What Should Your Medical Device Company Consider When Developing a Mock Recall Planning Strategy

Having a developed and tested mock recall plan is critical for medical device companies in the event of an actual product recall. Even if your company has never faced a recall, the complex and dynamic nature of healthcare innovation means that one day you might. Learn the 8 steps to effective mock recall planning strategy. Read on.

Did you know that there were 2607 medical device recalled in fiscal year 2021? The FDA regulates over 190,000 different devices manufactured by more than 18,000 firms across the world.

No matter the reason for the recall, how a medical device company handles it can make a big difference in how consumers, the FDA, and stakeholders view or interact with the company in the future. Planning and conducting mock recalls is highly recommended by the FDA. Make sure you’re putting the best foot forward by leveraging the right mock recall management strategy.

Mock Recall Planning Strategy for Medical Devices

What is a mock recall strategy?

A firm’s mock recall strategy is a planned specific course of action to be taken in in the event of an actual recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall.

8 Steps to an effective mock recall planning strategy takes into account:

  1. The results of the risk assessment
  2. Ease of identifying the affected products(s)
  3. Degree to which the product deficiency is obvious to the consumer or user
  4. Degree to which the product remains unused in the market-place
  5. Continued availablity of essential products
  6. Depth- levbel in the distribution chain
  7. Public Warning – purpose is to alert the public that the products being recalled presents a serious hazard to health
  8. Effectiveness Checks – verifies that all consignees at the recall depth specificed have received notification and have taken appropriate action.

The recall strategy will specify the methods(s) to be used for and the level of effectiveness checks that will be conducted.

Next are different examples of a medical device company’s mock recall communication strategy and responsibilities.

A recalling medical device company has a responsibility to its consignees, anyone who received, purchased, or used the product being recalled to:

Promptly notify its direct accounts via a recall communication which can include press releases or providing details instructions. Mock recall communications should also supply information to help users identify the product and take steps to minimize health consequences.

Medical Device Recall Communications should include:

  1. Identify product subject to recall
  2. Explain the reason(s) for othe recall and possible hazard involved
  3. Explain that further distribution or use should cease immediately
  4. Direct accounts should be notified
  5. Direct accounts should notify its customers who received the product, where appropriate
  6. Instructions regarding what to do with the product should be included

Medical Recall Communications should not include:

  1. Irrelevant qualifications
  2. Promotional materials
  3. Any other statement that may detract from the message

Consignees that receive a recall communications should immediately carry out the instructions set forth by the recalling firm, where necessary, and extend the recall to its consignees.

Record Keeping

Telephone calls, emails, texts, or other personal contacts should be confirmed by written communication and or documents in an appropriate manner.

Follow-Up Responsibilities

Quality System Requirements

  • Firms are responsible for following the Quality System Requirements found in 21 CFR Part 820.100 thru 21 CFR 820.250
    • Establishing and procedures implementing corrective and preventative action that will aid in ensuring that the necessary corrective fixes are made on all units.

Additional information can be viewed at FDA.gov.

Developing a mock recall plan can be overwhelming.

Take Nothing For Granted – IT’S TIME TO CHALLANGE YOUR ORGANIZATIONS RECALL READINESS

Learn everything there is to know about planning and conducting Mock Recalls and Recall Simulations for all industries

Meet Mock Recalls

MockRecalls is a mock recall planning, training and consulting company focused to test your recall readiness.

We are purely focused on protecting your product investment by working with you to create a new recall plan or analyze your current recall plan and then put it through a mock recall or recall simulation test to insure you are prepared for a possible product recall.

Mock Recalls, was created by our sister company Trievr Recall Management. Trievr has been helping organizations in pharma, medical device and several other industries successfully conduct product recalls and withdrawals seamlessly through its SaaS based on-demand system for over 10 years.

While working with many of its clients, TRIEVR discovered that most had a recall plan in place, but many had not tested the recall plan with a mock recall inventory-based traceability exercise or a recall simulation to test the organizations entire process.

To meet this vital need, Mock Recalls has partnered with RQA, Inc., a global leader in providing quality assurance, crisis management, and risk mitigation consultancy and training, to offer a recall simulation and mock recall training program, utilizing TRIEVR’s Recall platform, that challenges your organization’s capabilities and training and readiness, from initial incident identification to recovery of the affected product.

Looking to test your product recall readiness? MockRecalls will help create and/or test your recall program. Click here to learn more or call us!