Evaluating and Purchasing Surgical Apparel and Sharps
By Kris Ellis
The process of making informed and intelligent decisions regarding important supplies and equipment is an essential task at every facility. Infection Control Today magazine asked some leading vendors for advice regarding identification of the criteria that matter most in selecting surgical apparel and sharps.
What are the most important microbial barrier properties associated with surgical apparel and why?
The most important microbial barrier property for surgical apparel is that the product demonstrates the ability to resist both wet and dry microbial penetration. This feature will protect both the patient (from microbial contamination by the surgical team and the environment) and the surgical team (from microbial contamination by the patient and the environment). Only those products that have actually been tested against such organisms as S. aureus, B. subtilis, etc., can claim to be microbial barriers. Jay Sommers, PhD, director, clinical and scientific documentation at Kimberly-Clark Health Care.
The most important barrier factor associated with surgical apparel is appropriate barrier protection for the healthcare worker. The selection and level of barrier property should be guided by the ANSI (American National Standards Institute)/AAMI (Association for the Advancement of Medical Instrumentation) PB 70 guidance and assessment of the surgical procedure in relation to procedure time, pressure (gown front/ sleeves) and fluid volume. Lisette H. Swenson, RN, MS Ed., U.S. brand manager, Mölnlycke Health Care Inc.
Two of the most important microbial barrier properties associated with surgical apparel are fluid resistance and viral penetration. Over the past several decades, we have seen a rise in the number of incidents involving communicable fluid-borne diseases. New diseases, such as HIV, have even emerged. Healthcare professionals need to be protected not only from the diseases that we know exist, but also from the ones that have not yet emerged. Now, as a result of the new AAMI standard, healthcare professionals can know at a glance if their gowns protect them from liquid and viral penetration. Class 4 gowns have passed ASTM (American Society for Testing and Materials) test standard F1671, and thus have a demonstrable ability to resist such penetration. Amy Cash, product coordinator, Precept Medical Products, Inc.
For medical gloves, this includes physical properties such as tensile strength, elongation and thickness. These all combine to act upon the barrier efficacy of the gloves. Material can also have a great effect on barrier efficacy. For example, latex is better for long-term use than vinyl, which tends to break down during use due to oils in the skin. John Calhoun, product manager, Sempermed USA, Inc.
Surgical apparel plays a huge role in both patient and clinician protection from bacteria. Surgical gowns protect the clinician from blood and body fluids present in the case and protect the patient and their operative site from the skin particles and hair follicles of the clinician. Frank Czajka, senior product manager, Proxima Gowns & Drapes, Medline Industries, Inc.
Why is the fit of surgical apparel so critical to the protection of the healthcare worker and to the patient?
Proper fit of surgical gowns can ensure an optimal glove/gown interface. If the sleeves are too long, there can be an increased risk of fluid channeling which could cause strikethrough at the cuff area.
If sleeves are too short, there can be issues with closed gloving or cuff exposure during surgery. Jessica Lenhardt, market manager, surgical gowns, Cardinal Health Fit allows for better mobility and will resist rips and tears. That allows for peace of mind in a surgical gown. Obviously if a gown were to tear, the protective nature of that gown would be compromised. Frank Czajka, senior product manager, Proxima Gowns & Drapes, Medline Industries, Inc.
Proper donning technique plays a critical role in the fit of surgical facial protection. Healthcare workers must place the surgical ties at the crown of the head and the back of the neck to enable the filtering portion of the mask to provide the greatest level of protection. In regard to NIOSH (National Institute for Occupational Safety and Health)-certified N95 respirators, the wearer must be properly fit-tested to ensure a necessary seal to achieve the 95 percent filtration efficiency. Mike Duski, market manager, facial protection products, Cardinal Health Appropriate fit of a surgical gown eliminates the opportunity for exposure to bloodborne pathogens/OPIMS. When selecting a surgical gown, the neckline, sleeves, cuffs and overall fit are important attributes to consider for both comfort and protection. Surgical masks should be selected on level of protection required utilizing ASTM Standard F2100-04, guidance. The mask should additionally demonstrate facial compliance no gapping on the sides, proper fit for protection and facial comfort. Lisette H. Swenson, RN, MS Ed., U.S. brand manager, Mölnlycke Health Care Inc.
