Evaluating and Procuring Surgical Supplies
By Kathy Dix and Kris Ellis
Healthcare purchasers are often faced with a wealth of information an overwhelming amount of data that requires days or weeks to wade through, making supply evaluation and purchasing a weighty challenge. ICT spoke with product manufacturers to determine what, exactly, purchasers should be looking for when it comes time to start renewing contracts.
The most important factors clinicians must consider when evaluating surgical scalpels are sharpness, quality, durability, and ease of use, says Debra Eckard, product manager for Personna Medical (a division of America Safety Razor Company). Clinicians can be assured of getting a safe and effective product when those items are produced to GMP and ISO standards. The most important indications of quality in a surgical scalpel are sharpness and durability.
Disposable safety scalpels
Clinicians should consider sharpness of blade, ease of operation for the user-controlled retraction of the blade, and the feel of the scalpel in users hands, according to Amy Harlacher, product manager for Surgical, Miltex, Inc. Healthcare workers can know they are getting a safe and effective product if the product is tested and evaluated by clinicians prior to the product being released to the market to ensure that it works properly. Important properties of quality disposable safety scalpels include: sharpness of the blade; proper functionality of the retractable blade mechanism to reduce any possibility of injury; and sterility.
Dressings/wound care products
I think the market is getting infiltrated with low-quality products that look similar but are inferior in terms of quality, asserts Brian Dowd, wound care/marketing manager for Kendall/Tyco Healthcare. When evaluating dressings and wound care products in particular, gauze products and X-ray sponges clinicians should consider the following: cleanliness, bleaching quality of manufacturer, source of the cotton, and the reputation of the manufacturer. If the product is USP Type VII many companies dont meet the requirement for USP VII gauze. Clinicians can ensure they are purchasing a safe, effective product if they ensure the source is a reputable company and that the product is a USP VII grade gauze. According to Dowd, the most important signs of quality are:
- Chemical purity how well a manufacturer understands bleaching quality
- Quality of gauze used
- Source of the cotton
- Quality controls during manufacturing process
- Thread count how many threads are used per square inch of gauze
- How much fluid capacity does the product have?
- Does the quality of thread and cotton allow maximum absorbency?
Shannon Bennett, marketing manager for InnerSpace, says that with regard to OR furniture, specifically storage systems, clinicians need to consider some of the following factors, for both effectiveness and level of importance:
- Locking mechanisms
Bennett says, What are you storing? While keeping linens in a locked storage room may be sufficient, the department will want to keep non-stock items secure in an enclosed cart or cabinet with a lock. Additionally, narcotics require double locks, so storage carts or cabinets should feature an overall locking system and a secondary lock on the narcotics drawer(s). Keyless entry locks are gaining in popularity. With keyless entry systems, you reduce the need to carry keys. Some systems feature an automatic re-lock feature, which allows the department to determine when a cart should lock itself (i.e., after a minute 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 cart has been opened, thereby alerting you to check the inventory of supplies found within.
How easily can the storage system be reconfigured or modified? As case loads change and new procedures are added, your storage needs change, Bennett says. What youre storing today may not be the same next year. Save money and build in flexibility today. Look for interchangeable accessories and features that promote adjustability. Again, what are 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 to organize supplies in trays or baskets with adjustable dividers. Keeping items stored 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 utilizing cabinets with tambour (rolltop) doors instead of hinged doors. In procedure rooms, glass doors help to promote rapid retrieval of supplies, Bennett adds.
Personal protective equipment
As a manufacturer of face masks, we have an obligation to the end user to manufacture our masks with high-quality materials that meet and/or exceed the standards established within the healthcare industry, says Andrew Whitehead, vice president of sales and marketing at Crosstex International. The current standards are found in ASTM F-2100-04 and are called Standard Specification for Performance of Materials Used in Medical Face Masks. In the past few months, we have seen literature, ads and packaging that reflect the statement meets ASTM Standards. While this is a positive, the problem is that within the standard, there are three performance class specifications low barrier, moderate barrier, and high barrier which very few people are talking about. Whitehead continues, Each represents a different level of protection relative to fluid resistance. If someone is doing a basic exam with little or no exposure to fluid, then the low barrier is fine. However, if someone is involved in a procedure that has a large potential for blood, aerosols, and/or moisture, then they should be wearing a mask that meets the high barrier performance class specification. The manufacturer should clearly identify which masks meet which performance level. It is the wearers job to identify the appropriate mask for the procedure they are performing.
