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Occupational exposure to bloodborne pathogens from needlesticks and other sharps injuries is a serious problem, but it is often preventable. The Centers for Disease Control and Prevention (CDC) estimates that each year 385,000 needlesticks and other sharps-related injuries are sustained by hospital-based healthcare personnel. Sharps injuries are primarily associated with occupational transmission of hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), but they may be implicated in the transmission of more than 20 other pathogens.1
The CDC, in its Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program,1 says that an effective sharps injury prevention program includes several components that must work in concert to prevent healthcare personnel from suffering needlesticks and other sharps-related injuries, and this program should be integrated into existing performance improvement, infection control and safety programs. A good program should also be based on a model of continuous quality improvement.
The CDC’s workbook recommends specific organizational steps for developing and implementing a sharps injury prevention program, including administrative and organizational activities, beginning with the creation of a multidisciplinary working team and also including conducting a baseline assessment and setting priorities for development of an action plan. The program also recommends these operational processes:
Institutionalize a culture of safety in the work environment
Implement procedures for reporting and examining sharps injuries and injury hazards
Analyze sharps injury data for prevention planning and measuring performance improvement
Select sharps injury prevention devices (e.g., devices with safety features)
Educate and train healthcare personnel on sharps injury prevention
Industrial safety experts agree that safety-engineered devices and work practices alone will not prevent all sharps injuries; significant declines in sharps injuries also require:
• A reduction in the use of invasive procedures
• A secure work environment
• An adequate staff-to-patient ratio
• Simultaneous implementation of multiple interventions, including: formation of a needlestick prevention committee for compulsory in-service education programs; outsourcing of replacement and disposal of sharps boxes; revision of needlestick policies; and adoption and evaluation of a needleless IV access system, safety syringes and a prefilled cartridge needleless system
The CDC’s workbook notes, “The limited successes of implementation of work practice and engineering controls in reducing bloodborne pathogen exposures has led to the examination of organizational factors that could play an important role in reducing occupational exposures. One organization level factor, known as a safety culture, has been found to be notably important. Some industrial sectors are finding that a strong safety culture correlates with productivity, cost, product quality, and employee satisfaction. Organizations with strong safety cultures consistently report fewer injuries than organizations with weak safety cultures. This happens not only because the workplace has well-developed and effective safety programs, but also because management, through these programs, sends cues to employees about the organization’s commitment to safety. The concept of institutionalizing a culture of safety is relatively new for the healthcare industry and there is limited literature on the impact of such efforts. However, a recent study in one healthcare organization linked safety climate (a measure of overall safety culture) with both employee compliance with safe work practices and reduced exposure to blood and other body fluids, including reductions in sharps-related injuries. A second study in one healthcare organization, also noted correlations between specific dimensions of safety culture (such as perceived management commitment to safety and job hindrances) and compliance with standard precautions and accidents and injuries. Additionally, a recent study examining a statewide sample of healthcare personnel further indicated that greater levels of management support were associated with more consistent adherence with universal precautions (specifically, never recapping needles), while increased job demands was found to be a predictor of inconsistent adherence.”
The CDC’s workbook says that the process of selecting engineered sharps injury prevention devices gives healthcare organizations “a systematic way to determine and document which devices will best meet their needs. The selected devices must be acceptable for clinical care and provide optimal protection against injuries. The selection process includes collecting information that will allow the organization to make informed decisions about which devices to implement. The more this process can be standardized across clinical settings, the more information can be used to compare experiences among healthcare facilities. A key feature of the process is an in-use product evaluation. A product evaluation is not the same as a clinical trial. Whereas a clinical trial is a sophisticated scientific process requiring considerable methodological rigor, a product evaluation is simply a pilot test to determine how well a device performs in the clinical setting. Although the process does not need to be complex, it does need to be systematic.”1
The CDC workbook outlines an 11-step approach for selecting a product for implementation:1
Step 1. Organize a Product Selection and Evaluation Team
Healthcare organizations should designate a team to guide processes for the selection, evaluation, and implementation of engineered sharps injury prevention devices. Many institutions already have product evaluation committees that may be used for this purpose; others may want to assign this responsibility to a subcommittee of the prevention planning team. To ensure a successful outcome:
-- Assign responsibility for coordinating the process
-- Obtain input from persons with expertise in or perspectives on certain areas (e.g., front-line workers)
-- Maintain ties to the prevention planning team
Key departments and roles to consider when organizing a product selection team include:
-- Clinical departments (e.g., nursing, medicine, surgery, anesthesiology, respiratory therapy, radiology) and special units (e.g., pediatrics, intensive care) have insight into products used by their staff members and can identify departmental representatives to help with product selection and evaluation
-- Infection control staff can help identify potential infection risks or protective effects associated with particular devices
-- Materials management staff have information about vendors and manufacturers
(e.g., reliability, service record, in-service support) and can be involved with product purchasing;
-- Central service staff often know what devices are used in different settings in a facility and can identify supply and distribution issues
-- Other departments to consult include pharmacy, waste management and housekeeping.
