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This article was originally published in The Gray Sheet

Executive Summary

CENTRIFUGAL BYPASS BLOOD PUMPS SHOULD BE REGULATED BY SPECIAL CONTROLS such as testing requirements, guidelines, labeling requirements and good manufacturing practice regulations, the Health Industry Manufacturers Association contends in a July 21 petition for downclassification of the devices. The controls "provide FDA with the authority and regulatory oversight necessary to reasonably assure the safety and effectiveness of" centrifugal cardiopulmonary bypass pumps as Class II devices, HIMA says. HIMA submitted the petition to reclassify the preamendment Class III devices after FDA on July 6 published a proposed rule calling for premarket approval applications for non-roller bypass pumps ("The Gray Sheet" July 12, p. 4). Centrifugal pumps constitute one type of non-roller pump. Under the Safe Medical Devices Act of 1990, FDA now has 210 days in which to respond to HIMA's petition. The law provides that devices can be downclassified to Class II if special controls can "provide reasonable assurance of the safety and effectiveness of the device." The petition was submitted to FDA on behalf of HIMA's centrifugal pump task force. Members include Baxter, Bard, Cobe Cardiovascular, Medtronic Cardiopulmonary, Medtronic Biomedicus, St. Jude's Cardiac Assist Division, Sarns, Sorin Biomedical and Terumo Medical Corporation. Addressing possible testing requirements, HIMA asserts that FDA can "maintain regulatory control over specific aspects of the device" by making "certain testing...prerequisite to obtaining 510(k) clearance for the centrifugal pump." For example, "hemolysis testing, leak testing, biocompatibility testing, and pump performance flow data" can be used to "establish the necessary FDA oversight to reasonably assure the safety and effectiveness of the device." HIMA's petition also contains a recommended guideline "in the form of a centrifugal pumphead checklist" for health professionals as an additional special control. HIMA says the checklist should be incorporated in a "pre-bypass checklist, which FDA can further develop with the medical community and industry, if necessary." HIMA also argues that "new evidence" that has developed since FDA's 1980 Class III designation "demonstrates that centrifugal pumps for short-term application should not be classified in Class III." Noting that "the techniques for establishing the safety of the device are well established in the literature," HIMA says that "the body of data indicates that the performance with regard to blood trauma is similar between the roller and centrifugal pump at blood flow rates appropriate to perfusion." Roller cardiopulmonary bypass blood pumps are Class II devices. HIMA further asserts that "the risks associated with a Class II designation are consistent with those of other devices classified in Class II." In a same-day letter to FDA, Public Citizen's Health Research Group opposes downclassification of non-roller bypass pumps. "A prospective, randomized, controlled clinical trial...must be performed in order to adequately evaluate the safety and effectiveness of the device," HRG states. Placing the device in Class II, the group proclaims, "will allow manufacturers to avoid conducting these critical studies and possibly expose the public to unsafe devices." HRG argues that the critical nature of cardiopulmonary bypass pumps and the importance of proper device design require the devices to remain in Class III. "A pump failure analogous to a cardiac arrest," HRG says. "It is difficult to imagine a device which is more life-supporting and life-sustaining than a blood pump." In addition, "failure to adhere criteria could lead to serious complications in addition to embolism, retrograde perfusion and inadequate tissue perfusion," HRG maintains. A defective pump design could "aggravate" the alteration in blood composition that "occurs when blood comes in contact with a blood pump," leading to "abnormal bleeding problems, anemia, clot formation, and lung and kidney problems postoperatively."

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