The great cover up

Oct. 25, 2018

Personal protective equipment (PPE) provides a barrier between healthcare workers’ (HCW) skin and occupational exposure to bloodborne and other pathogens. It also protects patients from potentially contaminated hair and skin cells that are shed by HCWs.

Richard Best

Because exposure to blood and body fluids is an occupational hazard, the Occupational Safety and Health Administration (OSHA) plays a role in selection of PPE. Richard Best, PhD, Director, OSHA Compliance, Stericycle, explained why being familiar with OSHA’s role is important. “Navigating OSHA requirements for PPE is a straightforward process, but it could result in injury or illness to HCWs if any step is overlooked.”

Best outlined three steps that can help guide healthcare facilities through OSHA requirements for PPE:

  • Conduct a hazard assessment. Determine physical hazards (e.g., moving objects, electrical connections, or sharp edges) and health-related hazards (e.g., overexposure to harmful dusts, chemicals, bloodborne pathogens, or radiation). Determine which specific types of PPE are needed and, most importantly, select PPE that will provide a higher level of protection than the minimum level required. OSHA requires employers to certify, in writing, that this hazard assessment has been performed.
  • Select PPE with safety and comfort in mind. Choosing PPE that meets OSHA standards is non-negotiable, but facilities also should select PPE that encourages employee use. Size and fit should be taken into serious consideration. Employees are more likely to wear PPE that fits and is comfortable.
  • Train employees on proper PPE use. Proper employee training of PPE is absolutely paramount to ensuring safety. Employees must understand when PPE is, and is not, necessary; how to wear PPE properly; and the limits of PPE. Retraining should be administered for trained employees when needed or if changes to workplace processes have an impact on PPE use. PPE training should be documented.

“The role of OSHA compliance, whether it is providing PPE training, proper waste management (of sharps, chemicals, or pharmaceuticals), or resources to prevent workplace violence, is critical when it comes to ensuring the health and safety of HCWs,” stated Best. He highlighted an important point: “Facilities that put worker protection first will benefit from the retention of a knowledgeable workforce and a strong reputation for being committed to safety.”

Attributes of a good gown

Gown material should be resistant to penetration by blood and other body fluids, and proof of this should be required from the manufacturer before purchase. Other important gown features include, but are not limited to, durability, integrity, construction of materials appropriate to their purpose, combustible resistance, isothermal, lint-free, flexibility, and comfort.

Tronex MLN177 Series AAMI Level 2 Over-the-Head Isolation Gown

“Settings and duration of use are other key factors, in addition to the consideration of features or designs that help to ease donning, doffing, and overall compliance,” said Edmund S. Tai, Vice President of Healthcare, Tronex International, Inc. He also pointed out that materials and design can help to maximize range of motion and comfort while ensuring that critical exposure zones will have appropriate protection.

Tai observed that health systems look to maximize isolation-gown compliance while offering an excellent standard of protection and proper fit. Noting that Tronex International’s gown complies with Association for the Advancement of Medical Instrumentation (AAMI) recommendations, Tai added, “Our MLN177 series AAMI level-2 Over-the-Head Isolation Gown is one excellent example. It eliminates the extra step of tying at the neck. This series pairs easy-wear apron-style donning and thumb-hook cuffs, for secure placement under gloves, together with pull-away removal. With full frontal and back coverage, and AAMI level-2 fluid barrier protection, the advanced multilayer non-woven material is wonderfully soft, breathable, and durable for single-use applications.”

Tai added, “For maximal efficiency, and as organizations move to standardizing and consolidating their PPE programs, care should be taken to ensure that all staff have access to the proper level(s) of protection, while minimizing the purchasing of significantly more protection than needed or ideal for a given application.”

Greg Metcalf, Global Director for Gloves & Apparel, HALYARD, said, “Data show that 8 million U.S. HCWs are exposed to hazardous drugs annually.1 While new treatments for cancer care offer hope for patients, the toxicity of these drugs puts HCWs at risk for exposure and potential lifelong consequences.”

Metcalf explained that the “HALYARD CHEMO GEAR portfolio of PPE products helps to keep clinicians in compliance with United States Pharmacopeia (USP) Chapter <795> and the new, more rigorous USP Chapter <800> guidelines designed to protect all healthcare personnel in the handling, compounding, and administration of chemotherapy.”

