PURPOSE

"ReNú Medical utilizes the strictest criteria to produce the most reliable, high quality products that meet or exceed our customers’ needs. We believe it is of the utmost importance to convey our philosophies on quality and reliability which are embedded in every step of our process and in all personnel.
ReNú provides the highest commitment to our customers’ needs and constantly pursues excellence through continuous improvement at all levels of design, quality, reliability, reprocessing and all support programs of our company."

Reprocessing Industry

"ReNú Medical has always placed the highest emphasis on delivering medical products that meet and exceed our customer's total requirements and, as a result, generate complete customer satisfaction- critical for success and survival in the medical device reprocessing industry. This is achieved by incorporating quality and reliability not only in product and process design, but also in the reprocessing process as well. This is achieved through careful planning in the design phase of any new development or equipment introduction into any of our facilities utilizing communication and teamwork.
ReNú Medical strongly believes in the necessity of cross-functional teams and the contributions of individuals to attain excellence in quality and reliability. Our employees are committed to the quality and reliability goals of the company and to continually improving the quality and reliability of ReNú Medical devices, processes, and services.
No industry faces heavier market and legislative scrutiny than the medical device industry, specifically medical device reprocessors. Not only are new Codes of Conduct, Quality Standards, and Federal Regulations being placed upon these companies but in addition, recently passed regulations also add to the pressing need for organizations to have the tools to manage their compliance processes. The solutions instituted by ReNú Medical enable us to operationalize these new mandates across our employee base and provide the tools to manage all of the elements of a government-regulated and mandated compliance/regulatory program. All the while, remaining a technological leader and maintaining our progressive edge in the compliance and regulatory arena.
The effects of being cited for violating certain regulations or processes can be devastating to a medical device company. ReNú Medical proactively addresses our governance and compliance issues and acts to put solutions in place to manage these risks, protect the public from oversight, and prevent loss of goodwill. We at ReNú are committed to protecting the public by providing only the highest quality medical devices using the best process methods. The executives and Board of Directors alike are committed to real-time performance indicators in order to proactively manage the risk levels at ReNú. Additionally, our regulatory department views bulletproof audit trails as a key factor in maintaining our company's commitment to improving its level of regulatory compliance.
ReNú's regulatory and compliance staff are dedicated to mapping out optimal governance and compliance processes and policies, clearly define accountable individuals, communicate necessary information and requirements to appropriate employees, and track their subsequent adherence to the relevant policies and regulations, while providing the most comprehensive executive performance indicators and one of the most defensible audit trails available. This unprecedented compliance visibility allows ReNú to address specific "at risk" areas and/or improve our company's overall compliance process efficiency all the while making sure that ReNú keeps up to date with the dynamic and fluid forces that govern the medical device community.

QA/Infection Control
ReNú Medical believes in quality of product over quantity. Each member of our staff, from executive management to laboratory personnel, wants to provide healthcare facilities with the most cost effective, high quality product available in the reprocessing industry.

Quality Assurance
ReNú Medical meets or exceeds all recommendations for reprocessing by the FDA, CDC, and other regulatory agencies.
Highlights of our QA process:

• 100% visual testing of all products post-reprocessing
• 100% functional testing of all products post-reprocessing
• Barcode labels are attached to each device so that we can track through each step of its functional life
• Unique and progressive Corrective and Preventive Action protocol (CAPA)
• Each product is extensively tested by R&D and engineering professionals prior to being accepted to the product line and afterwards to continually improve our process
• Tri-level method of monitoring each HLD process, including time and temperature among other variables, to ensure each device receives proper treatment

Infection Control
ReNú's Infection Control policies were developed under the direction of Dr. James Farmer, III, former Nosocomial Infections Director for the CDC, and Dr. Don Van Nimwegen, a practicing Seattle area physician.

Our Infection Control process includes:

• All process equipment receives regular calibration and maintenance
• Regular process analysis including pre- and post-HLD efficacy
• Quarterly infection control training for all personnel regardless of department
• All new employees receive training in basic microbiological methods, handwashing protocols, and infection control procedures. Continual training and testing ensures on-going education for all employees.
• Post-HLD and testing environments are entirely isolated from other areas to prevent cross contamination.

HLD vs. Sterilization
ReNú Medical feels a responsibility to educate potential and current customers to the benefits of high-level disinfection (HLD) versus the dangers of sterilization methods.

High-level Disinfection
High-level disinfection is not sterilization. HLD utilizes only high temperature water and time to render medical devices free of bacteria, viruses, and numerous other potentially dangerous microbes. This method, also referred to as pasteurization technology, has been a standard in industry since Louis Pasteur discovered its benefits in the 19th century. The simplicity of the process revolves around the high thermal conductivity of water and the ability of this medium to transfer heat to product in order to kill pathogens. This entire process is completed without the use of chemicals that could degrade product, leave injurious residue, produce dangerous air emissions, or expose patients and caregivers to potential carcinogens. Consider the benefits of HLD for non-sterile, single use devices (SUD):

• Extensive study by regulatory agencies and academia since Nelson and Ryan's definitive 1971 study (Respiratory Care, May-June 1971)
• Extended functional life for each device. HLD offers more cycles per device than sterilization
• HLD is more cost effective
• The environment benefits from less medical waste disposal, less frequent waste burning helps the ozone, and HLD does not give off air emissions
• HLD technology allows fast turn around time because devices do not have to be aerated

Sterilization
Medical devices can be bulk sterilized in numerous ways. Choices include steam such as autoclaving and chemical methods with ethylene oxide (EtO) being the most common. Plasma and ozone technologies are currently being researched but neither method is currently approved by the FDA nor is it presently cost effective. Point of use sterilization is often utilized by physicians' offices or hospitals to render devices sterile for specific immediate use. Point of use methods often employ chemicals such as peracetic acid and ortho-glutaraldehyde. Consider the following:

• Why choose sterilization for devices that do not have to be sterile? Many SUDs such as blood pressure cuffs, sequential compression sleeves, and transducers are delivered non-sterile from the OEM, are normally not used in sterile environments, and do not require sterilization for re-use
• The government considers many sterilization chemicals such as EtO dangerous and toxic. Federal, state, and local government are charged with highly regulating its use
• Chemicals such as EtO compromise human health and safety. Patients, caregivers, and sterilization employees are particularly at risk
• EtO kills microorganisms by alkylation of proteins and DNA. Humans are composed of proteins and DNA
• The manufacture and use of sterilization chemicals such as EtO involves the release of said chemicals into the air and water
• Danger Ethylene Oxide - Supporting Article regarding the dangers of EtO

Marketing Information
Please contact ReNú Medical for additional marketing information mailed directly to you!