Medical device – Current Good Manufacturing Practices
Which medical devices require leak testing, flow testing, crack pressure testing, electronic calibration or other medical device testing for strict adherence to cGMP?
Medical device cGMP requires stringent testing standards for a wide range of medical products and medical devices. A short list includes:
- laparoscopic instruments
- blood collection kits
- IV bags
- medical tubing
- medical check valves
- oxygen delivery systems
- insulin pumps
- medical and pharmaceutical packaging
- pen injectors
- implanted medical devices
Which tests are critical to the cGMP of medical check valves
Plastic medical check valves need to work automatically with control by a person or any external control. An important concept in check valves is the cracking pressure, which is the minimum upstream pressure at which the valve will operate. Typically the medical check valve is designed for and can therefore be specified for a specific cracking pressure.
cGMP of medical check valves usually involves both leak testing and crack pressure testing. The most economical solutions combine both types of tests at a single test stand and use multi-channel leak test instruments.
Which tests are required for cGMP of on-demand oxygen delivery systems?
The triggering sensitivity of demand oxygen delivery systems is critical to the functionality of this type of medical device. Vacuum levels must be precisely calibrated to preclude both false triggering or difficulty in triggering such that patients’ breathing can be in sync with normal respiratory cycles.
cGMPs require that each unit is both thoroughly tested for function and fully calibrated.
Calibration is usually two-fold—
1) a sensitivity calibration monitors the pulse volume while adjusting the sensitivity potentiometer, and
2) a manifold calibration monitors the pulse volume while the flow is manually adjusted.
There are a wide range of oxygen delivery system product designs. Generally speaking, cGMP testing of such medical devices will minimally ensure that the device does not trigger unintentionally, checks that all pulse settings meet required volume limits, and meet flow test specifications. Usually ensuring that these medical devices also work in low-battery conditions is part of the functional testing process
Why and how is testing critical to medical product and medical device GMP?
Unlike sampling, GMP (Good Manufacturing Practice as defined by 501(B) of the 1938 Food, Drug, and Cosmetic Act (21USC351) looks at the integrity of the manufacturing process itself that is used for medical device manufacture.
An extremely important part of GMP is documentation of every aspect of the process, activities, and operations involved with medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US).
Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures demonstrate that they can perform their purported function. This bears on the integrity and FMP of a wide range of medical products and devices, such as leak testing blood collection kits and implanted medical devices such as pace makers, or flow testing obturators and other laparoscopic instruments, crack pressure testing of medical check valves, calibration of on-demand oxygen delivery systems, or functional testing such as the sufflation and insufflation capabilities of laparoscopic instruments.