A common medical device that is used in hospitals that is essential to run a stability test on is some sterile and non-sterile medical devices. Sterile devices specifically need to be stability tested to ensure that sterilization does not break down/degrade the components of the device. Also, a sterile device needs to stay sterile for the lifetime that it is needed before the instrument/device is being used. It is imperative that sterile items stay sterile until used or that will defeat the purpose of the item being sterile. If the device is something needed for surgery and the stability cannot hold and stay sterile that can pose a huge risk to the patient that is being operated on and can affect the outcome of a patient's risk of infections.

I think the common medical devices hospitals use are in fact drugs/pharmaceuticals. Knowing the stability life of pharmaceuticals is important because they need to know the product's storage life, storage conditions, and the overall quality for patients. Drug companies must observe the different chemical makeup of the product because this will impact the safety of the consumer, so it's vital for the company to conduct a stability test before putting it out on the market.      

@shkennedymsm-edu I agree with your point of view on this subject.  Stability testing is just as important as pre-clinical or clinical testing because the data shows the staying power and active ingredient or component has over time. For example, if data shows that the stability of aspirin degrades after an hour, researchers might consider adjusting the active ingredient to allow for a longer potency to benefit customers.  At my company, we evaluate the stability of our product every quarter over a period of 90 hours to examine how the product behaves in transit as well as once its been infused in the patient.  Even though our product has been on the market for decades, the stability data has been consistent which is beneficial to the patients.

Stability testing is important for the pharmaceutical industry and medical device industry. It is a process for determining, through storage at defined conditions and testing at specific intervals. It should be required for all companies to conduct stability testing to ensure their products and devices are performing at optimal levels before becoming available for patient use. I work at a pharmaceutical company any we test in-process samples, stability samples, and final container samples. Each of these have to pass testing or products could be taken off the market.

@alexbryant-harden I think this is a great choice and I want to elaborate a little bit. The sterility of some product is obviously important because if it is compromised, a patient could develop an infection and die. This is a high risk situation. What I think is interesting is that it isn't really the sterility of the device itself that needs stability testing, but the packaging that prevents a sterilized device from becoming nonsterile.

This means the autoclave bags or shrink-wrap packaging is actually what needs the stability testing in this case because the inner device or product can only fail the stability testing and become contaminated if the packaging fails. The packaging is not necessarily part of the design of the device so that may not be a part of the stability testing of the device, and instead it would be the responsibility of the packaging manufacturer (who may be different than the device manufacturer) to perform stability testing on the materials used in the packaging.

An extremely important device that should be stability tested is the IV needle. These needles vary in gauge and application depending on user age and vessel availability. As such, there are many factors to consider when creating the needles. The IV can be used for a couple hours or a couple weeks, and the needle should not have any biocompatibility issues through the whole duration. The drugs or saline delivered through this needle are distributed systemically, as such, hemocompatibity and systemic toxicity are important factors to consider when doing stability testing on this device. This can extend to the IV line and the IV bag as well, as all of these components can leech material into the fluid and potentially harm the patient. Stability testing on products like an IV must be strenuous and thorough, as the device directly interfaces with the patient's vital systems.

An example of a device from class that would require stability testing is a catheter. I think catheter tubes in particular need to be characterized for stability testing, as the polymer bonds will degrade if UV radiation starts forming free radicals within the polymer. This can lead to degradation byproducts, which can interact adversely and/or unexpectedly with blood plasma, leading to clotting and/or immune system activation.

I think another medical device that would be required to undergo stability testing would be wound dressings. The dressings need to be packaged in a sterile manner and must remain sterile until they are opened and applied to the patient. Also, depending on the type of dressing it is, its properties must remain stable. For example, you would want to open your dressing package and see that the dressing is intact, not degraded and not falling apart. Another example would be the hydrogel dressing -- you wouldn't want to open it and find a dehydrated dressing or one that couldn't keep its form. Having dressings that aren't stable until use would make it hard to treat a burn patient, for instance. Degradation of the product could produce undesirable by-products and generally just render the device useless.

One common device that comes to mind where stability is extremely important would be a stent. A stent is like a type of scaffold that is designed to help keep arteries open to allow blood to flow easily. If the stent is not stable enough to be implanted within a person, there is a high risk of blood clotting, aneurysms, and other complications. The device would essentially not serve its purpose if not stable enough to do its job in the artery.

I agree that stability testing is extremely important and I agree with @shkennedymsm-edu that the stability testing of drugs and other pharmaceuticals is definitely essential. Many drugs have multiple components and should the integrity or effect of one of these components change over a period of time, the overall effect the drug has could not only differ from what was intended but even become detrimental to the patient. While stability testing for needles and other sterile equipment is important, they tend to be made of less types of materials when compared to the different chemicals in drugs. 

I think that breathing tubes are definitely something that requires extreme stability testing. Breathing tubes are commonly used in surgery to help patients breathe. Depending on the difficulty of the procedure, a patient might be on a breathing tube for up to many hours or even days during surgery. Most modern breathing tubes are made up of the polymer polyvinyl chloride. This polymer can lead to many complications if left in a patient for too long, including bleeding, infection, fluid buildup, and aspiration.

Stability testing is done in order to maintain the function as well as to make sure the product is safe to use, such as the use of IV needles, which need to be sterilized. These types of products in the medical industry, such as needles, instruments, and medicine, among others, need to be sterile in order to protect the patient and not cause harm by introducing a foreign invader. These things need to have stability tests run in order to minimize any effect of microbial growth on the object. Making unnecessary bacteria infect these instruments and medical tools would harm the person and cause long-term effects, and this would signal the person how long the object has for a shelf life, to put it simply. Putting it in terms of drugs or cosmetics makes it simpler to think about this issue because these medical devices as well as these materials need stability testing done in order to find issues with the product months or years down the line. These kinds of studies are done in order to analyze any microbiological growth or any shelf-life issues of the similar products put here for medical devices.