http://veterans.house.gov/hearings/schedule106/oct99/10-28-99O/gao.htm Sometimes you can not get in by direct link ,If it wont work go to www.house.gov and search all files for y2k.I fell sorry for the Vets and I hope all vet lurkers are taking care of being prepared.

-- me (y2kme1@me.com), November 19, 1999

Answers

I have posted the testimony in two posts above.

 Veterans' Affairs assessment testimony by the GAO, Long and detailed (PART ONE)

 Veterans' Affairs assessment testimony by the GAO, Long and detailed (PART TWO)

-- Brian (imager@home.com), November 19, 1999.

interesting snip "

According to the August 1999 report, about 97 percent of the 568,000 medical devices in VHA medical facilities are compliant. The report indicated that, of about 18,000 noncompliant devices, about 14,000 will be repaired, and about 1,400 will be replaced.

The report did not discuss the renovation status of the remaining 2,200 noncompliant devices.

We were unable to accurately determine the status of medical facilities efforts to renovate noncompliant devices. As we discussed previously, the individual monthly reports submitted by the VISNs/medical facilities were inaccurate. Specifically, the July 1999 summary report that showed that about 21 percent of medical devices had been renovated was incorrect. However, according to several medical centers, their renovation percentages were higher than the numbers reflected in the report. We pointed this out to the Y2K project manager, who acknowledged that the percentages were incorrect. He added that the Y2K project office is in the process of following up with its medical centers to confirm their status on renovation of biomedical equipment.

VHA Position on Not Testing

Biomedical Equipment Unchanged

As we reported last September, VHA relies on manufacturers to validate, test, and certify that equipment is Y2K compliant. We also reported that there was no assurance that the manufacturers adequately addressed the Y2K problem for noncompliant equipment, because FDA did not require medical device manufacturers to submit test

results to it certifying compliance. Accordingly, we recommended that VA and HHS take prudent steps to jointly review manufacturers compliance test results for critical care/life support biomedical equipment. We were especially concerned that VA and FDA review test results for equipment previously determined to be noncompliant but now deemed compliant by manufacturers, or equipment for which concerns about compliance remain. We also recommended that VA and HHS determine what legislative, regulatory, or other changes were necessary to obtain assurances that manufacturers equipment was compliant, including performing independent verification and validation of the manufacturers certifications.

At that time, VA stated that it had no legislative or regulatory authority to implement the recommendation to review test results from manufacturers. VA and the Emergency Care Research Institute (ECRI) have stated that manufacturers are best qualified to analyze embedded systems or software to determine Y2K compliance. Accordingly, they do not encourage user testing of biomedical equipment for Y2K compliance. ECRI guidelines, however, suggest that health care facilities should consider testing interfaces between medical devices in cases where the facility cannot determine the Y2K compliance of the interface from the device manufacturer. FDA also agrees with the ECRI position on testing biomedical equipment and interface testing. Specifically, FDA has taken the position that manufacturers submissions of Y2K compliance certifications provide sufficient assurance of product compliance, and that such testing on the part of users is not necessary.

According to VHAs chief biomedical engineer, VHA guidance to the VISNs and medical facilities is not to conduct stand-alone compliance testing of biomedical equipment in their inventories. VHAs Y2K project manager told us that VHA relies on the manufacturers certifications; therefore, there is no need for such testing. However, he stated, in cases in which one medical device interacts with other systems or devices, the medical facilities should test these to ensure proper operation.

In contrast to VHAs and FDAs positions, some hospitals in the private sector believe that testing biomedical equipment is necessary to prove that they have exercised due diligence in the protection of patient health and safety. As we have previously testified, officials at three hospitals told us that their biomedical engineers established their own test programs for biomedical equipment and, in many cases, contacted the manufacturers for their test protocols. Several of these engineers informed us that their testing identified some noncompliant equipment that the manufacturers had earlier certified as compliant. According to these engineers, the equipment found to be noncompliant all had display problems; none was critical care/life support equipment. We were told that equipment found to be incorrectly certified as compliant included a cardiac catheterization unit, a pulse oxymeter, medical imaging equipment, and ultrasound equipment."

-- Brian (imager@home.com), November 19, 1999.

More

Because of the limitations cited above for many of the manufacturers web sites, our ability to determine the total number of biomedical equipment products reported and their compliance status was limited. Accordingly, the actual number of products reported by these manufacturers could be higher than the 32,598 that we counted.

As shown in figure 2, of the 32,598 products we identified on manufacturers web sites, about 54 percent reportedly do not employ a date, about 29 percent of the products are

considered compliant, and about 12 percent are reportedly noncompliant. The compliance status of the remaining 5 percent of products was unknown for reasons such as the manufacturers ongoing assessment of the product.

-- Brian (imager@home.com), November 19, 1999.