Modern Labeling News

An educational BLOG for professionals in the labeling, coding, marking and track / trace fields.

Mitigating Medical Device Recall Impacts

As a medical device manufacturer, what are the odds that you will be faced with a product recall? The chances have increased significantly if the number of medical device recalls continues along current trends. While rates were unusually low in the 1st quarter of 2015,, a research project that mines publically available data at OpenFDA API, reveals a total of 944 medical device recall enforcement reports were filed in the first six months of 2015. Considering the significant economic impact recalls can have on your business, taking steps to avoid recalls and respond efficiently when one does occur can be critical to the viability of your company. Here are some tips for mitigating potential fallout that can occur from medical device recalls:

Know the Major Reasons for Recalls. Modern Labeling News recently reviewed a report from  highlighting the Major Reasons for Medical Device Recalls. Ineffective device, software and component design and improper on-site manufacturing practices were at the top of the list.

Take Steps to Avoid Recalls. Taking proactive steps to have the most efficient, configurable and integrated packaging execution software running your production line can make a huge difference in avoiding recalls. Data collection, packing line management, labelling, metrics, scheduling, track-and-trace and mandatory reporting requirements can now be fully managed in one comprehensive interface. Keeping the medical device production line fully accountable to strict quality control measures while reducing the margin of employee error can substantially cut recall occurrences.

Have a Recall Strategy in Place. When a recall is necessary, having a recall strategy already in place will determine how well your business interacts with FDA inspectors, and ultimately how your company rebounds from a recall.

According to Rita Hoffman,RAC, Managing Partner Regs & Recall Strategies, LLC and Former FDA CDRH Recall Branch Chief, the following elements should be considered when developing an effective recall strategy:

  • Results of the firm’s health hazard evaluation (risk assessment).
  • Ease in identifying the product being recalled.
  • Degree to which the product’s deficiency is made clear to the user, consumer and consignees.
  • Degree to which the recalling product remains unused in the marketplace.
  • Continued availability of essential product.

“Firms should consider developing in-house programs to training all staff on each aspect for implementation of an effective recall. The training should include recall readiness assessment, recall plan development, staging a mock recalls, recall execution and results. Having a recall management plan in place before it is needed will assist employees in the knowledge of their roles and responsibilities during the recall process and will avoid a “Management by Crisis” scenario.”

Knowledge of what causes recalls, installing a packaging execution software that facilitates fast and accurate implementation of a well-planned recall strategy can make or break a firm’s ability to navigate medical device recalls with minimal damage to reputation and product success. Talk to an industry expert at Matrix SSI for more information about reducing the impact of medical device recalls today!, (716) 504-9700,

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