TECHNICAL BUSINESS SOLUTIONS PROGRAM and STERRAD Sterility Guide

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Amice Doyle
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TECHNICAL BUSINESS SOLUTIONS PROGRAM and STERRAD Sterility Guide THE DIFFERENCE

and is proud that more than 23,000 device listings are approved for STERRAD

The SSG is an easy-to-use, online database featuring STERRAD -approved device

The devices listed in the STERRAD Sterility Guide (SSG) are within STERRAD

1 TECHNICAL BUSINESS SOLUTIONS PROGRAM and STERRAD Sterility Guide THE DIFFERENCE BETWEEN ASSUMED AND ASSURED ASP is widely known for working closely with MDMs and is proud that more than 23,000 device listings are approved for STERRAD Systems and are included in the STERRAD Sterility Guide (SSG) as of The SSG is an easy-to-use, online database featuring STERRAD -approved device listings. The devices listed in the STERRAD Sterility Guide (SSG) are within STERRAD Systems sterility claims and have been approved by the manufacturer for use in the STERRAD system. Devices listed are all validated by model and/or category number by the medical device manufacturer for reprocessing in STERRAD Systems. This approval is based on verification of sterility and functionality validation of the devices.

Partnering with Medical Device Manufacturers as a part of ASP s Instrument Validation Process As pioneers of the hydrogen peroxide gas plasma technology and the recognized worldwide leader in

2 Partnering with Medical Device Manufacturers as a part of ASP s Instrument Validation Process As pioneers of the hydrogen peroxide gas plasma technology and the recognized worldwide leader in infection prevention, Advanced Sterilization Products (ASP) understands the importance of partnering with Medical Device Manufacturers (MDM) to ensure their instruments can safely and effectively be sterilized in STERRAD Systems. Our instrument validation process results in that when selecting a medical device for sterilization in a STERRAD system, the device has been validated for sterilization, functionality and material compatibility and the device manufacturer (MDM) has provided to ASP written documentation for STERRAD use. This gives your Central Sterilization Supply Department the broadest range of devices approved for STERRAD sterilization that meet operational efficiency and surgical schedules. the IFU, technical bulletin and/or written letter from the device manufacturer in order to meet documentation requirements of their Central Sterile quality management system. The number of device listings approved and documented in the SSG changes as additional devices are added over the year. Ongoing collaboration with MDMs as well as yearly reassessments work to keep all listings correct and up to date. This is extremely important since hospitals cannot validate devices in their own sterilizer because they do not have the necessary software, biological materials, or the microbiological analysis equipment to assure they have reached sterility. ASP follows ISO 14937, ½ cycle overkill method, which cannot be performed in a hospital setting. Overall, ASP s rigorous instrument validation process promises sterility assurance. The STERRAD Sterility Guide (SSG) provides customers with a list of medical devices that are within STERRAD sterility claims and that the medical device manufacturer has provided ASP with instructions for use. This means that the manufacturer has given approval for the medical device to be reprocessed in STERRAD Systems, ASP has written documentation of this approval and the customer can readily obtain THE STERRAD STERILITY GUIDE IS ONE WAY ASP PROVIDES STERILITY ASSURANCE AND PEACE OF MIND.

The Importance of the STERRAD Sterility Guide for the Medical Device Manufacturers MDMs seek to be included in the SSG so they can be known for providing the best in patient care for hospitals since

3 The Importance of the STERRAD Sterility Guide for the Medical Device Manufacturers MDMs seek to be included in the SSG so they can be known for providing the best in patient care for hospitals since the SSG is a guidebook to devices already validated for sterility for any hospital or healthcare institution. Some MDMs reach out to ASP during product development for advice on how to design new devices so they will be compatible for sterilization in a STERRAD System.

