fbpx Inspected in the USA | American Diagnostic Corporation

Inspected in the USA

Written By: 
Michael Falco / Quality Manager

ADC products, including our line of sphygmomanometers, are inspected and assembled in the USA for the highest quality.You hear it on the news all the time; some product has been recalled from the market due to a defect or safety concern. It is something that touches each of us, from concern over the foods we eat to the consumer products we purchase regularly. One of the most effective ways of combating the potential for defects and non-conformities is through the development of test protocols and equipment to ensure a higher level of quality.

To add this level of quality assurance, we perform all of our testing here in the USA using proprietary test equipment and processes. At our facility in Hauppauge, New York, we have installed and developed an ever-increasing number of test protocols that allow us to inspect each and every component that makes it into a finished medical device.

Sphygmomanometers and stethoscopes have many individual component parts, many of which have specific standards that apply to them. Using calibrated measurement equipment that includes calipers, scales, torque testers, and other tools, all of the component parts of our devices are carefully sampled and inspected.

Some of our proprietary test equipment, including the cuff endurance tester, the valve leak tester and the NIBP simulator.Our wide array of test equipment also includes a number of custom-built pneumatic machines that can test sphygmomanometer parts for leakage, gauge accuracy, cuff endurance, bladder leakage, and gauge endurance. Many of these tests are destructive, and we take samples from each batch and put them through a full lifetime of inflation and deflation cycles to ensure that they can stand up to the rigors of everyday use.

Of course, all of this test equipment would not be useful without proper calibration. We regularly check our measurement tools, using both internal and external references to ensure that they remain in calibration. For our primary reference tools and key pieces of equipment, we contract with external calibration companies to ensure that our equipment is traceable to NIST standards. With certified calibration of this equipment we can be sure that our measurements are accurate and that we are delivering the highest quality product.

What does all of this mean for our customers? It means that components used in an ADC medical device have been tested and inspected meticulously using calibrated tools. It means that our devices will last longer, withstand more rigorous use, and that when the time comes that they do need repair, the repair parts will fit properly and be just as tough as the original components. The steps we take to test our products in the US simply bring a higher quality of medical devices to the market.