It is essential that clinical staff participate in the evaluation of safety devices. They are the end-users who best understand the implications of product changes. They know the conventional and unconventional ways that different devices are used in clinical care. They can also identify expectations for device performance that will affect product selection.
Step 2. Set Priorities for Product Consideration
The team can use information from the intervention action plan (see Organizational Processes) to determine which device types to consider. To avoid unforeseen compatibility problems, teams should consider only one device type at a time. Consideration of more than one device type might be appropriate if the devices have different purposes (e.g., intravenous catheters and finger/heelstick lancets). Additional information regarding the number of devices used or purchased may also be helpful in setting priorities.
Step 3. Gather Information on Use of the Conventional Device
Before considering new products for evaluation, healthcare organizations must obtain information on use of the conventional device that it is replacing. Possible sources of information are purchasing and requisition requests. A survey of departments and nursing units might help identify additional issues. Key information to obtain from clinical areas includes:
-- Frequency of use and purchase volume of the conventional devices
-- Most commonly used sizes
-- Purpose(s) for which the device is used
-- Other products the device is used with that might pose compatibility concerns
-- Unique clinical needs that should be considered
-- Clinical expectations for device performance
Step 4. Establish Criteria for Product Selection and Identify Other Issues for Consideration
Product selection is based on two types of criteria: design criteria that specify the physical attributes of a device, including required features for clinical needs and desired characteristics of the safety feature; and performance criteria that specify how well a device functions for its intended patient care and safety purposes.
Other issues to consider include:
-- Impact on waste volume. Some safety features (e.g. extending needle guards added to syringes or single-use blood tube holders) increase the volume of waste and require changes in sharps container use, including container size and frequency of replacement.
-- Packaging. Changes or differences in device packaging may affect waste volume, ease of opening, and the ability to maintain aseptic technique. Also examine instructional material on or in packaging to determine if it is clear and useful in guiding healthcare personnel through activation of the safety feature.
Step 5. Obtain Information on Available Products
Potential sources of information on available products with engineered sharps injury prevention devices include:
-- Materials management staff members who have information on product vendors and manufacturers and are also familiar with the service reliability of manufacturers’ representatives;
-- Colleagues in other facilities who can share information on their experiences in evaluating, implementing, or rejecting certain devices.
-- Peer-reviewed articles in professional journals that describe a facility’s experience with a particular type of device and the efficacy of various devices in reducing injuries.
Step 6. Obtain Samples of Devices Under Consideration
Arrangements should be made to contact manufacturers or vendors to obtain samples of products for consideration. Once obtained, look at the devices based on the design and performance criteria and other issues that are important. Consider inviting manufacturers’ representatives to present information about their products to the team. Questions for the representatives might include:
-- Can the device be supplied in sufficient quantities to support institutional needs?
-- Is it available in all required sizes?
-- What type of training and technical support (e.g., onsite in-service training, teaching materials) will the company provide?
-- Will the company provide free products for a trial evaluation?
Discuss any technical questions related to the product. Based on these discussions, the team should narrow its choices to one or two products for an in-use evaluation.
Step 7. Develop a Product Evaluation Survey Form
The form used to survey healthcare personnel who evaluate the trial device must collect information necessary to make informed decisions for final product selection. Teams should try to use readily available forms, as this promotes standardization of the evaluation criteria and enhances the ability to compare responses among different healthcare organizations.
Product evaluation forms should be easy to complete and score, as well as relevant to in-use performance expectations for patient care and healthcare personnel safety. The form that is easiest to complete is usually one or two pages and allows users to circle or check responses. Use of a graded opinion or Likert-type scale (i.e., strongly agree, agree, disagree, strongly disagree) helps facilitate scoring. A few specific questions (e.g., ease of use, impact on technique, how long it took to become comfortable using the device) should always be asked about any device. Performance questions may be unique to the type of device (e.g., IV catheter, hypodermic syringe/needle), type of safety feature (e.g., sliding shield, retracting needle), or changes in equipment (e.g., single versus multiple use); these should be added as needed.
Step 8. Develop a Product Evaluation Plan
Developing a product evaluation plan requires several additional steps, but it is necessary to ensure that the form obtains the desired information and documents the process.
-- Select clinical areas for evaluation. The evaluation does not need to be performed institution-wide, but should include representatives from areas with unique needs. Whenever possible, include new and experienced staff.
-- Determine the duration of the evaluation. There is no formula for how long to pilot test a product, although two to four weeks is often suggested. Factors to consider include the frequency of device use and the learning curve, i.e., the length of time it takes to become comfortable using a product. It is important to balance staff interest in the product and the need for sufficient product experience. If more than one device is evaluated as the replacement for a conventional device, use the same populations and trial duration for each product. Make a defined decision on when to abort an evaluation because of unforeseen problems with a device.
