An example I can think that would require many different validation processes in order verify that it is doing what its supposed to is an artificial heart valve. The valve must have been tested in the laboratory to mimic its function in the living body. The heart valve's purpose is to prevent the backflow of blood as it is pumped by the ventricles in the heart. The valves allow oxygen rich blood to be pumped from the heart to the rest of the body through arteries. Artificial valves must have been tested with different parameters to test the withstanding of pressure from a pump and from the force generated by backflow of blood. In addition, it would have to be continuously tested for durability in increased pressure and flow rate to simulate increased blood pressure, but also tested with ultimate low pressure to make sure that it will open and no impede flow of blood. Other tests would also include the normal biocompatibility validations of toxicity, compatibility and degradation, and shelf life conditions like temperature, humidity and others.
Abbott Cell-Dyn (CBC instruments)
verification protocol should have to test the amount of blood the syringe take in from the tube in both open and closed mode, the time it take to give the results, the shear valve segmentation of blood, the laser bench, Hg cell, white blood cell chamber, background read, and amount of carry over between samples. Each medical device have it is own method for verification and that depends on the device type.
Verification protocol is very essential to demonstrate the safety of the device on the user. an example would of a product that needs verification protocol before it is allowed for the public to use be the covid 19 vaccines. this product needs a tremendous amount of clinical trials to confirm the safety of the vaccine. there are long and extensive efficacy studies happening for months to gather a lot of results to conclude whether the vaccine is effective or not.
As stated in the question: verification is required to ensure that the product works and that it is safe for a patient to use.
An example of this would be bandaids.
I think, when designing a bandaid, it would be necessary to verify that:
1. The product can stick to skin without causing irritation or removing skin
2. The product can effectively stop mild bleeding and protect cuts and other injuries
3. the product is sterile; i.e it does not carry anything that can infect the wound
4: the product is able to remain on the skin for an adequate amount of time
The most recent medical product that took the prime concern of the FDA was the Covid Vaccine. The U.S. Food and Drug Administration is responsible for regulating vaccines in the US. Pfizer, Moderna, and JOhnson and Johnson vaccines all went through the same stages of approval.
There should be comprehensive stages for the vaccines to be approved for human use.
FDA has various steps; Exploratory stage, Pre-clinical stage, IND application, clinical phases, and Post-License monitoring. The exploratory stage would be the basic laboratory research of the vaccine; research on the virus, antibodies, and antigens. The Preclinical stage would be testing this information on animals. If the mice produce an essential immune response then the vaccine moves to the next stage of the protocol which is the IND application. The first two steps are the backbones of the process, which take several years to complete. However, for the Covid Vaccine, due to the special circumstances brought by the pandemic, the time frame of the process was extremely fast.
Thanks!
I would like to talk about the verification protocol imposed by FDA on Surgical masks. Inadequate fluid resistance, Inadequate barrier for bacteria, Inadequate air exchange (differential pressure), Flammability, Inadequate respiratory barrier for bacteria are some of the tests needed to be performed. Since masks usually have prolonged contact with intact skin, biocompatibility evaluation of the materials used in masks based on ISO-10993 is recommended. ASTM F1862 test is a standard test method for resistance of surgical masks to penetration, used to ensure fluid resistance. ASTM F 1215-89 is the test for flat sheet filter and ASTM F2101-01 is required to ensure bacterial filtration efficiency. CPSC CS-191-53 is done for flammability testing of the mask. These test results with a detailed explanation have to be included in the Design History File (DHF) to get approval from FDA.
