PPE, Antimicrobial Textiles Manufacturers Address Maintaining Inventory in a Pandemic, Other Issues

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Infection Control Today invited manufacturers of personal protective equipment (PPE) and antimicrobial textiles to share their perspectives on key issues relating to pandemic preparedness as well as proper donning and doffing techniques.

Infection Control Today invited manufacturers of personal protective equipment (PPE) and antimicrobial textiles to share their perspectives on key issues relating to pandemic preparedness as well as proper donning and doffing techniques. 

PPE

ICT: What is your best advice for hospitals in maintaining PPE inventory as part of outbreak preparedness efforts and/or patients with emerging infectious diseases?

Ansell: With the arrival of Ebola in the United States, healthcare professionals have been giving more attention to the topic of PPE. Many acute-care facilities have increased their purchase orders for PPE in preparation for the possibility of caring for potentially infected patients. As a consequence of this greater demand for products, many facilities are experiencing delays in receiving some of their orders. In an effort to combat the supply chain delays, the Centers for Disease Control and Prevention (CDC) has developed tools, available on the agency's website, to assist organizations with evaluating and maintaining an appropriate PPE inventory. With this tool, hospitals can identify their role during an outbreak situation and purchase PPE to meet minimum recommendations based on that role.  It’s also important to stay connected with key organizations. If hospitals find they are in an urgent situation without the necessary quantity of PPE, state and local public health officials may be aware of regional, state, or local stockpiles of supplies available for these circumstances. Furthermore, maintaining an open dialogue with manufacturers and distributors of medical equipment and supplies is another tactic to maintain situational awareness.

References:
1. Centers for Disease Control and Prevention. (2014, Oct 29). Guidance for donning and doffing personal protective equipment (PPE) during management of patients with Ebola Virus Disease in U.S. hospitals. Accessed at: http://www.cdc.gov/vhf/ebola/hcp/ppe-training/
2. Centers for Disease Control and Prevention. (2015, Feb 20). Interim guidance for U.S. hospital preparedness for patients under investigation (PUIs) or with confirmed Ebola Virus Disease (EVD): A framework for a tiered approach. Accessed at: http://www.cdc.gov/vhf/ebola/healthcare-us/preparing/hospitals.html
3. Centers for Disease Control and Prevention. (2015, Feb 12). Considerations for U.S. healthcare facilities to ensure adequate supplies of personal protective equipment (PPE) for Ebola preparedness. Accessed April 8, 2015:  http://www.cdc.gov/vhf/ebola/healthcare-us/ppe/supplies.html

Cardinal Health: A disaster management preparedness plan is essential when it comes to outbreak preparedness. The plan should identify the types of PPE needed, as well as the quantity levels. Hospitals should consider stocking PPE that can be consumed in daily operations, as much as possible, to ensure the stock is consumed on a First in First Out (FIFO) basis (for example, try not to purchase a unique item that does not have current or alternative use in your facility). This will help eliminate scrapping stock due to expiration dates.  PPE kits that contain a variety of PPE, based on standard or expanded precaution types, can increase efficiency and convenience to the staff. According to the CDC, standard precautions, previously called universal precautions, assume blood and body fluid of any patient could be infectious and recommends PPE and other infection control practices to prevent transmission in any healthcare setting. In addition, according to the CDC, expanded precautions include contact precautions, droplet precautions and airborne infection isolation. It’s crucial to work closely with PPE suppliers and government officials to ask what their stocking plans are should an outbreak occur. PPE needs will fluctuate depending on the type of outbreak, so the CDC, or other government guidelines, regarding specific PPE should always be your first priority.

Crosstex: The type of PPE used will vary on the level of precautions required, e.g., standard and contact, droplet or airborne. When determining the appropriate PPE, you have to look at what the person is doing, and if they have the potential for coming in contact with blood and other potentially infectious material. The CDC offers a free PPE poster and PowerPoint slide program at http://www.cdc.gov/HAI/prevent/ppe.html for use by staff development, infection control, and occupational health personnel for training healthcare personnel on how to select and use PPE to protect themselves from exposure to microbiological hazards in the healthcare setting. In addition, they offer a colorful 13-inch by 22-inch poster for donning and removing PPE. The poster provides key instructions in both English and Spanish to reinforce best practices, and is intended to limit the spread of contamination.

