560 likes | 1.06k Views
Approvisionement Nord- Ouest. Who is Crosstex/ SPS medical. Develop and market sterility assurance products that offer advanced technologies Provide full day sterilization Seminars and on-site Facility sterilization audits
E N D
Who is Crosstex/SPSmedical • Develop and market sterility assurance products that offer advanced technologies • Provide full day sterilization Seminars and on-site Facility sterilization audits • Corporate member: CSA and AAMI, serving on numerous sterilization working groups • Now a part of Crosstex International, a Cantel Medical Company
Crosstex International Crosstex International is a leading global manufacturer of infection prevention consumables. Crosstex serves the global healthcare community from 10 strategically located manufacturing and distribution facilities all around the world,
Mission Statement Striving to continuously develop unique and innovative products is the cornerstone of our healthcare mission. We are proud to serve our healthcare community as a leading global manufacturer providing solutions for better infection control, prevention and safety.
Keir Surgical Add Keir Surgical write-up here…
Product Overview Sterilization Assurance Products • Chemical Indicators/Integrators • Biological Indicators • Record Keeping
Sterilization Assurance SPSmedical offers the most comprehensive line of sterilization assurance consumables!
Chemical Indicators CSAdefines six (6)classes of chemical indicators with recommendations for use for Classes 1 – 6 Class 1 – Process Indicators Class 2 – Specific Test Indicators Class 3 – Single-variable Indicators Class 4 – Multi-variable Indicators Class 5 – Integrating Indicators Class 6 – Emulating Indicators
Class 1 Chemical Indicators Class I Process indicators are intended for use as an external indicator to distinguish between processed and unprocessed items. Indicators on tape, cards and pouches are usually examples of Class 1 process indicators.
Class 1 Chemical Indicators SPSmedical manufactures indicator tapes for Steam and EO Gas sterilization processes. SPSmedical has also introduced the industry’s first and only Lead/Latex free steam indicator tape.
Chemical Indicator Tape Standard Steam Indicator Tape Cat. No.’s: ST-036, ST-048, BT-036, BT-048 Lead/Latex Free Indicator Tape Cat. No.’s: LF2-036, LF2-048 EO Gas Indicator Tape Cat. No.’s: GT-036, GT-048 NOTE: While VH2O2 tape is available, we recommend this only for customers with V-PRO as we continue to work on the design of this product
Chemical Indicators CSA defines six (6)classes of chemical indicators with recommendations for use for Classes 1 – 6 Class 1 – Process Indicators Class 2 – Specific Test Indicators Class 3 – Single-variable Indicators Class 4 – Multi-variable Indicators Class 5 – Integrating Indicators Class 6 – Emulating Indicators
Class 2 Chemical Indicators “Specific Test Indicators” are Bowie-Dicktype indicators for use with air removal testing. The Bowie-Dick test is purely a diagnostic test of a sterilizer's ability to remove air from the chamber of a prevacuum steam sterilizer.
Bowie Dick Frequency For dynamic air removal type sterilizers, an air removal test (Bowie-Dick test) shall be performed every day the sterilizer is used. CSA Z31403-09: Section 12.6.3.3.1
Bowie-Dick Test Packs SINGLE USE: AirView Bowie Dick Test Pack • Each box is pre-assembled and can be used only once. REUSABLE: Lantor Cube Bowie Dick Test Pack • Industry’s only reusable B-D test pack! • Cube can be re-used for 25 cycles • Saves waste, space and money! FACT: The Lantor Cube can reduce waste by up to 85% over single-use test packs.
AirView Bowie-Dick Test Pack Cat. No. SBD-030
Lantor Cube Bowie-Dick Test Pack Cat. No. LCR-025
Chemical Indicators CSAdefines six (6)classes of chemical indicators with recommendations for use for Classes 1 – 6 Class 1 – Process Indicators Class 2 – Specific Test Indicators Class 3 – Single-variable Indicators Class 4 – Multi-variable Indicators Class 5 – Integrating Indicators Class 6 – Emulating Indicators
Class 4 Chemical Indicators Class 4 Multi-variable indicators are designed to react to two (2) or more critical sterilization parameters, to indicate exposure at stated values. 1) Time 2) Temperature 3) Sterilant
Class 4 Chemical Indicators SPSmedical’s Self-Seal pouches are also printed with a multi-parameter (Class 4) internal indicator. This patented technology is only available through Crosstex/SPSmedical!
Chemical Indicators CSA defines six (6)classes of chemical indicators with recommendations for use for Classes 1 – 6 Class 1 – Process Indicators Class 2 – Specific Test Indicators Class 3 – Single-variable Indicators Class 4 – Multi-variable Indicators Class 5 – Integrating Indicators Class 6 – Emulating Indicators
Class 5 Chemical Indicators Class 5 Integrator Chemical indicator that reacts to all critical variables over a specified range of sterilization cycles and their performancecorrelatesto BI performance as stated on their labeling.
