Infection Control/Manufacturing

FDA-regulated, third-party reprocessing, provides safe, effective devices at greatly reduced costs — with no decrease in the quality of patient care, or change in practice patterns.

Reprocessing has wide clinical acceptance, both as a patient-safe, proven means of helping to control costs, and as an environmentally friendly practice. Clinicians who remember the days of unregulated re-use of ”single-use devices” and who are concerned about the amount of medical waste that is routinely generated in the clinical environment, embrace reprocessing for what it is – a patient safe practice that can positively impact your organization’s financial and environmental sustainability bottom lines.

AMDR asked the Association for Professionals in Infection Control & Epidemiology (APIC) to evaluate our members disinfection, cleaning and sterilization standards.  For their statement on reprocessing see:  : APIC Statement on Reprocessing

In 2000, GAO released, “Single Use Medical Devices: Little Available Evidence of Harm from Reuse, but Oversight Warranted.”
(Note: The list of reprocessed devices included in GAO’s 2000 report is outdated. It is not a current list of devices reprocessed in the United States today. For a listing of devices currently being reprocessed, see the link for AMDRs Commonly Reprocessed Devices (right) or search FDA’s device “Listing” database.)

GAO Written Testimony, presented by Dr. Janet Heinrich, Associate Director, Health Financing and Public Health Issues, GAO (2000).

In January, 2008 GAO released its report, “Reprocessed Single-Use Medical Devices — FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk.”

For an industry evaluation of the 2008 GAO report see:  AMDR’s Overview of January 2008 Government Accountability Office Report

95% of America’s Best Hospitals Reprocess!  For a complete listing seeUSNews and World Report America’s Honor Roll Hospitals

 

ISO Certification:

AMDR members are ISO 13485:2003(ISO) certified. ISO is an international device manufacturing standard and entails a level of excellence in device manufacturing compliance that is NOT required by the FDA, but that AMDR members have sought in addition to FDA requirements.

Some of the requirements that ISO 13485 certification entails include: development and implementation of a quality system, controls for customer satisfaction and methodology that provides for continual improvement in manufacturing processes. By achieving this standard, AMDR members have proven that they can consistently manufacture devices that not only meet regulatory requirements, but also consistently exceed customer requirements. ISO certification allows AMDR members to join the ranks of the most prestigious, high-quality device manufacturers in the world.

“SterilMed is committed to ensuring that our customers receive superior quality products and services. We are currently certified to the ISO 13485-2003 standard. To maintain ISO certification, we must undergo an annual audit of our adherence to our policies and procedures. All of our production related processes are validated and undergo FDA review and clearance. Each of these validated processes are continually monitored by our internal ISO-certified quality team to ensure we remain compliant with the ISO standard as well as the FDA’s requirements. Routine monitoring includes process control monitoring of our cleaning and refurbishment processes as well as 100% inspection of devices before they are packaged and shipped. Device history records are developed and retained for every job order to track that each process step was completed appropriately.”
— Garrett Ahlborg, Regulatory Affairs Manager, SterilMed Inc.

Ascent Healthcare Solutions goes beyond providing technically superior medical device reprocessing services to deliver guaranteed maximum supply-cost savings to leading health care organizations. Ascent is differentiated by our unwavering partnership commitment, clinical implementation expertise and dedicated field associates which together ensure that we exceed our partner’s goals and expectations. ISO 13485:2003 certification underscores our commitment to providing customers with the safest and most effective reprocessing program possible. ISO 13485:2003 – Medical devices—Quality management systems—Requirements for regulatory purposes” is an internationally recognized standard to ensure that companies are able to provide medical devices that consistently meet customer and regulatory requirements. In order to obtain certification, Ascent Healthcare Solutions had to meet strict requirements for a quality management system and demonstrate that it consistently meets customer requirements and regulatory requirements applicable to medical devices and related services. Ascent maintains continued certification through intensive annual surveillance audits.
— Ascent Healthcare Solutions, Inc.