Encompass Group, LLC: As described in the CDC’s guidance, Interim Guidance for U.S. Hospital Preparedness for Patients with Possible or Confirmed Ebola Virus Disease: A Framework for a Tiered Approach, “the role a facility plays in preparing to identify, isolate, evaluate, and in some facilities, treat patients under investigation will determine the amount of PPE needed." The amount of PPE needed for each day of patient care will depend on multiple factors including: the number of patients, the acuity of patients, projected number of staff and healthcare team configuration, length of shifts, number of required breaks for staff wearing PPE, isolation unit location and staff support strategies, waste management strategy, lab location, lab testing demand, and hospital protocols for products. The majority of products in this category are manufactured overseas. Therefore, we recommend a minimum of 120 days of PPE outbreak stock should be readily available. This will help prevent interruption in supply chain during critical times.

Halyard Health: It is difficult, if not impossible, to predict when the threat of a pandemic or infectious disease outbreak might occur. In recent years, we have seen threats from severe seasonal flu, Ebola, even local outbreaks of enterovirus and measles. Some of these viruses have no effective vaccine, so PPE is the last line of defense in preventing the spread of infection. The best strategy for a healthcare facility is to prepare in advance by stockpiling critical PPE locally, so they’ll have an adequate supply from the first day of the outbreak. Having a carefully planned supply on hand of items like N95 respirators, face masks, gowns and gloves is crucial to protecting patients, staff and visitors. The facility must have enough PPE to continue to function while the healthcare products industry adjusts to increased demand. OSHA and CDC provide specific guidance for stockpiling, and at Halyard Health, not only do we strongly recommend all facilities follow this guidance, we partner with hospitals to help them. We offer an easy-to-use online calculator to help hospitals figure how much product to stockpile. http://www.halyardhealth.com/solutions/infection-prevention/pandemic-preparedness.aspx OSHA encourages stockpiling soap, tissue, hand sanitizer, cleaning supplies and PPE including gloves, eye and face protection, face masks and respirators. Awareness of product shelf life and storage conditions is important, as is a product rotation strategy to keep the supply evergreen. The CDC recommends stockpiling enough consumable and durable supplies for the duration of a pandemic wave which is estimated at eight weeks, and to be prepared to replenish for subsequent eight-week pandemic waves.  In addition to the aforementioned list, CDC recommends including gowns, IV pumps, ventilators, pharmaceuticals and diagnostic testing items as well.
Sources:
Guidance on preparing workplaces for an influenza pandemic, OSHA, 2009.
Hospital pandemic influenza planning checklist, CDC, 2007.
http://www.flu.gov/planning-preparedness/hospital/hospitalchecklist.pdf

Medline Industries, Inc.: We understand how important it is to ensure hospitals are prepared and well-stocked. Our teams think and plan ahead so essential materials needed are not an issue. We also have the infrastructure needed to get hospitals and providers the right products at the right locations quickly.

TIDI Products LLC: Maintaining proper inventory of PPE items is essential and the amount of inventory must consider potential outbreaks where usage would be beyond normal. Equally as important to maintaining proper inventory is inventory accessibility. PPE, such as gloves, masks, gowns and protective eyewear need to be readily available at point of use. Data suggests most exposure incidents occur from lack of proper protection, for example splash exposure to the eyes – when only gloves were in use. The most common reason for lack of PPE use is ease of accessibility to the protective product. Gloves, masks, gowns and eyewear should be available at point of use so clinicians have a visual reminder to don proper protection if the clinical situation requires them to do so.

Tronex: It is imperative for healthcare facilities to proactively work with their PPE supplier to understand both ongoing projected usage and potential outbreak preparedness needs. This may include certain products and utilization required for daily consumption, as well as different products for outbreaks. Establishing strategic emergency preparedness plans with supplier partners will help ensure proper and sufficient supply in nearly all conditions. Regular preparedness inventory counts and periodic turning of this contingency stock are crucial, as is ongoing training on the proper applications and donning/doffing techniques. An updated and comprehensive risk-mitigation strategy within the hospital and with key suppliers can ensure that the right PPE is available when needed. With over a quarter century of expertise in delivering superior quality PPE solutions to leading healthcare systems nationwide through the major GPOs, Tronex understands the importance of being agile, efficient, and well prepared to support our committed customers through potential outbreak scenarios. In addition to a robust inventory planning process for every commitment, we maintain a comprehensive risk-mitigation and business-continuity strategy. In times of crisis, our vertically integrated global supply chain network, multiple warehouse locations, and buffer stocking system contribute to delivering leading quality and supply consistency to meet critical customer needs.

ICT: What is your best advice for instructing healthcare workers on the proper donning, wear and removal of PPE (related to your product category)?

