Healthcare Safety Devices SANDEL Product Line Review

Transcription

1 Healthcare Safety Devices SANDEL Product Line Sandel Medical Industries (SMI) was founded in the United States in March 2002 by Dan Sandel. The foundation for the company was based on new, innovative safety products that addressed common tasks healthcare professionals were involved with every day. Having strong relationships with the Association of perioperative Registered Nurses (AORN), it was predetermined that the Operating Room would be SMI s primary focus. With a US market place of 5,300 acute care hospitals (30 million surgeries per year) and 5,000 Ambulatory Surgery Centers (20 million surgeries per year) a tremendous opportunity to make a huge impact in healthcare safety existed. Submission Process To capture market unmet needs an Issue Submission Process was developed and implemented. This process gives healthcare professionals the opportunity to submit their issue/product solutions directly to Sandel Medical, and if a product is developed from a submission, the submitter will receive appropriate compensation. Regularly scheduled meetings are held to review each product submission to determine if it meets the established criteria to move forward. Examples of criteria considered: Is this a universal/global/country wide issue? Is the solution patentable? Can the product solution be manufactured and offered to the market at an affordable cost? Does the product fit into the brand personality and direction i.e., disposable, O.R. focused, fall into the patient and staff safety market? If the product submission meets these and other criteria, the developmental process is initiated. Ironically, the majority of the thousands of product ideas received are patient and staff safety focused. Today the submission process remains a vital part of our culture and continues to provide ideas for new and innovative safety products. Global program accessible by healthcare providers worldwide through Submissions are viewed by a global team monthly If a submission is accepted for further research an agreement between the submitter and Ansell is then created. The agreement will identify the terms of the agreement including royalties paid should the product idea/submission be launched into the market The Need for Safety Solutions The need for safety solutions was validated through the numerous patient and staff safety submissions from healthcare providers, the release of the 1990 Institute of Medicines report To Err is Human which stated that 98,000 people die each year in U.S. Hospitals due to a preventable error or mistake, and the subsequent 2004 Reuters report which stated 195,000 deaths annually due to preventable errors is much more accurate.

2 Regulatory/Professional Regulatory and Professional recognized the severity of patient and staff safety problems and established regulations, recommended practices and position statements to be followed. There are a number of professional organizations that contributed to the advancement of providing a safer environment for patients and healthcare professionals. Some key organizations include: Occupational Safety and Health Administration (OSHA) The Joint Commission (JCAHO) Association of perioperative Registered Nurses (AORN) American College of Surgeons (ACS) World Health Organization (WHO) Even though these organizations operate separately, the guidelines, recommendations, and standards of each carry a very helping to create a safer healthcare environment. The Asia Pacific equivalents, from the Royal Australasian College of Surgeons (RACS) and the Australia College of Operating Room Nurses (ACORN) to, for example, the Korean Association of Operating Room Nurses (KORN) are founded on the same underlying principles for recommended practices and position statements. The Joint Commission International (JCI) provides accreditation, education and advisory services to leading hospitals throughout this diverse region. Ansell purchased the Sandel Medical business in July Ansell remains dedicated to providing safety solutions that eliminate, prevent, or significantly reduce workplace accidents and resulting injuries before, during, and after surgery. By collaborating with nurses, surgical teams, and healthcare experts, we have been able to identify important safety issues and determine how the standard of care can be elevated to reduce safety hazards for both patients and healthcare staff. The resulting SANDEL products have been developed to resolve the specific safety and ergonomic needs identified in a cost-effective manner. Category of Products Being one of a number of product brands within the Ansell family, SANDEL, over the years has developed patient and staff safety products in the following categories: Sharps Safety Staff and Patient Ergonomics Fluid and Trip Management Operating Room Turnover Never Event Protection As not all countries offer the complete line of SANDEL products, we recommend that you utilize the regional SANDEL catalogs as you complete this training course. Links have been provided for those catalogs that are available online, otherwise; please ask your marketing department for a copy of the SANDEL catalog for your country. USA Catalog Australia Catalog SANDEL is a registered trademark of Ansell in the United States. Product and may vary by region. Always confirm correct usage of registered trademarks and trademark symbols with the regional legal team.

