This article is protected by copyright and is provided by Wisconsin TechSearch
`under license from Wolters Kluwer Health. All rights reserved.
`
`Fran Powers, MEd, CRNI
`
`Effectively Evaluating and Converting
`Your Organization to the Use of Infusion
`Safety Products
`
`Abstract
`
`• • • •
`
`This article explains the process of converting an
`organization to infusion safety products as
`mandated by the Needlestick Safety and
`Prevention Act and the subsequent OSHA
`directive regarding safer needle devices.
`
`T he first documented case of needlestick trans-
`
`mission of a bloodborne pathogen was
`reported 18 years ago. Two years later, the
`Occupational Safety and Health Administra-
`tion (OSHA) began the process of enacting a standard
`for the protection of healthcare workers from expo-
`sure to bloodborne pathogens.1 In 1991, OSHA intro-
`duced the Bloodborne Pathogens Standard, which
`mandated that facilities implement a hepatitis B vacci-
`nation program.
`Before the introduction of the Bloodborne Pathogen
`Standard, it was common practice in healthcare to
`handle equipment and perform procedures in a man-
`ner that today is considered totally unacceptable.
`Recapping of needles was accepted practice and gloves
`were seldom worn when caring for patients or han-
`dling blood and body fluids. It was not uncommon in
`some facilities to sharpen, sterilize, and re-use needles.
`Needle disposal was haphazard and needles were often
`thrown in the wastebasket after recapping. Once hard
`plastic sharps containers became available, healthcare
`workers often would bend or break the needle off
`before disposal. This was not done for protection of
`healthcare workers, but to prevent drug abusers from
`
`Fran PPowers is a Nursing Education and Policy Coordinator, PharMerica, Warwick, RI.
`Address correspondence to: Fran Powers, MEd, CRNI, PharMerica, 83 Vermont Ave.
`Warwick, RI 02888.
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`pilfering through the trash and finding usable needles
`and syringes.
`Until 1945, metal cannulas and metal needles that
`required cleaning and resharpening were used for
`intravenous administration. The plastic cannula was
`first developed in 1945. These catheters were made of
`flexible plastic tubing that required trimming or a nee-
`dle for introduction into the vein. In 1950, the first
`“over the needle” catheter was introduced.2 This is the
`forerunner of all our modern IV catheters. Metal nee-
`dles continued to be used for short-term therapy such
`as dye injection during an x-ray procedure or short-
`term one-time infusions.
`In March 2000, the Centers for Disease Control and
`Prevention (CDC) estimated that healthcare workers
`received more than 380,000 percutaneous injuries
`from contaminated sharps annually in US hospital set-
`tings alone. Although not all injuries are preventable
`and injuries may still occur with safety devices, the
`CDC has estimated that depending on the type of
`device used and the procedure involved, 62% to 88%
`of sharps injuries can potentially be prevented by the
`use of safer medical devices.3
`The risk of exposure varies with the type of device.
`According to the Health Care Worker Safety Center at
`the University of Virginia, the highest risk procedures
`are IV procedures, blood collection, and intramuscular
`injections.4 The risk for disease transmission is higher
`with hollow bore devices such as IV needles or phle-
`botomy needles that are filled with blood. IV tubing
`connection devices have been found to pose one of the
`highest risks for needlestick injuries.4
`In November 2000, The Needlestick Safety and Pre-
`vention Act was signed into law. This act mandated
`that OSHA revise its Bloodborne Pathogens Standard
`to specifically address the requirement for employers
`to identify, evaluate, and implement safer medical
`devices.6 Hospitals, nursing homes, homecare agencies,
`and any facility or workplace where exposure to
`bloodborne pathogens is possible, is required to com-
`ply with the new OSHA directive.