HALYARD chemo gear: procedure gowns for chemotherapy, PURPLE NITRILE-XTRA Gloves, and PINK UNDERGUARD Nitrile Exam Gloves

Noting that the products have been validated for protection against 52 widely used chemotherapy drugs, Metcalf said the portfolio includes HALYARD Procedure Gowns for Chemotherapy Use, a long-sleeved, disposable gown that meets OSHA, American Society of Health-System Pharmacists (ASHP), and Oncology Nursing Society (ONS) recommendations, as well as liquid barrier standards (American Society For Testing And Materials [ASTM] F1670 and ASTM F1671); PURPLE NITRILE-XTRA Gloves, which meet ASTM D6978-05 as well as OSHA, ASHP, and ONS recommendations; and the new HALYARD PINK UNDERGUARD Nitrile Exam Gloves, specifically designed to increase double-gloving compliance, featuring a unique, smooth coating for improved donning and, through a distinctive color that reveals rips or tears, providing additional breach protection.

Gloving up

Gloves share many of the same desirable qualities as gowns, but it is particularly important that gloves be puncture- and tear-resistant and have extraordinary ability to stretch.

Pam Werner, MBA, BSN, RN, CNOR, Senior Clinical Consultant, Healthcare Global Business Unit, Ansell, talked about gloves’ role in protection against bloodborne infections. “Double gloving is the recommended best practice when gloving for surgery. It provides an additional level of protection against bloodborne infections and greatly reduces the risk of glove penetrations.2 Evidence shows that the main causes of blood contact by operating personnel are surgical-glove punctures and tears in the operating room.3 Evidence also shows double gloving reduces the risk of inner-glove perforations by 71 percent compared to single gloving.4 It has been recommended by professional healthcare organizations such as the Association of periOperative Registered Nurses, American College of Surgeons, Centers for Disease Control and Prevention, and Association of Surgical Technologists for several years.”

Ansell’s GAMMEX PI Glove-in-Glove

Ansell’s new patent-pending GAMMEX PI Glove-in-Glove System employs two pre-donned, non-latex surgical gloves, allowing HCWs to don two gloves in half the time. “Since both the outer- and under glove are packed in one poly pouch and one inner wrap, the system also helps to reduce environmental waste by using fifty percent less plastic and paper,” said Werner.

Werner addressed the complaint of some surgeons and nurses who protest that the practice of double gloving causes loss of sensitivity and dexterity. “82 percent of perforations of the outer glove go unnoticed by those who double glove,” noted Werner, “posing a risk to the glove wearer.5 Wearing a colored under glove is preferred, as it increases visual identification of a breach by as much as 86 percent.6 To address these points, Ansell uses the thinnest polyisoprene under glove in the market, GAMMEX Non-Latex PI Underglove, together with our semi-transparent, standard-thickness top glove, GAMMEX PI Hybrid, to decrease bulk and increase sensitivity. Our under glove offers a comfortable fit and a contrasting green color to help with breach detection, while the outer glove offers the comfort of polyisoprene and the strength of neoprene. If there is a breach during the case, or the procedure calls for routine changing of gloves, the top hybrid glove comes off easily.” Werner added that GAMMEX Glove-in-Glove is an ideal option for allergy-sensitized individuals and latex-free facilities.

RoseMarie Squeo, RN, BSN, MA, Senior Consultant in Clinical Operations at Cardinal Health, referred to the coming new glove standards and how hospitals are responding. “With USP <800> standards set to go into effect next year, hospitals are re-evaluating their gloves to ensure compliance.7 Testing a glove against chemotherapy drugs alone won’t ensure protection if the gloves tear easily or cause allergic reactions for clinicians. Cardinal Health offers a broad portfolio of high-use and specialty examination gloves; ESTEEM Comfort is the latest addition to Cardinal Health’s high-use examination gloves developed to help healthcare facilities comply with the USP <800> standard for the safe handling of hazardous drugs.”

Pointing to a survey conducted in 2016, Squeo said that physicians, nurses, and purchasing managers selected the elimination of glove tears as the number-one way to add value to current examination gloves (Key Group Research: 2016 survey, data on file). The same survey found that the number-two way to add value was having ‘no skin-sensitivity issues’.

Cardinal Health’s ESTEEM Comfort nitrile exam glove

Cardinal Health’s new ESTEEM Comfort nitrile examination glove is designed with a minimum elongation of 650 percent (ultimate elongation before aging [%]; ASTM D6319), which can help reduce cuff tears. This is 30 percent higher than the minimum ASTM standard for a nitrile exam glove.

