Personal Protective Equipment, more commonly known as PPE, will certainly be a familiar term for quite some time. While most people were unaware of the impact of PPE for healthcare and other professions, the spotlight has never been brighter on essential items that we have most certainly taken for granted, even in the healthcare community. As we all adjust to “the new normal” of the impacts of COVID-19, PPE continues to be at the forefront of the conversation on how we will protect our most vulnerable populations, and go about our daily lives as individuals in a safe manner.
As for the healthcare community, there are many questions that need to be answered about PPE, especially considering how well health systems were fully prepared for responding to infectious disease control. As healthcare organizations continue to operate under their emergency response protocols, could they have been better prepared? And, how do healthcare organizations obtain the amount of PPE necessary to protect themselves and patients in the midst of responding to COVID-19? One thing is for sure, healthcare supply chain management and PPE compliance standards are likely to change. In this post, we’ll discuss some of the current rules and authorities for personal protective equipment and make some predictions about new regulations and facility best practices that could be implemented in the future.
U.S. Food and Drug Administration Medical PPE Regulations
The FDA regulates all personal protective equipment (PPE) intended for use as a medical device. Consensus standards for FDA requirements vary by the specific type of PPE (surgical masks, N95 respirators, medical gloves, and gowns). The FDA assures that if standards and regulations for each type of equipment are followed, there is reasonable assurance that the devices are safe and effective. To consider specific regulations for certain PPE items, read the following FDA requirements:
The Food and Drug Administration has faced some criticism for having too harsh or unrealistic standards for certain PPE requirements for premarket reviews or other supplier criteria for medical device manufacturing and sales. To some degree, it has been difficult for certain manufacturers to break through regulatory barriers to become FDA approved for PPE, which affects supply chain contracts and opportunities.
In regard to helping keep healthcare workers and the general public safe, the FDA has released numerous Enforcement Policies to reflect updates to face mask, gown, and glove requirements in accordance with the CDC Infection Control Guidance for the COVID-19 outbreak. With many new PPE exceptions, healthcare organizations are starting to partner with non-traditional medical PPE vendors who are entering the market to help meet the sudden demand.
HHS Center for Disease Control (CDC) PPE Optimization
Due to the lack of medical PPE available to protect healthcare workers from COVID-19, the HHS CDC has released PPE optimization strategy guidelines for health systems to understand capacity requirements and how to access and partner with suppliers. Unfortunately, because demand is so high during this time, the CDC has suggested that healthcare facilities operate under crisis capacity strategies. Here are some of the guidelines that these organizations are having to consider:
- Consider using intact PPE that is beyond the manufacturer-designated shelf life for patient care activities.
- Carefully prioritize PPE use for selected care activities. This could include reserving sterile gowns and gloves for urgent sterile patient procedures, such as surgery, and reserving respirators for aerosol-generating procedures and patient care with airborne transmitted disease risks, like tuberculosis, measles, and varicella.
- If no commercial PPE is available, carefully consider if alternative approaches will reduce the risk of HCP exposure, and are safe for patient care.
Many healthcare organizations are surprised by the lack of relief that is being provided by state and federal agencies. In the latest April HHS OIG Work Plan, the agency has released a review into CMS’s internal controls over hospital preparedness for emerging infectious disease, and an audit of the U.S. operation of the Strategic National Stockpile.
Healthcare Accreditation COVID-19 Responses to PPE Shortages
Many healthcare organizations are looking to accreditors to help answer some PPE compliance questions during the pandemic because of the general lack of oversight or clarity regarding the use of expired or unmarked personal protective equipment. In a recent article, the Joint Commission released Coronavirus clarification and guidance on addressing the lack of medical PPE.
Accreditation agencies such as the Joint Commission, NCQA, URAC, CARF, and more are deferring to the guidance from the FDA, CDC, OSHA, and other government agencies for how to respond to PPE shortages during this time.
Future PPE Standards Predictions
FDA Review of PPE Supplier Requirements
It has been encouraging to recognize the amazing output of so many small and large businesses helping contribute to providing PPE for healthcare heroes. It is hard to imagine how this time of emergency response will not have an impact on some rules and regulations once COVID-19 has subsided.
Because the FDA regulates medical PPE requirements and determines authenticity and supplier requirements, a review process will help determine how easy or difficult it is for legitimate manufacturers to enter the supply chain for America’s healthcare facilities. The hope is that new businesses, contracts, or negotiations can help meet demands and emergency preparedness requirements for future surges in demand for PPE.
Stricter Guidelines on Inventory and Emergency Preparedness
There’s no doubt that the lack of PPE for healthcare staff has created a need for healthcare organizations and government agencies to be more prepared for future infectious disease outbreaks or required emergency responses. It will certainly be interesting to see how federal and state governments prioritize PPE inventory requirements and distribution plans for similar situations.
As many healthcare organizations are adjusting to PPE availability and replenishment challenges, the need to more effectively manage supply and operational oversight will be crucial for compliance and supply chain managers given the lessons learned. PPE burn rate calculations, mask expiration dates, documentation of n95 sizes, department PPE usage metrics, sanitation products supply standards will become much more important factors in emergency preparedness plans since the Coronavirus outbreak.
Increased Supply Chain Vendor Screening
Successful business relationships always require trust, transparency, and effective communication. We recognize now more than ever that vendor compliance and supply chain screening are essential to efficient and reliable care delivery. It is critical that suppliers meet the demands of healthcare organizations when lives are on the line.
A huge lesson we’ve learned during COVID-19 is that a compliant, dependable, and flexible supply chain is essential in times of an emergency. At the same time, many bad actors are looking to manipulate system processes, take advantage of the demand for essential products and/or services, or exploit the most vulnerable in a time of need. We have seen recent examples of PPE scams and ways that the public and healthcare organizations are being targeted during this time of great need.
A large amount of personal protective equipment is being made in other countries that may not comply with U.S. standards. Recently, China has increased PPE export standards to help reduce the amount of fraudulent or defective supplies. It’s important that healthcare supply chain managers know the credibility and compliance standards of each vendor in their network. Healthcare providers have been outspoken about the need for more domestic-based manufacturing for essential materials such as PPE or medical devices such as ventilators and other life-saving technology. It is important for healthcare professionals to have access to local suppliers and resources during an emergency.
The VendorProof Marketplace by ProviderTrust
The VendorProof Marketplace is a public directory of more than 2,500 compliant businesses. We realized we could help connect organizations in need of PPE with vendors who have been properly screened and that have supplies available.
Our team has reached out to thousands of healthcare vendors in our VendorProof platform to answer the call. These vendors are updating their profiles daily with information about available PPE, including, face shields, masks, gloves, gowns, and more. These vendors can now be easily found within the VendorProof Marketplace.