`Since the implementation of the OSHA Bloodborne
`Pathogen Standard in 1991, medical product manufac-
`turers have been designing products that address the
`prevention of exposure to blood and other potentially
`infectious body substances. From 1984 to1996, more
`than 1000 patents were issued for safety devices
`designed to prevent needlesticks.1 With the new
`Needlestick Safety and Prevention Act, the number of
`new safety products has increased dramatically and
`will continue to increase.
`When converting your organization to the use of
`safety products, your goal will be to evaluate and
`choose the devices that are right for your specific prac-
`tice, and to successfully implement their use.
`
`• CONVERTING YOUR FACILITY TO
`SAFETY PRODUCTS
`
`Create Your Team
`
`A successful conversion program will begin with the
`formation of a multidisciplinary team to oversee the
`program. Administration, management, and frontline
`nurses should be involved in the process. It will be
`important to involve those employees with an interest
`and commitment to the successful implementation of
`the program and also a desire to be actively involved in
`product selection and evaluation. Qualities to look for
`when choosing employees to help with the implementa-
`tion of the program include: positive attitude; objective,
`critical thinkers; those respected by peers; good educa-
`tors; and clinical experts.7 Once you have chosen your
`team, then you can begin the conversion process.
`
`Identify What is Required by the OSHA
`Directive and the Needlestick Safety Act
`
`To comply with the OSHA directive, you need to know
`exactly what is mandated.
`The act requires that organizations:
`
`• Update or create a Bloodborne Exposure Control
`Plan and review it annually.
`• Evaluate and implement “safer medical devices.” This
`must be documented in the exposure control plan.
`• Involve frontline healthcare workers as part of the
`evaluation and selection process and document it in
`the exposure control plan.
`• Continuously monitor the effectiveness of safer med-
`ical devices.
`• Maintain a sharps injury log with detailed informa-
`tion on percutaneous injuries, including type and
`brand of device involved, where the exposure
`occurred, and an explanation of how it was incurred.
`• Update employee training on bloodborne pathogen
`exposure and the use of safer medical devices.8
`
`Identify Organization-specific Criteria for
`Selection of Safety Devices
`
`You will be looking at general performance criteria, and
`later at device-specific criteria. General performance cri-
`teria include, but are not limited to, the following:
`
`• The device should be simple and require minimal
`training to use correctly.
`• The safety feature should be a fixed, integral part of
`the device and not an add-on.
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`• The safety feature should allow the worker’s hands to
`remain behind the needle at all times.
`• The safety feature must be reliable and effective.
`• The safety feature should be designed to remain in
`effect before disassembly and during disposal.
`• The device should be compatible with other supplies
`and equipment being used.5,7,9
`
`Identify Devices That Should be Changed
`
`Infusion-related devices that may be changed include:
`
`• Peripheral catheters
`• Midline catheters/introducer needles
`• Peripherally inserted central catheters/introducer needles
`• Port access needles
`• Blood draw devices
`• Subcutaneous sets for non-IV pain management
`• Secondary set attachments
`• IV tubing
`• Sharps containers
`• Injection ports
`
`Determine Device-specific Criteria and
`Develop an Evaluation Tool
`
`The evaluation tool should be easy to use and will allow
`frontline workers to provide direct feedback on each
`product as well as identification of the most important
`product features.7 These device-specific criteria should
`be measurable and objective. Because risk of injury
`occurs at different times during the use of a device, you
`should divide device-specific criteria into at least 3 gen-
`eral categories:
`Before-use: the before-use criteria assesses the general
`ease of preparation. Labeling should be clear and the
`package should be easy to open. The assembly process
`should be easy and the instructions uncomplicated.
`During-use: the during-use criteria help to determine
`any product characteristics that could be barriers to suc-
`cessful implementation. The device should be simple to
`use, reliable, and compatible with other products being
`used. The during-use criteria also should include evalu-
`ation of patient comfort or safety while using the
`device. Although the focus of the OSHA directive is
`healthcare worker safety, patient safety must be consid-
`ered. In homecare, not only will healthcare worker edu-
`cation issues will be important, but also evaluation
`criteria must include different patient education strate-
`gies. Needleless systems may require specific changes in
`patient education.7
`After-use: once the device has been used the safety
`feature should be undefeatable and require little if any
`manipulation by the healthcare worker.3
`
`Investigate What is Available
`
`• Manufacturers should be contacted to get product
`information and samples, and arrange for a demon-
`stration of devices.