Class 5 Chemical Indicators Class 5 Integrating Indicators that comply with ISO 11140-1:2005 • More rigid criteria than prior Class 5 integrator document • Stated values must correlate to the results of the BI • at 250°F, 275°F, and a minimum of one point between • (Can be used for ALL steam cycles) • Stated value at 121C/250F must exceed 16.5 minutes • Class 5 indicator passes only if BI is killed. There are “Class 5” products on the market that do not meet this performance criteria! Class 5 chemical indicators should be used with implants
STEAMPlusIntegrator • ISO 11140-1:2005 printed on each strip • Has Lot # and expiration date printed on each indicator Cat. No. SSI-1000
STEAMPlusIntegrator • 4” in length, making it easier for OR to locate in sets • FDA cleared as “equivalent in performance to a BI
Chemical Indicators CSAdefines six (6)classes of chemical indicators with recommendations for use for Classes 1 – 6 Class 1 – Process Indicators Class 2 – Specific Test Indicators Class 3 – Single-variable Indicators Class 4 – Multi-variable Indicators Class 5 – Integrating Indicators Class 6 – Emulating Indicators
EmPlus 270ºF Steam Emulator The EmPlus Emulator is a Class 6 emulating indicator, as defined by ISO 11140-1:2005.. The industries only moving front Class 6 Emulator, the EmPlus provides easy to interpret results that are stable and will not revert post processing Cat. No. EMP-1004
Biological Indicators Biological Indicators should be used: • at least weekly inSteam, preferably every day the sterilizer is used and every load that contains an implant. Spore growth is indicated by a color change in the media during incubation
Biological Indicators Terminal Sterilization (Process Challenge Device) BI Test Packs are used to monitor hospital size sterilizers. Each mode used (gravity or pre-vacuum) should be tested in the shortest cycle used. Steam- place the PCD flat on the bottom shelf, directly above the drain with a load.
The health care facility needs to ensure that the medical device manufacturer’s instructions are followed for extended cycle times unless the manufacturer provides written documentation that the device can be properly sterilized for 4 min at 132°C or 3 min at 135°C. The health care facility should request information from the manufacturer as to the means whereby the extended cycle should be monitored in order to ensure that effective sterilization of the device is assured.
SporViewPlus BI Test Pack • Includes a an immediate readout Class 5 integrator. • Class 5 Integrator is FDA cleared as “equivalent in performance to a BI” and provides an immediate readout that can help eliminate the need to wait 3 hours to release loads. • Validated for use in standard and extended steam cycles. • Complies with CSA Standards for monitoring non-implant and implant loads.
SporViewPlus BI Test Pack Cat. No. SBT-024
Class 5 PCD for Routine Loads Use BI daily and with implants, per CSA standards while running a Class 5 Test Pack for all other, “routine” loads. Daily BI Test Pack Routine Load Test Cat. No. STP-025 Cat. No. SBT-025
STEAMPlus Class 5 Test Pack • PCD includes ISO 11140-1:2005 Class 5 • Cost effective over BI testing every load • Immediate results • Accuracy & reliability of BI Cat. No. STP-025
BI Testing Immediate Use Steam Sterilizers BI testing in IUSS sterilizers should be done DAILY with a loose Biological Indicator. Special Note: 3M offers two products for monitoring IUSS, one for Gravity cycles and another for Pre-vacuum. The SPSmedical BI has been validated for both Gravity and Pre-vacuum cycles (Cat. No. SCS-025/SCS-100).
SporView Self ContainedBI Cat. No. SCS-025 and SCS-100
STEAMPlus Tray Record Card Tray Record Card • Provides immediaterelease • Permanent record Cat. No. TRC-050
VH2O2 Sterilizers SPSmedical offers the following for usein VH2O2 sterilizers (STERRAD and VPRO) SPSmedical offers: • Chemical Indicators • Sterilization Pouches • Load Record Stickers • Load Record Cards Special Note: SPSmedical offers UNIVERSAL products that can be used in Steam, EO Gas and VH2O2 sterilizers!
Paracetic Acid Sterilizers SPSmedical manufactures the only BI approved for both the SYSTEM 1 (SS1) and SYSTEM 1E (SS1E). Final BI results in just 16 hours! Cat. No. PCS-025
Sterilization Packaging Crosstex/SPSmedical offers a wide variety of sterilization packaging systems.
Non-Acute Product Line In addition to your hospital style equipment, SPSmedical manufactures products to test table top sterilizers found in clinics, labs, offices, etc.
What are your peers saying? Add referrals from Ottawa General and Fraser Health Authority.
Sterility Assurance Rewards Program • What is it? • Loyalty program designed to support customer education and enhance MDR sterility assurance • Who qualifies? • Any account purchasing over $3,000 of SPSmedical products from Keir Surgical in a 6-month period (Jan-June, July-Dec)
Benefits of the StAR Program • Earn 3% back in StAR Points • Redeem points for: • Quality Assurance Products • Educational Products • Consulting and Educational Services 126 -408 East Kent Avenue S. , Vancouver, BC V5X 2X7 T. 604.261.9596 / 800.663.4525 | F.604.261.9549 www.keirsurgical.com ISO 13485:2003 Certified
Qualifying customers receive a statement of points in January and July • StAR points expire 2 years from the period earned • Points are redeemable year-round • Points may be combined with regional facilities (upon approval of Keir Surgical) 126 -408 East Kent Avenue S. , Vancouver, BC V5X 2X7 T. 604.261.9596 / 800.663.4525 | F.604.261.9549 www.keirsurgical.com ISO 13485:2003 Certified