-- Plan for staff training. Healthcare personnel participating in an evaluation must understand how to use the new device properly and what impact, if any, the integration of a safety feature will have on clinical use or technique. Training should be tailored to the audience needs and should include discussion of why the change is being proposed, how the evaluation will proceed, and what is expected of participants. It is important to provide information on the criteria used to evaluate clinical performance and to answer any questions about the interpretation of these criteria. A team approach, using in-house staff and device manufacturer’s representatives, is one effective way to provide training. In-house staff know how products are used in a facility, including any unique applications, but manufacturer’s representatives understand the design and use of the safety feature. Give trainees an opportunity to handle the device and ask questions about its use, as well as an opportunity to simulate use of the device during patient care, in order to help reinforce proper use.
-- Determine how products will be distributed for the evaluation. Whenever possible, remove the conventional device from areas where the evaluation will take place and replace it with the device under study. This approach eliminates a choice of product alternatives and promotes use of the device undergoing evaluation. If the device undergoing evaluation does not meet all needs (e.g., all sizes are not available; the study device can be used for only one purpose and the conventional device has multiple purposes), it may be necessary to maintain a stock of the conventional product along with the product under study. In such instances, provide and reinforce information on the appropriate and inappropriate use of the conventional device. Precede and coordinate staff training with any switch in devices.
-- Determine when and how end-user feedback will be obtained. Obtain feedback on device performance in two stages. The first stage is informal and occurs shortly after the onset of pilot testing. Members of the evaluation team should visit clinical areas where the device is being piloted and engage in discussions about the device in order to get some preliminary indication of its acceptability for clinical use. These interactions can also reveal problems that might require terminating the evaluation early or providing additional training. more of these factors may be influencing opinions if the response of certain groups of personnel to the product change is different from what was expected or differs from other groups in the organization. Meet with these groups to understand their issues; it might provide new insights for the evaluation team.
Step 10. Select and Implement the Preferred Product
The evaluation team should make a product selection based on user feedback and other considerations established by the selection team. Model the process for implementing the selected device after the pilot evaluation process, and coordinate training with product replacement. It may be necessary to implement a product change over several weeks, moving by unit within the hospital. The team should also consider a back-up plan in case the selected device is recalled or production is unable to meet current demands. Questions to ask include:
-- Should a less-preferred product be introduced as a replacement?
-- Should the conventional device be returned to stock?
-- If the conventional device is still being used for other purposes, should the stock be increased to meet current needs?
These questions are not easy to answer. Furthermore, it is counter to the prevention plan to return to a conventional device once one with a safety feature has been introduced, and it may raise questions among staff. However, in some instances it may be the only option available. Some manufacturers may take back unused devices. It is worth asking the representative that works with the hospital about this option.
Step 11. Perform Post-implementation Monitoring
Once a new device is implemented, assess continued satisfaction with the product through follow-up monitoring and respond to those issues not identified or considered during the evaluation period. In addition, some facilities may wish to assess post-implementation compliance with use of the safety feature. Each product selection team will need to consider the most effective and efficient way to perform post-implementation monitoring.
1. Centers for Disease Control and Prevention. Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program. Accessed at: http://www.cdc.gov/Sharpssafety/
A needlestick injury is reported in this country every 30 seconds. That figure translates into U.S. healthcare workers suffering between 850,000 and 1 million injuries from conventional needles and sharps each year, with as many as 5 million annual needlestick injuries gone unreported. Of these injuries, 1 out of every 7, or 18,000, U.S. healthcare workers is accidentally stuck by a contaminated sharp each year. These accidental exposures can have serious consequences, from the spread of hepatitis B, hepatitis C and HIV, to more than 20 other infections that can be transmitted through needlesticks.
According to the American Hospital Association, one case of serious infection by bloodborne pathogens can add up to $1 million or more in expenditures for testing follow-up, lost time and disability payments. And even when no infection occurs, the cost of follow-up for a high-risk exposure can exceed $3,000 per needlestick injury. In 1991, the Occupational Safety and Health Administration (OSHA) issued the original Bloodborne Pathogens Standard to protect workers from these risks. In 2001, OSHA substantially revised the ruling to clarify the need for employers to select safer needle devices and maintain a log of injuries that occur due to contaminated sharps.
MedPro Safety Products, Inc. is developing and commercializing products in four related product sectors: blood collection devices, syringes for the clinical healthcare market, intravenous devices, and pre-filled medicament safety delivery systems. These technologies are predominately “passive,” meaning that their safety mechanisms are automatically activated and are integrated into current and traditional needle administration techniques. MedPro’s Blood Collection Safety Needle System is a blood collection device formatted in both tube-touch and skin-touch models. The phlebotomist cannot draw a patient’s blood without having engaged the safety system, and the needle is encapsulated once pulled out of the patient after blood collection. These products are accompanied with MedPro’s Blood Collection Safety Needle Set, which provides a “winged” blood collection device that utilizes a system that is both fully passive and engages in a manner familiar to the operator. Looking to the intravenous product sector, the company is currently working on modifications to its existing Key-Lok® Needleless IV System. This system enables healthcare providers to administer medications directly into an existing IV patient line while utilizing a plastic cannula, eliminating the likelihood of accidental needlestick injuries and reducing cross-contamination dangers.
