The arrival of the Ebola virus in the US last fall caught the healthcare community by surprise and unprepared. A single case diagnosed in Dallas, TX, followed by the cases of two healthcare providers connected to the original case, dramatically illustrated this reality. The analysis and criticism from the media coverage of those events did not help to resolve or lessen them, but only raised concern and fear among the public. We can all consider ourselves fortunate the outbreak did not become much, much worse.
Now is the time for the healthcare community, which includes care providers, hospital administrators, government entities, CDC and OSHA, as well as manufacturers of personal protective equipment (PPE), to assess the events and learn from our mistakes and lack of resources. Some actions have already been completed, but others are needed to ensure all healthcare providers are adequately protected when this type scenario arises again.
For healthcare professionals, perhaps the key takeaway from this reality-check is the need for official standards in the selection and use of PPE. OSHA and CDC have now issued a comprehensive guidance document related to viral protection, which is a critical step. But the job is not complete until the guidance can be tied to performance-based standards backed by independent third-party testing and certifications.
OSHA and CDC have now issued a comprehensive guidance document
Before the Ebola virus arrived in the US, most of us viewed the events in West Africa like we were watching the movie Outbreak â€“ we were distanced from it and could not imagine it would show up here. We saw example after example of workers not being properly protected for the task at hand. However, one could not blame those healthcare workers who were not properly outfitted, trained or advised. We as a nation thought, quite incorrectly, that the types of issues encountered and the spread of the disease would not happen here, because we are supposedly better trained and equipped than those unfortunate victims in West Africa. But for those of us working for companies that manufacture chemical protective clothing, where performance-based standards are the norm, the improper use of PPE was obvious.
After a few previous unsuccessful attempts to provide specification and performance guidance for PPE use in the Ebola virus response, OSHA and CDC have now issued a comprehensive guidance document. It outlines all types of activities involved in treating and transporting patients, analyzing samples, cleaning treatment areas and other exposure scenarios.
The guidance is presented in a matrix format, with a list of PPE types on the left side and multiple exposure scenarios across the top. The matrix then cross-references the type and level of protection required. For protective gowns and coveralls, they can be described as either fluid resistant or impermeable. The document defines fluid-resistant garments as those that have fabrics and seams that meet certain industry standards for liquid repellency. The impermeable definition references other industry standards and test methods for blood and viral penetration resistance under pressure. The fluid resistant garments are specified for scenarios where the anticipated risk of exposure to blood and body fluids is low. The impermeable garments are specified for those scenarios where the risk of exposure to blood and body fluids is high.
The guidance document lists other types of PPE as well, including gloves, facemasks, face and eye protection, head/neck coverings, shoe/boot covers, respirators, powered air purifying respirators (PAPR) and full body air-supplied suits. It is important to remember that proper protection is achieved by a system of components, properly sized and integrated.
In addition to this new guidance, other actions are necessary to ensure proper protection. Comprehensive worker training for the special PPE required for these events is critical. Authorities having jurisdiction must continue with acquisition and inventorying of resources for future events. During the fall, when many hospitals, emergency response teams and ambulance agencies were all trying to purchase at the same time, supplies ran out and lead times for PPE increased dramatically.
Even though OSHA and CDC have produced this new guidance, many healthcare providers are not involved in the PPE selection and procurement process itself. In addition, trying to understand the guidance â€“ and relate that information to what is available from PPE manufacturers â€“ leaves room for error. This is why industry-recognized performance standards should be utilized in the specification and procurement of PPE for blood and viral hazard scenarios.
Two standards currently exist in the US that could be referenced for use in specifying and procuring protective clothing. The American National Standards Institute (ANSI) and the American Association for the Advancement of Medical Instrumentation (AAMI) have issued a standard known as PB 70, Liquid Barrier Performance And Classification Of Protective Apparel And Drapes Intended For Use In Healthcare Facilities. This is one of the documents referenced in the new OSHA guidance, although the guidance does not specify that the standard must be met. Also, the guidance only provides requirements for a surgical gown and not the other system components required.
The second standard, although not referenced in the guidance, is published by the National Fire Protection Association (NFPA) as NFPA 1999, Standard On Protective Clothing For Emergency Medical Operations. This standard is comprehensive and provides performance requirements for other components in addition to the garment itself. The NFPA is currently in the process of revising the standard through a tentative interim amendment (TIA), an expedited process to the normal standard update cycle to provide improved requirements to better support the healthcare community and their needs.
The use of standards by procurement agencies for acquisition of PPE will ensure healthcare providers are getting products that effectively and consistently meet their protection needs. The standards process requires independent third-party testing and certification. Manufacturer facilities must meet ISO 9001 quality system requirements. Facility audits are performed periodically and samples are obtained for testing on an annual basis. This type of approach provides benefits to users, purchasers and manufacturers alike.