Infection Prevention Solutions

Transcription

1 3 Volume 1 newsletter 3M Acquires Les Entreprises Solumed Inc. 3M Canada is pleased to announce it has acquired Les Entreprises Solumed Inc., a Quebec-based developer and marketer of leading-edge medical products designed to prevent infections in operating rooms and hospitals. Founded in 1990, Les Entreprises Solumed Inc. is a Canadian company that develops and markets skin asepsis (infection prevention) products intended for intravenous therapy, preoperative care, operating room care, home care and hand hygiene. Solumed s products are available in Canada, Australia, New Zealand, and Singapore. Solumed brings a chlorhexidine gluconate (CHG) and alcohol-based line of products to 3M s already robust core offering for infection prevention. Solumed s products such as antiseptic wipes and swabsticks, along with surgical scrub brush-sponges and antiseptic gels, complement 3M s existing line of trusted health care products intended to improve patient skin health and help reduce the risk of infection in patients and health care workers. These products from 3M provide cost-effective solutions and are supported by educational services, professional and technical support, as well as ongoing research and development.

2 Canadian medicine saves millions of lives around the world Medical aid organization Health Partners International of Canada (HPIC) has provided $250 million of medicines, vaccines and medical supplies to the developing world since 1990, thanks to the generosity of Canadian health-care companies. Dr. Pierre Plourde of Winnipeg carries PTPs on medical missions every year Medical supplies from 3M are in great demand by healthcare providers working in the developing world and we are deeply grateful for the continuing generosity of 3M in responding to this need - John Kelsall, HPIC President These companies are in the business of health, says HPIC president John Kelsall. Through their donations, they are saving lives and offering the gift of health to people living in poverty. According to Kelsall, in 2007 alone, Canadian companies donated more than $45 million of medicines, vaccines and medical supplies. You can treat a lot of people with that much medicine. Companies from the five sectors of the health-care industry researchbased and generic pharmaceutical companies, and manufacturers of vaccines, over-the-counter medicines, and medical devices have donated the medical products for humanitarian purposes. 3M has partnered with HPIC since Medical supplies from 3M are in great demand by healthcare providers working in the developing world and we are deeply grateful for the continuing generosity of 3M in responding to this need says Kelsall. 3M bandages and dressings are essential components of our Physician Travel Pack. The PTP is a portable pharmacy hand-carried by healthcare professionals travelling on medical missions in the developing world. Along with cuts and wounds common to all of us, many people in the developing world suffer from burns caused by cooking on open fires, cuts from machetes, and wounds caused by untreated skin lesions. Littmann Stethoscopes are also a valuable contribution to the PTP, as a basic instrument necessary to primary health care. (continued on next page)

3 3M products including masks and Filtek TM Supreme Plus Restoratives are included in the Dental Travel Pack, the kit specifically designed for dental missions. The popularity of the DTP is growing rapidly as dentists returning from overseas share their enthusiasm for the kits and the products it contains with their colleagues. 3M has products have also responded to needs in countries such as Afghanistan, Guyana, Zimbabwe and the Democratic Republic of Congo, where partners of HPIC are delivering basic health care to people who would otherwise have to do without. HPIC works closely with government agencies, Canadian medical professionals and NGOs to ensure that the medicine is delivered directly to the people who need it most. Medical aid programs include emergency response, community health projects, hand-carried medical packs and capacity-building programs in cooperation with foreign ministries of health. Dr. Reyes is thrilled to receive a PTP for her clinic serving a slum in the Dominican Republic Since 1990, medical aid has been provided to communities ravaged by conflict, natural disasters and extreme poverty. According to Kelsall, millions of people who would not otherwise have access to basic health care have been treated and healed. For more details on the PTP and the DTP, please visit the HPIC website ( lives and offering the gift of health to people living in poverty... - John Kelsall, HPIC President

