This raises a broader issue, he adds. For example, consider a patient who is hooked up to an ECG or other type of recorder that collects and digitizes a signal. That signal is transmitted to another piece of equipment, where it is compressed and then sent to a storage system, from where it can be retrieved and examined at a later date. But it's important to check all links in the chain for the possibility that your device might export the wrong data in two years. US FDA has also suggested a course of action in a letter from Bruce Burlington, director of the agency's Center for Devices and Radiological Health.
Experts advise manufacturers to get started now on their risk assessments, testing, and corrections.
It's too late then to analyze all of the equipment, he adds. If you haven't begun yet, identify the most critical systems and devices, and treat them first. A key aspect of the new Melton Mowbray facility will be its division by a concrete wall into two plants for the separate production of regulated and nonregulated products, according to Lane Shaw, general business manager for regulated and medical markets. We don't want to take any chances with cross-contamination between plants. The Melton Mowbray facility is projected for start-up in the first quarter of next year, and should be fully operational by June, according to the firm.