Cardinal Health Safe T™ PLUS diagnostic and procedure trays help healthcare workers comply with today’s safety requirements and recommendations and assist with compliance for three major safety initiatives: sharps safety, preventable medical error reduction and infection prevention. The Centers for Disease Control (CDC), Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) have set forth specific recommendations for each of these major safety initiatives, especially in the realm of sharps safety.
To comply with these recommendations, Safe T™ PLUS trays contain a number of sharps safety components, including: the BD SafetyGlide™ needle, the BD Bard-Parker™ protected disposable scalpel, the Filter Straw® particulate matter filter and the Point Lok® and NeedleVISE™ sharps securing devices. In the arena of sharps safety, the CDC estimates that each year 385,000 needlesticks and other sharps-related injuries are sustained by hospital-based healthcare personnel; an average of 1,000 sharps injuries per day.1
As part of Cardinal Health’s Safe-T™ PLUS diagnostic procedure trays, the BD SafetyGlide™ needle with BD Activation-Assist™ technology allows for fast and easy, single-handed needle shielding. It can help prevent needlestick injuries by allowing easy and secure shielding of the needle tip immediately after injection. NIOSH further recommends that sharps injury prevention devices should include either sharps disposal containers and needles or other devices with an integrated engineered sharps injury prevention feature.2 The Cardinal Health Safe-T™ PLUS tray solution for this NIOSH recommendation is the BD Bard-Parker™ protected disposable scalpel. The scalpels are designed with one-handed activation and protection before and after use. Similar to the CDC and NIOSH, OSHA — in its 2001 revision of Bloodborne Pathogens & Needlestick Prevention Standards — requires safer needle devices that reflect technology changes to eliminate or reduce exposure to bloodborne pathogens. The Cardinal Health Safe-T™ PLUS diagnostic procedure trays offer multiple components that address OSHA’s requirement. The Filter Straw® particulate matter filter allows the user to access medication contained in an ampoule while filtering out glass particles that may have entered during opening. And the Point Lok® and NeedleVISE™ sharps securing devices are designed to lock onto and contain a single contaminated needle. The components are used with instruments such as spinal, bone marrow or biopsy needles for which integrated sharps injury protection technology is not feasible.
1. CDC. Workbook for Designing, Implementing and Evaluating a Sharps Injury Prevention Program.
U.S. healthcare workers report between 600,000 and 1 million sharps injuries per year,1 and 7 percent to 11 percent of sharps injuries are caused by scalpel blades.2 Scalpels are the second most frequent cause of injury among operating room personnel, after needlesticks.3 Theoretically, it only takes one accidental injury from a contaminated sharp, and you are open to the risk of contracting deadly infections such as HIV, hepatitis B or hepatitis C.
One reason scalpel injuries can be so severe is because scalpels are made to cut. Scalpel blades are likely to penetrate the flesh of the surgeon or other personnel in the operating room more deeply than needle-stick injuries and therefore can cause more serious harm. In recent years, safety scalpels were introduced into hospitals to replace traditional scalpel handles in attempt to solve this problem.
Safety scalpels are active devices (opposed to passive devices that activate automatically), requiring users to consciously retract the blade into the handle or to slide a cover over the blade after use and before passing the scalpel to another person. Therefore the device will only work if it is used correctly. Furthermore, many surgeons feel that these plastic scalpels are too light and cumbersome to use, the thicker safety scalpel obstruct their view, and they cannot make deep incisions like with traditional scalpels, hence compromising patient safety.4
An OSHA interpretation for the Bloodborne Pathogen Guidelines (29 CFR 1910.1030(d)(1)(iv)(B)) states that “in situations where an employer has demonstrated that the use of a scalpel with a reusable handle is required, that blade removal must be accomplished through the use of a mechanical device or a one-handed technique. The use of a single-handed scalpel blade remover meets these criteria.”5
A new technique in preventing scalpel injuries involves the use of a single-handed scalpel blade remover and hands-free passing technique (HFPT).6 This avoids potential patient safety concerns by allowing the surgeon to continue using a traditional reusable scalpel handle. Scalpels are passed using a neutral zone or a passing tray, meaning there will be no hand-to-hand passing, thus eliminating the risk of injury.