4 The Importance of Hand Hygiene Five moments of hand hygiene (as stated by the World Health Organization): Before Patient Contact Before an Aseptic Task After Body fluid exposure risk After patient contact After contact with patients surroundings Hand hygiene is the single most effective way to prevent the spread of communicable diseases and infections. There is no simpler way to put it. Yet this one simple truth that applies across all of health care (and society at large) is surprisingly difficult to achieve. Everyone understands the importance of hand hygiene in health care, but the true difficulty of hand hygiene is in the implementation. According to the World Health Organization and their Guidelines on Hand Hygiene in Health Care, the average frequency of opportunities for hand hygiene per Health Care Worker varies markedly, anywhere between eight opportunities for hand hygiene per hour of patient care (paediatric wards) to an average of 22 opportunities per hour for nurses in ICUs 1. Adherence of HCWs to recommended hand hygiene procedures has been traditionally low, with mean baseline rates ranging from 5% to 81%, with an overall average of about 40% 1. So why do we typically have such poor compliance? The most common reasons are: Access to Product Time Patient empowerment and awareness Staff awareness Culture Patient safety is coming to the forefront of the health care system. Anyone can open a paper to read about a new MRSA outbreak attributed to poor hand hygiene compliance. The advent of strong guidelines from groups like the CDC and WHO on hand hygiene; new organizations such as Safer Health Care Now and the Canadian Patient Safety Institute (CPSI), and a myriad of scientific research in this area are all helping to advance the cause. In fact, the CCHSA (Canadian Council on Health Accreditation) now has requirements for both Infection Control and hand hygiene education programs in their accreditation. All of this is causing a shift, helping to alleviate some of the factors above. CPSI for example recently announced that it has signed a major agreement with 3M s Infection Prevention business, to participate in the co-development of a human factor project that will include identifying where hand hygiene products should be located at point of care as well provide key tools for CEO and healthcare professional engagement in hand hygiene. With organizations such as the WHO stating that According to scientific evidence arising from efficacy and cost effectiveness, alcoholbased handrubs are currently considered the gold standard approach. 1 alcohol based hand sanitizers are cropping up everywhere. With a variety of different types available (gels, lotions, and foams), there are options for even the most discerning hands. However, probably the single biggest factor in this process is the culture aspect. There are various programs that have been started that are trying to address just this issue. The Ministry of Health in Ontario recently launched a hand hygiene program in 10 facilities to try and drive compliance as did CPSI on a national basis. Industry has also stepped in to try and offer compliance solutions / programs based around change management principles. The importance of hand hygiene is put best by Dr. Michael Gardam, Infection Control Director of the University Health Network in Toronto: Why does your facility need a hand hygiene program? With all the scrutiny health care is getting now. You no longer have a choice 1 WHO Guidelines on Hand Hygiene in Health Care (Advanced Draft) Draft Guidelines. who.int/mediacentre/news/releases/2005/pr50/en/

5 Canada s Hand Hygiene Campaign The Canadian Patient Safety Institute (CPSI) has announced the Getting Ready phase of Canada s Hand Hygiene campaign aimed at getting organizations ready to adopt and measure hand hygiene practices and compliance within their organizations. This multimodal strategy is based on the World Health Organization s challenge Clean Care is Safer Care initiative launched worldwide two years ago aimed at raising awareness that healthcare associated infections as an important priority for patient safety. CPSI has also announced as part of the launch that it has signed a major agreement with 3M Infection Prevention, the international diversified technology company renowned for serving customers and communities with innovative products and services, to participate in the co-development of a human factor project that will include identifying where hand hygiene products should be located at point of care as well provide key tools for CEO and healthcare professional engagement in hand hygiene. More information can be found on the CPSI campaign website (