Ansell: While it’s important to have the appropriate PPE on hand, ensuring that staff is able to correctly utilize the equipment is equally important to the safety of the healthcare workers, patients and the community as a whole. Healthcare workers should be trained to: recognize the type of PPE necessary for the procedures to be performed; understand the different gloving material options and how this effects protection; and demonstrate the proper usage of the applicable equipment. The CDC has educational material available to help hospitals train staff regarding the appropriate use of PPE. These materials include videos, posters and handouts which can be used by hospital education departments to develop lesson plans for staff training.  In addition, for more than 20 years, Ansell has been widely recognized for providing high quality, accredited and non-accredited Continuing Education (CE) programs to registered nurses and other healthcare professionals through Ansell Cares. Our goal is to create a culture of safety for healthcare providers and patients through the implementation of best practices. As an approved provider of accredited education programs, Ansell is proud to sponsor numerous professional learning activities including PPE, in a wide variety of formats both instructor-led and on-line self-paced learning. Each course is developed in collaboration with experts; it is balanced, scientifically sound, based on evidence, and meets national and institutional standards. These activities enhance professional development & training and may be used to meet license requirements.  Further, it’s important to utilize a variety on teaching methods to ensure every learning style is addressed. Using interactive teaching methods, like return demonstrations and simulated patient scenarios, allows staff to experience possible outbreak situations, gives staff the ability to practice in a safe environment and brings training sessions out of a two dimensional learning platform. It also allows educators and trained observers to pinpoint possible ongoing issues with proper PPE usage and correct them before an actual situation occurs.

Cardinal Health: Proper donning, wear and removal of PPE should be a part of every facility’s disaster management preparedness plan. This should include, but not be limited to: 
- Education during new employee orientation
- Continuing education and practice drills at the facility
- Posted instruction at key areas, including facility policy and procedure, CDC website and the facility infection control practitioner’s name and number. 
To increase efficiency and convenience for healthcare workers, a kit can provide many of the necessary PPE to support either standard or expanded precaution types of PPE.  

Crosstex: PPE best practices must be adhered to in all healthcare settings to protect both patients and health care workers. Unfortunately, some personnel may neglect to wear PPE for one reason or another. The best remedy for neglect is to use “consciousness raising” tactics, such as putting up PPE signs or posters and scheduling brief safety meetings at which PPE is discussed. Establishing safety conscious policies and effectively communicating them to the professional team are critical aspects of compliance with best practices. Of course, enforcement of policies is often needed; therefore, periodic audits for PPE compliance should be conducted. You can select an experienced staffer with a strong commitment to infection prevention to be your auditor and give them a checklist. Perform the PPE audits as often as you see fit, comparing results from one evaluation to the next. Personnel found to be in non-compliance should not be openly reprimanded, but rather talked to in private, stressing the importance of PPE compliance and how it creates a safer environment for themselves, their peers, and the patients.

Encompass Group, LLC: CDC guidance reflects an emphasis on the importance of training, practice, competence, and observation of healthcare workers in correct donning and doffing of PPE selected by the facility. Additionally, evaluation of standardized attire under PPE (surgical scrubs or disposable garments) facilitates the donning and doffing process and eliminates concerns of contamination of personal clothing.

Halyard Health: We recommend relying on guidelines from CDC and AORN on the proper donning and doffing of PPE. CDC has issued guidance in the past few months, in the wake of the Ebola outbreak, which emphasizes the importance of healthcare professionals receiving training on an ongoing basis and being able to demonstrate competency in the sometimes complicated tasks of donning and doffing of PPE. CDC also calls for the role of the trained observer to oversee donning and doffing by individuals.  In particular, since all PPE that has been used is considered contaminated, CDC guidelines say that removal of used PPE is considered a high-risk process. It requires a specific procedure, a trained observer, and a designated area for removal to ensure no cross-contamination occurs during the doffing process. AORN provides “Recommended Practices for Surgical Attire,” which also addresses general guidelines for the selection and use of PPE items, including face masks, gloves, and protective apparel. Whether in or around the surgical setting, there is excellent guidance here about how to wear, when to change, and how to remove PPE. For example, you sometimes see face masks pulled down from the face and dangling around the neck. AORN guidelines say face masks that have been used should be immediately discarded, to reduce risk of cross-contamination.
Sources:
CDC, http://www.cdc.gov/vhf/ebola/healthcare-us/ppe/index.html

