Midbrook Medical Tempest Surgical Device Washer Classified as Class II Device by FDA

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Midbrook Medical, the Jackson, Michigan, based designer and manufacturer of healthcare cleaning systems has announced that the United States Food and Drug Administration has classified the Tempest Surgical Device Washer as a Class II Exempt Device. The Tempest is classified as a medical washer-disinfector.

Midbrook Medical, the Jackson, Michigan, based designer and manufacturer of healthcare cleaning systems has announced that the United States Food and Drug Administration has classified the Tempest Surgical Device Washer as a Class II Exempt Device. The Tempest is classified as a medical washer-disinfector.

Midbrook Medical developed the Tempest Surgical Device Washer as an improved solution for notoriously difficult to clean cannulated instruments. Simple manual washing will not consistently and reliably remove bioburden from cannulated instrumentation and ultrasonic agitation cannot effectively remove soil from interior surfaces. Midbrook recognized that these problem devices could not be consistently cleaned to an acceptable level without giving special attention to the interior passages.

The Tempest Washer addresses the problem of cleaning interior lumen by utilizing the power of hydrodynamics to forcibly flush and evacuate interior device surfaces using a directed high pressure, concentrated flow of cleaning agent across all device interior surfaces. When cannulated instruments are loaded into the system, they are placed in baskets and connected to special ports. During the wash cycle, solution is flushed through the ports and flows directly through the interior of the instruments. This eliminates human variables in the cleaning process and cleans tools them in a way that conventional manual washing is unable to repeat, reducing the amount of bioburden remaining on the tools beyond the level required by AAMI TIR30:2003 standards and making them safer for repeated use.

Classification as a Class II Exempt device in the medical washer-disinfector category means that the FDA has reviewed the Tempest Surgical Device Washer and determined that this device is exempt from the premarket notification process. This classification identifies that the Tempest is not intended to be used as a sterilizer. Instead, the Tempest Washer is designed to prepare devices for sterilization through a highly effective and reliable washing / disinfecting process. Items that need to be sterilized still have to be run through a sterilizer. The idea behind the Tempest is that tools with bioburden retained on them after washing cannot be sterilized. By removing more material from these devices during the washing process, the Tempest cleans instruments to a level at which the sterilizers that comprise the next step in the washing process can effectively do what they are intended to do.

The FDA classification of the Tempest Surgical Device Washer is an important step. It represents the fact that the FDA has reviewed the device, and is satisfied that it meets the requirements of its device classification and is available to market within the United States. Customers can be assured that the Tempest is a safe and reliable system that can improve their ability to provide acceptable levels of cleanliness for both cannulated and non-cannulated instruments.

For more information about Midbrook Medical and its custom fabricated medical equipment and decontamination systems visit http://www.midbrookmedical.com, or call 1-517-787-3481.

Midbrook Medical is the minority owned, women owned, Michigan based solution provider to the Healthcare market. Midbrook is not a medical company looking to be a copy cat distributer of decontamination equipment. Rather, Midbrook is the world leader in custom designed, process specific cleaning equipment focused on taking the expertise learned in other industries and applying it effectively to issues within the medical industry in order to provide cleaner instruments that will, in turn, make sterilization more effective.

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Andrew Dexter

Jamie Crowley
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