6 Understanding the Differences Between Class 5 Chemical Integrators and Class 6 Emulating Indicators Background: In December, 2005 the International Organization for Standardization (ISO) published a new document, ISO : 2005 Sterilization of healthcare products Chemical Indicators Part 1: general requirements. The C.S.A organization has approved this standard without deviations, which means this document is now a recognized C.S.A Standard. There are two key changes you should be aware of: 1. Class 5 Integrating Indicator requirements were upgraded. 2. Class 6 Emulating Indicators, which were already part of an earlier ISO standard, are now included in the C.S.A Standard. 1 Today, there are six classes of Chemical Indicators. The current ISO document classifies chemical indicators by their intended use and these classifications have no hierarchical significance. 1 For example the Bowie Dick Test is a Class 2 Chemical Indicator and probably provides more information about the steam sterilizer performance than any other class of chemical indicators. ISO provides performance requirements for each classification. The design differences are outlined in the table below: Design of Class 5 Chemical Integrators Class 5 Integrating indicators are designed to react to all critical variables (time, temperature, and the presence of steam) and have Stated Values that correlate to a biological indicator (BI) at three time/temperature relationships. 1 Class 5 Integrating indicators must have three Stated Values at 121 C, 135 C, and at one temperature in between that correlate to a BI. 1 Additionally, the Stated Value at 121 C must not be less than 16.5 minutes. This guarantees the time/temperature response for a Class 5 Integrating Indicator will respond like the BI when exposed to ideal, saturated steam (see Figure 1). Therefore, if the exposure temperature was not achieved where the Class 5 CI is located and the BI result was positive (a sterilization failure), the Class 5 CI will respond like the BI performance (thermal death rate curve of G. stearothermophilus) and also indicate that a failure had occurred. Integrating Indicator Integrating Indicator Time (Min.) Needs 3 Stated Values (121 C, 135 C, and 1 in between) G. stearothermophilus Thermal Death Time Temperature ( C) Figure 1: Time/Temperature Response for Class 5 Integrating Indicator Compared to Biological Indicator Response Source: 3M internal test result Design of Class 6 Emulating Indicators Class 6 Emulating indicators are designed to react to all critical variables (time, temperature, and the presence of steam) for a specified sterilization cycle. 1 You may hear Class 6 indicators referred to as cycle specific indicators. Class 6 Emulating indicators have one Stated Value for time and temperature for the specific cycle it is designed for. 1 There is no requirement for three Stated Values for time and temperature and therefore the response may not correlate to a BI. (see Figure 3) Note that at lower temperatures the Class 6 response can fall below that of the BI performance (thermal death rate curve of G. stearothermophilus). (see Figure 2) Emulating Indicator Steam Emulating Indicators Time (Min.) How does this affect my monitoring processes? If your Sterile Processing Department runs multiple exposure times (e.g. 4, 10 and 18 minutes at 272 F), a distinct Class 6 emulating indicator would be required to monitor each cycle. Because the Class 5 Integrating Indicator response at lower temperatures parallels the biological response, Class 5 CIs are able to detect the failure condition where the desired exposure temperature is not achieved. This condition is likely to occur when there is: incorrect packaging incorrect loading air/steam mixtures an incorrect cycle for load contents. Because the Class 6 response at lower temperatures can fall below the thermal death curve of G. stearothermophilus, the Class 6 Emulating Indicator can reveal a pass when the BI would indicate a failure. Only Require One Stated Value for Time and Temperature Note: Class 6 response at lower teps can fall below BI thermal death curve G. stearothermophilus Thermal Death Time Temperature ( C) Figure 2: Time/Temperature Response for Class 6 Emulating Indicator Compared to Biological Indicator Response Source: 3M internal test result (continued on next page)

