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By Kathy Dix and Kris Ellis
Healthcare purchasers are often faced with a wealth ofinformation an overwhelming amount of data that requires days or weeks towade through, making supply evaluation and purchasing a weighty challenge. ICTspoke with product manufacturers to determine what,exactly, purchasers should be looking for when it comes time to start renewingcontracts.
The most important factors clinicians must consider whenevaluating surgical scalpels are sharpness, quality, durability, and ease ofuse, says Debra Eckard, product manager for Personna Medical (a division ofAmerica Safety Razor Company). Clinicians can be assured of getting a safeand effective product when those items are produced to GMP and ISO standards.The most important indications of quality in a surgical scalpel are sharpnessand durability.
Disposable safety scalpels
Clinicians should consider sharpness of blade, ease ofoperation for the user-controlled retraction of the blade, and the feel ofthe scalpel in users hands, according to Amy Harlacher, product managerfor Surgical, Miltex, Inc. Healthcare workers can know they are getting asafe and effective product if the product is tested and evaluated by cliniciansprior to the product being released to the market to ensure that it worksproperly. Important properties of quality disposable safety scalpels include:sharpness of the blade; proper functionality of the retractable blade mechanismto reduce any possibility of injury; and sterility.
Dressings/wound care products
I think the market is getting infiltrated with low-qualityproducts that look similar but are inferior in terms of quality, assertsBrian Dowd, wound care/marketing manager for Kendall/Tyco Healthcare. When evaluating dressings and wound care products inparticular, gauze products and X-ray sponges clinicians should consider thefollowing: cleanliness, bleaching quality of manufacturer, source of the cotton,and the reputation of the manufacturer. If the product is USP Type VII manycompanies dont meet the requirement for USP VII gauze. Clinicians can ensurethey are purchasing a safe, effective product if they ensure the source is areputable company and that the product is a USP VII grade gauze. According toDowd, the most important signs of quality are:
Shannon Bennett, marketing manager for InnerSpace, says thatwith regard to OR furniture, specifically storage systems, clinicians need toconsider some of the following factors, for both effectiveness and level ofimportance:
Bennett says, What are you storing? While keeping linens ina locked storage room may be sufficient, the department will want to keepnon-stock items secure in an enclosed cart or cabinet with a lock. Additionally,narcotics require double locks, so storage carts or cabinets should feature anoverall locking system and a secondary lock on the narcotics drawer(s). Keylessentry locks are gaining in popularity. With keyless entry systems, you reducethe need to carry keys. Some systems feature an automatic re-lock feature, whichallows the department to determine when a cart should lock itself (i.e., after aminute or at the end of a shift). Also, there are break-away locks and seals.Once a cart is stocked and locked, break-away seals will tell you if your carthas been opened, thereby alerting you to check the inventory of supplies foundwithin.
How easily can the storage system be reconfigured ormodified? As case loads change and new procedures are added, yourstorage needs change, Bennett says. What youre storing today may not bethe same next year. Save money and build in flexibility today. Look forinterchangeable accessories and features that promote adjustability. Again, whatare you storing? Smaller items, or products in plastic non-sturdy packaging,tend to get lost in a cabinet when stored on a standard shelf. Look toorganize supplies in trays or baskets with adjustable dividers. Keeping itemsstored in labeled trays also simplifies retrieval and the inventory process.
Doors It sounds simple enough,but how much space are you working with? Maximize small areas by utilizingcabinets with tambour (rolltop) doors instead of hinged doors. In procedurerooms, glass doors help to promote rapid retrieval of supplies, Bennett adds.
Personal protective equipment
As a manufacturer of face masks, we have an obligation tothe end user to manufacture our masks with high-quality materials that meetand/or exceed the standards established within the healthcare industry, saysAndrew Whitehead, vice president of sales and marketing at CrosstexInternational. The current standards are found in ASTM F-2100-04 and arecalled Standard Specification for Performance of Materials Used in MedicalFace Masks. In the past few months, we have seen literature, ads andpackaging that reflect the statement meets ASTM Standards. While this is apositive, the problem is that within the standard, there are three performanceclass specifications low barrier, moderate barrier, and high barrier which very few people are talking about. Whitehead continues, Eachrepresents a different level of protection relative to fluid resistance. Ifsomeone is doing a basic exam with little or no exposure to fluid, then the lowbarrier is fine. However, if someone is involved in a procedure that has a largepotential for blood, aerosols, and/or moisture, then they should be wearing amask that meets the high barrier performance class specification. Themanufacturer should clearly identify which masks meet which performance level.It is the wearers job to identify the appropriate mask for the procedure theyare performing.