Squeo said, “In a focus group for ESTEEM Comfort, one clinician stated, ‘They just feel like an extra layer of skin. I’m able to stretch them without breaking, but it’s not so thin that I’m worried about it tearing.’ A purchasing manager in another group said, ‘It reduces the number of times staff will have to change gloves, which should drive lower usage and risk.’”

Squeo added, “ESTEEM Comfort shows no clinical evidence of the presence of residual chemical additives at the level that may induce type-IV allergy in the sensitized general-user population. Based on a skin-sensitization study of 205 non-sensitized human volunteers, ESTEEM Comfort showed a 95 percent confidence on low chemical sensitization potential (low chemical sensitization potential (P<0.05; data on file).”

Respirator fit testing

Rick Marquez

“Whether in a hospital, laboratory, pre-hospital care, or manufacturing environment, worldwide workers using respiratory protection are required to be fit tested regularly, to assure they have the proper product, fit, and seal for maximum safety,” stated Rick Marquez, Vice President of Sales–Americas, CleanSpace Technology. “Fit testing typically is done in one of two methods: (1) qualitative, e.g., Bitrix, and (2) quantitative, e.g., Porta-Count. While qualitative methods can be used with greater frequency and less cost,” said Marquez, “they are oftentimes less reliable. Quantitative testing is reliable but time-consuming and expensive.”

Marquez said that, while most people who wear respiratory protection dislike or struggle with fit testing, “it is a necessity both from a safe use and regulatory standpoint. Fit testing, either qualitative or quantitative, has been used widely for decades and is currently the only way to ensure the wearer has the right-sized, correctly fitted mask that is working properly. Despite the importance of fit testing in best-practice respiratory protection, fit testing is a lengthy, costly, and technically complex process, which restricts it from being done regularly.”

The downside of doing yearly fit testing, which is typically recommended, is that the wearer’s mask requirements may change during that time, resulting in less than optimal protection from the respirator. Marquez described changes that necessitate re-fitting, such as growth of facial hair, weight loss or gain, or other instances where people change. “Just like our clothes, what fit right last month, let alone last year, may not fit now.”

Marquez explained the advantage of powered respirator products, such as CleanSpace AirSensit technology. “CleanSpace AirSensit provides a sensor that constantly monitors mask leakage and notifies the worker when they do not have a good fit. This does not replace the need for regular fit testing as part of an overall respiratory program, but it does help workers on a consistent basis know if they have a proper fit.”

References

  1. Centers for Disease Control and Prevention. Hazardous drug exposures in healthcare. www.cdc.gov/niosh/topics/hazdrug/default.html. Last accessed October 1, 2018.
  2. European Commission Health & Consumer Protection Directorate-General Directorate C – Public Health and Risk Assessment C7 – Risk assessment Brussels, C7/SANCO/SCMPMD/2003/00023 final D(03). Opinion of the Scientific Committee on Medicinal Products and Medical Devices on “The protection offered by natural rubber latex medical devices (medical gloves and condoms) against transmissible diseases.” Adopted by the SCMPMD, 24th Plenary Meeting, October 16, 2003.
  3. Smoot EC. Practical precautions for avoiding sharp injuries and blood exposure. Plast Reconstr Surg. 1998; Feb 101(2): 528-534.
  4. Mischke C, Verbeek JH, Saarto A, et al. Gloves, extra gloves or special types of gloves for preventing percutaneous exposure injuries in healthcare personnel. Cochrane Database Syst Rev. 2014 Mar 7;(3):CD009573. Review.
  5. Partecke LI, Goerdt AM, Langner I, et al. Incidence of microperforation for surgical gloves depends on duration of wear. Infect Control Hosp Epidemiol. 2009 May;30:409-414.
  6. Laine T, Aarnio P. How often does glove perforation occur in surgery? Comparison between single gloves and a double-gloving system. Am J Surg 2001 Jun;181(6):564-566.
  7. American Society for Testing and Materials. ASTM D6978. Standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs. West Conshohocken, PA: ASTM International; 2013. https://www.astm.org/Standards/D6978.htm. Last accessed October 1, 2018.

About the Author

Susan Cantrell

Susan Cantrell is Infection Prevention Editor for Healthcare Purchasing News.