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Postmarket Safety Starts within Companies

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Examine the quality policy first when designing a postmarket surveillance system, says Heyer.

With the recent attention focused on postmarket surveillance, manufacturers should revisit (and perhaps redesign) the postmarket programs at their own companies, according to one expert. These programs are essential tools that help ensure the efficacy of products on the market.

“In a perfect world, every product would be safe and effective,” said Sheila Hemeon-Heyer, vice president of global regulatory affairs at Boston Scientific Corp. “In reality, despite our best efforts, all medical products carry some risk.” Heyer explained strategies for building an effective postmarket surveillance program—a timely issue for Boston Scientific—at the Massachusetts Medical Device Industry Council's FDA update in December.

Companies such as Boston Scientific that have to monitor products on a global scale have an even greater challenge. They need to comply with global regulatory requirements, manage multiple facilities with component and finished-product manufacturing, ensure the quality of different types of products, and tackle communication issues across different cultures and time zones.

Heyer said the first step in designing a postmarket surveillance system is to revisit the company's quality policy. One of the most important building blocks is to ingrain the notion that everyone in the company is responsible for product quality. Every employee must be trained to have an active approach in bringing about culture change. Members of management should also be involved at all levels, because they ultimately make the decisions.

There are five elements for an effective system, according to Heyer. First, build safety into the device, because surveillance should start before a product goes out the door. Monitoring products will help identify any quality issues. In this case, registries serve as a good tool, because the data provide real-world experience. Companies should analyze the data, and, if quality is brought into question, take action. Begin communicating with stakeholders, regulatory agencies, and people within the company, advised Heyer.

Other ways to maximize data from postmarket monitoring include opening corrective and preventive action items to correct problems and improve processes and to consider whether the information requires a change in the product's risk profile, design, or labeling.

Postmarket surveillance is an integral factor in ensuring product quality, patient safety, and continual improvement of patient care, said Heyer. “As FDA's Postmarket Transformation Initiative begins moving forward, companies must stay on top of internal policies.”

Copyright ©2007 Medical Device & Diagnostic Industry
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