Personal protective equipment (surgical gowns)
Clinicians need to look at barrier performance of the protective apparel, along with comfort and overall price, advises Lori Gettelfinger, sales and marketing manager for DuPont Medical Fabrics. The combination of those three generally is the key component going into evaluating surgical gowns. One of the nice things that just happened in the industry is the development of the new AAMI PV-70 guidelines, which give clinicians an objective way to look at, for instance, barrier performance. All manufacturers would be reporting their barrier performance the same way, looking at the hydrohead level of performance and the spray impact. From the safety perspective, theres an objective way to evaluate protection. From a performance perspective, what we find is that trial and use are the end users best way to evaluate comfort and protection.
Gettelfinger explains that hydrohead is the technical test method that is used to evaluate the fluid repellence of a surgical fabric under pressure. There are two standardized test methods that are part of that AAMI standard; one is hydrohead and the other is spray impact. If one gown is a hydrohead 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 year and then adopted by the agency at the very beginning of this year. You can see this is such an advantage to clinicians, because they dont have to try to decipher different test methods from different manufacturers. Before a manufacturer can provide documentation on its labeling claiming an AAMI standard, it must submit the appropriate documentation to the FDA. Before they claim they are, for instance, an AAMI level 3, they have to provide appropriate documentation to that effect to the FDA, so that really does give an overarching credibility to the claim. Its really important for hospitals to ask for that information from their manufacturers.
Gettelfinger says that every manufacturer must follow the exact same test methods and report that information so that it is objective to end users. End users can then determine what their needs are for barrier depending on the procedures they are performing, she adds. Finally, they can really evaluate products in their OR through trials. The important properties of a gown are fluid protection, along with comfort, and an important benchmark to measure comfort would be the moisture vapor transmission how well that fabric allows moisture vapor to escape so heat doesnt build up for the surgeon or the clinician.
Interestingly enough, there is a standard in the AAMI PV-70 document 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 the features built in, say, the size of the absorbent fenestration is very important. The fenestration is the area around the incision site, so that is generally where blood and other body fluids will be able to be absorbed, so you want to make sure you have a very good absorbent capacity in that fenestration area for good fluid management.
She adds that other features include the size of the anesthesia screen or the Velcro® line holders that might be built in. At DuPont, we make fabric used for drapes; we dont make finished drapes, Gettelfinger comments. Were a fabric supplier to Medline Industries, so Medline through clinician input decides on the features that are important. From a fabric perspective, its very important that the fabric be very 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, so that you dont have the potential for rips or tear-outs when youre clamping or repositioning that drape. You can also look at how the drape is performing in terms of PV-70, and overall the fenestration barrier, but you can also find out through trial and use which product is going to meet the needs of your clinicians and surgeons. It depends on what surgical techniques theyre using, etc. Overall barrier performance is important. The strength and durability of the 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 will actually stay in place.
Jean Fleming, RN, MPM, CIC, infection control education manager for Professional Disposables International (PDI), says that important factors to consider in evaluating antiseptics include:
- Method of application of antiseptic is packaging easy to open with risk of excess dripping of product on clothing/environment?
- Is the antiseptic fast-drying?
- Is the antiseptic easy to apply or use?
- What is the persistence of bacterial, viral, and fungal kill (log reduction) over time, or, how long is it effective?
- Is the product price-competitive?
Fleming adds that clinicians may be assured they are getting a safe and effective product by:
- Toxicity studies demonstrating safety
- Testing/studies regarding skin irritation
- The incidence of allergic reactions reported
- Safety for use on infants and children
Dressings/wound care products
Andrew Whitehead, vice president of sales and marketing at Crosstex International says that non-woven sponges are becoming increasingly popular because they are more absorbent than standard cotton/gauze sponges. High-quality non-woven sponges are non-linting and will not adhere to wounds, he adds. While nonwoven sponges will tend to cost more per case than traditional cotton/ gauze sponges, fewer sponges will be required per use due to their superior absorbency and strength. Regarding strength, nonwoven sponges range in gram weight from 30-50 grams the heavier the gram weight, the more absorbency and strength the sponge will have.
Whitehead emphasizes that purchasing from a reputable manufacturer that is ISO-certified is a good start. There are many knock-off products available on the market today. Many healthcare products require a 510(k) issued by the FDA. Ask your supplier whether or not the product you are interested in requires this or another form of certification or government approval. If it does and you are still concerned, ask for proof and/or a copy of the approval/certification. Any company that does not elect to provide any substantiating documents to support their claims should be cause for you to question the product and/or company.
