Ensuring Effective Medical Device Recall Management

In order to do well in the medical device marketplace, it is critical for manufacturers to have high confidence in their products. This comes from a strong belief in a product’s “idea” that in the end must be supported with good and thoughtful design and diligent compliance with risk management practices. Despite the best of intentions and so much hard work during the premarket phase, unanticipated problems will happen once a product is on the market.

Unfortunately, all too often, the problems can be serious enough to result in recalls. US FDA’s definition is a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. In the US, recalls can be initiated by FDA or the manufacturer of the recalled product.

Sadly, the medical device industry has many examples of companies that are caught flat-footed when recalls happen. A company’s poor response to a recall can have a major impact on its reputation and can risk serious patient injury or death if devices in the field are not corrected to address the cause of the recall in a timely manner.

To help prevent this from happening, medical device companies need to have a complete recall management plan as part of their postmarket surveillance responsibilities. That plan must include an understanding that clear communication about the cause, impact, and solution for the recall problem is critical. It is only natural for the “owner” of a product to try to put a positive spin on communications about the product’s problems. However, this type of “sugar coating” is not helpful and could potentially put patients at risk by causing customers to misunderstand the seriousness of a problem and potentially delay or simply not bother with taking appropriate corrective actions.

Importance of Clear Communication and Distributor Responsibilities

A key responsibility of any medical device manufacturer is to make sure that a well-defined process is in place to communicate information about recalls to all end users of affected products. It is very common for medical device manufacturers to use one or often many distributors as sales agents for their products. Manufacturers should have clear language in their agreements with distributors about the distributors’ responsibilities for recall management. This should include maintaining an accurate database of its customers and a commitment to disseminate recall-related information to those customers. The communication needs to include a feedback loop that sends information back to the original manufacturer that confirms an end user’s receipt of recall information and shares information on the actions taken to address the recall problem. A similar process should be used if the original equipment manufacturer is also the distributor of the products to its end customers.

Keep in mind that requirements for medical device recall management will vary depending on the markets where devices are being sold. Example guidance and requirements for medical device manufacturers regarding recalls from different markets around the world include:

• US 21 CFR Subpart A, Part 7 - Enforcement Policy
• EU MEDDEV 2.12/1 rev.8 - Guidance document - Market surveillance - Guidelines on a Medical Devices Vigilance System
• Australia Uniform Recall Procedure for Therapeutic Goods (URPTG)
• UK: Medical devices: guidance for manufacturers on vigilance
• China NMPA - Provisions for Administration of Medical Device Recall

Contact Pure Global for assistance with planning and managing your medical device recall responsibilities in the markets that you are selling to. Pure Global’s services include worldwide authorized representation services along with custom consulting for recall management strategies and other premarket and postmarket responsibilities.

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