The fit of surgical apparel is critical to both the healthcare worker and the patient since it directly affects the surgical environment. For instance, an ill-fitting surgical gown can provide the healthcare worker with extreme discomfort, making it more difficult to focus on the delicate task at hand. Ill-fitting gowns may also lead to excess material coming into contact with the surgical site. Amy Cash, product coordinator, Precept Medical Products, Inc.
Fit helps deliver and define the range of motion a healthcare worker can expect. A greater range of motion then allows the healthcare worker the ability to focus on the procedure, which in turn results in a higher standard of patient care. Jeff Schneider, global general manager, surgical products, Kimberly-Clark Health Care It is important to wear the correct size glove, since poorly fitting gloves can compromise technique and pose a potential risk for contamination to the wearer and patient. Deborah Davis, technical director, gloves, Cardinal Health Proper fit of medical gloves allows the user to have better tactile sensitivity and range of motion. Excess material can more effectively harbor bacteria as well, creating an environment less safe for the patient. John Calhoun, product manager, Sempermed USA, Inc.
What should healthcare professionals look for specifically when evaluating the efficacy of surgical apparel?
Healthcare professionals should use the guidance available through various professional, technical or governmental agencies such as OSHA (Occupational Safety and Health Administration), ASTM, AAMI and AORN (Association of periOperative Registered Nurses), to name a few. Lisette H. Swenson, RN, MS Ed., U.S. brand manager, Mölnlycke Health Care Inc.
The AAMI PB:70 standard makes evaluation of surgical gowns very simple. It is a leveling system that ranks gowns from 1 to 4 on the level of barrier protection they offer. Level 4 is the highest level of barrier protection, indicating the gown is impervious in the critical zones, which include the sleeve seams. Jessica Lenhardt, market manager, surgical gowns, Cardinal Health In conjunction with cost, we recommend evaluating specific barrier, linting, flammability and comfort properties to get a comprehensive view of all critical proprieties. In fact, Kimberly-Clark has created a guide to the guidelines which incorporates the latest AAMI guidelines regarding the barrier for surgical apparel with the consideration of other attributes that creates the appropriate balance of properties for healthcare workers. Jeff Schneider, global general manager, surgical products, Kimberly- Clark Health Care Consistency of the product and its suitability for the intended use.
Healthcare professionals should educate themselves on the various options available and make the correct choice. Knowledge is the most important criteria for choice. John Calhoun, product manager, Sempermed USA, Inc.
Healthcare workers need to identify the level of risk, determine the level of protection needed based on that risk and then choose the appropriate product. If there is a risk of exposure to splashes or bodily fluid, a good choice is a product that such as ASTM F1862 160 mm/hg Fluid Resistant Face Mask and eye protection (such as a fluid-resistant mask with visor, goggles or disposable face shields). If there is a risk of respiratory transmission, healthcare workers should use a procedure mask that can block or absorb respiratory droplets. Katie Goss, market manager, facial protection programs, Cardinal Health A good surgical gown should effectively combine comfort with protection. Raglan sleeves are used on some surgical gowns to help provide healthcare professionals with better ease of movement. However, the seam in raglan sleeve gowns is often located on the underside of the arm, where the potential for strikethrough by bodily fluids is highest. Amy Cash, product coordinator, Precept Medical Products, Inc.
As mentioned before, fit and strength of fabric are key to the products. Choosing the right barrier level for fluid exposure in the case is also very important. In very wet cases, impervious protection should be worn for both parties benefit. The right gown for the right procedure will virtually eliminate incidents of break-through and help to reduce the risk of cross-contamination. Frank Czajka, senior product manager, Proxima gowns & drapes, Medline Industries, Inc.
Healthcare professionals should look for manufacturers that meet or exceed industry standards; for manufacturers with a good track record and history of product innovation. Surgical glove selection should be based on clinical requirements of the procedure being performed, exposure risks, anticipated stress placed on the glove and personal preference of the wearer. A major, more recent consideration is the glove wearers skin condition. Contact dermatitis is a growing concern for healthcare professionals. Healthcare professionals should look for gloves with emollient coatings. Deborah Davis, technical director, Gloves, Cardinal Health
What should healthcare professionals know about the testing requirements of surgical apparel?