Personal protective equipment (surgical gowns)
Clinicians need to look at barrier performance of theprotective apparel, along with comfort and overall price, advises LoriGettelfinger, sales and marketing manager for DuPont Medical Fabrics. Thecombination of those three generally is the key component going into evaluatingsurgical gowns. One of the nice things that just happened in the industry is thedevelopment of the new AAMI PV-70 guidelines, which give clinicians an objectiveway to look at, for instance, barrier performance. All manufacturers would bereporting their barrier performance the same way, looking at the hydrohead levelof performance and the spray impact. From the safety perspective, theres anobjective way to evaluate protection. From a performance perspective, what we find is that trial anduse are the end users best way to evaluate comfort and protection.
Gettelfinger explains that hydrohead is the technical testmethod that is used to evaluate the fluid repellence of a surgical fabric underpressure. There are two standardized test methods that are part of that AAMIstandard; one is hydrohead and the other is spray impact. If one gown is ahydrohead of 85 and another is 75, and theyre from two different companies,you can compare the two because the test method is very well defined, she adds. It was just introduced at the end of last yearand then adopted by the agency at the very beginning of this year. You can seethis is such an advantage to clinicians, because they dont have to try todecipher different test methods from different manufacturers. Before a manufacturer can provide documentation on itslabeling claiming an AAMI standard, it must submit the appropriate documentationto the FDA. Before they claim they are, for instance, an AAMI level 3, they haveto provide appropriate documentation to that effect to the FDA, so that reallydoes give an overarching credibility to the claim. Its really important forhospitals to ask for that information from their manufacturers.
Gettelfinger says that every manufacturer must follow theexact same test methods and report that information so that it is objective toend users. End users can then determine what their needs are for barrierdepending on the procedures they are performing, she adds. Finally, they can really evaluate products intheir OR through trials. The important properties of a gown are fluidprotection, along with comfort, and an important benchmark to measure comfortwould be the moisture vapor transmission how well that fabric allowsmoisture vapor to escape so heat doesnt build up for the surgeon or theclinician.
Interestingly enough, there is a standard in the AAMI PV-70document for drapes, and the performance of drapes gets little bit unique,because one of the important measures is that its more feature-oriented,adds Gettelfinger. There is a lot more differentiation of drapes based on thefeatures built in, say, the size of the absorbent fenestration is veryimportant. The fenestration is the area around the incision site, so that isgenerally where blood and other body fluids will be able to be absorbed, so youwant to make sure you have a very good absorbent capacity in that fenestrationarea for good fluid management.
She adds that other features include the size of theanesthesia screen or the VelcroÂ® line holders that might be built in. AtDuPont, we make fabric used for drapes; we dont make finished drapes, Gettelfinger comments. Were a fabric supplier to MedlineIndustries, so Medline through clinician input decides on the features that areimportant. From a fabric perspective, its very important that the fabric bevery drapable and conformable to the body. Also, it should be not too slippery,so it stays in place, and it should be very strong and have good integrity, sothat you dont have the potential for rips or tear-outs when youre clampingor repositioning that drape. You can also look at how the drape is performing interms of PV-70, and overall the fenestration barrier, but you can also find outthrough trial and use which product is going to meet the needs of yourclinicians and surgeons. It depends on what surgical techniques theyre using,etc. Overall barrier performance is important. The strength and durability ofthe fabric is important, and the drapability, the conformability of that fabric,so that it in fact is not super-stiff and slipping on the patient but willactually stay in place.
Jean Fleming, RN, MPM, CIC, infection control educationmanager for Professional Disposables International (PDI), says that importantfactors to consider in evaluating antiseptics include:
Fleming adds that clinicians may be assured they are getting asafe and effective product by:
Dressings/wound care products
Andrew Whitehead, vice president of sales and marketing atCrosstex International says that non-woven sponges are becoming increasinglypopular because they are more absorbent than standard cotton/gauze sponges. High-qualitynon-woven sponges are non-linting and will not adhere to wounds, he adds. Whilenonwoven sponges will tend to cost more per case than traditional cotton/ gauzesponges, fewer sponges will be required per use due to their superior absorbencyand strength. Regarding strength, nonwoven sponges range in gram weight from30-50 grams the heavier the gram weight, the more absorbency and strengththe sponge will have.
Whitehead emphasizes that purchasing from a reputablemanufacturer that is ISO-certified is a good start. There are many knock-offproducts available on the market today. Many healthcare products require a510(k) issued by the FDA. Ask your supplier whether or not the product you areinterested in requires this or another form of certification or governmentapproval. If it does and you are still concerned, ask for proof and/or a copy ofthe approval/certification. Any company that does not elect to provide anysubstantiating documents to support their claims should be cause for you toquestion the product and/or company.
