Hospital seeks FDA review of equipment

March 20, 2004|By Walter F. Roche Jr. | Walter F. Roche Jr.,SUN STAFF

Maryland General Hospital officials say they will ask the U.S. Food and Drug Administration to investigate the reliability of blood testing equipment used in generating 460 suspect HIV and hepatitis tests for patients at the 245-bed facility.

"We have made a determination to report the laboratory analyzer to the FDA," hospital officials said in a written statement. "We believe there are possible issues worth investigating with this equipment."

An FDA spokeswoman said yesterday she could not comment because the request had not been submitted.

The FDA review request comes as the Baltimore hospital, an affiliate of the University of Maryland Health System, undergoes a review of its laboratory operations by state and federal regulators and a private accrediting agency.

Those inquiries followed a limited state review in January that uncovered problems with the hospital's HIV and hepatitis testing program. State inspectors concluded that hospital personnel erased data showing that recently completed test results were suspect.

Then, ignoring guidelines calling for an automatic retest, hospital staff sent the results to patients.

The hospital and the manufacturer of the analyzer, Adaltis US Inc., also were hit last week with a multimillion-dollar lawsuit filed by a former hospital laboratory technician who contends she became infected with HIV and hepatitis C as the result of a malfunction of the analyzer, known as a Labotech.

Richard Eckloff, vice president and general manager of the Allentown, Pa.-based firm, declined to comment yesterday on the lawsuit or the request for a federal review.

Five years ago, the National Health Service (NHS) of Britain issued a notice warning of intermittent failures of Labotech analyzers.

"There have been a number of reports of intermittent failures to sample with these analyzers possibly resulting in false negative test results," a memo issued in 1999 by NHS health services director Sheila Adam states.

An FDA database called MedWatch, which lists reported problems with medical devices, contains no references to problems with the Labotech.

Maryland General officials have acknowledged that suspect test results were sent to about 460 patients.

Under a corrective action plan filed with the state, the hospital has sent two letters to each patient urging him or her to go in for a retest. A hot line - 877-225-5660 - has been set up by the hospital to answer questions.

Hospital officials say they expect to find that most of the results were accurate.

In an interview last week, Maryland General President Timothy D. Miller stated that although there were problems with the testing equipment, the hospital did not learn there were questions about the accuracy of the tests until state inspectors completed their first on-site inspection in late January.

Records obtained by The Sun, however, show that Miller was one of 22 Maryland General officials sent an e-mail Dec. 7 by Kristin S. Turner, the former lab technician who has sued the hospital.

In the e-mail to administrative laboratory director James Stewart, Turner, who had just learned that she had been terminated, wrote that she and her co-workers had made numerous complaints about the safety and accuracy of the testing equipment.

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