Alliance Medical Corporation

According to a survey accompanying the Medical Device User Fee and Modernization released by the by the FDA, 45.2% of hospitals with 250 beds or more utilize reprocessing as a primary supply cost reduction strategy.¹ As word spreads about the tremendous savings opportunities resulting from reprocessing and the FDA's guidelines for device safety and efficacy in the reprocessing industry, more and more hospitals, and specifically EP labs, are looking to third-party reprocessors to provide reprocessing services. Alliance Medical Corporation, a trusted provider of reprocessing services for 15 years, has safely reprocessed over 7 million single-use medical devices (SUDs), saving hospitals and surgery centers in excess of $75 million. Alliance reprocessing leads to improved patient care in our communities as our hospital partners are using the found savings to fund vital patient services and outreach programs, nursing salaries and new medical technologies. In addition, Alliance customers divert thousands of tons each year away from our nation s overflowing landfills. Alliance's corporate headquarters and reprocessing facility is located in Phoenix, Arizona, where the company occupies a new 42,000 plus square foot facility that rivals the most sophisticated medical device manufacturing operations. Designed by respected national clinical consultants, this advanced SUD reprocessing center, incorporates Alliance's state-of-the-art practices, regulatory requirements and complex operational needs.

Our Mission

To assist decision-makers responsible for improved patient care with innovative cost containment services that guarantee maximum cost savings and clinical satisfaction. We do this by supplying practical alternatives that lessen the economic burden associated with rendering medical care. Reprocessing customers collect and save more with Alliance programs because of our extensive network of direct Account Executives and clinically trained Account Service Representatives who provide on-site collection assistance and education. In addition, Alliance works with a number of medical supply distributors when requested by our hospital partners.

Our Compliance

Alliance Medical Corporation is one of the founding members of the Association of Medical Device Reprocessors (AMDR) and is registered with the FDA as a medical device manufacturer. All Medical Device manufacturers, including Alliance Medical, are required to be inspected at least every two years. Also, Alliance s operations have established a proven track record of successfully passing numerous inspections by FDA officials of our physical facility, processing protocols, sterilization parameters, etc. Alliance continues to comply with FDA, OSHA, and other Federal and State regulations and guidelines. As required by the FDA to demonstrate substantial equivalence to Original Equipment Manufacturers (OEM), Alliance submits and receives clearance for premarket notifications [510(k)s] covering the Class II products we reprocess, including Electrophysiology catheters. The FDA s Guidance Document for reprocessing single-use devices, published on August 14, 2000, mandated that to continue reprocessing devices without interruption, third-party reprocessors like Alliance were required to submit premarket notifications and receive clearance. These 510(k)s are model-number specific, meaning that although a company may have a clearance for a particular product group, such as EP Catheters, Alliance s 510(k) clearances include the most comprehensive list of approved model numbers manufactured by Bard, Cordis Webster, Daig, EP Technologies and Medtronic. All reprocessors are required to support their reprocessing cycle claims with data included in their 510(k) submissions for each reprocessed device. For example, Alliance performs functional, mechanical and electrical tests that support each reprocessing cycle. This testing consists of 15 destructive and nondestructive tests, that when compared to new catheters, show reprocessed catheters to not have a lower functionality than new devices. Our years of experience have shown that most reprocessed devices cycle out prior to their sixth use (five reprocessings). As such, all of Alliance s 510(k) submissions included data that support five or less reprocessing cycles. In the event we determine that a product could support additional uses, further testing would be completed and submitted to FDA in order to up the usable life of the device. Reject rates and reasons are constantly analyzed to determine if and when this situation is occurring for a particular device or device family. To ensure that all reprocessed catheters meet or exceed clinical expectations, functional testing and 100% inspection are performed on every reprocessed device. Routine verification testing includes: distal tip torque gauge which ensures tip attachment to catheter body, continuity-of and resistance-limit-between electrodes, deflection for assurance of catheter curve memory and visual inspection under 10x magnification. At Alliance, we have developed proprietary processes and/or equipment for each component of our system. Listed below is an overview of our process and sequence:

Receiving

All orders are assigned a unique sales order number ensuring that orders are never intermingled and provides a mechanism to track orders through our entire process.

Sorting

An initial sort of each order's contents takes place to eliminate obvious rejects, heavily soiled items, or unapproved products.

Cleaning

An array of automated cleaning equipment, including ultrasonic, are augmented by manual processes. All cleaning protocols are proprietary and device specific.

Data Entry and Cycle Marking

Once cleaned, each device is identified and coded with a distinct mark to indicate reprocessing cycles. The mark allows us to store and retrieve information about the device, including the number of times it has been reprocessed.

Restoring

Many devices must be functionally restored. This may include meticulously removing burrs or dull edges on cutting instruments or the replacement of sheathing on laparoscopic instruments. While automation is our preferred method of processing, there is no substitute for the delicate touch of a skilled and trained technician for some tasks, such as fine instrument sharpening. Alliance utilizes the same hand techniques used by the country s top durable instrument repair and maintenance companies.

Testing

Verifying that devices perform as intended is an integral component of the Alliance system. This can involve electrical profiling, examining high-speed rotation, measuring curvature, evaluating pressure decay, or other device-specific functional indicators.

Final Clean

The process of restoring and testing can reintroduce debris onto devices. Our heated purified water RO/DI (reverse osmosis/de-ionized) final rinse system removes any remaining residuals.

Packaging 

In packaging areas where highly filtered air circulates at more than twice the rate as that of the typical hospital operating room, all devices are packaged, sealed and labeled in Mylar/Tyvek ® pouches, using precisely calibrated and validated machinery.

Sterilization

Preconditioning, sterilization and residual removal are performed in state-of-the-art EO gas sterilizers. Every load contains 10 biological indicators (Bacillis subtilis var. niger) that are sent to an independent certified laboratory for testing. For devices that require non-pyrogenic processing, we add a limulus amoebocyte lysate (LAL) biological indicator to the load to test for pyrogenicity.

Final Inspection and Product Release

After undergoing a final inspection, all devices are quarantined for 72 hours until an independent lab notifies us that sterilization has occurred. Only then do we return the devices to our customers.

Reprocessing is an Exact Science

At Alliance, we rely on engineering, regulatory and quality experts to design, build and guide a system that meets or exceeds medical device manufacturing safety standards.

Alliance Means Compliance

Our conservative approach to reprocessing shelters our customers from unnecessary risk and liability. And, with integration programs such as QUICKStart, which is designed to save hospitals significant dollars within 30 days of enrolling, reprocessing savings can be earned fast with minor changes in our customer s internal service and inventory process. For additional information about reprocessing, visit Alliance online at www.alliance-medical.com. Alliance s industry-leading website not only provides information about our company, but also serves as a clearinghouse for information about the reprocessing industry. If you aren't a regular visitor, log on and investigate the site's many helpful features including: a library of downloadable documents; position statements from and links to key organizations such as the FDA, APIC, AAMI, ACC, NASPE; online forums; savings calculators; press releases; virtual tours; and much more.