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Recall Classifications and the Importance of Electronic Communication in Healthcare

July 5, 2022

Over 45% of Americans take at least one prescription drug. These patients rely on their physicians, the U.S. Food and Drug Administration (FDA), and suppliers to protect their safety and wellbeing regarding medications and medical devices.

We wouldn’t need a recall communication program to ensure public safety in a perfect world, but unfortunately, mistakes happen. There is an average of 4,500 prescription drugs and medical devices recalled every year in the United States. These mistakes can be hazardous to public health and jeopardize manufacturers, suppliers, and providers financially.

Recall guidelines, classifications, and electronic communication in healthcare through recall management are vital in identifying risks to public safety and taking action to mitigate those risks. 

What is a Recall? 

A recall is the process of removing or correcting defective or potentially harmful products that violate FDA-administered laws. In most cases, a manufacturer or supplier voluntarily issues recalls.

Medical device recalls are generally conducted voluntarily by the manufacturer as the result of some quality issue that has the potential to impact public health. Although not always mandated by the FDA,  That being said, the FDA can raise concerns and suggest a product recall. Under FDA regulations, the manufacturer or importer is then required to make a formal communication to the inform the agency of any corrections or removals and the steps taken to remove any risk to health.

During a recall, patients may be provided with refunds or replacements with clinical equivalents of the product. Furthermore, medical recalls can also significantly impact drug shortages and supply interruptions. 

Once a recall is issued, electronic communication in healthcare is key to improving supplier compliance times and informing providers and patients promptly. 

Recall Classifications 

A significant part of the recall communication program is the recall classification. Recall classifications are defined through an FDA health hazard evaluation. That classification is based on the severity and probability of injury that a medical device or prescription drug may impose.

Additionally, a supplier may issue a market withdrawal to correct or remove a product that involves minor FDA violations that may not impose legal action by the FDA.

Recall classifications include:

Class 1 Recall. Class 1 recalls are the most severe and present a reasonable probability that the exposure to or use of a product will result in severe harm, lasting health consequences, or death.

Class 2 Recall. Class 2 recalls are issued when the use or exposure to a product may result in medically reversible or temporary health consequences.

Class 3 Recall. Class 3 recalls refer to minor errors and defects in a product that is unlikely to harm a patient’s health or wellbeing.

Market Withdrawals. Products that do not show evidence of problems in manufacturing and impose minimal or no FDA violations may be removed or corrected through market withdrawals. 

Product Advisory vs Product Recall 

Product recalls, and product advisories are often used interchangeably. However, while these recall communication program processes are interlinked, they do not refer to the same step in recall management strategies.

A product advisory is the process of notifying providers, patients, or the general public of product recalls.

Traditionally, these notices are inefficiently sent by mail, leading to recall delays, miscommunications, and duplicate notifications. This inefficiency can endanger public safety and lead to recall fatigue, furthering patient risk.

Fortunately, electronic communication in healthcare streamlines the recall process, resulting in faster communication, accuracy, and patient safety. 

Embracing Electronic Communication in Healthcare With NotiSphere 

The FDA recommends all medical suppliers and providers use electronic communication in healthcare as part of their recall management strategy.

NotiSphere is a leading recall management solution connecting suppliers and providers to improve patient safety while reducing the time and money spent on the recall process. No matter what steps must be taken to minimize risks to public safety, electronic notifications ensure that communications go to the right person quickly.

Let’s improve recall communications together. Contact NotiSphere to receive and manage recall alerts effortlessly.  

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