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Be prepared: Lithium-ion batteries pose severe recall challenges for medical devices

The reduced size, weight and power consumption of lithium-ion (Li-ion) batteries has been a boon for medical device manufacturers seeking to create more portable and convenient products. But the efficiency gains of Li-ion batteries are tempered by the increased safety risks and regulatory concerns the technology poses.

As multitudes of viral videos confirm, products with Li-ion rechargeable batteries have the potential to overheat, explode and catch fire. Any defect that could lead to overheating or cause a life-sustaining medical device to simply stop working can be catastrophic.

The risks then are compounded when the defect leads to a nationwide or global recall of the device. Speed in implementing the recall becomes paramount, because patients’ lives could be at stake. Transportation of the recalled devices creates serious complications because of air flight bans and other cargo rules. And because defective Li-ion batteries are considered to be bio-hazards, safe handling, disposal, and recycling of the products require well-trained, expert care from professionals.

Compliance complications
Any Li-ion battery-prompted recall results in multiple regulatory agencies getting involved to oversee safety procedures from shipping to disposal—even when the recall is limited to one country. In the U.S., medical device recalls involve the Food and Drug Administration (FDA), with the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) and the Environmental Protection Agency (EPA) often jumping into the fray as well. The regulatory complexity is compounded when a recall crosses international borders.

While there are exceptions for small sizes, most Li-ion-powered devices are classified as hazardous and bound by specific transportation requirements across multiple regulatory bodies. The International Air Transport Association (IATA) guidance states that Li-ion batteries that have been identified as defective for safety reasons cannot be transported by air. Ground transportation may be an option for recalled devices but “any product deemed liable to rapidly disassemble; dangerously react; produce a flame; or emit toxic, corrosive, or flammable gases or vapors under normal conditions” can’t be transported without special permission from the consigning country. Whatever the transport method, failing to comply with these requirements can result in hefty fines from regulators, which can also mean negative news headlines.

Medical devices with Li-ion batteries are also difficult, if not impossible, for patients and healthcare providers to remove. That’s because designers aim for a slimmer, sleeker appearance, while also needing extra protection from dust, liquid, humidity, and other elements that could affect their performance.

If a faulty battery can be removed, the recall remedy may be to simply ship a replacement directly to healthcare providers and patients — without the level of specialized packaging required for batteries with a potential safety issue — instructing them to dispose of the faulty battery locally.

Reverse logistics can also intensify complications for medical device manufacturers ill-prepared to handle a surge of products that need to be retrieved for repair or disposal. Medical device supply chains are not designed to retrieve products, causing current operations to clog and the retrieval process to take longer than necessary. Planning for this eventuality can ease the stress of a recall but working with a third party to handle product retrieval is often a more economical option as it enables regular operations to proceed uninhibited.

Environmental protections
Defective Li-ion batteries are also considered hazardous waste. The costs associated with hazardous waste disposal can add up quickly, making a small issue concerning a small part of a product an incredibly pricey affair.

The good news is that there are often various options to recycle other parts of the recalled medical device. By separating the battery from the rest of the device and only paying for hazardous waste disposal on the battery itself, the overall cost of the recall can be slashed while also helping the manufacturer be more environmentally friendly. Whatever the type of recalled product, landfills should be avoided, or at least considered a last resort.

In the end, the advantages of Li-ion batteries far outweigh the costs of potential recalls. But medical device manufacturers should do more to be ready, as the processes and regulations can be far more complex than other product issues. At minimum, medical device manufacturers should prepare strategies around four key issues:

  • How quickly they could secure the necessary materials for shipping recalled batteries.
  • How they would go about notifying their customers and answering a potential surge of urgent questions.
  • How they would manage the extraordinary manpower required to collect the affected product and send replacements or reimbursements.
  • How they would manage the data and documentation required for regulatory reporting.

In most cases, these issues can’t be addressed alone, especially when you consider how quickly both regulators and the public expect action. Third-party suppliers and partners should be identified and secured in advance so they are ready to spring into action right alongside internal staff. That includes companies that will provide the specialized boxes, labels and other materials needed for a lithium-ion battery recall and those who will solve any pain points in the plan, such as increased contact center support, product processing and data collection for regulatory reporting.

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