On October 23, 2000, the FDA’s Center for Devices and Radiological Health (CDRH) issued a Warning Letter to R. McIntiyre Bridges, M.D., Bridges to Beauty Center for Cosmetic Surgery, Shreveport, Louisiana. The Warning Letter was based on an FDA inspection from October 12 through 24, 2000. The Warning Letter cited the following violations of FDA regulations: (1) failure to follow written procedures for Institutional Review Board (IRB) functions and operations; (2) failure to maintain records of the IRB functions and activities; and (3) failure to provide a procedure that describes how the IRB will determine which device studies are significant risk or non-significant risk. These deficiencies included the following: failure to obtain FDA or IRB approval prior to treating human subjects with investigational medical devices; failure to obtain approval of a supplemental application prior to implementing protocol changes; and failure to submit and obtain approval of a supplemental application prior to implementing a change to an investigational plan; failure to ensure that the requirements for obtaining informed consent were met; failure to conduct the investigations in accordance with the investigational plans, other applicable regulations and conditions of approval imposed by an IRB or FDA; failure to maintain accurate, complete, and current records relating to the investigations; failure to have adequate written monitoring procedures, select qualified monitors, and monitor the clinical investigations in accordance with federal regulations.
The following violations of federal regulations were detailed in the Warning Letter: failure to prepare and submit complete, accurate, and timely reports of unanticipated adverse device effects; failure to conduct an investigation in accordance with the investigational plan; and failure to submit to the Institutional Review Board for review and approval changes in the investigational plan. Observations noted during the FDA inspection included failure by the IRB to take prompt action concerning a sponsor-initiated suspension of a principal investigator. On March 7, 2001, the FDA’s Center for Device Evaluation and Research issued a Warning Letter to St. Mary’s Medical Center Institutional Review Board (IRB), San Francisco, California. The inspection was conducted from March 5 – May 10, 2001, and revealed serious deficiencies regarding Dr. Lentz activities as a sponsor/monitor of investigational studies of apheresis devices. The FDA conducted an inspection of the facility from July 25 – 27, 2000. The inspection was conducted to determine if Dr. McIntiyre Bridges activities as a clinical investigator complied with FDA regulations and to ensure that the information contained in the requests for Investigational Device Exemptions, Premarket Approval Applications, and Premarket Notifications were scientifically valid and accurate.
FDA’s inspection revealed serious violations of FDA regulations as contained Title 21 Code of Federal Regulations Part 50 – Protection of Human Subjects and Part 56 – Institutional Review Boards. In addition, the IRB failed to maintain minutes of the IRBÂ’s meetings in sufficient detail to show attendance at the meetings, actions taken by the IRB, the vote on these actions including the number of members voting for, against and home remodeling minneapolis mn abstaining as required by FDA regulations. In addition, no documentation was available to show the number of members voting for, against, and abstaining from voting at IRB meetings. In addition, the inspection was conducted to ensure that human subjects were protected from undue hazards or risks during the course of the clinical study. The deviations noted during the inspection and cited in the Warning Letter included: failure to obtain informed consent per 21 CFR 50.20 and failure to obtain approval from the Institutional Review Board prior to changes or deviations in the study protocol. The reason for the recall was that the Heartstream XLT (also known as Laerdal Heartstart 4000) and the Heartstream XL might shut down or fail to power on due to a failure of a component on the printed circuit board.
The firm confirmed 6 failures among 1200 in the Heartstream XLT and 1 failure in approximately 500 of the Heartstream XL units distributed. The FDA’s New England District Office reported that on February 5, 2001, Agilent Technologies, Inc., Andover, Massachusetts, initiated a voluntary recall for the Agilent Model M3500B Heartstream XLT Defibrillator. Agilent Technologies, Inc., notified consignees on February 5, 2001, to advise them of the problem and suggested using an alternate defibrillator until repair occurs. The recall involved all meters with serial numbers starting with K, L, M and N. The device is manufactured by Inverness Medical, Inc., Waltham, Massachusetts. The recall included the United States, Europe and South America. A patrol consisting of one light tank, six jeeps mounting machine guns, and a half-track was driving south on the Manila Road, headed for Angeles, some 48 miles from Manila. Writer and former National Writers Union president Jonathan Tasini, blogging about the conference, complained, “Environmentalists and other policy folks have gotten the lingo down about ‘high-wage, good-paying’ jobs, but they still don’t seem to be able to use the word ‘union’ consistently.” He praised as an exception one speaker who said that green jobs generated with public monies have to include commitments of neutrality in union recognition campaigns.