Evaluating and Purchasing Surgical Apparel and Sharps

March 1, 2005

Evaluating and Purchasing Surgical Apparel and Sharps

By Kris Ellis

The process of making informed andintelligent decisions regarding important supplies and equipment is an essentialtask at every facility. Infection Control Today magazine asked someleading vendors for advice regarding identification of the criteria that mattermost in selecting surgical apparel and sharps.

Surgical Apparel

What are the most important microbial barrier propertiesassociated with surgical apparel and why?

The most important microbial barrier property for surgicalapparel is that the product demonstrates the ability to resist both wet and drymicrobial penetration. This feature will protect both the patient (frommicrobial contamination by the surgical team and the environment) and thesurgical 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. JaySommers, PhD, director, clinical and scientific documentation at Kimberly-ClarkHealth Care.

The most important barrier factor associated with surgicalapparel is appropriate barrier protection for the healthcare worker. Theselection and level of barrier property should be guided by the ANSI (AmericanNational Standards Institute)/AAMI (Association for the Advancement of MedicalInstrumentation) PB 70 guidance and assessment of the surgical procedure inrelation 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 propertiesassociated with surgical apparel are fluid resistance and viral penetration.Over the past several decades, we have seen a rise in the number of incidentsinvolving communicable fluid-borne diseases. New diseases, such as HIV, haveeven emerged. Healthcare professionals need to be protected not only from thediseases 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 ata glance if their gowns protect them from liquid and viral penetration. Class 4gowns have passed ASTM (American Society for Testing and Materials) teststandard 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 suchas tensile strength, elongation and thickness. These all combine to act upon thebarrier efficacy of the gloves. Material can also have a great effect on barrierefficacy. For example, latex is better for long-term use than vinyl, which tendsto break down during use due to oils in the skin. John Calhoun, productmanager, Sempermed USA, Inc.

Surgical apparel plays a huge role in both patient andclinician protection from bacteria. Surgical gowns protect the clinician fromblood and body fluids present in the case and protect the patient and theiroperative site from the skin particles and hair follicles of the clinician. Frank Czajka, senior product manager, Proxima Gowns & Drapes, MedlineIndustries, Inc.

Why is the fit of surgical apparel so critical to theprotection of the healthcare worker and to the patient?

Proper fit of surgical gowns can ensure an optimalglove/gown interface. If the sleeves are too long, there can be an increasedrisk of fluid channeling which could cause strikethrough at the cuff area.

If sleeves are too short, there can be issues with closedgloving or cuff exposure during surgery. Jessica Lenhardt, marketmanager, surgical gowns, Cardinal Health Fit allows for better mobility andwill 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 becompromised. Frank Czajka, senior product manager, Proxima Gowns &Drapes, Medline Industries, Inc.

Proper donning technique plays a critical role in the fitof surgical facial protection. Healthcare workers must place the surgical tiesat the crown of the head and the back of the neck to enable the filteringportion of the mask to provide the greatest level of protection. In regard toNIOSH (National Institute for Occupational Safety and Health)-certified N95respirators, the wearer must be properly fit-tested to ensure a necessary sealto achieve the 95 percent filtration efficiency. Mike Duski, marketmanager, facial protection products, Cardinal Health Appropriate fit of asurgical gown eliminates the opportunity for exposure to bloodbornepathogens/OPIMS. When selecting a surgical gown, the neckline, sleeves, cuffsand overall fit are important attributes to consider for both comfort andprotection. Surgical masks should be selected on level of protection requiredutilizing ASTM Standard F2100-04, guidance. The mask should additionallydemonstrate facial compliance no gapping on the sides, proper fit forprotection and facial comfort. Lisette H. Swenson, RN, MS Ed., U.S. brandmanager, Mölnlycke Health Care Inc.

