What is the proper way to store medical devices?

There is an opinion that storage and transportation conditions do not have to be strictly observed for MI, unlike for medicines. However, this is incorrect. Storage of medical devices is directly related to two indicators - stability and quality of the packaging material. It does not matter where exactly the MI is waiting to be used, whether at home, in a pharmacy or in the manufacturer's warehouse, it is important that the prescribed storage conditions are observed. We have previously discussed in LCS Blog product testing and detailed stability.

There is also an opinion that rubber medical devices do not have to be stored in the right conditions, it is enough not to open the packaging. However, this is also incorrect. Rubber products are also subdivided into perpetual and shelf-life products. It should also be understood that such products are indefinite conditionally. Most likely, their stability is proven within 10-15 years. These are, for example, rubber heating pads, forceps, pipettes, pacifiers, etc. These are reusable goods, which means that they are disinfected and treated after or before each use. But there are also medical rubber products with a shelf life and a fairly high risk class. For example, condoms, Folley catheters, gloves. And they are most often limited to 3 to 5 years before opening the package and are disposable. For both products, it is necessary to follow the rules for storage of rubber products in the pharmacy, hospital and at home.

Medical devices are stored according to the manufacturer's instructions and most often avoid critical temperatures and humidity. Because if the same perpetual rubber products are stored under very dry and hot criteria, they will not wait for use, the rubber will crack and fall apart. Therefore, the storage of rubber products in the pharmacy, before they are bought by the customer, is under the same conditions as in the warehouse at the manufacturer. And then, at home, it is also necessary to follow the manufacturer's instructions to preserve the MI and prolong its service.

When it comes to sterile products, it is important for us to remember that their shelf life depends on the packaging. The extent to which the packaging is a reliable barrier determines both the length of preservation and the effectiveness of the product once opened. Why does humidity have a big impact on sterile packaging? If MI is sterilized by steam or gas, it is made vapor/gas permeable and at elevated humidity, such packaging can allow microorganisms to pass through. Critical temperatures, such as extreme cold or heat, can lead to cracking of the package or damage to the adhesive bond, which also affects the maintenance of sterility and other product properties.

Transportation and storage rules must be strictly observed for medical devices, as the devices and their software are sensitive to changes in climatic conditions and may malfunction or produce false results. Failure to comply with the rules when maintaining the safety of MI can lead to many negative consequences, such as inefficiency in use, user complaints and even harm to health. It is particularly important to follow these rules for in vitro diagnostic products. All kinds of tests for the detection of substances contain thin layers of reagents that are very sensitive to temperature. Therefore, many such products have very strict thermal limits, +2+8, refrigerated environment only and so on. If such products and techniques are tampered with, false results are guaranteed. 

Storage and use requirements are also marked on product labeling and are most often indicated by symbols. Not only temperature and humidity can adversely affect quality, but also open sunlight, excessive shaking, and sudden changes in climatic conditions. And for some devices, physical isolation is also necessary to prevent interference from noise sources, vibration and other signals from affecting the performance of the equipment.

Storage criteria are strictly adhered to when transferring specimens for laboratory testing as part of registration. Those species that require special conditions are transferred with temperature and humidity loggers. And until the moment of their testing, the laboratory must adhere to the instructions for proper storage. Because, if they are violated, the test results of such samples may be incorrect, and such a situation may be interpreted as a defect. In such cases, the laboratory's records and source data should first of all be used to verify that the prescribed rules on specimen storage and preparation were followed during and before testing. More detailed advice on the subject of specimen submission during registration can be obtained by clicking here LCS-kz.