7 Stated values for all classes of Chemical indication are determined in a Resistometer. Resistometers are specialized vessels that can create reproducible test cycles. They were chosen by the Standard Committees so manufacturers utilize common reproducible cycles to verify CI and BI performance. There are hundreds of possible hospital cycles where the depth of vacuum, the number of steam/vacuum pulses, the sterilizer come-up time, and the steam quality differ. These differences would make it impossible to provide consistent CI performance results for hospitals. Steam resistometers must reach the desired temperature in < 10 seconds (see Figure 3). Hospital sterilizers, however, may have up to 10 minutes of pre-conditioning or come-up time (see Figure 4). BI inactivation and CI progression toward endpoint begins to occur during this pre-conditioning or come-up time in hospital sterilizers. The cycle specific data for Class 6 Emulating Indicators is generated in a resistometer as well, not in a hospital sterilizer. Therefore, in a hospital sterilizer, Class 6 Emulating Indicators could have significant progression toward their endpoint during the come-up time and reach their endpoint much sooner than their Stated Value time and temperature. Temperature ( C) Profile of Steam Resistometer Cycle Come-up time (less than 10 sec.) One vacuum Pulse (less than 2 minutes) Time Figure 3: Resistometer Cycle Profile Source: 3M internal test result Profile of Hospital Gravity Cycle Temperature ( C) Come-up time (less than 10 min.) 3M recommends the use of a Class 5 Integrating Indicator: inside a BI Process Challenge Device (PCD) as required by the AAMI ST79 for monitoring implant loads inside a PCD for monitoring loads when a BI PCD is not being run for internal pack monitoring a Class 6 Emulating Indicator could be used as an internal indicator at the pack/tray level in cycles for which it is labelled Time Figure 4: Hospital Cycle Profile Source: 3M internal test result This recommendation is based on the following: A Class 5 Integrating Indicator reacts to all critical variables and has three Stated Values that correlate to a BI at three time/temperature relationships (see Figure 1). This means a Class 5 integrating indicator will detect failure conditions where the selected exposure temperature is not achieved. The Class 5 Integrating Indicator Stated Value at 121 C must not be less than 16.5 minutes. A CI with a Stated Value at 121 C of less than 16.5 minutes can reach its endpoint too quickly at lower temperatures and miss a sterilization process failure. If a load is being released on the results of a Class 5 Integrating Indicator, it is critical the CI be able to show correct results at lower temperatures that is similar with BI performance (see Figure 1). Figure 2 shows how an Emulating Indicator might compare to BI performance in a Resistometer test vessel. Because Emulating Indicators only require one stated value for time and temperature, at lower temperatures the response of a Class 6 Emulating Indicator can fall below the BI thermal death curve. (see Figure 2) 1. Canadian Standards Association, Sterilization of health care products Chemical indicators Part 1: General requirements, CAN/CSA/ISO :2005

8 Introducing New Products to the 3M TM Steri-Drape TM Surgical Drapes Line As part of our ongoing effort to increase the value and performance of 3M TM Surgical Drapes, we are pleased to announce the introduction of the following products to the 3M TM Steri-Drape TM Surgical Drapes line. These new products were developed by working with leading clinicians and surgeons asking for products that increased the efficiency of surgical procedures while maintaining the quality that you ve come to expect from the 3M TM Steri-Drape TM Surgical Drapes line of products. A drape that is absorbent, designed to help prevent the risks of both strike-through and roll-off, and eliminates the need for layering while protecting the healthcare worker, 3M TM Steri-Drapes TM Surgical Drapes are made with materials designed for better infection prevention. 3M TM Steri-Drape TM Tube Organiser Securely positions and organizes multiple tubes and cords of different sizes. Conveniently adheres to tables, stands, drapes and other OR equipment. Reusable tab allows you to reposition, add, or replace tubes and cords during the procedure. Middle portion of the tab s adhesive can be folded onto itself, allowing tubes and cords to move freely between the adhered ends. Individually wrapped and sterilized in peel-open envelopes to maintain the sterile environment. 3M TM Ioban TM 2 Antimicrobial Incise Drape EZ Unique framed delivery system enables simplified one person drape application. Size (26 cm x 20 cm) is ideally suited for minimally invasive surgical procedures using implantable devices. Iodophor-impregnated adhesive provides continuous, broad-spectrum antimicrobial activity, and superior adhesion to the skin and wound edge. Strong, conformable and breathable polyester incise film provides a sterile surface, and helps to decrease bacterial contamination from skin to gloves, gowns, instruments, and implants. 3M TM Steri-Drape TM One Piece Hip Drape with Side Pouches Uniquely prepared to hold the edge of the drape in place during surgery, and to prevent strike-through. The adhesive strip provides secure adhesion to the skin throughout the procedure, preventing the edge of the drape from migrating into the incision area during surgery. Large side pockets with flaps for fluid collection and control. Extra long and wide drape assures complete coverage even during manipulation of the leg. Designed for one piece draping, eliminating multiple drape application saving time and money. Low linting (INDA IST ). Absorbent Prevention Fabric meets Flammability Class I (CFR Title 16 Part 1610).

