Definition: A Medical Cloth is a disposable, pre-moistened, medicated (impregnated with a number of formulations) towel (typically a nonwoven material), usually supplied in a plastic drum or packet, used for delivering a well-defined concentration of an essential active treatment component to a patient’s skin for cleansing, protecting or preparing sites for surgery. Like other medical grade nonwoven products, these cloths are totally lint free.
Between 2007 and 2017 the wipes market is forecast to increase from more than $7.6 billion to $12.6 billion and has an annual projected growth rate of 5.2%1. Fluctuations in the growth rate over time are attributed to market maturity and a shift to environmentally friendly technologies. Many wet wipes on the market fall into the general-purpose space and are now considered commodity products.
Therefore, defining medical wipes more appropriately as medical cloths—and in a comprehensive manner—is a valuable means to maintain differentiation within this market. It is also an approach clearly outlining how requirements associated with regulatory issues and clinical effectiveness protect this segment from commoditization.
Medical cloths were developed as a unique product segment in response to special and particular needs in healthcare. The market includes a combination of breakthrough innovations, including the Sage 2% chlorhexidine gluconate (CHG) cloths (a drug device combination in which the delivery mechanism is critical); fever relief and jellyfish sting relief wipes; more familiar products such as antiseptic or anti-hemorrhoid wipes, which are mostly alcohol based; popular patient care wipes used for bathing and incontinence care products that are aqueous/lotion based systems2. For new "Specialized Medical Wipes" products, see Figure 1.
Significant features of all medical cloths, as opposed to those designed for more general use like surface cleaning, include the active formulation contained therein, the mode of delivery, as well as the concentration level of any delivered active ingredient that results in a clinical effect/impact on the skin surface.
The most popular nonwoven technology currently utilized in the medical wipe market is spunlace, which combines a soft, cotton-like feel with extra strength and durability that is highly desirable by the patient. Requiring no chemicals, spunlace is bonded through a hydroentangling process, making it safe and ecologically sound. Spunlace wipes can be manufactured to meet a broad range of requirements; in addition, wipes are available in different weights (grams per square meter, or gsm). Formats include smooth or abrasive and can be embossed or printed according to the needs or requests of manufacturers.
State-of-the-art, high-speed equipment allow wipes to be delivered with the widest array of finishing touches for every possible need—down to the smallest detail. Virtually any design, in any cut, can be created to meet customer product requirements, including extra large sizes that are “desirable for cleansing wipes,” says Judy Lovejoy, RN, BSN, WCC.
Wipes can be saturated with lotions or other additives to provide customers with maximum benefits. Wipe manufacturing companies typically have formulation experts on staff to develop a wide variety of formulas—including aqueous, gel, lotion and wax—to create functionalized coatings or padding of the nonwoven and therefore tailor the wipes for best performance, texture and user experience. In addition, it is also important to present wipes in a number of folding configurations, including cross folded, inter folded and z-folded (stacked)—again to meet customer needs and for ease of use.
There is much to expect in terms of future development for this segment. Medical cloths are well positioned for further advancement with new and novel developments in fiber technology. For example, the source of resin for the base material, the morphology, the geometry—including size and shape of the fibers—are all critical components that can be used to differentiate products and the active delivery of various topical skin treatment and preventative formulations.
FDA approvals will be required to achieve appropriate and relevant medical claims. Organizations and manufacturers are correspondingly researching and developing ways to convert recycled fibers into materials for wipes. The Poole Company, Greenville, SC, for example, reports that recycled fibers produce an equivalent wipe product and receive the exact same levels of testing and approvals as virgin fibers, yet they are environmentally friendly and sustainable.
Packaging is a critical feature for medical wipes. While it must be economical, packaging has to be strong and provide superior protection—allowing ease of use—yet also maintain the integrity of any remaining product. In addition, packaging also needs to provide a clear, distinct differentiation on use/purpose of a product. “Skin cleansing cloths and surface disinfection wipes should be packaged in such a way as to easily differentiate the two products,” notes Lovejoy. “Situations have been reported where people mistakenly use a surface wipe to cleanse a patient after incontinence. This can lead to severe skin damage and much irritation.”
Many packaging formats are currently used, including: plastic tubs in an array of sizes and shapes—with reach-in, re-sealable or pop-up lids; round or oval cylinders; refill packages in different configurations; packages with hard seal or re-sealable labels; a variety of plastic caps; and travel, “one at a time” packs—sometimes foil or thin films.
Customized medical wipes are very popular and there are many private brand manufacturers in this space. Such wipes are specially designed to meet defined market segments.