The fit of surgical apparel is critical to both thehealthcare worker and the patient since it directly affects the surgicalenvironment. For instance, an ill-fitting surgical gown can provide thehealthcare worker with extreme discomfort, making it more difficult to focus onthe delicate task at hand. Ill-fitting gowns may also lead to excess materialcoming into contact with the surgical site. Amy Cash, productcoordinator, Precept Medical Products, Inc.

Fit helps deliver and define the range of motion ahealthcare worker can expect. A greater range of motion then allows thehealthcare worker the ability to focus on the procedure, which in turn resultsin a higher standard of patient care. Jeff Schneider, global generalmanager, surgical products, Kimberly-Clark Health Care It is important towear the correct size glove, since poorly fitting gloves can compromisetechnique and pose a potential risk for contamination to the wearer and patient. Deborah Davis, technical director, gloves, Cardinal Health Proper fit ofmedical gloves allows the user to have better tactile sensitivity and range ofmotion. Excess material can more effectively harbor bacteria as well, creatingan environment less safe for the patient. John Calhoun, product manager,Sempermed USA, Inc.

What should healthcare professionals look for specificallywhen evaluating the efficacy of surgical apparel?

Healthcare professionals should use the guidance availablethrough 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 gownsvery simple. It is a leveling system that ranks gowns from 1 to 4 on the levelof barrier protection they offer. Level 4 is the highest level of barrierprotection, indicating the gown is impervious in the critical zones, whichinclude the sleeve seams. Jessica Lenhardt, market manager, surgicalgowns, Cardinal Health In conjunction with cost, we recommend evaluatingspecific barrier, linting, flammability and comfort properties to get acomprehensive view of all critical proprieties. In fact, Kimberly-Clark hascreated a guide to the guidelines which incorporates the latest AAMIguidelines regarding the barrier for surgical apparel with the consideration ofother attributes that creates the appropriate balance of properties forhealthcare workers. Jeff Schneider, global general manager, surgical products,Kimberly- Clark Health Care Consistency of the product and its suitabilityfor the intended use.

Healthcare professionals should educate themselves on thevarious options available and make the correct choice. Knowledge is the mostimportant criteria for choice. John Calhoun, product manager, SempermedUSA, Inc.

Healthcare workers need to identify the level of risk,determine the level of protection needed based on that risk and then choose theappropriate 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 ResistantFace Mask and eye protection (such as a fluid-resistant mask with visor, gogglesor disposable face shields). If there is a risk of respiratory transmission,healthcare workers should use a procedure mask that can block or absorbrespiratory droplets. Katie Goss, market manager, facial protectionprograms, Cardinal Health A good surgical gown should effectively combinecomfort with protection. Raglan sleeves are used on some surgical gowns to helpprovide healthcare professionals with better ease of movement. However, the seamin raglan sleeve gowns is often located on the underside of the arm, where thepotential 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 tothe products. Choosing the right barrier level for fluid exposure in the case isalso very important. In very wet cases, impervious protection should be worn forboth parties benefit. The right gown for the right procedure willvirtually eliminate incidents of break-through and help to reduce the risk ofcross-contamination. Frank Czajka, senior product manager, Proxima gowns& drapes, Medline Industries, Inc.

Healthcare professionals should look for manufacturers thatmeet or exceed industry standards; for manufacturers with a good track recordand history of product innovation. Surgical glove selection should be based onclinical requirements of the procedure being performed, exposure risks,anticipated stress placed on the glove and personal preference of the wearer. Amajor, more recent consideration is the glove wearers skin condition. Contactdermatitis is a growing concern for healthcare professionals. Healthcareprofessionals should look for gloves with emollient coatings. DeborahDavis, technical director, Gloves, Cardinal Health

What should healthcare professionals know about the testingrequirements of surgical apparel?