`• Criteria developed by the team should be used to look
`at each device separately.
`• The support of manufacturers should be reviewed. Is
`there 24-hour clinical support available? Are there
`teaching materials available? This is especially impor-
`tant if the conversion will involve extensive in-servicing.
`• The product should be readily available. The demand
`for safety products is increasing significantly. Verify
`that the manufacturer is able to meet these demands
`in a timely manner.7
`
`Educate and Train the Staff on the Use of the
`Device(s)
`
`Staff education and training is essential for successful
`implementation of the program. Inadequate training on a
`new device is a guarantee for failure. A key reason for
`noncompliance with safety systems is unfamiliarity with a
`device. Educating and training can enhance program
`implementation by identifying the essential skills needed
`to use the device correctly. A well-organized training pro-
`gram will allow the staff to practice using the device with
`supervision, to demonstrate correct use of the device, and
`to recognize and manage potential problems associated
`with use of the device.7 In addition to a facility-based
`training program, most manufacturers provide a wide
`array of educational materials
`including videos,
`brochures, posters, CDs, etc. Manufacturers also have
`Web sites with downloadable educational materials.
`
`Perform Ongoing Staff Training and Monitor
`for Compliance
`
`Once the facility has converted to needleless IV safety
`devices, it will be necessary to continually monitor for
`compliance and to reeducate staff as needed. A sharps
`injury log should be kept and the exposure control plan
`should be updated yearly. An educational plan should exist
`for new staff and reviews should be done for all staff. Just
`because the staff has learned something once does not
`guarantee correct use, especially if the device is not used
`frequently.
`
`Reevaluate the Product
`
`Once conversion is complete, a continual reevaluation
`of products is essential. Staff may discover unacceptable
`characteristics of a device that were not evident at the
`initial evaluation. The facility should create a long-
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`range plan for monitoring effectiveness. Periodically
`collecting data will help to evaluate the success of safety
`devices in the prevention of injuries, although the
`annual usage of specific types of needles in an organiza-
`tion is likely to be less than the number required to con-
`duct a needlestick efficacy trial.7 Presently there is
`limited data on effectiveness of safety devices. Needle-
`stick injuries range from 40 injuries per 100,000 devices
`used to 1 or fewer injuries per 100,000 devices used. 4
`Under-reporting of injuries also makes it more difficult
`to accurately assess device efficacy.
`
`Recognize Potential Problems
`
`It is important to recognize potential challenges to suc-
`cessful implementation of the program. Challenges to a
`successful implementation may include product avail-
`ability, worker resistance, and cost.3
`
`• Product availability: Because of the increased demand
`for safety needle systems, some products may be back-
`ordered or all sizes and gauges may not be available.
`• Worker resistance: Change can be difficult for some
`staff members especially when change involves a
`major adjustment in technique. Mandating safety
`devices does not guarantee use. Resistance to change
`was cited as a significant factor in noncompliance in
`OSHA’s response to a “call for information” about
`sharps injury prevention.1 Worker resistance often can
`be minimized through proper education and training.
`• Cost: Although safety devices are sometimes more
`expensive than conventional devices, cost is not appro-
`priate as the deciding factor for purchasing safety
`devices. In the selection process, the involvement of
`frontline workers with clinical expertise will help to
`ensure that quality, performance and reliability must
`not be sacrificed simply to get the cheapest product. 7
`
`• CONCLUSION:
`
`Although there are many safety products currently
`available, the process of converting a facility to their use
`is not always easy. The first reaction to a new device
`often is enthusiasm and praise. Once frontline workers
`begin to use the device, a more critical assessment usu-
`ally is done and dissatisfaction with the device may be
`expressed. Because safety devices are used in response to
`a problem and their use is mandated, they are looked at
`more closely than devices with needles ever were. Con-
`
`sequently, more problems are likely to be found.