3 The Centers for Disease Control and Prevention (CDC) estimate that about 385,000 sharps-related injuries occur annually among healthcare workers in hospitals, with thousands of injuries going unreported. Recent data from the Exposure Prevention Information Network (EPINet) suggest these injuries can be reduced, as sharpsrelated injuries in non-surgical hospital settings decreased 31.6% during (following the Needlestick Safety and Prevention Act of 2000). However, injuries in surgical settings increased 6.5% in the same period where adoption of safety devices has been limited compared to nonsurgical settings. (CDC Stop Sticks program) Three quarters (75%) of the injuries in the O.R. occurred during use or passing of the sharp devices, with the top 3 causes coming from Suture Needles (43.4%), Scalpel Blades (17%), and Syringes with needles (12%). Surgeons and surgical residents are most often the original users of the devices causing injuries, with nurses and surgical technicians being most often injured by devices originally used by others. It is clear that hospitals need to comply with requirements for adoption of safer surgical technologies and to promote policies and practices to reduce blood exposure to Surgeons, their co-workers and patients. An estimated one million sharps injury occur in the European Union each year EU commission 2010); with more than 100,000 of these taking place in UK. (Health and Safety Executive 2010) No country in the Asia/Asia Pacific region has a policy or law mandating the use of safety-engineered sharps devices. In Australia, only three states Western Australia, Queensland and Victoria have policy guidelines or directives regarding sharps injuries and needle stick prevention. In Asia Pacific, the incidence of sharps injuries varies from country to country dependent on practices and adherence to the recommended practices. In Australia, for example, it has been estimated that at least 18,000 nurses and other healthcare employees suffer needle stick and sharp object injuries every year, while in Japan, for example, a nationwide epidemiologic study (EPINet Japan) conducted between 1996 and 1998 recorded 4,786 sharps injuries annually.

4 Surgeons have been reluctant to implement the use of available safety scalpels due to the inability of manufacturers to provide the handling characteristics of the traditional #3 reusable scalpel handle. Primarily, surgeons are looking for: The weight (27 grams) of a reusable #3 handle Complete visibility of the blade Choice of blade type, carbon or steel, and manufacturer; the majority of surgeons prefer a carbon blade over stainless steel due to sharpness The ability to change blades during the case No outside interference when making punctures Can be used by a right or left handed surgeon Because of the inability of manufacturers to provide these requirements, it is estimated that less than 10% of the US scalpel market has been converted to safety scalpels. In EMEA, the penetration of safety scalpels is quite low, around 2-3%. However with the released European directive 2010/32 on the preventions of the sharps injuries which is transposed into local laws we anticipate a rapid growth of this segment. The use of in Asia Pacific, especially in South East Asia, is fairly low due to the lack of enforcement and awareness of the risk levels healthcare workers are exposed to. This scenario will change as education and public awareness surrounding this issue becomes more consistent and constant. SANDEL Weighted and SANDEL Non-Weighted The first SANDEL product entry into the safety scalpel market was the disposable weighted safety scalpel. Today we offer a complete line of weighted and non-weighted disposable safety scalpels, with a sliding shield to cover the surgical blade and help prevent injuries. Features and benefits include: Easy locking and unlocking retractable safety shield with either left- or right-hand use Color-coded protective safety shields for proper blade identification Weighted scalpels weighs 27 gram to match that of the #3 handle Blade attached, no loading or unloading of blades Available with blade sizes 10, 11, and 15 Come with a SANDEL TIME OUT Sleeve Completely disposable Although quality products, after a number of months in the market it was apparent that these products did not meet the needs of the surgeon in the O.R., but that it does meet the needs in departments such as Emergency, Labor and Delivery, and on the floors for minor procedures. SANDEL Video 0:41

