According to NY Times, medical devices have resulted in 80,000 deaths and 2 million injuries. There are different types of defects in medical devices that can cause injuries to patients.
A design defect means that a product was manufactured according to its specs, but something in the design makes it dangerous to consumer. In most medical device companies, in order to bring an idea to life, a team of Engineers and scientists work together to create a feasible design. This process may take years to develop and often includes multiple variations of a prototype before the final design. Even though lots of studies are done prior to making a final design, not every aspect of a design can be evaluated and sometimes the defect can show itself after a period of time. However, at that point, most likely a patient is harmed.
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- Brain Injury
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Manufacturing defect means the defective product does not meet the manufacture’s intended design spec. Medical device manufactures have many quality control steps during the manufacturing of a medical device. Quality control team use different sampling methods such as 100% inspection or AQL sampling inspection. AQL Inspection or Acceptance Quality Limit is defined as “quality level that is the worse tolerable” in ISO 28591 as used in Medical Device Industry. The AQL defines the total number of rejects allowed in one batch of components or devices before that lot is being rejected.
The number of AQL sampling is determined by factors such as lot size, Inspection Type (General vs. Special) and Inspection Level. Quality Control team determines these classifications based on the severity of the defect, the chance of identifying the defect during the proceeding manufacturing steps, and the harm level. After this classifications, Quality Control team uses AQL inspection table to determine the sample size.
Not all lot/batches are inspected 100%. Some can be deemed acceptable if only 5 out of 30 units pass the inspection criteria. However, your defective product can be among one of the uninspected units.
Even if everything goes as planned during design and manufacturing, a product can still be defective if the manufacture does not properly inform the consumer of the risks involved with the particular product.
Our firm possesses lawyer with years of engineering background of working as manufacturing engineers in industry-leading US medical device companies. Our experience comes from years of working hand-in-hand with design, new process development, manufacturing and quality team.
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