`Healthcare workers’ concerns should be addressed, but
`it is important that when comparisons to conventional
`technology are made, the potential problems with con-
`ventional products should be pointed out.1
`Needlestick injuries can still occur with safety
`devices, especially if the device is used incorrectly. This
`does not mean the device is not effective, especially if
`the number of needlesticks is very low. What is impor-
`tant is how many injuries a device prevents. If the device
`prevents more injuries than it causes, it is better than
`conventional nonsafety devices.1
`Converting an organization to the use of infusion
`safety products can be challenging. It is vital that
`healthcare workers recognize the possible impediments
`to compliance and deal with them as quickly as possi-
`ble. It is also important that facilities use all the
`resources available and stay informed of all the latest
`changes and regulations that could affect the organiza-
`tion. Creating an environment where frontline workers
`are an integral part of the process and providing con-
`tinuing support and education to the staff can pave the
`way for a smooth conversion.
`
`R E F E R E N C E S
`
`1. Jagger J. Reducing occupational exposure to bloodborne
`pathogens: where do we stand a decade later [online editorial]?
`Infect Control Hosp Epidemiol. 1996. Available at: www.slack-
`inc.com/general/iche/stor0996/edit.htm. Accessed July 27, 2001.
`2. Terry J, Baranowski L, Baranowski L, Lonsway RA, Hedrick C.
`Intravenous Therapy Clinical Principles and Practice. Philadel-
`phia, Pa: WB Saunders; 1995.
`3. Luebbert P. Under OSHA’s umbrella, US healthcare workers pro-
`tected. Advance Online Edition. April 2001. Available at:
`www.advanceforar.com/pastarticles/apr23_01feature1.html.
`Accesses July 6, 2001.
`4. BD healthcare worker safety, needlestick safety and prevention
`law. Available at: www.bd.com/safety. Accessed May 24, 2001.
`5. OSHA. Safer needle devices: protecting health care workers. Pre-
`pared by the OSHA Directorate of Technical Support, October
`1997. Available at: 222.thebody.com/osha/saferneedle04.html.
`Accessed July 21, 2001.
`6. OSHA Needlestick Safety and Prevention Act (HR 5178). 2000.
`7. Eck E, DeBaun B, Pugliese G. Achieving sharps injury reduction:
`moving from theory to implementation. Infection Control Today.
`2000.
`8. Pugliese G, Perry J. The needlestick safety and prevention act (HR
`5178): what does it require? EPINet/University of Virginia. 2001.
`Available at: hsc.virginia.edu/medcntr/centers/epinet/hr5178rv.html.
`Accessed May 24, 2001.
`9. Johnson & Johnson Gateway. The four tenets of sharps safety
`design. 2001. Available at: www./gateway.cfm?jnjgateway=
`contentDetail&productGroupld=1469&mediald=569.
`
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`• APPENDIX. RESOURCES FOR SAFETY
`DEVICE CONVERSION
`
`The following organizations have downloadable forms
`and information about converting an organization to
`safety devices.
`
`TDICT (Training for Development of Innovative
`Control Technology Project)
`info@tdict.org
`Trauma Foundation Building #1
`Room 300
`San Francisco General Hospital
`1001 Potrero Ave
`San Francisco, CA 94110-3518
`
`OSHA
`www.osha.gov
`US Department of Labor
`Occupational Safety & Health Administration
`Office of Public Affairs, Room N3647
`200 Constitution Avenue
`Washington, D.C. 20210
`(202) 693-1999
`
`EPINet (Exposure Prevention Information Network)
`epinet@virginia.edu
`International Health Care Worker Safety Center
`Suite 400, Blake Center
`1224 West Main Street
`Charlottesville, VA 22908
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