I know this lecture did not touch much of product recall. But, how should company/researcher response when there is recall request from FDA or other regulations? Are there different stages of severity of recall and how to react?
FDA and manufacturer monitors the products in the market whenever the manufacturer founds any product defective or potential harmful they would recall it or sometime FDA recalled the product after customer complaints. There can be number of reasons like health hazard,poorly packed or labeled. Recall effects the business badly ,it often tarnishes the brand behind the product due to the lack of faith in the products they produce, causing sales to decrease. It can be avoided by using highly specialized skills in quality control, automated manufacturing, validation, and verification. From the initiation phase make sure that the product is defect free. All segments of the supply chain must work tightly together to avoid product recalls Damage occurred during transportation of product also causes recall that means the product should be delivered unspoiled to the end customer. The product should be closely monitored during design and production phase and even after production stage to identify the defect and deal with them. Any changes regarding. design,engineering,manufacturing ,cost, performance should not effect safety of product.There are classI ,classII, classIII recall.In an FDA Class I Recall, there is significant and immediate danger of death or other serious injury from the use of the product being recalled. Class I recalls are pretty rare, but they should be obeyed as soon as you become aware of them. A Class II recall is issued where there is no immediate danger of death or other serious injury linked to the product, but the risk of death or a serious injury is still present. A Class III recall is more preventative in nature, but there are still health and safety risks involved.A Class II recall is typically issued where there is no immediate or perceived danger of any health issues, but where items have been released that are in violation of FDA regulations. An example of a Class III Recall is the 2010 recall of children’s medicines that were potentially contaminated with small pieces of plastic during the manufacturing process.
As mentioned previously, there are different stages to recalls; each one being more severe than the other. The FDA can inform the company on a strategy on how to proceed with the recall, either through public announcements or coordinating return of the products to the manufacturing company. Much of this is done through formal documentation as a paper trial indicates compliance with regulatory agencies. Recalls can be a huge legal issue which is why many cross-functional teams should be employed in the recall process. Regardless of the recall, companies might be required to file a CAPA to prevent a recall from happening again. This document may include the specific design changes and quality improvements depending on why the recall was issued in the first place. Overall, recalls can make or break companies as recalls really impact the reputation of pharmaceutical companies. A bad response to a recall, or an involuntary recall that severely endangered patients can easily lead to the failure of the company.
In the case of a recall, Medical Device Manufacturers should take the following steps on what to do.
First, a letter should be sent to clinics, doctors, patients, and all stakeholders of the recalled device describing the reason for recall, and the requested action to take. Depending on the severity, the device may either need to be destroyed, returned, adjusted, or modified. The Manufacturers also need to create a new protocol or treatment plan for all patients affected by the recall. The Manufacturers need to be in constant communication with the FDA regarding its recall process, and all progress and updates. The FDA will decide whether to approve the recall strategy.
