Smart Pump Recall Landscape Reiterates the Importance of Recall Preparation

By Mike Rozembajgier

A new report on the reaction from smart pump providers to new FDA standards once again highlights the importance of recall preparedness. Research firm KLAS found that every single smart pump provider has been involved in a recall in the past two years, leading many customers and providers to view recalls as a necessary part of owning smart pumps. While this particular industry may be unique, the lesson remains that recalls are a growing part of everyday life, and companies must be prepared to manage them with comprehensive recall plans.

With the FDA and other regulatory agencies more closely regulating products and requiring more stringent standards, smart pump providers in particular expect that these standards will lead to more testing and review, which in turn will delay enhancement releases. These delays in enhancement releases may, in turn, lead to more recalls.

With regulators more likely to order mandatory recalls in an effort to and err on the side of caution, companies in every industry must be prepared. Waiting until a product safety investigation has been announced or a recall has been initiated is no longer sufficient. Working from an old recall plan that has to be dusted off from the company archives will not protect either consumers or the company.

Instead, every company that produces or distributes products that could – even if only in theory – be recalled because of safety concerns must have a recall plan prepared in advance. This recall plan should outline who is responsible for recall management, how customers will be notified, the process for documenting all recall activities to ensure compliance, and at what point an outside recall management company might need to be called in.

But just developing the recall plan is not enough. A good recall plan is a living document, updated regularly and practiced vigorously. All employees and managers who may be involved in a recall should know their roles. It is only by developing a comprehensive recall plan well in advance – and practicing and updating it regularly – that companies can protect their reputations and their bottom lines.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.