’s classification for medical devices, reusable ear syringes are considered to be semi-critical medical devices as they come in contact with mucous membranes. As with all reusable semi-critical medical devices, reusable ear syringes have specific reprocessing requirements to make them safe for use on patients. However reusable ear syringes are also available in two different materials: metal and plastic.

Reusable metal ear syringes must be reprocessed by steam sterilization, packaged prior to sterilization, and meet all the required steam sterilization parameters. See the POMDRA Assessment Tool for Steam Sterilization for more information. Reusable metal ear syringes must not be reprocessed by soaking in a chemical soaking solution; simple washing is insufficient for these semi-critical medical devices.

Although the procedure for ear syringing is not considered to be sterile, reusable metal ear equipment must be sterilized after use to fully remove any microorganisms such as human papillomavirus (HPV) from the device. Physicians should review the manufacturer’s instructions for use to confirm that the reusable metal ear syringe being used can withstand steam sterilization. If the device is not validated for steam sterilization it must be replaced with a disposable or plastic reusable equivalent.

Reusable plastic ear syringe systems are where the tips are single-use disposable, but the bottle is reusable and can be cleaned and low level disinfected. Physicians should review and follow the manufacturer’s instructions for use. These disposable tip ear syringe systems are not required to be sterile prior to use because they have not been exposed to another patient.

As a final option, there are disposable ear syringes where the entire ear syringe/bulb is single-use disposable and discarded after use on a patient. For this type of ear syringe, no part of the device is reprocessed or reused.