AORN, http://www.aornjournal.org/article/S0001-2092(11)01112-4/abstract

Medline Industries, Inc.: Once the correct barrier has been selected in an isolation gown, it is recommended to don the gown so the area subject to standard or specialty isolation precautions is protected; to outline existing don/removal guidelines for PPE, specifically isolation gowns, Medline has put together short videos on recommended ways to don and remove isolation gowns based on the gown’s neck style.
Reference: http://www.medline.com/pages/isolation-gowns/videos

TIDI Products LLC: All hospitals should have resource links available to CDC pages that are constantly updated with the most current recommendations related to use of PPE in various situations. During initial phases of an outbreak there is always significant learning related to proper protection from the outbreak that may influence how and when PPE is utilized. As such, we feel it is paramount that live links are available to the CDC guidelines related to standard PPE use and also PPE use for the particular situation. For eye protection in particular, we believe that proper disposable of the eye protection after each use can reduce contamination risk. Research has demonstrated there is a significant risk of contact/cross contamination from reusable eyewear or single use eyewear that has been worn for multiple patient contacts. The best way to avoid this risk is to dispose of the eye protection after single patient contact.

Tronex: Proper PPE or gown selection is of primary importance to ensure that the design, cut, length and materials employed will provide not only the required levels of protection but also comfort, breathability, fit, and range of motion, all of which contribute significantly to high compliance in use. As a general rule, the donning sequence for disposable PPE is gown first, followed by mask or respirator, then goggles/face shield (if needed), and exam gloves last.  The doffing sequence is gloves first, followed by goggles/face shield (if worn), then gown, and mask/respirator last. It is critical for wearers to dispose of the PPE according to their facility’s policies and perform proper hand hygiene before, after, and in between each contact.

ANTIMICROBIAL TEXTILES

ICT: Why should healthcare facilities consider including antimicrobial textiles in their infection prevention and control programs?

LifeThreads: In healthcare facilities where patients have compromised immunity and a higher risk for acquiring infections, healthcare-associated infections (HAIs) are a major threat. According to the CDC, each year in the U.S. 1 in 25 hospital patients – approximately 722,000 people – contract at least one HAI and about 75,000 hospital patients with HAIs die during their hospitalization. However, the most recent CDC progress report on national and state HAIs published in January 2015 cited research that shows when healthcare facilities, care teams, and individual doctors and nurses are aware of infection problems and take specific steps to prevent them, rates of some targeted HAIs can decrease by more than 70 percent.  A comprehensive infection control program is the best way to reduce HAIs. Hand sanitation is a quick and easy way to interrupt bacteria transfer but is not effective alone. The moment clean hands come in contact with any surface harboring bacteria; that sanitation is rendered useless. Textiles such as scrubs, patient gowns and bed sheets can harbor bacteria for significant periods of time and provide an easy transfer path for infections that is more difficult to sanitize than hands. Antimicrobial textiles reduce the chances of cross-contamination, offering a cleaner, safer environment.

Noble Biomaterials: Healthcare facilities should consider including antimicrobial textiles because they are an engineering control solution to the problem of contaminated fabrics. And this is a big problem and an important link in the chain of infection. Outside of the mounting body of evidence proving all types of healthcare fabrics such as scrubs and apparel, privacy curtains and bed linens are contaminated, in the past year alone we’ve seen two incidents where fabrics have been identified as the source of infection outbreaks. One incident involved a fungal outbreak investigated by the CDC and attributed to linens, and the second involved a lab outbreak that was potentially linked to apparel of lab workers. According to the Occupational Safety and Health Administration (OSHA), engineering controls refer to items in the environment or the actual design of the environment that works to eliminate hazards or exposure to hazards. In this case, we’re talking about exposure to bacteria as a potential threat to the health of patients and staff. Antimicrobial fabrics require no effort on behalf of nurses or doctors, but inherently work to reduce dangerous bacteria on soft surfaces in the patient and environment while those items are in use. An overall reduction in the bioburden around patients and staff logically leads to an overall reduction in risk for transmission of infection.

Vestagen Technical Textiles, Inc.: Active barrier apparel, which combines antimicrobial properties with fluid repellent technology, is the only apparel solution with documented effectiveness in peer-reviewed, published research performed in a clinical setting. Adopting active barrier apparel for healthcare workers strengthens the organization’s broader infection prevention program and can become an essential element in larger strategic initiatives to enhance patient safety, care quality and recruitment. Unprotected scrubs and lab coats don’t protect healthcare workers from retaining harmful pathogens on their uniforms, essentially making them mobile vectors of contamination. In addition, we continue to see more and more published research directly linking contaminated clothing to infections in both patients and healthcare workers.(1) Protective active barrier attire can significantly reduce unanticipated healthcare worker and patient exposures to better protect them and help lower the risk of hospital-acquired infections. In fact, active barrier apparel has been proven to reduce methicillin-resistant Staphylococcus aureus (MRSA) on the fabric by 99.99 percent in an intensive care unit setting compared to the non-protective scrubs that are worn today.(2)