5 SANDEL Change-A-Blade (CAB), a patented disposable safety scalpel handle, was developed to fill the gaps the Weighted Safety Scalpel could not fill according to the Surgeons. With Change-A-Blade, no change in surgeon s technique is required and the surgeon can use his preferred choice of blade. SANDEL Change-A-Blade Change-A-Blade SANDEL Change-A-Blade meets the 6 criteria surgeons generally want in a scalpel handle: 1. The weight (27 grams) of a reusable #3 handle, CAB weighs 27 grams 2. Complete visibility of the blade, the metal neck of the CAB is a mirror image of the #3 handle 3. Choice of Blade type, carbon or steel, and manufacturer, the CAB will accept any manufacturer s blade, sizes 10, 11 or The ability to change blades during the case, CAB allows the user to change blades as many times as needed during the procedure 5. No outside interference when making punctures, the safety shield retracts inside the handle not outside like our competitors 6. Can be used by a right or left handed surgeon, as the safety shield button is on the top of the handle thus allowing for either right or left hand activation The #1 competitor to SANDEL Change-A-Blade remains the #3 reusable scalpel handle. This is the only product surgeons for decades have been trained on and use. Aspen/BD has a reusable metal handle that is used in conjunction with their safety cartridge system. It has proven to be bulky and it is only available with a stainless steel blade Medline also has a reusable metal handle that requires their cartridge system which only comes with a stainless steel blade. Medline has recently introduced a completely reusable CAB type product that will accept anyone s standard blade Southmedic, a Canadian company has a cartridge system, which can be used on any existing reusable scalpel handle. It comes only with a stainless blade and its design changes the attachment distance and feel of the blade for the surgeon Swan Morton is the market leader in Europe with an overall market share of 65%. This old UK company is known for producing a full range of high quality products (surgical blades all sizes, carbon and carbon steel, scalpel, safety scalpel, and handles) Aesculap (10% MS) which is a division of B BRAUN offers a large range of product dedicated to surgeons with a very strong position in Germany SANDEL Change-A-Blade Video 4:50

6 The SANDEL NEOX Safety Scalpel was developed to extend the SANDEL scalpel range with larger blade sizes; to offer competitive prices to our customers, and to offer a safety scalpel with a permanent lock position, conforming to the European regulations on sharps injuries prevention in healthcare settings. SANDEL NEOX SANDEL NEOX Safety Scalpel is sterile, disposable and non-weighted Available in a wide variety of surgical blade size (10, 11, 15, 21, 22, 23, 24) and handle sizes (#3 and #4) Sliding safety sheath to cover the blade and protect against sharp injuries Permanent lock for safe disposal Ribbed grip for enhanced tactile sensitivity Rigid handle and firmly mounted blade to prevent unwanted flexibility during surgery Weighs more than historic safety scalpels Can be used by a right or left handed surgeon, the safety shield button is on the top of the handle thus allowing for either right or left hand activation Audible click confirms that the safety sheath is in the ship/pass position or in the use position Compliant with European Directive on Prevention of Sharps Injuries (2010/32/EU) Europe, Australia and New Zealand only Southmedic has two types of non-weighted safety scalpel, with a permanent lock position of the safety shield for safe disposal. On the SPSS model, there is a safety tab on the shield prior to the first use and the possibility to dispose the whole scalpel or the covered blade separately from the handle BD/Aspen has a safety scalpel with a translucent retractable shield, with a permanent lock position Medi-Safe, Merit Medical, Cardinal and Swann Morton/De Royal have safety scalpels with a retractable blade and a permanent lock position for safe disposal In Australia, SANDEL disposable scalpels (from Belgium) and the Kai brand (from Japan) are prevalent

7 Designed and launched in 2013, to help safely remove scalpel blades from handles including Beaver Blades. The SANDEL Disarm-It-All also provides a safe resting place for loaded syringe/needle set ups to eliminate the need to recap, it and allows for the safe removal of needles from syringes. Additionally, it serves as an approved needle counter for any case. SANDEL Disarm-It-All In Europe, the EN ISO 23902:2012 norm provides requirements and test methods for sharps containers i.e., labeling, resistance, closure and instruction, and in certain countries, national regulations may require a specific color such as yellow. Allows for the safe, single-handed removal of standard scalpel blades, Beaver Blades and syringe needles Two separate, removable halves with adhesive tape to provide safety and stability on any surface Provides magnet and foam surfaces for easy counting of blades and needles Permanent lock for safe disposal Bright orange and easily recognizable on the sterile field In North America the competition for the SANDEL Disarm-It-All is limited to Advance Medical Innovations (AMI) In EMEA competitors include: Medline, Aspen and Devon In Asia Pacific, indirect competition continue to be conventional use of disarming scalpel blades or syringes; while, direct competitors are not common place In Australia, Multigate, a surgical pack provider, has just introduced an orangebased range of disarmers and counter plus disposal boxes Around Asia Pacific, Medline s Gold Standard range of sharps safety devices is available SANDEL Scalpel Disarmer Video 0:22

