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Reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecological or other minimally invasive surgical procedures. Trocars are single patient used devices.

AMI intends to market Surgical Trocars that have been reprocessed. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. AMI is a third party reprocessor. If all protocol parameters are met, AMI will reprocess each disposable trocar up to two times. Trocars are sold new by the original manufacture to the hospital uses the trocars, collects them and ships them to AMI for reprocessing. Trocars are reprocessed by AMI as described in our reprocessing protocol Control Document Number 40005 and returned to the hospital to be reused. Trocars that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the trocar is not reprocessed at all) or second reprocessing.

Sequential compression sleeves are intended to increase venous return from the lower extemities in as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients. Sequential compression sleeves are single patient use devices only.

AMI intends to market reprocessed sequential compression sleeves and wraps. Reprocessing sequential compression sleeves and wraps is performed by AMI to AMI protocol Number 40009. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). AMI is a "third party reprocessor" and reprocesses used single-used medical devices. AMI believes that sequential compression sleeves and wraps can be considered "reusable" - by AMI, as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use. Sequential compression sleeves and wraps are designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism. AMI intends to reprocess disposable sequential compression sleeves and wraps manufactured by Kendall (sleeves and foot wraps), Huntleigh and Plexipulse.

Blades, burs, bits and taps are metal accessories and attachments used with powered surgical tools for re-constructive and traumatic bone surgery. AMI intends to reprocess all brands of used disposable surgical saw blades, burs, bits and taps. Reprocessing includes all the steps performed to make a contaminated single use device patient ready. Only blades, burs, bits and taps that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.

AMI intends to market used disposable surgical blades, burs, bits and taps that have been reprocessed. Reprocessing blades, burs, bits and taps is performed by AMI to AMI protocol Number 40014. "Reprocessed," means all operations performed to render a contaminated singleuse device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). AMI is a "third party reprocessor" and reprocesses used single-used medical devices. Used blades, burs, bits and taps that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the item is not reprocessed at all) or anytime during subsequent reprocessings. AMI believes that used single-use blades, burs, bits and taps can be considered "reusable" as defined in the Food and Drug Administration Compliance Policy Guide #7124: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use. Blades, burs, bits and taps are metal accessories and attachments used with powered surgical tools for re-constructive and traumatic bone surgery. AMI reprocessed blades, burs, bits and taps are composed of the same materials as currently marketed blades, burs, bits and taps sold new. Only blades, burs, bits and taps that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) are reprocessed by Adven Medical, Inc.

Arthroscopic blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.

Arthroscopic blades and burs are single use instruments consisting of several tubes and designs. The inner blade rotation is driven by a motor. AMI intends to reprocess arthroscopy blades and burs. Reprocessing includes all the steps performed to make a contaminated single use device patient ready. Only dispossible, non angled arthroscopy blades and burs manufactured by Dyonics and Stryker, that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.