References:
1. Wright S, et al. Gordonia bronchialis Sternal Wound Infection in 3 Patients following Open Heart Surgery: Intraoperative Transmission from a Healthcare Worker. Infection Control and Hospital Epidemiology. December 2012; 33(12).
2. Bearman G, et al. A Crossover Trial of Antimicrobial Scrubs to Reduce Methicillin-Resistant Staphylococcus aureus Burden on Healthcare Worker Apparel. Infection Control and Hospital Epidemiology. March 2012; 33(3).

ICT: What is your best advice for evaluating and purchasing healthcare products made from antimicrobial textiles?

LifeThreads: The purchasing decision should be determined by a combination of factors including efficacy, technology and application, washing/handling protocols, price and overall protection. The first and most important element to consider is efficacy, including technology and application. To make an informed decision, the purchasing officer should understand exactly what chemical or additive is providing the antimicrobial protection and how. Is the additive embedded and therefore offering inherent protection? Or is it a topical treatment that is at risk of washing off? After determining the application, one must evaluate how the textiles can be washed and handled. When managing large textile inventories such as those in a healthcare facility, the easier the laundry protocols, the better.  Managing large inventories also means cost is a huge factor, but great protection doesn’t have to cost a lot. For example, textiles treated with a zinc-based substance such as LifeThreads are much more cost effective compared to the silver nitrate treatment commonly used in other antimicrobial textiles. Finally, when buying garments made from antimicrobial textiles, it is important to validate just how much of the garment is protected. For example, does the drawstring on scrub pants also have antimicrobial protection? If it doesn’t, the garment isn’t truly protected and can still serve as a point of contamination.

Noble Biomaterials: Antimicrobials are not all the same. Key questions to ask when evaluating these products are:
- Is it currently registered as an antimicrobial with the EPA, or is that pending?
- What is the mechanism of action?
- For apparel, does the technology affect the comfort of the fabric? Will my staff want to wear it?
- What is the durability? Will it wash out after 50 washes or will it last the life of the product?
- Is the technology certified and tested effective in the actual end product (the apparel, linen or privacy curtain)? If so, how do they test it?
It’s also important to pay close attention to any kill claims made by antimicrobial fabric manufacturers and ensure those claims are backed by the appropriate approvals. For example, a fabric that claims it “kills MRSA” needs to have a public health claim approved by the Environmental Protection Agency (EPA).

Vestagen Technical Textiles, Inc.: The first piece of advice is to ask to see peer-reviewed, published effectiveness and safety research performed in a hospital setting. As reported by Mitchell,(1) only active barrier apparel with combined fluid repellency and antimicrobial technology, have been able to clear this hurdle. Other antimicrobial textiles have been studied in a clinical setting by Burden,(2) Gross,(3) and Boutin,(4) but none of these technologies or products were able to reduce bioburden levels on the clothing. The second is to look for products or technologies that meet published guidelines/standards and have third party endorsements or recommendations. The American Hospital Association recently conducted an extensive due diligence evaluation of this growing market and the Association of periOperative Registered Nurses (AORN) recently released OR attire recommended practices. Additionally, the American Society for Testing and Materials (ASTM) has a pending standard performance specification that should be announced later this year and the International Safety Center, formerly the International Healthcare Worker Safety Center, has published recommendations as well.

References:
1. Mitchell A. Making the Case for Textiles with a Dual Mechanism of Action. Infection Control & Hospital Epidemiology. April 2015; 36 (4).

2. Burden M, Cervantes L, Weed D, Keniston A, Price C, Albert R. Newly cleaned physician uniforms and infrequently washed white coats have similar rates of bacterial contamination after an 8-hour workday: a randomized control trial. J HospMed 2011;6:177–182.

3. Boutin MA, Thom KA, Zhan M, Johnson JK. A randomized crossover trial to decrease bacterial contamination on hospital scrubs. Infect Control Hosp Epidemiol 2014;35:1411–1413.

4. Gross R, Hubner N, Assadian O, Jibson B, Kramer A. Pilot study on the microbial contamination of conventional vs. silver impregnated uniforms worn by ambulance personnel during one week of emergency medical service. GMS Krankenhhyg Interdiszip 2010;5.pii:Doc09.







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