The AAMI standard PB:70 has combined industry standard tests and requires that all of them be used to calculate the overall level of protection, so a product is not just evaluated on a single test. The AAMI standard has created a simple leveling system so clinicians do not need to understand the details of every test. All they need to know is there are 4 levels, level 4 being the highest level of protection. Jessica Lenhardt, market manager, surgical gowns, Cardinal Health With everything being asked of todays healthcare professionals, it is difficult to expect that they are in a position to intricately understand testing requirements and specifications. What they should know is that manufacturers like Kimberly-Clark have documentation across the critical attributes of barrier, linting, flammability and comfort that can be used to make a more informed usage and purchasing decision. Jeff Schneider, global general manager, surgical products, Kimberly-Clark Health Care All medical products must be approved by the Food and Drug Administration (FDA), thus some testing is required prior to their entry into the market. However, glove products are routinely tested for such things as latex proteins, leakage and viral penetration. Understand the various tests that are most appropriate for the type of product and learn how to properly interpret the results. John Calhoun, product manager, Sempermed USA, Inc.
The most important testing requirements in facial protection include fluid resistance, laser plume protection and OSHA guidelines and regulations for N95 respirators. To protect against harmful fluids and exposure, healthcare professionals should wear products that achieve the highest level of fluid protection, meeting the ASTM F1862 standard of 160mm/Hg. To protect against laser or smoke plumes, the wearer should select a mask that achieves particulate filtration efficiency between .01 and .03 microns of particulate. Be sure to check the packaging to see if it product is effective against laser plume. All N95 respirators must meet and pass all OSHA guidelines and regulations. Mike Duski, market manager, facial protection products, Cardinal Health Healthcare professionals may find support materials that explain the test criteria through the various organizations mentioned previously that publish the literature. This information will state the test and define the test requirement and appropriate application to the guidance. Lisette H. Swenson, RN, MS Ed., U.S. brand manager, Mölnlycke Health Care Inc.
Healthcare professionals should know the amount of protection being provided by their surgical apparel. It is not enough to know just the test result healthcare professionals need to understand how that test result relates to them in their personal work environment. They need to understand the context of the test results, so that they can understand the limitations and benefits of their surgical apparel. Amy Cash, product coordinator, Precept Medical Products, Inc.
Healthcare professionals should select surgical gloves that meet or exceed industry (ASTM) standards for pinholes, puncture resistance, chemical resistance, bacteriophage penetration, strength and durability, and allergy/irritation levels. Deborah Davis, technical director, gloves, Cardinal Health
How can clinicians balance quality and cost savings when purchasing surgical apparel?
Product education, utilization and standardization are the keys to balancing quality and cost savings. Clinicians have many product choices, and it is very important for them to understand the relevant performance recommendations and standards for surgical apparel developed by organizations such as AAMI and ASTM. Clinicians need to choose products based on the level of risk that might be encountered during a specific procedure. Higher risk incurs products of higher cost. Amy Cash, product coordinator, Precept Medical Products, Inc.
Primarily by selecting the appropriate level of protection needed for the procedure or anticipated exposure, i.e. for a procedure with relatively little bloodborne pathogen exposure a standard surgical gown may be appropriate as opposed to a Viral/Fluid impermeable barrier surgical gown. The assessment of the procedure and appropriate selection of the personal protective equipment will assist in cost management. Lisette H. Swenson, RN, MS Ed., U.S. brand manager, Mölnlycke Health Care Inc.
Clinicians should not sacrifice protection for economic reasons. However, facilities can work to realize cost savings by analyzing the risk level of each procedure and ensuring that the appropriate level of protection mask is selected. Facilities can minimize the number of mask SKUs stocked by each facility to eliminate unnecessary stocking costs. (Dont carry multiple codes when a single code could be used). Also, facilities should not stock laser masks when other fluid-resistant masks being purchased by the facility meet all requirements for a laser mask as well. Mike Duski, market manager, facial protection products, Cardinal Health We understand that all of the people involved in the selection of surgical apparel have to first consider the protection that is being provided to the patients who are having surgery and the people who care for them. But we also understand that this selection involves consideration of the impact this decision will have on the institutions financial situation. We dont believe that a facility has to sacrifice protection for cost. Jeff Schneider, global general manager, surgical products, Kimberly-Clark Health Care The AAMI standard is an excellent way to evaluate the quality of construction and barrier protection of surgical gowns. By evaluating the level of protection needed for each procedure and staff member, overall gown expenses can be reduced. Jessica Lenhardt, market manager, surgical gowns, Cardinal Health
The onus is on the manufacturer to present top quality products at a good price. Listening to the clinicians needs, evaluating the environment and suggesting the right product for that need is always the key. By suggesting the right product, not over-suggesting or under-suggesting, you will end up at the right value. Frank Czajka, senior product manager, Proxima Gowns & Drapes, Medline Industries, Inc.
