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Much has been written recently regarding this topic, but the reality is that January 1, 2000 is rapidly approaching and with it comes the unknown impact of the Year 2000 (Y2K) computer hardware and software date problem. Depending on who is addressing this issue, the impact of this problem varies from those who predict a doomsday situation, to those who are not even aware of the circumstances. The reality hopefully lies somewhere in between, but it is clearly unknown. One thing is obvious, the impact of avoiding any potential problems is time consuming and expensive.

In case you are not aware, the problem is simple enough. It is based on the fact that software programs, computer chips, and firmware have been developed with two digit numerals to identify the year, instead of the actual four digit numerals. There, once January 1, 2000 arrives, it is possible that computers having a two year code, ñ00î representing the Year 2000, may recognize the digits to apply to the year 1900, and as a result the systems may not work or may not function properly.

As manufacturers of medical devices we have added reasons for ensuring that our products function properly. These include regulations promulgating product safety and effectiveness, as well as regulations such as the Quality System Regulation. The FDA has notified medical device manufacturers of their responsibility for ensuring that their products and systems are in compliance. They have required that manufacturers list their product readiness in the FDA Web site. Most companies have followed this advice and currently provide this information in the FDAÍs Web site or in the companiesÍ own Web site.

Clearly, the FDA can use several sections of the QSR to review compliance of products and systems. These include the Design Control, Purchasing Control, and the Production and Process Control provisions of the QSR regulations.

Most recently, the U.S. Congress passed a law providing additional protection to companies who disclose Year 2000 information. The law is intended to provide protection for companies who openly and voluntarily provide information relating to their Y2K readiness. The requirements include clearly identifying statements about a productÍs Y2K compliance as ñYear 2000 Readiness Disclosure.î This must be done retroactively for previously provided statements. In addition, this law also provides provisions to reject or object to Year 2000 statements provided by others. There is a 45 day time frame from the time of your receipt of a Y2K notice to reject the notice, and until April 17, 1999 to object to a Web site designation.

There are at least three main areas within our businesses which must be addressed to ensure that our products and companies are ready for the Y2K. The first one involves the ability of instruments which we sell to our customers to function properly; this will involve correcting software, firmware, semiconductor chips, etc. After correction, systems must be tested and validated to ensure their adequacy. Several companies are using the British Standard InstituteÍs Y2K guidance to ensure conformance. You must also recognize that the Y2K situation may impact you sooner than January 1, 2000; for example, instruments which use products with expiration dates may be impacted much sooner, depending on the interaction of the Year 2000 expiration dates and the instrument.

The second area which requires attention involves all the internal systems within your company. To be prepared, you should review and test computerized systems throughout your facility. In todayÍs workplace, this probably involves systems ranging from manufacturing and quality control to MRP, telephones, security systems, etc. the reality is that computers probably handle or interact with most, if not all, of the systems within our companies.

The third, and perhaps the most difficult area, involves our suppliers. We must ensure that our suppliers will be able to deliver products which are Y2K compliant, and also that their internal systems will be compliant, so that they are able to continue to provide our products and service.

As you can discern from the preceding, addressing the Y2K situation will require a great amount of time, resources, and effort. Since time is the most limiting factor, hopefully most companies are well on their way to addressing this issue. Good Luck!