Regulatory and Quality Information

As an FDA registered medical device manufacturer in good standing, SterilMed, Inc., complies with all relevant US Food and Drug Administration regulations as well as compliance to all international standards pertaining to the quality manufacture of medical devices.

FDA

SterilMed is subjected to periodic audits of its Quality System and all related systems by the US Food and Drug Administration. Full quality system inspections to ensure compliance with the Quality System Regulation are conducted bi-annually by the FDA against all elements of the Regulation ( 21 CFR 820).

FDA most recently conducted a full Quality System periodic inspection on August 16, 17, and 18, 2006. This was a routine inspection of SterilMed in which auditors extensively reviewed areas of management controls, design controls, corrective and preventive actions, and production and process controls. This inspection found SterilMed to be in full compliance with FDA defined quality practices.

ISO

ISO is the International Organization for Standardization. ISO is the world’s premier organization for quality standards based in Geneva, Switzerland. ISO was founded in 1947 for the purpose of advancing standardization around the world. It is a non-governmental organization comprised of over 130 member countries. Each country is represented by its respective national standards body and participates in developing standards to facilitate trade of goods and services in the global marketplace.

ISO 13485 – This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices, and the design, development, and provision of related services.

Orion Registrar most recently conducted their annual audit on July 27, 28, 29 and 30, 2009. Like the FDA audit no major non-conformities were identified and no trends concerning nonconformities were identified. Full registration against ISO 13485 was extended for another year or until the next scheduled audit.

AMDR

SterilMed, Inc. is a member of the Association of Medical Device Reprocessors (AMDR). AMDR is a Washington, D.C.-based trade association representing third-party reprocessors of medical devices labeled for "single-use." ADMR member companies reprocess for America’s best hospitals and account for approximately 95 percent of the third-party reprocessing done in the United States. To date, AMDR members have collectively reprocessed over 25 million devices.

AMDR's mission is to promote proper reprocessing of medical devices, ensure the highest standards of regulatory and professional conduct, reduce the cost of health care while maintaining patient safety and care, advance the right of medical professionals to have choices in the use of reprocessed devices, provide a forum for reprocessing issues, and to educate patients,health care providers, government officials, the news media, and others about reprocessing issues. For more information, visit www.amdr.org.

For additional information, please call us at 1-888-856-4870 or email us at info@sterilmed.com.

Reprocessing

Conserve Your Healthcare Resources

SterilMed is offering a
short executive briefing to show how medical facilities can save 40 to 50% on medical device purchases and reduce repair and equipment costs. Please contact us to learn more.

Reprocessing helps make healthcare more affordable

"The FDA believes that reprocessed SUDs are as safe and effective as a new device."- Dr. Daniel Schultz,
Director Center for Devices and Radiological Health, FDA