How to Evaluate Personal Protective Equipment Products

ICT introduces a new, regular column in which members of industry suggest strategies for the evaluation and purchasing of infection prevention and control products. This month we take a look at personal protective equipment (PPE).

Participants are:

Pam Werner, RN, BSN, CNOR, MBA, clinical consultant for Ansell Healthcare Inc.

Judson Boothe, marketing director of medical supplies for Kimberly-Clark Healthcare

Milt Hinsch, MS, technical services director for Mölnlycke Health Care U.S., LLC

What are the most critical infection prevention-related aspects of PPE that clinicians must bear in mind to keep themselves and their patients safe from pathogenic organisms?

Werner: Informed use of PPE is a critical component of a hospital’s infection prevention program. Where there is a likelihood of contact with bodily fluids or potential hazardous chemicals, appropriate PPE includes gloves, gowns, face shield, mask, eye protection and ventilation devices. Aside from having the right product for the task at hand, the healthcare provider has to use the PPE according to the product directions for use and according to the hospital’s protocol. Hospital protocols usually include other conventions surrounding PPE use. For example: washing hands first, donning PPE according to directions, removing the PPE in a fashion that does not contaminate the healthcare provider, properly disposing of the PPE, and following up with adequate hand hygiene.

Boothe: Even the most scrupulously maintained healthcare facility can be teeming with germs that can cause healthcare-associated infections in patients, staff, and visitors. Outside contaminants that are brought into the environment on a daily basis and contaminant from the patients themselves are a constant hazard. Something as seemingly innocent as a visitor’s hug, or even a clinician’s healing touch, can leave behind dangerous germs. The first line of defense to protecting staff and patients from cross-contamination of such germs is through the proper use of PPE. According to the 2007 isolation guideline published by the Centers for Disease Control and Prevention (CDC), the need for and type of isolation gown selected should be based on:

1.The nature of the patient interaction

2. The anticipated degree of contact with infectious material

3. Potential for blood and body fluid penetration of the barrier apparel

Clinicians must be aware of their environment as well as what they touch before coming into contact with each patient. Organisms such as methicillin-resistant Staphylococcus aureus (MRSA) can survive as long as several months on virtually any surface with patient or healthcare worker contact, such as stethoscopes, pagers, pens, blood pressure cuffs, otoscopes, bed rails, bed tables, doorknobs, patient charts, etc., proper use of personal protective equipment is crucial in preventing the contact transfer of infection—to patients, visitors and to fellow HCWs. Clinicians should also note that not all PPE provides the same level of protection. It is important for both the HCW and purchasing manager to determine what level of protection is needed based on the tasks being routinely performed. For example, clinicians attending to patients in a burn unit who are at very high risk of developing an infection due to their compromised immune systems would need to don PPE that offers the highest level of isolation protection. However, one would not need to use the same gowns, gloves and masks when performing a standard examination or drawing blood.

Overall, consistency is key. Providing PPE and hand hygiene dispensers throughout the facility offers visual reminders to HCWs as they perform their tasks each day.

Hinsch: PPE must be easy to use, effective and used to keep themselves and their patients safe. To help prevent needlestick injuries, retracting needles, blunt needles (surgery), improved sharps containers and education have helped reduce chances of needlestick injuries during the past decade because they are easy to use, effective and are being used more often. In addition, more double gloving is taking place in surgery as OR personnel realize that, despite all of the new needlestick safety products and initiatives, barrier failures, needlestick injuries and sharps injuries still occur. Newer latex and non-latex surgical glove indication systems provide greater protection from injury and reduce possible exposure to bloodborne pathogens by providing greater glove thickness and indicating an outer glove failure when fluids are present. Double-gloving reduces chances of needlestick injuries and wipes more of the blood off of solid needles should they penetrate. The indication enables wearers to change their gloves to help avoid potential bloodborne pathogen contamination of the wearer and/or patient. Indicator gloves are easy to use and are effective. More operating room personnel are double gloving and are making indication gloves part of their PPE armamentarium.

What are the key principles of evaluating PPE products for their barrier-protection properties?

Werner: When selecting a medical glove, an important consideration should be the barrier requirements related to the procedure. Be aware of the level of exposure risk that the patient-care activities require. The barrier protection properties of medical gloves can be divided into three categories:

1. Tensile strength: The gloves should not tear when subjected to the pressures of donning or normal use.

2. Abrasion and pin-hole resistance: The gloves should be resistant to the formation of holes by puncture or abrasion.

3. Permeability: The gloves should prevent the passage of solution and the infectious or toxic materials contained herein. Although chemical resistance is not the primary purpose of gloves, clinicians handle harsh chemicals in many situations. The chemical resistance of various glove materials range from poor to excellent. Before handling chemicals, be sure to select a suitable glove.

In short, medical gloves must provide a continuous and durable layer of material between the healthcare provider’s hand and the patient’s bodily fluid or chemical solutions. This layer should be flexible, free from holes, breaches, and cracks, and strong enough to prevent breakage or permeation during use.

Boothe: Evaluating cost is a reality of PPE consideration and selection. To help reduce costs without compromising protection it is important to select a PPE that provides the level of protection required for the task at hand.

For exam gloves, there are major determinants as to whether or not a glove can maintain protection on a number of factors:

1. The base material composition from which it is manufactured

2. The formulation and manufacturing processes producing the glove

3. The activities and substances to which the glove is exposed

Understanding the significance of each factor is important to ensure appropriate glove selection for specific healthcare activities and exposure levels.

According to the CDC Guidelines for Isolation Precautions, the use of latex or nitrile gloves, rather than vinyl, is recommended for clinical procedures that require manual dexterity and/or involve more than brief patient contact. Clinical studies show vinyl exam gloves fail in use more than one-third of the time.

When choosing protective apparel it is important to consider its functionality. Healthcare workers should examine the barrier fabric, which at a minimum should perform four basic functions:

1. Be resistant to liquid penetration (blood and body fluids)

2. Be resistant to microbial penetration under various in-use conditions where impact under pressure may occur

3. Provide high bacterial filtration efficiency (BFE) to dry spore organisms (MRSA)

4. Be permeable to moisture-vapors

For isolation gowns, it is impossible to tell which gown will provide the right level of protection needed based solely on the how it looks. By understanding the different types and characteristics of barrier fabric, the better armed the healthcare worker will be when choosing the right level of protection needed when treating their patients.

Hinsch: The key principle of evaluating PPE products for their barrier-protection properties is to challenge every PPE product claim. Because healthcare facilities do not have testing labs, they must request some information from the manufacturer and perhaps obtain some from the internet. To evaluate PPE claims:

1. List PPE product claims

2. Review PPE product standards (ASTM, AAMI, etc.) related to the product and claims

3. Review laboratory testing results related to PPE product claims

4. Review clinical studies related to PPE product claims