Understanding Shelf Life in the SPD

Why These Basics are Essential

Working in the Sterile Processing Department is so much more important than it may seem from the outside. A successful SPD professional pays constant attention to detail, is all about teamwork, and has a willingness to engage in continuous learning. Detailed information comes in the form of guidelines, recommended practices, instructions for use, facility policies and procedures, research studies, and other industry publications. Today, we focus on why Shelf Life and Storage Instructions deserve your close attention.

Caring for Consumables

Items that come into the department and must be used within a defined amount of time, often called consumables, range from detergents to instrument brushes to chemical and biological indicators. What they all have in common is that the FDA requires manufacturers to conduct testing to determine the shelf life of the product and define storage instructions. The labeling for these products has an expiration date which indicates that the device or product will perform as intended through that date, when handled and stored properly. However, these studies are conducted in industrial settings or in independent laboratories where conditions may be different than in a health care facility.

Storage and Handling Instructions are the parameters that allow a product to reach the stated expiration date. For instance, most cleaning products specify a storage temperature range and environmental conditions. If the product is stored in too warm or too cold an environment or exposed to contamination in the environment, the cleaning properties can be compromised. Another consideration is whether the package was compromised. For example, once a product has been opened, it is important to store it away from potential sources of contamination. This is particularly true in the decontamination area.

Do’s and Don’ts of Durable items

When looking at more durable or reusable items, manufacturers usually refer to the “useful life” of the product. This can be defined by time or by handling events leading to event related sterility maintenance.  As for shelf life testing, durable items are validated by the manufacturer and instructions provided for reprocessing, use, storage, and handling, all of which can affect the useful life of the item. For instance, with Case Medical’s SteriTite® Universal Containers, the IFU states that a pH-neutral detergent should be used, and abrasive cleaners or pads should be avoided. Following these and other stated recommendations helps ensure the long 10-15-year useful life of the containers.

For sterilized items, the integrity of the package is critical. That is why the SteriTite container utilizes tamper-proof locks, a standard in the industry, and has incorporated proprietary design features, such as a knife-edge fit with gasket between lid and base, rivetless case construction, and an offset vent pattern to prevent strike through.

Success in the SPD

To get the best results in your department, read the instructions and labeling for the products you use. Help your teammates understand them, too. And speak up if you or someone else is unsure. Your attention to detail is crucial to the success of your department, your facility, and the patients you serve.