Articles on Law, Science, and Engineering

Part VII: The Medical Device Reporting Regulation: The First Year (cont'd)

FDA RESPONSES TO REPORTS

The FDA responded to Reports with 459 field follow-ups, 824 requests for additional information and 121 in-house follow-ups. The ten devices receiving field follow-up most frequently were heart values (50), sets for intravenous administration (38), implantable pacemakers (37), infusion pumps (27), hexokinase/glucose devices (25), sets for administration of peritoneal dialysis (22), low energy DC defibrillator (17), ventilators (14), gas anesthesia machines (11), and intravascular infusion controllers (9).

Thirteen of the field follow-ups were given top priority, 157 were assigned high priority, and 289 were assigned routine priority. Devices receiving high priority field follow-ups were: 4 ventilators, 3 multiple patient dialysate delivery systems, 2 infusion pumps, and a cardiovascular bypass tubing pump, an intra-aortic balloon, an angiographic injector, and a gas anesthesia machine.

The ten devices receiving high priority field follow-up most frequently were heart valve (50) hexokinase/glucose devices (25), low energy DC defibrillator (17), non-absorbable sutures (8), implantable pacemakers (6), infusion pumps and implantable subcutaneous intravenous catheters (5 each), ventilators (4), and dialysate delivery systems, long term indwelling peritoneal catheters and electrocardiograph monitors (3 each).

The ten devices most frequently receiving field follow-up at routine priority were sets for intravenous administration (38), implantable pacemakers (31), sets for the administration of peritoneal dialysis (22), infusion pumps (20), gas anesthesia machines (10), intravascular infusion controllers (9), dressings (8), flow directed catheters (7), ventilators (6), and impotence devices (5).

FDA was unable to identify the cause of the problem in 61% of the cases considered during the first year. FDA's final problem assessment indicated that the user was the cause of the reported event in 8% of the cases, and the manufacturing process or the device was the cause in 26% of the cases. In the cases where use was the cause, death occurred in 8%, and serious injury occurred in 50% of the cases. In 76% of the cases, FDA concluded that no corrective action was indicated, but recalls were indicated for 17% of the cases, and voluntary action by the manufacturer occurred in 2% of the cases.

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