Currently, there are the two known single-handed scalpel blade removers available in the market: Qlicksmart BladeCassette is a safe and convenient way to remove scalpel blades in the sterile field, without using fingers or artery forceps. The disposable unit removes up to three blades which remain visible in the cartridge. The immediate containment of contaminated blades in the OR reduces exposure and risk to the bare minimum. It also allows single-handed scalpel blade removal and disposal, avoiding the risk and cost of injury and infection. For non-sterile environments, the Qlicksmart BladeFlask is a scalpel blade remover and sharps container that allows removal of up to 100 blades. It can be mounted on either a wall or a bench for easy access and removal of blades in clinics, laboratories, dental surgeries, pathology, and anywhere else that requires blade removal from a scalpel handle.
1. Matson K. States begin passing sharps and needlestick legislation to protect healthcare workers. AORN J. 72(4):699-703, 705-7. 2000.
2. CDC. Sharps Injury Prevention Workbook. Accessed at: http://www.cdc.gov/SharpsSafety/workbook.html
3. Jagger J, Bentley M, et al. A study of patterns and prevention of blood exposures in OR personnel. AORN J. 67(5):979-81, 983-4, 986-7. 1998.
4. Stoker R. Scalpel safety: protecting patients and clinicians. Man Infect Control. May 2008.
6. Fuentes et al. Scalpel safety: Modeling the effectiveness of different safety devices’ ability to reduce scalpel blade injuries. Int J Risk Safety Med. 2008; 20(1-2):83-89.
Data suggest that at an average hospital, workers may incur as many as 30 needlestick injuries per 100 beds per year, and at least 1,000 healthcare workers contract serious infections every year from needlestick and sharps injuries; however, as many as 80 percent of needlestick injuries could be prevented with the use of preventive devices with safety features.1
B. Braun’s experience as a major provider of vascular access devices led it to becoming a pioneer in passive safety IV catheters, with the B. Braun Introcan Safety® IV Catheter. The company focused on passive technology development after studies showed passive or safety devices that work “automatically” are more effective in reducing needlesticks and more acceptable to clinicians than “active” devices that require a healthcare worker to activate them.2
Studies of needlestick injuries suffered by hospital employees using active devices revealed many cases in which clinicians thought the safety features had been activated when they weren’t or situations where the devices had been improperly activated.3
Some healthcare workers bypass active safety features because they either do not know how to activate the devices, believe that the safety mechanism will interfere with their technique or do not take the time to activate them in emergencies. In one hospital, 90 percent of the staff did not use the safety feature of an active safety device and 72 percent of active safety devices randomly retrieved from disposal had not been activated.4
These statistics make a strong case for adopting passive safety devices. With the B. Braun Introcan Safety® IV Catheter, for example, all the user has to do is use it. The safety mechanism does not require any extra steps for activation. There is no risk of forgetting to make the needle safe. From insertion to advancing the catheter to needle removal, the clinician is protected by a system that is activated automatically and cannot be bypassed. The patented safety shield covers the needle tip and eliminates the risk of inadvertent activation. There’s no need for clinicians to modify their technique because the B. Braun Introcan Safety® IV Catheter’s Universal Bevel provides for easier, more comfortable and more flexible insertion from a variety of angles. This means less training time, and makes the B. Braun Introcan Safety® IV Catheter a quick, cost-effective way for providers to comply with legislative requirements.5 A syringe can be pre-attached to the flashback chamber to facilitate aspiration and injection during insertion.
While a needlestick injury reduction program starts with providing clinicians with products that incorporate safety features, information and best practices also play a key role in healthcare worker and patient safety. Guided by its “Sharing Expertise®” philosophy, B. Braun works with clinical experts to develop and promote best practices that help customers and their employees address critical safety issues like needlestick injuries and healthcare-acquired infections (HAIs). B. Braun actively develops and disseminates information about procedures and guidelines clinicians should follow to maintain a safer environment and reduce the risk of needlestick injuries and infections.
1. National Institute of Occupational Safety and Health (NIOSH).
2. Infection Control and Epidemiology: Prevent Needle Sticks. Washington, D.C.: APIC.
3. American Health Consultants. ‘Safe’ needles still can lead to needlesticks. Hospital Employee Health. Nov. 2002.
4. Schrager J, Raffa R, Currie BP. Documented lack of efficacy of safety butterfly needle device. Presented at SHEA 2001 meeting in Toronto.
5. Lucas LJ, Georges BC. Assessment of training needs for new safety IV catheter. Abstract presented at: The 1999 National Association of Vascular Access Network. Orlando, Fla.
Sharps Compliance Inc.
Healthcare workers are familiar with proper sharps disposal, and clearly understand that sharps, such as needles and syringes, are not thrown into the trash. However, in the U.S., more than 3 billion sharps are discarded every year into the trash by self-injectors
Self-injectors include patients with conditions ranging from diabetes to hepatitis C. Even sharps placed into containers can expose waste workers when the containers break open upon garbage truck compaction. States such as California, Massachusetts, Wisconsin, Oregon, Louisiana, New Jersey, and Mississippi, as well as counties in a variety of states such as Minnesota, Nevada, New Hampshire and Washington have taken action to protect the public from potential disease transmission from needlesticks. They have either passed laws or have established in their regulations that disposal of sharps into the solid waste stream is prohibited, even by home users, and even if first placed in containers. Environmental Protection Agency (EPA) guidelines, which most other states follow, also make this recommendation.