The AAMI standard PB:70 has combined industry standardtests and requires that all of them be used to calculate the overall level ofprotection, so a product is not just evaluated on a single test. The AAMIstandard has created a simple leveling system so clinicians do not need tounderstand the details of every test. All they need to know is there are 4levels, level 4 being the highest level of protection. Jessica Lenhardt,market manager, surgical gowns, Cardinal Health With everything being askedof todays healthcare professionals, it is difficult to expect that they arein a position to intricately understand testing requirements and specifications.What they should know is that manufacturers like Kimberly-Clark havedocumentation across the critical attributes of barrier, linting, flammabilityand comfort that can be used to make a more informed usage and purchasingdecision. Jeff Schneider, global general manager, surgical products,Kimberly-Clark Health Care All medical products must be approved by the Foodand Drug Administration (FDA), thus some testing is required prior to theirentry into the market. However, glove products are routinely tested for suchthings as latex proteins, leakage and viral penetration. Understand the varioustests that are most appropriate for the type of product and learn how toproperly interpret the results. John Calhoun, product manager, SempermedUSA, Inc.

The most important testing requirements in facialprotection include fluid resistance, laser plume protection and OSHA guidelinesand regulations for N95 respirators. To protect against harmful fluids andexposure, healthcare professionals should wear products that achieve the highestlevel of fluid protection, meeting the ASTM F1862 standard of 160mm/Hg. Toprotect against laser or smoke plumes, the wearer should select a mask thatachieves particulate filtration efficiency between .01 and .03 microns ofparticulate. Be sure to check the packaging to see if it product is effectiveagainst laser plume. All N95 respirators must meet and pass all OSHA guidelinesand regulations. Mike Duski, market manager, facial protection products,Cardinal Health Healthcare professionals may find support materials thatexplain the test criteria through the various organizations mentioned previouslythat publish the literature. This information will state the test and define thetest requirement and appropriate application to the guidance. Lisette H. Swenson, RN, MS Ed., U.S. brand manager, Mölnlycke HealthCare Inc.

Healthcare professionals should know the amount ofprotection being provided by their surgical apparel. It is not enough to knowjust the test result healthcare professionals need to understand how thattest result relates to them in their personal work environment. They need tounderstand the context of the test results, so that they can understand thelimitations and benefits of their surgical apparel. Amy Cash, productcoordinator, Precept Medical Products, Inc.

Healthcare professionals should select surgical gloves thatmeet or exceed industry (ASTM) standards for pinholes, puncture resistance,chemical resistance, bacteriophage penetration, strength and durability, andallergy/irritation levels. Deborah Davis, technical director, gloves,Cardinal Health

How can clinicians balance quality and cost savings whenpurchasing surgical apparel?

Product education, utilization and standardization are thekeys to balancing quality and cost savings. Clinicians have many productchoices, and it is very important for them to understand the relevantperformance recommendations and standards for surgical apparel developed byorganizations such as AAMI and ASTM. Clinicians need to choose products based onthe level of risk that might be encountered during a specific procedure. Higherrisk incurs products of higher cost. Amy Cash, product coordinator, Precept Medical Products,Inc.

Primarily by selecting the appropriate level of protectionneeded for the procedure or anticipated exposure, i.e. for a procedure withrelatively little bloodborne pathogen exposure a standard surgical gownmay be appropriate as opposed to a Viral/Fluid impermeable barrier surgicalgown. The assessment of the procedure and appropriate selection of thepersonal 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 economicreasons. However, facilities can work to realize cost savings by analyzing therisk level of each procedure and ensuring that the appropriate level ofprotection mask is selected. Facilities can minimize the number of mask SKUsstocked by each facility to eliminate unnecessary stocking costs. (Dont carrymultiple codes when a single code could be used). Also, facilities should notstock laser masks when other fluid-resistant masks being purchased by thefacility meet all requirements for a laser mask as well. Mike Duski,market manager, facial protection products, Cardinal Health We understandthat all of the people involved in the selection of surgical apparel have tofirst consider the protection that is being provided to the patients who arehaving surgery and the people who care for them. But we also understand thatthis selection involves consideration of the impact this decision will have onthe institutions financial situation. We dont believe that a facility hasto sacrifice protection for cost. Jeff Schneider, global general manager,surgical products, Kimberly-Clark Health Care The AAMI standard is anexcellent way to evaluate the quality of construction and barrier protection ofsurgical gowns. By evaluating the level of protection needed for each procedureand staff member, overall gown expenses can be reduced. Jessica Lenhardt,market manager, surgical gowns, Cardinal Health

