When does a custom medical procedure tray expire? What determines the expiration date?
Custom medical trays are an exceptional product that make the flow of a medical office or facility so much more efficient and successful. The customization of the product allows for specific tools to be included in each kit; tailoring certain procedures to the needs of the medical professional using them. However, most people don’t consider that these custom trays actually have an expiration date and there are a number of factors that go into determining what this expiration date will be. Such determining factors are usually put into place by the Food and Drug Administration and followed by the company that is manufacturing the custom trays.
About Expiration Dates
The expiration of any product applies to the amount of time that a product is safe to use and will function how intended. If used after the expiration date is up, this can be a risk to the patient or consumer. When dealing with custom trays, the expiration date usually will be determined based on what exactly is in each tray. Certain items may last longer than others. For example, a tray with metal tools in it will last much longer than a tray that has something like a battery intended for a pacemaker.
What Determines An Expiration Date?
Ideally, items are analyzed in order to conclude when degradation of the products would occur. Degradation is present when there is a risk involved with continuing use of the products. Every product is different when it comes to expiration date so there are not always pre-set parameters that outline how an expiration date should be set. Serious consequences just aren’t worth it in these instances and the kit should either be returned or disposed of. There are typically five different sections that medical-grade products fall into when being assessed and that includes:
- Physical
- Chemical
- Therapeutic
- Toxicological
- Microbiological
Physical Breakdown
Over time, with the packaging or the items in the tray change their composition?
This applies to viscosity, elasticity, appearance, strength, etc. Storage conditions may affect the product integrity and this is often listed on the exterior of the package as it applies to an expiration date.
Chemical Breakdown
A custom medical procedure tray will expire based on ingredients that may be present that are known to break down over time. Also, does the packaging break down over time in a way that would compromise the safety of the tray?
Microbiological
Medical procedure trays must stay sterile in order to be safe to use. Over time, this can change based on storage factors and the amount of time that passes. Sometimes preservatives are used and those have their own expiration date. Sometimes, special inspections need to be done periodically to ensure the sterile nature of the tray is in tact.
Therapeutic Breakdown
When expiration is considered, will the tools or device included in the procedure tray be able to function after a certain point?
Toxicological Breakdown
If the expiration date reaches its full maturity, will the product become toxic or unsafe?
Custom medical trays can be very simple or very elaborate with some trays dealing with minor conditions while others are used for more complex surgical procedures and such. When the expiration date is set according to proper standards and a medical facility follows these guidelines, the tools in the custom trays will work how they were designed. While there are other factors that may go into a natural defect with a tray, shelf life or expiration dates generally mean the product will be structurally in tact when needed.
