How Medical Device Packaging Protects Life-Saving Devices
In the crucial cycle of developing a medical device, all the other processes, such as coming up with the device itself, takes center stage while the packaging is thought of last. But if one thinks of the medical device development cycle critically, it is impossible to ignore the ramifications that come with improper packaging.
What is a medical device?
In healthcare care, the range of medical devices is broad, but basically, we can define it as any tool used for medical purposes. It can be as plain as a glove or a blood glucose thermometer to the more complicated devices such as CAT scan machines. Its sole purpose is to help a health professional carry out his duties in diagnosing and treating patients.
Why is a medical device package important?
A medical device package is simply any packaging that is used to ensure that the medical device remains sterile and safe after production until it has been opened and ready for use by a healthcare professional. This could be clamshells and blister packs for pills and syringes or special barriers for packaging medical devices that are complex, like transplant kits.
Compliance with the FDA
It is crucial for a manufacturer to pay attention to the medical device packaging they use so as to remain compliant with The Food and Drug Administration (FDA). The FDA’s policies require the packaging used to be not only resilient but sterile and well labeled for ease of tracking.
Avoid money and time wastage
While packing medical devices, all efforts should go towards ensuring maximum protection from external elements during transportation, such as bumps or vibrations that could shake the contents of the package. Unlike in the case of non-medical products that can be returned and exchanged for another one in case of damage, the process of returning a medical device is more complicated and expensive. The situation can be worse if a hospital receives a shipment of life-saving devices that are defective and there are patients in dire need of them.
Protect the life of a patient
Unfortunately, not all damages are evident from the offloading of a shipment. A medical device could fail during use or after it has already been implanted in a patient. While the manufacturer could have made sure the device passed all the quality tests and analysis, damage that is not immediately visible could have occurred during transportation, storage, or before use due.
Such a situation could mean serious issues for the manufacturer, such as lawsuits, bad reputation, harm, and death. It is, therefore, its crucial to note that maintaining high standards while packaging medical devices is just as critical as manufacturing the product itself.
In conclusion, the manufacturer of the medical device should include the process of coming up with packages before, during, and after the production of the said devices. Every element of the device is critical to the production of the package, such as the size, weight, shape, and texture. The package should go through various tests like shake, drop, vibrations and package strength tests to ensure it will protect its contents well.