Ensure that the products, regardless of cost, are appropriate for the job. Purchasing a product on cost can have serious implications if the material or other factors are not considered. John Calhoun, product manager, Sempermed USA, Inc.
Through a comprehensive glove management program, such as the one offered by Cardinal Health, healthcare professionals can get help in choosing and managing the most protective and cost-effective mix of gloves. Healthcare professionals should look for a vendor who can demonstrate exactly how and where glove dollars are being spent by examining utilization patterns and providing industry benchmarks for comparisons. Manufacturers and distributors should have a team of dedicated glove specialists and clinical nurse consultants to help manage everything from proper glove use to latex allergy guidelines. Deborah Davis, technical director, Gloves, Cardinal Health
What should healthcare professionals look for specifically when evaluating the safety of sharps, safety devices and/ or sharps disposal products?
Scalpels should be weighted to feel more like a traditional scalpel so the surgeon requires less of a change in technique, which may make the surgeon less resistant to change. The safety mechanism should be easy to engage and have the ability to lock and unlock in place. The safety mechanism should have the ability to be engaged by using one hand right- or left-handed. The locking mechanism should have an audible click that signifies the safety mechanism is in place. Lucy B. Reday, product manager, Sandel Medical Industries, LLC
Sharps should perform reliably, be easy to use, provide visual confirmation of safety, should not be reusable, be protective throughout disposal, require minimal change in technique, keep fingers behind the needle at all times, and needles should be sharp. Karen L. Dunlap, senior vice president, sales and marketing, Inviro Medical Healthcare professionals should be looking for needlestick prevention devices that eliminate or minimize exposure to contaminated sharps, as required by OSHA regulations. Eliminating exposure to contaminated sharps basically eliminates the risk of needlestick injuries. In addition, devices must be relatively easy to use and be safe and effective for patients. Kathryn Duesman, RN, director of clinical affairs, Retractable Technologies, Inc.
Healthcare professionals should look for safety devices that are intuitive in use and do not require a lot of training. Safety devices should keep the sharp covered or concealed, unless actively performing their primary function. Safety devices should be cost effective without sacrificing quality. Safety devices should not have the ability to be used more than one time. April Kellar, marketing manager, SurgiLance, Inc.
Healthcare professionals should consider the ease-of-use and the safety features and benefits of sharps, safety devices and/or sharps disposable products. Amy Harlacher, product manager - surgical, Miltex, Inc.
What are some specific features to look for that address healthcare worker injury or needlestick prevention?
In addition to effectively eliminating or minimizing exposure to the contaminated sharp, specific features to look for are single-handed, preferably passive, activation. Safety devices should allow clinicians to keep their hands behind the sharp at all times. The safety mechanism should be integral to the device. Users should be able to easily tell if the device has been activated and the device should be safe before, during and after disposal. Of course any device should be reliable and relatively easy to use. Kathryn Duesman, RN, director of clinical affairs, Retractable Technologies, Inc.
Some features to look for that address healthcare worker injuries or needlestick prevention could be how easy the product is to use, does the blade fully retract when not in use (safety scalpels), does the blade lock into place during use (safety scalpels), and disposability. Amy Harlacher, product manager - surgical, Miltex, Inc.
Features to look for include ease-of-use and effectiveness. Used needles should be contained in the syringe barrel they should not be re-useable. Visual confirmation of safety should also be available. Karen L. Dunlap, senior vice president, Sales & Marketing, Inviro Medical
Again, the ease of use of the product, which encourages the surgeon to engage the safety mechanism. If the product is not easy to use, then the surgeon may refuse to use it, and it is the support staff (nurses) who are endangered. Lucy B. Reday, product manager, Sandel Medical Industries, LLC Features to look for include concealment of blade/needle/sharp; single-use/ease of disposal; simplicity, but current technology; and compliance to OSHA standards for that specific category of device. April Kellar, marketing manager, SurgiLance, Inc.
