Rigid Container Gaskets-Managing a Known Failure Point

Rob Turbett, President Turbett Surgical

Rigid containers, since their introduction to the US last century, have become commonplace for reprocessing reusable instruments. They offer many operational benefits and greater protection for the instruments than cloth, paper or polymer wraps. To make the device a complete microbial barrier, manufacturers use silicone/ polymer gaskets to create a seal between the lid and the container. Gaskets are also used between the retention plates and filter medium.

Gaskets, when new, are an excellent tool for creating a seal between surfaces. They easily form and compress to surfaces. Without the forgiveness that gaskets provide, it would be very difficult to create a device that was repeatably able to create a microbial seal.

The challenge is that the gaskets wear out over time. When gaskets are exposed to repeated high temperatures and pressures, they lose their mechanical properties of being pliable and flexible. High temperature and pressure is utilized in steam sterilization. Gaskets are also subject to repeated handling and movement while the parts they are attached to- lids and retention plates- are being washed and assembled. This also subjects them to damage.

The 2006 Dunkelberg study published in the American Journal of Infection Control does an excellent job showing the effectiveness of rigid containers after having been in use for a year. The take home message:

If you are going to use rigid containers, you need to have a robust maintenance and inspection program to ensure the gaskets have not worn out or have not become damaged. Gaskets should be inspected before each use, and integrity confirmed at each opening.

Fortunately most manufactures recognize the limitations of reusing gaskets in the high temperature/pressure environment. Most specifically state in their Instructions For Use to inspect the gaskets at each use. Gaskets should be checked for pliability and to ensure there are no cracks, splits, dings, or chips. Damaged gaskets should be returned to the manufacture for replacement. The container must be removed from use until the repair has been completed.

Some have suggested that reusable gaskets are the greatest for ensuring a repeatable seal, without recognizing the inspection process that must take place at each use. This is irresponsible, and contradicts the science, multiple studies, and IFU's of every other rigid container manufacturer. The concern is that as rigid containers have become commonplace, manufactures can not become complacent with the critical function that reusable gaskets provide. In the automotive world, a bad gasket results in an oil leak. In the world of sterilization and medicine, a bad gasket can affect a patients life.

Turbett Surgical's Instrument Pod Eliminates the Risk of Reusable Gaskets

Turbett Surgical created a new large rigid container called the Instrument Pod. Understanding the limitations of reusable gaskets, Turbett Surgical designed a filter cartridge for the Instrument Pod that is placed in the door. The filter cartridge contains the gasket, which is compressed by placing the door and latching it closed. The benefit is that it reduces down to just one way germs can get in, compared to the multiple pathogen pathways ( up to six) found in other containers. This patented process reduces patient risk. It also eliminates the suspected failure point - gaskets at retention plates- demonstrated in the Shaffer/ Halyard study published in the AJIC 2015.

Having the gasket be part of the filter means that the Instrument Pod has NO REUSABLE GASKETS. This eliminates the failure point found in other rigid containers. It eliminates the need for reusable gasket inspection, and dramatically simplifies daily use. Most importantly, every patient gets a brand new seal.

The use of rigid containers can be a very effective way of improving reprocessing efficiency and eliminating waste. To effectively use the containers, inspection of reusable gaskets must be performed. The Turbett Instrument Pod eliminates this requirement.