8 and One-fourth of suture needle injuries and more than one-half of scalpel injuries occur when an instrument is passed from one person to another during a surgical procedure. (AORN) A neutral zone or safe zone is a designated area on the sterile field where a sharp can be placed and then picked up by the user. The ideal device for a neutral zone should be large enough to hold sharps, not easily tipped over, and preferably mobile. The rules of incorporating a Hands-Free Neutral Zone are simple, yet extremely effective in reducing the possibility of accidental sharp injuries due to hand to hand passing: Only one sharp should be in the neutral zone at a time The person passing the sharp can announce sharp when moving the instrument There will be times when a surgeon cannot safely use the neutral zone because eye contact must be maintained with the surgical site Non-sharp instruments may still be passed hand-to-hand Ansell has developed a system of products to help in the facilitation of the hands-free technique of passing instruments. The system takes the no nonsense approach to handling contaminated sharp instruments and gives the end user a choice of products to use. The SANDEL Trays protect the surgical team by providing a designated area for placement and retrieval of sharps, minimizing the risk of sharps injuries.

9 SANDEL Z-Tray SANDEL Stretch-A-Tray The SANDEL Z-Tray is a molded orange plastic tray. By using the adhesive on the bottom, the SANDEL Z-Tray can be secured in one place on the sterile field. The SANDEL Z-Tray should be place as close to the operative site as possible for the convenience of the surgeon. The features and benefits of the SANDEL Z-Tray are the following: A rigid, sharp resistant tray Bright orange color, easy to see peripherally Ribs on the bottom of the tray to allow for easy instrument retrieval Finger notches for secure movement and control Adhesive strip that allows the SANDEL Z-Tray to be secured on the sterile field The SANDEL Stretch-A-Tray is a proprietary product to Ansell. Even though hands-free transfer trays have been available for a number of years, there was on inherent problem. Instruments come in different lengths. Every hands-free transfer tray on the market was made the same length for standard size instruments. Through our submission process we received the idea to make a tray that would stretch to accommodate those frequently used longer instruments. Features and benefits of the Stretch-A-Tray: A rigid sharp resistant tray Bright orange color, easy to see peripherally Easily expands to double the size to accommodate longer sharps and instruments Finger notches for secure movement and control Adhesive strip allows the SANDEL Stretch-A-Tray to be secured on the sterile field There are a number of manufacturers of hands-free transfer trays on the market. Keep in mind that this is a simple product as far a function so differentiation is made with color and shape. They all do the same thing, with the exception of the SANDEL Stretch-A Tray. The companies that provide disposable hands free transfer trays are: Cardinal NA Medline Gold Standard Transfer Trays NA, EMEA & Asia Pacific Covidien NA Exodus NA Advanced Medical NA Remember, when it comes to competition, the metal reusable emesis basin, or the plastic disposable emesis basins found in all O.R.s, are viable competitors. SANDEL Trays 0:41