In early 2011, bathing wipes (warmed in microwave/cabinet) amounted to $53.5 million for basin-less bathing wash kits3. Flushing issues with basin-less bathing continue to be a major challenge. Meanwhile, all-purpose personal wipes represented a market value of $158 million.
CHG wipes sales amounted to about $19 million. Sage 2% CHG cloths are the only pre-operative skin preparation cloths on the market. The clinical effectiveness of the Sage 2% CHG cloth product is supported by publications outlining results of a clinical study in 2006 by Weinstein et al., showing a 65% reduction of vancomycin-resistant enterococci (VRE) infections when this CHG wipe is used compared to a non-medicated wipe4. This influential clinical study is still cited actively by infection control practitioners (ICPs) and clinicians.
A study in the intensive care unit by Kassakian et al. produced similar results5. In addition, replacing traditional ways of bathing and cleansing patients are advantageous to minimize potential infections. It has been demonstrated that the washbasin is a patient safety risk, as a reservoir for contamination. Two recent published studies show a link between use of basins and multi-drug resistant organisms (MDROs) and catheter-associated urinary tract infections (CAUTIs)6,7. The more remote possibility of water supply contamination in hospitals must also be considered.
Market penetration for wipe solutions associated with patient care, such as hand and body wipes, including those for bathroom hygiene and general purpose bathing, will continue to see increases. General bathing wipes are also undergoing increased acceptance for individuals who find themselves bedridden or experience difficulty entering and exiting a bathtub; furthermore, eliminating the need to use basin fixtures provides a way to minimize infection transmission.
The key aim of the medical wipes industry is therefore to continue introducing value-added products to the healthcare market. With an innovative touch, often regulated and sometimes patent-protected products will make a difference in the medical field. Medical cloths will benefit from features that support ease-of-use and reduced risk of contamination, the need for foolproof identification and characteristics such as disposability, portability, flushability and sustainability considerations.
As a reaction to the growing trend in healthcare to minimize the total cost of a procedure, as well as increase safety via controlled and managed delivery, it is expected that manufacturers of medical cloths will focus on new treatment and prevention possibilities that can be managed via wipe technology. Wipes are necessarily in direct contact with a patient’s skin and can treat a large surface area quickly, efficiently and simultaneously. Advances for chemicals/surfactants and/or other active ingredients used to impregnate or deposit topically on the surface of medical cloths will be necessary to meet the diversity of applications. In addition, surfactants can often offer biocidal properties and will therefore drive overall gains due to the increasing concerns regarding bacterial contamination in many healthcare institutions.
Market pressure from similar medical wipes products being introduced on a global basis, notably from manufacturers in Asia, will undoubtedly be a concern for U.S.-based companies. Yet the challenge will be acceptance of the products in the absence of clinical studies and a demonstrated track record. Switching from tried and tested products in today’s healthcare environment is not an easy task to accomplish. Risk management controls are present in healthcare, and the need to secure the necessary clinical data can prove tortuous, given the size and length of any study, and the costly path that one accepts even when the future outcomes are unknown. For this reason alone, manufacturers that have regulatory approval, substantiated claims and demonstrated value-added outcomes from their products already in the market have minimal concern, given there are huge hurdles to overcome for acceptance and any future change.
About the author: Vicki Barbur works with leading edge companies in their efforts to spur, track and manage innovation through portfolio management and technology partnering. She is based in Chicago, IL, and can be reached at email@example.com.
1. The Future of Global Markets for Nonwoven Wipes: Market Forecasts to 2017, Smithers Apex (2012)
2. Sage Products: www.sageproducts.com
3. GHX Trend Report, 2011
4. Effectiveness of Routine Patient Cleansing with Chlorhexidine Gluconate (CHG) for Infection Prevention in the Medical Intensive Care Unit, Infection Control and Hospital Epidemiology, 2009, 30, 10: Kyle J. Popovich, MD; Bala Hota, MD, MPH; Robert Hayes, BA; Robert A. Weinstein, MD; Mary K. Hayden, MD
5. Impact of Chlorhexidine Bathing on Hospital-Acquired Infections among General Medical Patients, Infection Control and Hospital Epidemiology, 2011, 32, 3: Steven Z. Kassakian, MD; Leonard A. Mermel, DO, ScM; Julie A. Jefferson, RN, MPH; Stephen L. Parenteau, MS; Jason T. Machan, PhD
6. Patients’ Bath Basins as Potential Sources of Infection: A Multicenter Sampling Study, Am J Crit.Care, 2009, 01, Johnson, D., Lineweaver, L. and Maze, L.M.
7. Antibiotic Resistant Bacteria Risk from Hospital Sinks, Nursing Times, 2010, 09, Ford, S. and Clover, B.