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Disaster Preparedness

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

When performing a location analysis, medical device manufacturers must take into consideration the risk of disasters—natural and otherwise—associated with particular geographic areas. Prospective facilities in a selected location must meet the safety and security requirements for any occurrence for which there is a reasonable risk. If a building is located in an area where earthquakes, tornadoes, hurricanes, or terrorist attacks are a significant concern, the facility's owner should have procedures in place to cope with possible power failures, floods, waterline breaks, and other potential consequences of a given disaster. To ensure that such systems can stand up to a disaster, manufacturers can consult a regional specialist who can perform a detailed survey and advise the company as to what changes, if any, should be made.

Medtech firms that manufacture devices upon which human lives depend must develop disaster management plans that enable them to sustain their supply chains in the event of an unplanned incident or catastrophe. “We put resources into disaster planning every year, putting together a disaster recovery plan that is updated yearly and reviewed quarterly to make sure it's still current,” says Don Chigazola, director of operations for Medtronic Inc. (Minneapolis) at its facility in Santa Rosa, CA. “We have a group of identified people on a steering committee who are charged with making sure it's current, and we conduct a drill once per year. The first time we did that, it was a real eye-opener. You may think that in the event of an emergency you'll call the manager of manufacturing and ask him something, but then you realize that you can't call him. You can't even assume that cell phones will be working. Until you really do a tabletop exercise, you don't realize where all your vulnerabilities are.”

Ann Brown, real estate manager at Medtronic, adds, “It's more of a business continuation plan. What are you going to do if you cannot use your building? Where is your backup? What's the chain of command for making decisions? How do the phone calls go? It's identifying your critical operations and making sure that you do have another way to produce product, ship product, or answer customer phone calls.”

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