Standards

Standards

AMDR’s Fundamental Safety Principles:

AMDR members have always been committed to complying with all U.S. Food and Drug Administration (FDA) requirements applicable to third-party reprocessors. AMDR members adhere to and meet all the same regulatory requirements as original equipment manufacturers (OEMs). In addition to regulatory compliance, AMDR members adhere to a number of fundamental safety principles that have made them leaders in the reprocessing industry:

  • AMDR members recognize that not every device should be reprocessed. In fact, AMDR members reprocess only a small percentage of the thousands of devices used by hospitals
  • 100 percent testing / inspection. This is in contrast to original device manufacturers, who test / inspect only a small sampling of their devices.
  • AMDR members are committed to ensuring device traceability. AMDR members have implemented sophisticated systems that mark each reprocessed device with a unique identification code that allows the device to be traced back to the reprocessor.

Tips for Evaluating a Third-Party Reprocessor:

AMDR members work hard to ensure that their reprocessing practices meet all Federal regulatory requirements and, most importantly, are safe and effective. Our members recognize that significant differences exist among third-party reprocessors. To maximize the benefits of third-party reprocessing, AMDR members encourage hospitals to ask the following questions before engaging the services of a third-party reprocessor:

General FDA Requirements:

  1. Is the company registered with FDA and can the company provide evidence of such FDA-registration?
  2. Does the company have a reputable FDA inspection record?
  3. Has the company listed its products with FDA and can the company share a listing of its product offerings?
  4. Does the company comply with FDA’s Quality System Regulation (QSR) requirements for medical device manufacturers?
  5. Does the company comply with FDA’s Medical Device Reporting requirements for medical device manufacturers?

 

Sterilization Requirements:

  1. Is sterilization performed by a commissioned and certified sterilization system, in accordance with ANSI/AAMI/ISO ST 11135 ST 1994?
  2. Is the sterilization cycle requalified annually?
  3. Are biological indicators used to monitor routine sterilization?
  4. Are the sterilization systems routinely calibrated?
  5. Is the residual sterilant level routinely tested?

 

Reprocessing Procedures:

  1. Does the company have reprocessing procedures tailored to the specific types of medical devices you wish to have reprocessed?
  2. Does the reprocessor have in place validated cleaning procedures?
  3. Is product functionality routinely tested?
  4. Does the company track the number of uses per device?
  5. Does the company recycle the raw materials from a device when it is no longer capable or eligible to be reprocessed?

 

Business Considerations:

  1. Does the company have adequate liability insurance coverage?
  2. Will the company permit you to visit its plant and review its quality manual?
  3. How will the company partner with you and your staff to integrate a reprocessing program into your established supply, storage and usage patterns?
  4. Is the collection program designed to ensure optimal compliance?
  5. Does the reprocessing partner support your efforts with regular business reviews, tracking programs and educational services that maximize staff participation?