9 Saturated Steam: Just what the heck is it? Saturated steam, as we all know, is the sterilant for most reusable medical devices. But what makes it so special? And why do we sometimes see sterilization failures due to poor steam? Saturated steam is crucial to the steam sterilization process. wet-steam, air or carbon dioxide in the steam interfere with the sterilization process. But we must ask why? What makes saturated steam such an effective sterilant? An understanding of how saturated steam works can lead to a better understanding of the whole sterilization process. When water boils it creates a gas, which we call steam. At normal pressures, gaseous water (steam) exists at any temperature above 100ºC, the boiling point of water. If gaseous water is allowed to cool down, it will eventually condense back into liquid water. That happens at 100ºC or lower temperatures at normal pressures. The cloudy jet coming from a boiling kettle is steam that has started to condense back to liquid (as it contacts the cooler air) and the cloudiness is as a result of small droplets of moisture in the jet. The cloudy stuff is not saturated steam it s more like wet steam. Saturated steam is what you see very close to the spout of that boiling kettle. A clear, hazy gas. The temperature of that steam is 100ºC, but most importantly, it contains a huge amount of heat energy, but where does it get the heat energy? Consider one kilogram of water at normal pressures. It takes 80 Kilocalories of energy to heat that water from 20ºC to boiling point at 100ºC. Once at boiling point, if the heating continues, the liquid water will be converted to steam. It then takes 538 Kilocalories to convert the kilogram of steam to water into steam. This heat energy is stored in the steam until it condenses back, so the reverse is also true. If that kilogram of steam condenses back to water it immediately releases the 538 Kcals as heat energy into whatever it is contacting at the time. That can happen with saturated steam with a temperature difference as low as 1ºC. So, consider an item at 99ºC that comes in contact with a kilogram of saturated steam at 100ºC. The steam will condense, to liquid. One kilogram of saturated steam condensing will deliver 538 Kcals to the item instantaneously. If that item is a contaminated surgical instrument, microbes will be killed by the heat energy. We also know that the boiling point is the critical temperature for saturated steam to exist and that boiling point increases as pressure increases. That s why hospital sterilizers operate at pressures around 30 PSIG rather than atmospheric. By doing so they are able to use saturated steam at higher temperatures ( ºC) and thus get more effective sterilization processes. Please visit the 3M Booth at the following tradeshows: CSAO (Central Service Association of Ontario) from Sept 15-16, 2008 in Toronto, ON AGS (Association des Gestionnaires en Sterilisation) from Oct 9-10, 2008 in Montreal, QC

10 Sales Representative Contact List British Columbia: Sterilization Specialist Bruce Billett Perioperative Specialist Dianne Ritchie x7424 Alberta: Sterilization Specialist Tyler Nicholetts x7494 Perioperative Specialist Brent Christensen x7457 Saskatchewan/Manitoba: Matthew Reimer x7483 Ontario: Toronto West Jamie Hollingsworth x3805 Downtown Toronto/East Toronto Sterilization Specialist Carol Norrish x3806 Southwestern Ontario Sterilization Specialist Christine Broomfield x3784 Southwestern Ontario Perioperative Specialist Jodie Allen x2363 Ottawa/Northern Ontario Lyne Taylor x3817 Quebec: Northern Quebec Josee Letourneau x4757 Montreal/Southern Quebec Perioperative Specialist Sylvain Roy x4595 Montreal/Southern Quebec Sterilization Specialist Christian Gagner x4767 Maritimes Larry Corscadden Your story ideas are always welcome! Please send your comments, questions and suggestions to: 3M, Filtek, Littmann, Ioban and Steri-Drape are trademarks of 3M. Used under license in Canada. Please recycle. Printed in Canada. 2008, 3M. All rights reserved