Ready for Recalls: Effective Procedures are Critical for Manufacturers, Distributors, and Hospitals

Medical product recalls are costly, sometimes debilitating.  Medical device recalls surged in early 2018 to the highest level in over a decade.  These recalls largely resulted from problems with device software or errors by contract or in-house manufacturing (quality issues, labeling, or manufacturing defects).  While rigorous design controls, supplier quality programs, and in-house quality controls may prevent such issues at medical product manufacturers, some recalls are inevitable.  During a period of financial uncertainty and a limited (and highly mobile) pool of experienced personnel, medical product manufacturers cannot expect a decrease in recalls resulting from such errors.  Every organization in the chain of custody therefore must be prepared to handle inevitable recalls of medical products.

Poor execution and handling of a medical product recall poses a health risk to patients, a financial burden to all involved parties, and liability for the use of recalled product in a health facility.  Timely initiation and handling of medical product recalls is critical to minimize the impact of potentially defective products.  And, recall expenses can be minimized for health facilities, healthcare payers, manufacturers, and distributors with appropriate recall policies in place across all organizations in the chain of custody.  In 15 years of coordinating product recalls, I’ve noted two greatest challenges in reaching timely resolution of recalls:

1) communication and policy gaps between the organizations in the chain of custody (e.g. manufacturers, distributors, hospitals, etc.)

2) inadequate planning for initiating recalls (manufacturers and distributors) and handling recall notifications (health facilities)

These problems prevent health facilities and distributors of medical products from receiving or acting on recall notifications in a timely manner or at all.  The use of recalled products is easily prevented but many organizations do not have adequate recall procedures.  Fortunately, in coordinating numerous medical product recalls affecting thousands of hospitals, I’ve also identified solutions to these challenges.  To ensure patient safety and increase healthcare value, let’s work together in building strong quality management systems that prevent design defects, reduce quality defects, and quickly address any issues that do arise despite a robust quality management system.  We must synergize our recall systems to ensure seamless and rapid completion of recalls.

Brosseau Consulting provides consulting services to both healthcare organizations and medical product companies to ensure that recalls are effectively executed and that recall information is appropriately processed by distributors and healthcare organization.  If you are part of a healthcare organization, Brosseau Consulting will streamline and greatly improve your processes for acting on recall notifications.  As a healthcare organization, ensuring that recalled product is quickly quarantined and replaced results in better patient care and lower risks and costs for your organization.  For medical product companies, Brosseau Consulting will enhance your recall processes for regulatory compliance and to minimize financial and liability risks.  Distributors, Brosseau Consulting implements simple solutions to ensure your clients receive the best service in the event a recall impacts your product portfolio.

You can best manage the financial impact of a recall and effect on your reputation with expertly designed recall policies and procedures. In many cases, consultation pays for itself with enhanced safety, reduced risk, and financial savings for all parties involved. Please contact me at to arrange an introductory meeting or call to discuss our part in this critical and needed improvement of our healthcare system.