Self-injectors want to properly dispose of their sharps, not only because it’s the law, but because they want to do the right thing. However, for the most part, they have not been provided simple, convenient and cost-effective options. In their effort to find ways to safely and legally dispose of their sharps, patients often bring sharps in detergent bottles or paper bags to their healthcare provider. They also discard sharps into restroom trash receptacles. This presents a risk of needlestick and liability for the facility staff encountering those sharps.
Simple solutions for self-injector syringe containment and disposal include the Sharps Disposal by Mail System® which can be ordered and used at home; and the SharpsSecure® System designed for public restrooms. Putting sharps into a sharps container is no different than putting them in a detergent bottle except for the labeling — it does not provide a proper disposal method for the full container.
The Sharps Disposal by Mail Systems provide complete sharps management for the self-injector at home and while in the healthcare facility. The systems include the sharps container, packaging, prepaid postage to the treatment facility and documentation of proper disposal. The SharpsSecure System also includes a steel, tamper-resistant cabinet for mounting in public restrooms. The System is ordered, used, packaged when full, and handed to the mail carrier. There is no need for patients to drive to a healthcare facility or county drop-off site.
According to the CDC, healthcare-associated infections (HAIs) account for an estimated 1.7 million total infections and approximately 100,000 associated deaths each year. Of the 1.7 million reported infections, about 250,000 are catheter-related bloodstream infections (CRBSIs), which are the second-leading cause of death associated with HAIs.1 CRBSIs can be caused by bacteria that migrate into a patient’s bloodstream where they are dangerous and difficult to treat. While handwashing and equipment sterilization are essential infection control practices, these practices alone are not enough. The most effective solution is to combine the best hygiene processes with the most proven technology. Not only are CRBSIs dangerous for patients, treatment cost an average of $34,508 to $56,000 per infection.2
Cook Medical’s Interventional Radiology division introduces the Spectrum Turbo-Ject PICC, the first-ever power injectable antimicrobial-impregnated peripherally inserted central venous catheter (PICC) that was designed specifically to prevent CRBSIs. The patented antibiotic combination of minocycline and rifampin in Spectrum has undergone extensive testing and has been proven the most effective combination in preventing CRBSIs without creating antibiotic resistance.3 Minocycline and rifampin work synergistically to provide broad-spectrum antibiotic protection against the leading causes of CRBSI, including bacteria such as MRSA, VRE and VRSA.4-5 Unlike most systemic antibiotics, this unique combination has the ability to penetrate the biofilm. According to research in the American Journal of Infection Control, the use of these catheters does not promote the growth of antibiotic-resistant strains of bacteria in patients receiving Spectrum catheters. In fact, the use of Spectrum technology has demonstrated reduced antibiotic-resistant strains in one single-center study.6
In addition to the infection control benefits of the Spectrum Turbo-Ject PICC, it is the industry’s first antibiotic-impregnated PICC capable of accepting the contrast media injection rates required for CT scans. The ability to power-inject contrast media, combined with Spectrum technology’s proven ability to prevent CRBSIs, means that patients will gain the highest possible protection from deadly CRBSIs, while clinicians will have access to the industry’s best injection rates.
1. CDC. Estimates of healthcare-associated infections. Accessed at: http://www.cdc.gov/ncidod/dhqp/hai.html.
2. O’Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related infections. Morb Mortal Wkly Rep. 2002;51(RR-10):1-26.
3. Raad I, Ramos E, et al. Process & technology: complimentary, not mutually exclusive. Presented at the SHEA annual meeting April 5-8, 2008.
4. Raad I, Reitzel R, Jiang Y, et al. Anti-adhearance activity and antimicrobial durability of anti-infective-coated catheters against multidrug-resistent bacteria. J Antimicrob Chemother. 2008;62(4):746-750.
5. Darouiche R, Raad I, Bodey G, et al. Antibiotic susceptibility of staphylococcal isolated from patients with vascular catheter-related bacteremia: potential role of the combination of minocycline and rifampin. Int J Antimicrob Agents. 1995;6(1):31-36
6. Ramritu P, Halton K, Collignon P, et al. A systematic review comparing the relative effectiveness of antimicrobial-coated catheters in intensive care units. Am J Infect Control. 2008;36(2):104-117.