The onus is on themanufacturer to present top quality products at a good price. Listening to theclinicians needs, evaluating the environment and suggesting the right productfor that need is always the key. By suggesting the right product, notover-suggesting or under-suggesting, you will end up at the right value. Frank Czajka, senior product manager, Proxima Gowns & Drapes, MedlineIndustries, Inc.

Ensure that the products, regardless of cost, areappropriate for the job. Purchasing a product on cost can have seriousimplications if the material or other factors are not considered. JohnCalhoun, product manager, Sempermed USA, Inc.

Through a comprehensive glove management program, such asthe one offered by Cardinal Health, healthcare professionals can get help inchoosing and managing the most protective and cost-effectivemix of gloves. Healthcare professionals should look for avendor who can demonstrate exactly how and where glove dollars are being spentby examining utilization patterns and providing industry benchmarks forcomparisons. Manufacturers and distributors should have a team of dedicatedglove specialists and clinical nurse consultants to help manage everything fromproper glove use to latex allergy guidelines. Deborah Davis, technical director, Gloves, Cardinal Health

Sharps

What should healthcare professionals look for specificallywhen evaluating the safety of sharps, safety devices and/ or sharps disposalproducts?

Scalpels should be weighted to feel more like a traditionalscalpel so the surgeon requires less of a change in technique, which may makethe surgeon less resistant to change. The safety mechanism should be easy toengage and have the ability to lock and unlock in place. The safety mechanismshould have the ability to be engaged by using one hand right- orleft-handed. The locking mechanism should have an audible click that signifiesthe safety mechanism is in place. Lucy B. Reday, product manager, Sandel Medical Industries,LLC

Sharps should perform reliably, be easy to use, provide visualconfirmation of safety, should not be reusable, be protective throughoutdisposal, require minimal change in technique, keep fingers behind the needle atall times, and needles should be sharp. Karen L. Dunlap, senior vicepresident, sales and marketing, Inviro Medical Healthcare professionalsshould be looking for needlestick prevention devices that eliminate or minimizeexposure to contaminated sharps, as required by OSHA regulations. Eliminatingexposure to contaminated sharps basically eliminates the risk of needlestickinjuries. In addition, devices must be relatively easy to use and besafe and effective for patients. Kathryn Duesman, RN, director ofclinical affairs, Retractable Technologies, Inc.

Healthcare professionals should look for safety devicesthat are intuitive in use and do not require a lot of training. Safety devicesshould keep the sharp covered or concealed, unless actively performing theirprimary function. Safety devices should be cost effective without sacrificingquality. Safety devices should not have the ability to be used more than onetime. April Kellar, marketing manager, SurgiLance, Inc.

Healthcare professionals should consider the ease-of-useand the safety features and benefits of sharps, safety devices and/or sharpsdisposable products. Amy Harlacher, product manager - surgical, Miltex,Inc.

What are some specific features to look for that addresshealthcare worker injury or needlestick prevention?

In addition to effectively eliminating or minimizingexposure to the contaminated sharp, specific features to look for aresingle-handed, preferably passive, activation. Safety devices should allowclinicians to keep their hands behind the sharp at all times. The safetymechanismshould be integral to the device. Users should be able toeasily tell if the device has been activated and the device should be safebefore, during and after disposal. Of course any device should be reliable andrelatively easy to use. Kathryn Duesman, RN, director of clinicalaffairs, Retractable Technologies, Inc.

