OCD FY2000: Preparations for Y2K
Final Y2K Preparations and Y2K-Readiness within the Center
- Desktop Computers, Network Infrastructure and Facilities
The CDRH computer and network infrastructure was validated as Y2K-compliant in March 1999. However, our computer support staff tested and installed software upgrades and Y2K patches on desktop computers, servers and network equipment throughout the Fall and up until the last weeks in December, in order to keep current with last minute software vendor releases correcting Y2K-bugs. We finalized Day One testing plans and coordinated efforts with other FDA components and the FDA Network Control Center.
- Day One Testing
Our computer support staff gathered on the evening of December 31, 1999, and by noon on January 1, 2000, completed the testing of servers, electronic mail system, network infrastructure, desktop computers, and database applications. Staff was especially vigilant for virus and hacker attacks, none of which were encountered. The Y2K rollover was uneventful and we were able to report a successful Y2K transition to the FDA Y2K Command Center. During the first few weeks of 2000, a few minor Y2K problems were encountered in several application report programs. All were corrected immediately and no problems have been encountered since January 2000.
- Leap Day
Because of additional date issues arising with the leap year in 2000, staff prepared and conducted additional computer system testing on February 28 and February 29. There were no leap day problems discovered.
Response to Y2K outside the Center
- Web-based Biomedical Equipment Clearinghouse
Data regarding the Y2K status of biomedical products was made available to the healthcare community through the FDA-operated Federal Y2K Biomedical Equipment Clearinghouse. Data from over 4,200 manufacturers was provided via this mechanism.
- Assessment of Manufacturers’ Y2K Readiness
We completed and reported on a survey of the manufacturers of essential medical and surgical supplies whose availability is critical to patient care. The voluntary survey of 3,070 manufacturers demonstrated that the medical devices industry had taken appropriate steps to assure the uninterrupted supply of necessary supplies. Following January 1, 2000, no significant shortages of medical supplies were encountered.
- Assessment of Computer-Controlled, Potentially High Risk Devices
We completed focused, on-site assessments of a sample of manufacturers (US and foreign)of computer-controlled potentially high risk devices to assess the adequacy of their actions to assure device safety and to implement needed corrective actions. Results of this survey indicated that the medical device industry had made appropriate evaluations and preparations.
- Outreach to Healthcare Facilities
We communicated with healthcare facilities to urge that they assess theY2K status of the devices they use, to provide information on the resources available to assist withY2K preparations, and to explain how to report Y2K-related medical device problems or malfunctions to the FDA and to urge such reporting in conjunction with the "roll-over" to January 1, 2000. We also provided an internet-based, rapid reporting mechanism for use by healthcare facilities to report Y2K-related problems with medical devices to FDA.
- Preparation for Rapid Response to Y2K Problems
We developed plans and procedures for rapidly dealing with any Y2K-related medical device problems during transition to January 1, 2000 and February 29, 2000. We also staffed FDA’s Emergency Operating Center and the Federal Y2K Information Coordination Center with medical device expertise during transition periods to provide immediate response and investigation of any reported problems. Our staff followed up on a number of reports of Y2K device problems from the press and other sources with the result that no significant incidents affecting patient care or safety in the US were identified.