4 CRITICAL DIFFERENTIATOR: STERILITY VALIDATION CAN ONLY BE PERFORMED WITH THE MEDICAL DEVICE MANUFACTURER. The false practice of testing lumens on a full cycle is inadequate to assure sterility of a marketed medical device. Why is this important? Testing lumens do not represent an actual medical device since they are quite simply constructed a homogenous hollow tube composed of one material (typically polypropylene) with the same diameter throughout. Little variability in material composition and diameter make a testing lumen easy to sterilize. Testing of lumens is not a validated method for assuring sterility. On the contrary hand, medical devices are incredibly complex and made with many types of materials and adhesives that react differently to different sterilization methods. In addition, lumened endoscopes are available in varying sizes (lengths and diameters). For example, flexible endoscope lumens may be tapered, making them difficult to sterilize at their most narrow diameters. Only the medical device manufacturer understands the necessary testing points for a medical device. ASP performs the sterility testing so the device manufacturer can validate the sterilizing process to meet ISO and regulatory requirements. The CSSD does not have to assume responsibility for what are non-regulated testing services. These services may not follow ISO /2 cycle overkill methods and any results are not verifiable according to the sterilization system or the medical device manufacturer. The testing performed by Technical Business Solutions Team eliminates a hospital s risk by assuring that the device was tested in accordance with the medical device manufacturer s assurance of sterility. This necessary process is for the safety of patients and hospital workers. Medical device companies must validate each sterilization modality and system for low temperature hydrogen peroxide systems.

ASSURING SAFE & EFFECTIVE STERILIZATION - WHO IS RESPONSIBLE FOR WHAT?

compatibility in a STERRAD System ASP evaluates products for sterile efficacy based on the approved materials & lumen claims for a specific STERRAD System STERILITY ASSURANCE Receives information

System sterility claims, and a trusted resource of up-to-date sterilization information for more than 10 years.

A NEW LEVEL OF REPROCESSING CONFIDENCE EASY ACCESS TO THE MOST CRUCIAL DEVICE LISTINGS FOR YOUR CSSD 3 23,000+ listings for devices that meet STERRAD Systems sterility claims 100+ original device

5 ASSURING SAFE & EFFECTIVE STERILIZATION - WHO IS RESPONSIBLE FOR WHAT? FUNCTIONALITY STERILITY RE-PROCESSING ISO /TIR 12 ISO MDM IFU / AAMI ST 81 MEDICAL DEVICE MANUFACTURER (MDM) ASP SSG HEALTH CARE PROVIDER (HOSPITAL) The MDM determines the functional compatibility in a STERRAD System ASP evaluates products for sterile efficacy based on the approved materials & lumen claims for a specific STERRAD System STERILITY ASSURANCE Receives information through manufacturer s IFU or the SSG for assurance in terminal sterilization Your source for STERRAD Systems sterilization information SSG is a reference database of devices that meets STERRAD System sterility claims, and a trusted resource of up-to-date sterilization information for more than 10 years. Now redesigned with simple, intuitive navigation, and inventory personalization through My STERRAD Center. Reprocessing confidence awaits, only at STERRADSterilityGuide.com. A NEW LEVEL OF REPROCESSING CONFIDENCE EASY ACCESS TO THE MOST CRUCIAL DEVICE LISTINGS FOR YOUR CSSD 3 23,000+ listings for devices that meet STERRAD Systems sterility claims 100+ original device manufacturers worldwide 100% endorsement of listings by original manufacturer A PERSONALIZED RESOURCE FOR REPROCESSING ASSURANCE My STERRAD Center is an inventory-building application that allows you to create a database of low-temperature reprocessing information specific to your CSSD. Enhance efficiency with quick access to up-to-date sterilization information and help reduce the potential for delayed turnaround, human error, and the risk of damage, from improper sterilization. ENHANCED SEARCH CAPABILITIES Versatile search options help you navigate listings for thousands of devices, where you can browse by manufacturer and device name, or conduct advanced searches with the help of auto-load form fields.

STERRADSterilityGuide.com Create your free account and discover the difference between ASSUMED and ASSURED www.

com 3 instrument validations, 100% endorsed by medical device manufacturers Easily select the appropriate cycle to

6 STERRADSterilityGuide.com Create your free account and discover the difference between ASSUMED and ASSURED 3 instrument validations, 100% endorsed by medical device manufacturers Easily select the appropriate cycle to reprocess your medical device Build your personal instruments & resources online archive Division of Cilag GmbH International Gubelstrasse 34, 6300 Zug, Switzerland Cilag GmbH International, All rights reserved AD CT_E

ASTM Workshop on Medical Device Cleanliness

ASTM Workshop on Medical Device Cleanliness Steve Goldstine Consultants SteveGoldstine@Yahoo.com 11/16/2010 ASTM: Cleanliness of Medical Devices ASTM Workshop on Medical Device Cleanliness Standard Practices