Reinventing Sterilization Quality Practices

Sterilization quality practices have come under increased scrutiny in recent years. Many are the stories in the media about problems that have occurred with sterilization of medical devices at healthcare facilities. Medical devices/surgical instruments have not been properly cleaned in accordance with the manufacturer’s instructions. This has potentially jeopardized the safety and health of the patients on who those devices were used. Ensuring that appropriate cleaning and sterilization practices are followed can be a daunting task.

There are many regulations/standards/recommended practices that medical device reprocessors must follow to ensure patient safety. These include national and international standards/recommended practices developed by professional organizations such as those published by the Association for the Advancement of Medical Instrumentation (AAMI), The Association of periOperatve Registered Nurses (AORN), The Association for Professionals in Infection Control and Epidemiology (APIC), The Society for Gastroenterology Nurses and Associates, Inc. (SGNA) and the International Organization for Standardization (ISO). Various legal regulations also need to be followed such as those required by: The Centers for Medicaid and Medicare Services (CMS), the Food and Drug Administration (FDA) and state, county and local public health departments. There are also organizations that accredit compliance with international/national quality practices, e.g., The Joint Commission (TJC), Healthcare Facilities Accreditation Program and quality system registrars who accredit company/facility compliance with standards, e.g. ISO 9000, ISO 13485, ISO 14000, etc.. Ensuring compliance with all of these standards and regulations can indeed be a mind boggling task.

Sterile Processing Quality Services, Inc. was formed to assist healthcare facilities and companies to ensure compliance with all of these standards and regulations. Each of the company principles brings years of experience in sterilization and medical device reprocessing to the table. We are familiar with the standards and compliance and will work with your management team to assess and analyze your current practices. Then we will work with you to develop action plans and assist with the implementation of those plans.