Self-sealing sterilization pouches
Self-sealing sterilization pouches are an important part oftodays central sterilization protocol, Whitehead adds. Sterilizationproducts require a 510(k). There are many pouches available, some of which arenot suited for the medical industry. Make sure the pouches you are using meetmedical grade specifications. Whitehead advises, In particular, make sure that your pouchof choice has complete paper/film separation; medical-grade, paper-basis weight;corner tack seals to prevent the collection of dust at the opening end of thepouch; a thumb notch for quick and easy opening of the pouch; transparent film,preferably tinted, to both easily identify the contents of the pouch and make iteasy to identify any compromises to the integrity of the film relative topunctures and/or tears; and strong, even side- and end-seals to preventpenetration by instruments and provide strength after sterilization duringstorage.
Nathan Carver, product manager for STERIS Corporation, has afew words of wisdom for clinicians when it comes to evaluating and purchasingsterilization products.
First, consider which application for which the system willbe used. Will the sterilizer be in the central services department or in the ORsuite? This will determine options such as the chamber size and doorconfiguration (single-door or double-door pass-through, for example) of thesystem you will need. The buyer must consider whether the equipmentscapabilities will mesh with that facilitys workflows and capacity needs. Thesterilizer should also provide fail-safe systems such as alarms and should meetapplicable safety standards for staff safety.
Carver adds, Purchasers should ensure that the product canbe serviced easily and quickly. Choose a manufacturer that has sufficienttechnical experts available to provide in-house training to hospital staff aswell as on-site technical service and preventative maintenance for theirsystems. This will help to assure that the equipment has a long, useful life.Buyers should look for the lowest total cost of ownership, which is more thanjust the price of the equipment. Look for long-term benefits such as a systemthat offers reduced utility consumption, a lower cost per cycle, an increasedload capacity, maximum uptime, and high quality that provides ongoing optimalperformance.
According to Carver, the materials and construction of thesterilizer will say a lot about quality. For example:
Beth Minnich, product manager for Surgical, Miltex, Inc.,suggests that clinicians consider purchasing quality instruments from areputable manufacturer who can offer a full selection of patterns, providedetailed care and handling instructions, as well as repair and re-insulatingservices. It is also important for the clinician to evaluate the ease of useof the instrumentation, such as rotation features, electrosurgical capability,insulation, and minimized component designs such as one-piece instrumentpatterns to minimize mismatched components and lengthy disassembly andreassembly time typically needed for modular designs, she adds. Inaddition, the clinician should consider the weight and ergonomic design of theinstrumentation for minimized hand fatigue.
OR cleaning supplies
Whitehead says that an ideal disinfectant would have some, ifnot all, of the following benefits: be ready-to-use; have no noxious fumes; haveno need for waste treatment or rinsing; be non-corrosive/non-toxic; have noharmful dermal, ocular, inhalation, or ingestion effects; and pose no healthrisks. Additionally, it should be effective against a broad range ofmicroorganisms, he adds.
Stephen A. Schneider, president and CEO of Inviro SystemsInc., states, For every pathogen you kill, you have to have performed a testaccording to criteria laid out by the EPA, under good laboratory practices byreputable institutions. If we say we kill E. coli, testing has to be done onthat particular bacteria, under certain conditions laid out by the EPA. We dothose tests under independent laboratories, and then forward those results tothe EPA with an application to have that claim added to the label. If the claimis not on the label, you cant make the claim. There are quite a fewdisinfectants out there that are not registered with the EPA and dont makeclaims about killing particular bacteria, viruses, or fungi.
Schneider continues, Those independent labs have to followcertain guidelines, and when purchasing a disinfectant, you must make sure thatthe people doing it are reputable and well known. In addition to the label onthe actual bottle that would be used in the OR suite, there are also testresults that can be made available to people in charge of thesepurchasing/selection decisions usually an infection control committee and aphysician as well as an infection control nurse. Secondly, you can get the datasheet, the MSDS, which spells out the physical properties and capabilities ofthe product. And you have an EPA master label that the company could provide. Werehappy to provide the test summary data, because the people in the hospitals maywant to see that information to make sure the product really does what it saysits going to do. Theyre going to want to find out the safety profile,which they can get off the MSDS, because that tells them how toxic it is andwhat the warnings are. A category 4 is so safe that you dont need to have anywarnings on the label at all. Other important qualities of a disinfectantinclude what [pathogens] have been tested, and how long it takes for it to kill.