What should healthcare professionals look for specifically when evaluating the efficacy of sharps and sharps-related products?
Whenever healthcare professionals are evaluating any sharps safety device, the most important question must be: Does this product eliminate exposure to the contaminated sharp? Kathryn Duesman, RN, director of clinical affairs, Retractable Technologies, Inc.
Questions to ask when evaluating efficacy include: Does the user have to arm or engage the safety device to get it to work? Is there a visible or audible indication that the safety device has been activated? Is the safety device self-contained? Does the safety device take more time to use than the methods you currently use? Is the safety device easy to use while wearing gloves? Did the safety device operate reliably each time you used it? Is the contaminated needle or blade covered after use and before disposal? Is the safety device harder to dispose of than the device you currently use? Do you think that this device will require extensive training to use effectively? Does this device offer more safety and patient comfort than devices currently used? Finally, do you think that this is a safer device than the method that you currently use? April Kellar, marketing manager, SurgiLance, Inc.
Healthcare professionals should make sure the product performs as advertised, does the product meet their overall needs, and is the product easy to use. Amy Harlacher, product manager surgical, Miltex, Inc.
Needles should be sharp to avoid drag on skin. The graduations on syringes should also be clear and easy to read. Karen L. Dunlap, senior vice president, sales and marketing, Inviro Medical
What should healthcare professionals know about the testing requirements of sharps and sharps-related products?
Healthcare professionals should conduct evaluations with champions of safety within institutions for easy transition from one product to another. Documentation of evaluation for/against safety products to determine acceptability can be employed as well. Also, inservicing for all involved of safety product into the facility. Karen L. Dunlap, senior vice president, Sales & Marketing, Inviro Medical
If a device is commercially available, it must have FDA approval for market. Please be aware that OSHA does not approve devices. OSHA has a list of criteria, which healthcare facilities should try to obtain in all the sharp devices they use. Kathryn Duesman, RN, director of clinical affairs, Retractable Technologies, Inc.
Healthcare professionals should obtain the testing requirements/ forms from OSHA or an organization that promotes sharps safety and use them as regular practice. April Kellar, marketing manager, SurgiLance, Inc.
Quality of the product, and ability of the manufacturer to respond to new safety requirements of OSHA, JCAHO and other regulatory agencies. Lucy B. Reday, product manager, Sandel Medical Industries, LLC
How can clinicians balance quality and cost savings when purchasing sharps and sharps-related products?
Clinician decision should be based on overall performance of device. Cost savings should be associated with the reduction/elimination of needle-stick injuries within the facility, thus reducing/eliminating high medical costs incurred by this needlestick. Karen L. Dunlap, senior vice president, Sales & Marketing, Inviro Medical
Clinicians must look for cost-effective safety devices. If a sharps injury prevention device does not eliminate exposure to the contaminated sharp, it is not cost-effective. The prevention of sharp injuries constitutes a significant cost savings, not to mention the fact that safe devices save lives! Kathryn Duesman, RN, director of clinical affairs, Retractable Technologies, Inc.
When non-compliance to OSHA standards could cost a facility tens of thousands of dollars per violation, it is difficult to put up front costs ahead of safety. Additionally, there are an estimated 800,000 accidental sticks per year costing an average of $3,500 per clinician to investigate and treat. This is an annual industry cost of $2.8 billion dollars. Clearly compliance is the easiest and cheapest option. April Kellar, marketing manager, SurgiLance, Inc.
Balancing quality and cost savings is important when purchasing sharps and sharps-related products, however products that meet the needs of the clinician are most important. Amy Harlacher, product manager - surgical, Miltex, Inc.
The cost of a non-infecting sharps exposure to one staff member will run between $500 (low risk) to $3000 (high risk), due to reporting, medical testing, precautionary treatment, and lost work hours. The social and psychological costs can be immeasurable. The objective should be cost avoidance rather than measuring the cost of the injury. For example, spend $5,000 on a safety product to save the potential of spending $30,000 on an injury. Lucy B. Reday, product manager, Sandel Medical Industries, LLC