The hospital also uses a share point site, where everyone can log in and keep updated on what's going on daily. Hollenbeck said a phone tree should also be in place-- just like it would be in any disaster.

Knowing when to take action


According to a quarterly index on recalls published by ExpertRecall, a subsidiary of medical waste management giant Stericycle, FDA Enforcement Reports for the third quarter of 2012 documented 407 medical device recalls, "reflecting the highest number of recalls in at least the last nine quarters," stated the report.

With product recalls on the rise, Sacks said knowing when to take serious action is a skill. A certificate of medical necessity can be a viable solution for some facilities.

During the recent safety alert concerning Stryker Neptune's waste management systems, for example, Sacks said no replacements were immediately available. He said some hospitals removed the product but others felt they would be worse off doing so. In those cases, hospitals filed the certificate of medical necessity and kept using the product after a benefits assessment was conducted. They had guidelines in place and knew when to involve legal counsel when filing the certificate.

Sacks said this can also be an example of an organization handling a recall well.

During the webinar, which included a record 300 registered attendees, a virtual vote was cast asking audience participants the question: Do you have a recall team that includes risk management and legal representation? Forty-five said yes, 42 said no and 11 were not sure.

ECRI Institute's webinar, "High-Impact Recalls — Building a Process to Avoid Disaster" also covers the framework necessary to prepare for high-impact recalls, the problems expected with a widespread recall and how to avoid common mistakes in the hazard and recall process. The webinar is available for viewing in full (for a fee) here.

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