Recall Case Study: Achieving FDA Compliance in an Average of 10 Weeks

A global healthcare organization had multiple nationwide recalls with over 1.8 million units in 2,500 facilities. Facing internal bandwidth constraints, Novasyte was hired as the partner-of-choice to manage the recall execution.

Goals

The customer’s goal was to complete the following tasks as quickly as possible.

• Notifications: 100 percent notification attempts, as per FDA guidelines, with a minimum of three attempts per facility/consignee
• Response Rate: 80 percent response rate from facilities/consignees
• Timeline: No hard deadline was provided but the request was for the recall to be completed as soon as possible

Solution

Novasyte responded immediately by integrating the consignee data provided by the client into the S.M.A.R.T. Platform to start the validation and notification outreach process. The response plan also included leveraging the S.M.A.R.T. Platform to track and manage the initial notification, acknowledgment, remediation and effectiveness check validation – all in real-time, against a unique ID.

Novasyte built a customized response portal and provided a scalable call center to perform outbound phone calls in an effort to notify non-responding facilities. Weekly status reports were provided to the client to ensure close monitoring of the recall progress, facility responses and expected product returns.

Results

By working with the customer to prioritize accounts, Novasyte was able to achieve the following results.

• Time to Close: 
  • 4.6 average days for the FDA to close each recall
  • 24-week average to complete all recalls
• Compliance: Achieved FDA compliance in an average of 10 weeks 
• Response: 83 percent response from facilities/consignees
• Product Returned: 55,320 units of product returned
• Consignee Satisfaction: 81 percent of survey results said the entire process was simple to follow, with a number of consignees indicating it was the simplest recall experience they have ever faced
• Budget: $2,000 under budget
• Data Cleansing: 1,941 new contacts were identified (name, title, email, phone)

Learn more strategies for how Novasyte increases the accuracy and speed of a medical device recall in the white paper here.