The CDC reports that of about 98,000 healthcare-acquired infections (HAI)-related deaths per year, approximately 30,000 of them are caused by bloodstream infections (BSIs).1 What many healthcare professionals are beginning to realize, however, is the impact IV access devices may have on catheter-related bloodstream infection (CRBSI) cases. Although a small and seemingly inconsequential component of an infusion therapy system, a needleless access device can be the place of origin for microbial growth.2 Purposefully simple in design and function, split-septum devices eliminate the complexities of mechanical valves, and with them, the places that may harbor bacteria.2 In fact, studies comparing devices found that patients are three times more likely, on average, to develop a CRBSI with the use of mechanical valves vs. a split-septum needleless access system.3-4
BD understands that split-septum features such as simple internal design, ease of use, and a straight, clear fluid path, are critical to achieve CRBSI reductions. Now, BD Medical extends the benefits of split septum to the convenience of luer access with BD Q-Syte™ Luer Access Split Septum. Because treating CRBSI cases can cost more than $103,000 per hospital stay,5 taking strides to reduce the risk of CRBSIs is in the best interest of hospitals and patients alike. Utilizing a split-septum device such as BD Q-Syte may help hospitals reduce their rate of CRBSIs, an outcome that is good for patients and the bottom line.
1. Klevens RM, Edwards JR, Richards CL, et al. Estimating health care-associated infections and deaths in U. S. hospitals, 2002. Public Health Reports. 2007;122:160-166.
2. Karchmer TB, Wood D, Ohl CA, et al. Contamination of mechanical valve needleless devices may contribute to catheter-related bloodstream infections. SHEA 2006 Presentation Number: 221 Poster Board Number 47.
3. Rupp ME, Sholtz LA, Jourdan DR, et al. Outbreak of bloodstream infection temporally associated with the use of an intravascular needleless valve. CID. 2007;44:1408-1414.
4. Salgado CD, Chinnes L, Paczesney TH, Cantey JR. Increased rate of catheter-related bloodstream infection associated with use of a needleless mechanical valve device at a long-term acute care hospital. Infect Control Hops Epidemiol. 2007;28:684-688.
5. Centers for Medicare & Medicaid Services. (2008, April 14). CMS proposes additions to list of hospital-acquired conditions for fiscal year 2009. Available at http://www.cms.hhs.gov/apps/media/fact_sheets.asp
Unilife Medical Solutions
Unilife Medical Solutions announces the launch of its Unitract range of 1mL safety syringes. Unitract 1mL syringes incorporate a unique series of passive and fully integrated safety features which can help protect those at risk of needlestick injury and enhance patient care. The key distinctive feature of all Unitract 1mL syringes is a fully automatic needle retraction mechanism allowing operators to withdraw the needle directly from the body into the barrel where it is locked in place. Passive activation of the retraction mechanism occurs while the needle is still inside the body to virtually eliminate the risk of needlestick injury. Operators can retain full control over the speed at which the needle is retracted directly from the body into the barrel of the syringe by relieving thumb or finger pressure on the plunger. This ability for operators to control the speed of needle retraction using a one-handed technique can also help to minimize other potential infection risks such as aerosol (splatter). Extra wide flanges are also included on the barrel of Unitract 1mL Syringes to further encourage easy product handling during all stages of the injection process. Once the needle has been fully retracted into the barrel, an auto-disable feature locks the plunger in place and tilts the needle to one side to prevent product tampering and reduce the risk of needle re-exposure. The combination of passive, fully integrated safety features means operators of Unitract 1mL Syringes are not required to undertake any additional action to render the device safe for convenient compact disposal.
The 2009 launch of the Unitract range of 1mL syringes comes at an important time. Despite the widespread transition of U.S. healthcare facilities to safety-engineered medical devices, evidence suggests that many healthcare workers are continuing to report needlestick injuries with these devices. In the 2005 Massachusetts Annual Summary of Sharps Injuries released last year, data indicated that safety syringes now generate more reported needlestick injuries per year than did standard products in 2002. Any safety syringe product where operators either can, or must, remove the non-sterile needle from the body into the open air prior to the activation of the safety mechanism places healthcare workers at potential risk of needlestick injury. Accordingly, the Emergency Care Research Institute in its Sharps Safety and Needlestick Prevention Guide (2nd edition) lists pre-removal activation as a primary safety advantage because operators can activate the safety device before the needle is removed from the patient. Unitract 1mL Syringes are designed to facilitate pre-removal activation, as the needle retraction mechanism is activated automatically inside the body. Furthermore, operators can control the speed at which the needle is withdrawn from the body into the barrel.
The WAND is the world’s first all-in-one safety introducer, with a closed system for infection control, plus passive needlestick safety for sharps injury protection. This new device enables clinicians to more quickly and safely insert a sheath or catheter into the vasculature using the Accelerated Seldinger Technique (AST). Designed to improve first-attempt success rates while decreasing procedure times, The WAND combines all components of the older, Modified Seldinger Technique (MST) into a unitary device that provides faster, safer, simpler over-wire vascular access. The original Seldinger technique was developed in 1953 to reduce complications associated with the introduction of catheters and other medical devices into blood vessels and hollow organs. Because there have been few significant improvements to the technique since it was invented, the so-called modified Seldinger technique (MST) still carries risks for patients and clinicians.