10 SANDEL Z-Friction Drape Z-Friction Drape One of the first submissions received was that items fall off the sterile field. This simple statement and the fact that instruments do fall off the sterile field led to the development of the SANDEL Z-Friction Drape. During a surgical procedure it is common for the surgeon to lay instruments on the patient, especially if they know they will be using that same instrument repeatedly. Drapes being somewhat slick these instruments have a tendency to slide off and hit the floor. This leads to damaged instruments, the case being stopped until a backup instrument is provided or the contaminated instrument is flashed sterilized. The SANDEL Z-Friction Drape provides that non-slick surface to keep the instruments securely on the sterile field. Over time, the SANDEL Z-Friction Drape has evolved into a Neutral Zone for handsfree transfer. Drapes for hands-free transfer have been available for a number of years. But the drapes that are promoted contain magnets, which will magnetize the instruments placed on the drape, not a good thing. Additionally, they are blue or green in color which reduces their visibility on the field. The bright orange color of the SANDEL Z-Friction Drape makes a perfect target for placing contaminated sharp instruments and allows for easy and safe retrieval of those instruments. Additionally, some hospitals have used the SANDEL Z-Friction Drape as a Sharps Zone, meaning that every sharp instrument being used on a case is placed on a SANDEL Z-Friction Drape. This way the surgical team will always know where the danger is located. The features and benefits of the SANDEL Z-Friction Drape are: Made of a light weight, breathable material Tacky surface holds instrumentation in place for easy retrieval Bright orange color makes locating the drape a non-issue Nonmagnetic so it will not magnetize instruments Extremely cost effective compared to magnetic drapes SANDEL Mini Z Drape provides a sharps zone on the Mayo stand or back table Adaptable design, allowing it to be cut and placed in multiple locations Magnetic drapes are the strongest competition for the SANDEL Z-Friction Drape. The use of magnetic drapes has declined over the years due to the magnetization of instruments occurring. With the emphasis on sharps safety around the world, we are seeing a resurgence of hospitals incorporating a neutral zone into their policies and procedures, and with neutral zones being recommended by the AORN and ACS, this makes opportunities for the SANDEL Z-Friction Drape easy to find. Covidien, magnetic drapes disposable and reusable NA & Asia Pacific Xodus, disposable magnetic drapes NA & Asia Pacific Medline, disposable magnetic and nonmagnetic drapes NA, EMEA & Asia Pacific Medline also has a yellow anti-skid instrument mat for hands-free passing with an anti-skid texture that helps grip instruments and prevent them from falling off the sterile field; this mat is part of Medline s total Gold Standard range Pacif Hospital offers a blue magnetic mat EMEA SANDEL Neutral Zone 0:51

11 The administering of local anesthetic for post-op pain is a common occurrence in surgery. Whether the patient is under general anesthesia or when Monitored Anesthesia Care (MAC), i.e. Local with Sedation, the need to have a needle and syringe on the sterile field is present. This poses a recurring challenge to the surgical team, how to reduce the possibility of an accidental needle stick occurring. One must understand that medication will be drawn into a syringe, in order to be ready when the Surgeon calls for the local. Once the medication is drawn into the syringe, the needle must be protected or shielded. Historically, the needle has been recapped by the scrub nurse or tech, using the Scoop Technique, which is simply scooping the needle, cover up with the needle on the syringe. You do not use your other hand to recap. During the procedure the Surgeon will periodically call for the mediation to make multiple injections during the case. Each time the scrub tech/nurse must uncap the needle, pass it to the Surgeon for use, and then recap it once it is passed back to them. Make no mistake; recapping is highly frowned upon by all regulatory groups, and hospitals will have strong policies and procedures against recapping. Unfortunately, until the, no one has been able to come up with a better solution to handle that exposed needle on the sterile field. The is a card used to position the syringe cap at an angle to increase the ease and safety of capping a syringe using a one-handed technique. shields hands from exposed needles to help prevent accidental needlesticks and comply with OSHA. The features and benefits include: Securely holds the syringe cap an angle for easy access Allows for safe and easy one handed use Protects the hand if one hand use is not possible Complies with OSHA requirements for using engineered controlled devices Disposable/single patient use Compatible with all standard syringes provides the safest way to do something you are not supposed to do, RECAP that needle! There are no disposable products on the market to compete with the.

12 Anytime a needle has to be handled there is the possibility of someone getting injured. These possibilities include drawing medication from a vial, whether that is by you or when holding that vial of medication for someone else. Designed by a Surgeon, the virtually eliminates the change of that accidental needle stick occurring. Anytime anyplace medication is being drawn from a vial, the SANDEL Safety Shield should be used. Shield The is designed to reduce accidental needlestick injuries caused when drawing medication from a vial using a needle and syringe. It provides a protective barrier between the needle and the hand holding the vial, reducing the risk of injury and in some cases, exposure to bloodborne pathogens. Features and benefits of the : Provides a protective barrier to the person holding the medication vial Is compatible with most ml medication vials and any needle Perfect for high risk areas, pain management, oncology, cath lab, Emergency Department and the Operating Room Extremely cost effective since it is reusable Complies with OSHA requirements to use engineered controlled devices Basically if OSHA recommends, APAC countries would see this as best practice Dimensions: 2-7/8 diameter Reusable/Recyclable (Must be disposed of or cleaned per each facility s protocol) There are no disposable products on the market to compete with the.