Disposable Medical Device Manufacturing – Consultants | Operon Strategist
Disposable Medical device manufacturing or single-use medical devices are medical devices or any medical apparatus or instrument which has the capacity of being used only for once or which has one time use. Disposable devices are used in hospital or healthcare sectors and then after used is been disposed of. The FDA defines that this device is entitled by the manufacturer and the intended use for this medical device is for one single patient and one procedure only. This means that the device is not reusable and has a short lifespan and it is only limited to one patient.
There are numerous types of single-use medical devices, ranging from external, such as plastic gumboots, gloves and bandages merely used to assist a patient to more complex and internal devices, consisting of sharp blades, needles and tubes. Both these devices are Disposable or Single used, because of some reasons, but most importantly when it came in contact with radioactivity, blood infection and disease or the human tissues and must, therefore, be Disposed or terminated.
We provide regulatory consulting for medical devices manufacturing
Each country has its own strict rules and regulations regarding Disposable medical devices and the reprocessing of medical devices in hospitals and clinics.
The only reason for creating Disposable medical devices is for infection control. When a medical device is used only once it cannot pass any infectious disease to or any infectious agents to subsequent patients. One might think the most important factor in the design of Disposable medical devices manufacturing needs to be careful and balanced between performance, cost, reliability, materials and shelf life.
Plastics are often used in the Disposable medical devices manufacturing because they are comparatively inexpensive and there are many different types of it. In a medical device such as syringe that has to sustain extreme pressure, polycarbonates are used because of their strength. PVC Polyvinyl Chloride which is the third most widely produced synthetic polymer after polythene can also be used for its flexibility.
On the other hand, Reusable medical devices are more costly materials such as ceramic or steel.
Disposable medical device manufacturing mainly depends mainly on injection moulding plastics which is assembled by bonding, glueing, and ultrasonic welding or radio frequency welding. The high producing volume of disposable medical devices calls for an automated assembly in clean rooms to avoid human contact. Unlike Reusable device which is frequently sterilized at the healthcare facility, disposable devices are sterilized before leaving the manufacturing site. The medical device design and packaging must be accommodating the sterilization.
Operon Strategist has a team of trained professionals, As Turnkey Project Consultants, we work on complex technical problems and guide in planning the medical device manufacturing plant layout, manufacturing plant layout design.
The reusing or the reprocessing of medical devices labelled as disposable medical devices have been standard practice in U.S. hospitals for years because it makes it less expensive and also reduces the material waste. But before the medical devices are being reprocessed or reused theirs a third party or a hospital reprocesses should comply with the same requirements that apply to the original equipment manufacturers according to the US.FDA regulations.