Self-sealing sterilization pouches
Self-sealing sterilization pouches are an important part of todays central sterilization protocol, Whitehead adds. Sterilization products require a 510(k). There are many pouches available, some of which are not suited for the medical industry. Make sure the pouches you are using meet medical grade specifications. Whitehead advises, In particular, make sure that your pouch of 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 the pouch; 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 it easy to identify any compromises to the integrity of the film relative to punctures and/or tears; and strong, even side- and end-seals to prevent penetration by instruments and provide strength after sterilization during storage.
Nathan Carver, product manager for STERIS Corporation, has a few words of wisdom for clinicians when it comes to evaluating and purchasing sterilization products.
First, consider which application for which the system will be used. Will the sterilizer be in the central services department or in the OR suite? This will determine options such as the chamber size and door configuration (single-door or double-door pass-through, for example) of the system you will need. The buyer must consider whether the equipments capabilities will mesh with that facilitys workflows and capacity needs. The sterilizer should also provide fail-safe systems such as alarms and should meet applicable safety standards for staff safety.
Carver adds, Purchasers should ensure that the product can be serviced easily and quickly. Choose a manufacturer that has sufficient technical experts available to provide in-house training to hospital staff as well as on-site technical service and preventative maintenance for their systems. 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 than just the price of the equipment. Look for long-term benefits such as a system that offers reduced utility consumption, a lower cost per cycle, an increased load capacity, maximum uptime, and high quality that provides ongoing optimal performance.
According to Carver, the materials and construction of the sterilizer will say a lot about quality. For example:
- Sterilizer chambers: 316L stainless steel is considered a quality standard for steam sterilizers; elliptical chambers with sturdy construction assure even pressure distribution; and the quality of the welding will differentiate some systems from others
- The functionality of control systems can make the difference between productivity and frustration. Make sure they are easy to program and operate, to prevent operator error and achieve sterilization for every cycle. There is added value if the control system has the capability to integrate with other technology to track instruments and improve workflow and efficiency
- Door mechanisms are another quality element. Because of the extreme heat, steam, and the need to keep air out of the chamber to achieve sterilization, the door mechanism and seal must be of the highest quality
- The manufacturer of a quality sterilizer should be able to stand behind their products with good warranties and quality preventative maintenance programs. They should also be able to provide experienced technical professionals to maintain all installed systems.
Beth Minnich, product manager for Surgical, Miltex, Inc., suggests that clinicians consider purchasing quality instruments from a reputable manufacturer who can offer a full selection of patterns, provide detailed care and handling instructions, as well as repair and re-insulating services. It is also important for the clinician to evaluate the ease of use of the instrumentation, such as rotation features, electrosurgical capability, insulation, and minimized component designs such as one-piece instrument patterns to minimize mismatched components and lengthy disassembly and reassembly time typically needed for modular designs, she adds. In addition, the clinician should consider the weight and ergonomic design of the instrumentation for minimized hand fatigue.
OR cleaning supplies
Whitehead says that an ideal disinfectant would have some, if not all, of the following benefits: be ready-to-use; have no noxious fumes; have no need for waste treatment or rinsing; be non-corrosive/non-toxic; have no harmful dermal, ocular, inhalation, or ingestion effects; and pose no health risks. Additionally, it should be effective against a broad range of microorganisms, he adds.
Stephen A. Schneider, president and CEO of Inviro Systems Inc., states, For every pathogen you kill, you have to have performed a test according to criteria laid out by the EPA, under good laboratory practices by reputable institutions. If we say we kill E. coli, testing has to be done on that particular bacteria, under certain conditions laid out by the EPA. We do those tests under independent laboratories, and then forward those results to the EPA with an application to have that claim added to the label. If the claim is not on the label, you cant make the claim. There are quite a few disinfectants out there that are not registered with the EPA and dont make claims about killing particular bacteria, viruses, or fungi.
Schneider continues, Those independent labs have to follow certain guidelines, and when purchasing a disinfectant, you must make sure that the people doing it are reputable and well known. In addition to the label on the actual bottle that would be used in the OR suite, there are also test results that can be made available to people in charge of these purchasing/selection decisions usually an infection control committee and a physician as well as an infection control nurse. Secondly, you can get the data sheet, the MSDS, which spells out the physical properties and capabilities of the product. And you have an EPA master label that the company could provide. Were happy to provide the test summary data, because the people in the hospitals may want to see that information to make sure the product really does what it says its 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 and what the warnings are. A category 4 is so safe that you dont need to have any warnings on the label at all. Other important qualities of a disinfectant include what [pathogens] have been tested, and how long it takes for it to kill.