We were in a meeting room in a downtown Madison, Wisconsin, hotel. It was -25oF outside, and I was talking with Dan Brinkman, Vice President and Chief Operating Officer of Medical Equipment Repair Associates (MERA), a large independent medical service company. It was crazy cold outside, yet Dan was getting warm as he talked about how a medical device recall can raise pure havoc with a smooth-running manufacturer’s service organization. And as Dan talked and I kept learning, I finally interrupted him and said, “I have to write a blog post about this.” So, here it is:
WHAT IS A PRODUCT RECALL?
According to the U.S. Government, a recall is an action taken by a manufacturer, or the government, to protect the public from products (such as medications, food, vehicles, child safety seats, cosmetics, and more) that may cause health or safety problems.
WHAT IS A MEDICAL DEVICE RECALL?
According to the FDA:
When a company learns that there is a problem with one of their medical devices, it proposes a correction or a removal depending on where the action takes place.
- Correction – Addresses a problem with a medical device in the place where it is used or sold.
- Removal – Addresses a problem with a medical device by removing it from where it is used or sold.
FDA uses the term “recall” when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, an artificial hip) is recalled, it does not always have to be explanted from patients. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.
Examples of the types of actions that may be considered recalls:
- Inspecting the device for problems
- Repairing the device
- Adjusting settings on the device
- Re-labeling the device
- Destroying device
- Notifying patients of a problem
- Monitoring patients for health issues
Sometimes a company may be aware that there is a problem with a group of products, but it cannot predict which individual devices will be affected. To appropriately address the concern, the company may recall an entire lot, model, or product line.
WHAT DOES THE FDA DO ABOUT MEDICAL DEVICE RECALLS?
When the FDA learns of a company’s correction or removal action, it reviews the strategy the company proposes to address the problem, assesses the health hazard presented by the product, determines if the problem violates FDA law, potential violations of FDA requirements, and if appropriate assigns the recall a classification (I, II, or III) to indicate the relative degree of risk.
Class I: A situation where there is a reasonable chance that a product will cause serious health problems or death.
Class II: A situation where a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.
Class III: A situation where a product is not likely to cause any health problem or injury.
Once classified, the FDA monitors the recall to ensure that the recall strategy has been effective. Only after the FDA is assured that a product no longer violates the law and no longer presents a health hazard, does the FDA terminate the recall.
ASIDE FROM THE OBVIOUS, WHY IS A RECALL SUCH A BIG DEAL FOR THE SERVICE DEPARTMENT?
The biggest issue is that a recall is never scheduled or even projected. It comes on top of the service department’s normal workload. And for Class 1 and 2 recalls, there is always a high sense of urgency because both lives and the company’s reputation are at stake.
Also, recalls hit a significant number of product models and quantities. Here is the U.S. recall data from Stericycle for Q4 2016 and all of 2017 and 2018.
Stericycle also reported that:
- The average recall size was 575,449 units
- At 28.2%, software was the top cause by a large margin
- Five companies said ten or more recalls in Q4 2018
Think about how you would handle a product recall impacting 10% of your installed base. Do you know where every unit is physically installed? Do you see the revision level of each unit? Or the date installed or the status of recently shipped units?
Can your logistics people get emergency shipments of conforming items, inspect them, coordinate shipments with your FSE dispatch organization so that people and parts meet up when needed, and then track return shipments to close each work order?
Do you have the workforce flexibility to visit each unit and do something easy like change a decal on the back near the power input? What if you have to partially disassemble an instrument, remove and replace a transformer, reassemble the device, and perform a test to measure the current draw? And while doing this, you must fill out a form and take pictures of the reinstallation to demonstrate that it was done correctly.
And, of course, someone has to check each report and manage a master list so you can issue a daily status report to your Quality Director and other interested people in the company.
If you were the poor soul whose company was one of the five companies with ten separate recalls in one quarter, would your body, mind, and marriage survive these three months?
CREATE A RECALL PLAN
If you are a Service Executive in the medical device industry, you should have an up-to-date recall plan in your desk drawer. And at a minimum, your plan should include a relationship with an Independent Service Organization that can quickly step in and either supplement your team or, better yet, take over a large part of the recall process. In contrast, your team manages your day-to-day work.
In my conversation in Madison, Wisconsin, Dan Brinkman also highlighted some of the operational issues his organization has encountered often enough for him to know they are avoidable and should be included in your plan.
UNIT LOCATION
First, it is wise to emphasize unit location and an updated contact list on the front end. In our experience, this is overlooked about 50% of the time and this can cause a lot of admin headache and delays, ESPECIALLY if the OEM used distributors in their sales process. Also, smaller items such as IV pumps can be shipped to a central holding facility in a hospital system and then be distributed throughout multiple locations. Finding units and a having valid site contact info is important.
DOCUMENTATION PROCESS
The second thing that gets overlooked is the documentation process. If the actual physical remediation is quick and there are a lot of units at a given site, again like IV pumps, it is important to make sure that the documentation process is efficient. Just something like designing a form that uses a check mark and has the ability to capture multiple units per page can save tens of thousands of dollars.
QUALITY AND REGULATORY DEPARTMENT INVOLVEMENT
Third, service managers need to get their quality and regulatory departments involved early and make sure that they have approved the documentation output. We have seen several instances where key documentation processes are changed a month into a program and then a lot of work or a lot of documentation has to be redone, again at a substantial cost.
PLAN FOR CHANGE
Finally, at least on the operational side, plan for changes at the outset. In our experience, 100% of the recall operations we have been involved in have had changes to the procedure within the first month, and sometimes several changes are made. This happens either because of the quality/regulatory issues mentioned above, parts supply and logistical issues, communication issues-how the recall is represented to customer users, and because someone, somewhere encounters a set of circumstances that cause unanticipated and unknowable consequences-things like ambient temperature, bizarre combinations of electronic interference etc.
Dan’s insights show that having an identified “plug and play” resource who can help plan and execute a recall campaign can significantly reduce your blood pressure level when you must organize a recall.
About Middlesex Consulting
Middlesex Consulting is an experienced team of professionals with the primary goal of helping capital equipment companies create more value for their clients and stakeholders. Middlesex Consulting continues to provide superior solutions to meet the needs of its clients by focusing on our strengths in Services, Manufacturing, Customer Experience, and Engineering. If you want to learn more about how we can help your organization prepare for a product recall, please get in touch with us or check out some of our free articles and white papers here.