Those risks are reduced or even eliminated through the Accelerated Seldinger Technique provided by The WAND. A study of The WAND’s attributes was presented at the 2008 annual conference of the Association for Vascular Access (AVA). Researcher Bonnie Smith, RN, of Holmes Regional Medical Center in Melbourne, Fla., compared The WAND to MST in three areas, including needlestick safety. The study showed that The WAND’s passive needlestick safety feature appeared to be failure-proof. Passive needlestick safety is safer than active needlestick safety because it eliminates the risk of operator error.
In Smith’s study, The WAND’s passive safety mechanism was rigorously challenged against a hard surface at much higher forces than would be generated in the normal clinical setting. There were no mechanical failures, leading to Smith’s conclusion that the feature was likely fail-safe. “The WAND performed impressively in our study,” Smith says. “The modified Seldinger technique was originally developed as a safer procedure, but most clinicians don’t recognize that the remaining challenges with MST are avoidable. It’s noteworthy that this new device appears to significantly improve upon the old technique.” The first iteration of the device is the MicroAccess WAND, which is expected to be used primarily in interventional radiology suites and cardiac catheterization labs. Subsequent iterations — including the PICC WAND™ and Power WAND™ now in development – are designed to be used primarily by vascular nurse specialists for insertion of peripherally inserted central catheters (PICCs) and extended-dwell peripheral IVs. The MicroAccess WAND incorporates a 21g thin-walled needle, Nitinol® guidewire, and state-of-the-art dilator and sheath into a single device. Available in initially in 5.0 Fr., it is supplied with an echogenic needle, a .018” Nitinol® guidewire and a radiopaque sheath.
Retractable Technologies, Inc.
Recent outbreaks of highly contagious diseases such as H1N1 (swine flu) raise the potential for emergent mass immunizations. As with any health crisis, healthcare workers will be on the frontlines, so sharps safety will be of paramount importance. Often emergency campaigns require the use of temporary health stations such as schools, libraries and other public places. In such settings, it is imperative to use sharps devices that have effective safety mechanisms to prevent needlestick injuries and provide for safe, efficient disposal. VanishPoint® syringes and blood collection devices feature automated retraction mechanisms that allow for pre-removal activation, virtually eliminating exposure to contaminated sharps.
VanishPoint blood collection tube holders can be used with standard, multiple sample blood collection needles. The healthcare worker closes the end-cap of the VanishPoint blood collection tube holder after removing the last tube of blood. This automatically retracts the needle directly from the patient’s vein into the tube holder, protecting the user from both ends of the blood-filled needle. VanishPoint tube holders are for single use. The VanishPoint syringe utilizes a patented friction ring mechanism that automatically retracts the needle in conjunction with the full depression of the plunger and delivery of the full medication dose. The retraction mechanism is an integral part of the device’s design and is passive in nature, requiring the healthcare worker to perform no additional steps. The VanishPoint syringe is easy to use, requires minimal training, and allows for single-handed activation. The needle is retracted directly from the patient into the barrel of the syringe, effectively reducing risk of a contaminated needlestick injury. Once activated, VanishPoint syringes cannot be reused; they prevent disposal-related needlestick injuries and minimize disposal volume.
VanishPoint® IV catheters also feature automated retraction. A push-off tab facilitates one-handed advancement and indicates bevel orientation. Clear, transparent finger grips and flashback chamber allow for handling ease and flashback visualization. A slight depression of the needle housing activates needle retraction into the housing, reducing the risk of needlestick injury. Once activated, the needle remains securely retracted through disposal.
Retractable Technologies also manufactures non-needled syringes designed to reduce the risk of contact contamination and the risk of healthcare associated infections. According to the CDC, an estimated 250,000 catheter-related bloodstream infections occur in U.S. hospitals each year. Patient Safe™ syringes have a unique extended luer guard that protects the luer tip of the syringe from contact contamination. Studies have shown that contaminants on the luer tip of syringes result in medication/infusate contamination, placing patients at risk for infection. The luer tip of standard syringes is exposed and can easily become contaminated if it comes in contact with surfaces, linens, or the hands of healthcare workers. The extended luer guard protects the luer tip from contact, promoting aseptic handling. The Patient Safe syringe reduces the risk of healthcare worker exposure to hazardous drugs during reconstitution, preparation, transport, and disposal. The petal-design of the luer guard makes the Patient Safe syringe compatible with most available luer-fitting devices.
Terumo SurGuard®2 Safety Needles feature a needle-locking mechanism to help reduce the risk of needlestick injury; an audible click* indicates device activation. They also feature one-handed activation for ease of use, as well as a bevel-up, sheath right orientation, especially useful for low-angle injections. The ratchet mechanism allows for precise positioning of sheath so as not to obscure injection site. The standard hub fits all luer lock and luer slip syringes, and there is a broad range of available gauge sizes: 18g to 30g. *Audible click may not be heard on small needle sizes; visual confirmation is required.