Some features to look for that address healthcare workerinjuries or needlestick prevention could be how easy the product is to use, doesthe blade fully retract when not in use (safety scalpels), does the blade lockinto place during use (safety scalpels), and disposability. AmyHarlacher, 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 bere-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, whichencourages the surgeon to engage the safety mechanism. If the product is noteasy 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, SandelMedical Industries, LLC Features to look for include concealment ofblade/needle/sharp; single-use/ease of disposal; simplicity, but currenttechnology; and compliance to OSHA standards for that specific category ofdevice. April Kellar, marketing manager, SurgiLance, Inc.

What should healthcare professionals look for specificallywhen evaluating the efficacy of sharps and sharps-related products?

Whenever healthcare professionals are evaluating any sharpssafety device, the most important question must be: Does this product eliminateexposure to the contaminated sharp? Kathryn Duesman, RN, director ofclinical affairs, Retractable Technologies, Inc.

Questions to ask when evaluating efficacy include: Does theuser have to arm or engage the safety device to get it to work? Is there avisible or audible indication that the safety device has been activated? Is thesafety device self-contained? Does the safety device take more time to use thanthe methods you currently use? Is the safety device easy to use while wearinggloves? Did the safety device operate reliably each time you used it? Is thecontaminated needle or blade covered after use and before disposal? Is thesafety device harder to dispose of than the device you currently use? Do youthink that this device will require extensive training to use effectively? Doesthis 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 youcurrently use? April Kellar, marketing manager, SurgiLance, Inc.

Healthcare professionals should make sure the productperforms as advertised, does the product meet their overall needs, and is theproduct easy to use. Amy Harlacher, product manager surgical, Miltex,Inc.

Needles should be sharp to avoid drag on skin. Thegraduations 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 testingrequirements of sharps and sharps-related products?

Healthcare professionals should conduct evaluations withchampions of safety within institutions for easy transition from one product toanother. Documentation of evaluation for/against safety products to determineacceptability can be employed as well. Also, inservicing for all involved ofsafety product into the facility. Karen L. Dunlap, senior vice president, Sales & Marketing, InviroMedical

If a device is commercially available, it must have FDA approval formarket. Please be aware that OSHA does not approve devices. OSHA has alist of criteria, which healthcare facilities should try to obtain in all thesharp devices they use. Kathryn Duesman, RN, director of clinicalaffairs, Retractable Technologies, Inc.

Healthcare professionals should obtain the testingrequirements/ forms from OSHA or an organization that promotes sharps safety anduse them as regular practice. April Kellar, marketing manager,SurgiLance, Inc.

Quality of the product, and ability of the manufacturer torespond 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 whenpurchasing sharps and sharps-related products?

Clinician decision should be based on overall performanceof device. Cost savings should be associated with thereduction/elimination of needle-stick injuries within the facility, thusreducing/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 injuryprevention device does not eliminate exposure to the contaminated sharp, it isnot cost-effective. The prevention of sharp injuries constitutes a significantcost 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 facilitytens of thousands of dollars per violation, it is difficult to put up frontcosts ahead of safety. Additionally, there are an estimated 800,000 accidentalsticks per year costing an average of $3,500 per clinician to investigate andtreat. This is an annual industry cost of $2.8 billion dollars. Clearlycompliance is the easiest and cheapest option. April Kellar, marketingmanager, SurgiLance, Inc.

Balancing quality and cost savings is important whenpurchasing sharps and sharps-related products, however products that meet theneeds of the clinician are most important. Amy Harlacher, product manager- surgical, Miltex, Inc.

The cost of a non-infecting sharps exposure to one staffmember will run between $500 (low risk) to $3000 (high risk), due to reporting,medical testing, precautionary treatment, and lost work hours. The social andpsychological costs can be immeasurable. The objective should be cost avoidancerather than measuring the cost of the injury. For example, spend $5,000 on asafety product to save the potential of spending $30,000 on an injury. Lucy B. Reday, product manager, Sandel Medical Industries, LLC