In the rapidly evolving realm of medical technology, a major focus must be maintained regarding...
Effective Management of Medical Device and Pharmaceutical Recalls
Product recalls are an unfortunate part of any manufacturing industry. For medical devices and pharmaceuticals, recalls are serious affairs requiring swift corrective action. Each year, an average of 4,500 drugs and devices are removed from the market due to recall. In 2017, the FDA identified more than 30 Class I recalls, where further use of the product could result in serious injury or death. Already in 2018, an additional 6 more Class I recalls have been identified.
If you have recently identified a product recall, there is no time to waste. Once a recall has been recognized, management must work quickly begin the process of pulling faulty product out of the market. An effective strategy is imperative to a successful recall operation. Medpoint has consultants available with extensive recall experience who can help you develop a plan of action and get the process started. Here are some areas we can help.
Building Your Team
Apart from all the affected internal departments, the ideal recall team may need to include qualified consultants with expertise in regulatory, quality, operations, and manufacturing. Beyond the additional resource that consultants provide to assist with the recall process, an experienced consultant may also be able to identify risk areas and QMS shortfalls that led to the recall in the first place.
Identifying Extent of the Recall
With the team in place, time must be taken to identify all the possible affected products. One component may be used in or interact with a variety of medical devices. If the exact extent of the recall is not correctly determined, faulty product could be left in the market, with potentially fatal results. Knowledgeable Medpoint consultants can help to review the necessary documentation and ensure nothing is overlooked.
Notifying Affected Parties
Increased use of automation in the notification process has greatly aided the efficiency the recall process; however, depending on the nature of the recall, additional steps may be needed to ensure faulty product is removed from shelves and no longer presents a hazard. Consultants can greatly aid in effectively communicating the recall, allowing management to focus on strategic decisions.
Isolation and Destruction
Ensuring faulty product is correctly and fully retrieved from the market is not the end of the recall process. If it is not adequately destroyed, there is always the chance it could be accidentally released back to the market. Because of this, the FDA has strict expectations when it comes to the methods of isolation and destruction used to render recalled devices unusable. Medpoint consultants can help you develop a plan of how best to isolate and destroy recalled products.
Root Cause Analysis
While completing the recall process is the priority, if the root cause is not identified and corrected, it is only a matter of time until another recall. An effective recall team cannot stop with simply addressing the immediate problem. Consultants experienced in root cause analysis will help you determine if the recall was due to physical, human, or organizational causes. Medpoint has consultants familiar with a variety of root cause analysis techniques, including: 5 Whys, Drill Down, and Fault Trees, among others.
If you are currently facing a recall operation, Medpoint can help.
While the process can seem overwhelming, our consultants have experience developing recall strategies, evaluating the root cause, and effectively contributing or managing the overall process. Find out how you can partner with Medpoint today: firstname.lastname@example.org.