Right about 50 years ago, in April 1970, the Apollo 13 space mission went into crisis mode. An explosion prompted the astronauts and their support team at Mission Control, all acting around the clock under tremendous pressure, to resort to backup systems and improvised solutions. The spacecraft, its supplies, and equipment had to be used in ways that far exceeded manufacturers’ specifications. Survival depended on it. “I don’t care about what anything was designed to do. I care about what it can do,” NASA Flight Director Gene Kranz famously said, as portrayed in the movie Apollo 13.
As healthcare institutions across the United States and globally grapple with shortages of personal protective equipment (PPE), some unfortunately are faced with taking extreme measures to conserve, reuse, and extend PPE life span far beyond standard protocols. In worst-case scenarios, healthcare providers may have to improvise and implement do-it-yourself solutions to protect themselves and their patients, perhaps even to survive.
The U.S. Centers for Disease Control (CDC) has issued “Strategies to Optimize the Supply of PPE and Equipment.”1 Among other tactics, the CDC Crisis Capacity Strategies call for using homemade masks and bandanas as a last resort if the supply of proper face masks runs out at a healthcare facility. This is just one example of vulnerabilities that the COVID-19 pandemic has exposed in the U.S. healthcare supply chain.
While the situation has been alarming and dangerous, it is not without hope. Collaboration and innovation, born of necessity, hold potential to improve the healthcare industry’s PPE product choices and supply reliability.
Better User Experience
The goal: To provide healthcare providers (HCP) and patients with appropriate personal protection while also delivering greater PPE comfort and quality of life.
Right now, the healthcare industry and its PPE suppliers are doing their best to cope with the crisis. As it should be, the focus is on providing caregivers with PPE with proven technical performance. However, the pandemic has exposed a need for PPE that not only offers safe protection but also a comfortable user experience.
When COVID-19 began to spread across the United States, healthcare institutions had to make quick decisions about PPE, among many other urgent priorities. To protect caregivers from inhaling airborne virus particles, they turned to a known PPE solution, the N95 disposable filtering facepiece respirator (FFR). As supply became scarce and COVID-19 caseloads surged, some HCP wore FFR for extended time periods. Doctors and nurses began to post social media selfies showing skin trauma where FFR pressed tightly against their faces after long work shifts.2
Other issues include discomfort due to elevated temperature in the facial area, fogging of glasses, and difficulty speaking with patients through FFR. Also, many N95 FFR contain metal, which prohibits their use during MRI procedures. All are challenges that have exposed opportunities for improvement. Now, the industry has a chance to design alternative respirators with better user comfort and enhanced wearability. For example, an alternative respirator design could potentially feature:
Lighter weight materials with greater breathability.
A gentle adhesive seal to hold the respirator to the face, eliminating the need for tight elastic bands to secure the device against the face.
Easy donning and doffing for single use between patient encounters.
MRI-compatible construction with no metal.
The current crisis is prompting the industry to ask: Is there a better way to achieve the same goal? New designs and materials could be developed for other PPE types, such as face shields, masks, isolation gowns, gloves, and goggles. To determine the suitability of PPE alternatives, collaboration is essential between clinical product specialists, healthcare supplies distributors, PPE manufacturers, materials suppliers, and governmental agencies. A spirit of innovation and cooperation between these stakeholders has been unleashed by the COVID-19 pandemic response. A fruit of its continuation could be new PPE products that prioritize both technical performance and user comfort.
Stronger Supply Chains
The goal: To provide healthcare institutions with reliable PPE supply in times of pandemic or other crises so that healthcare providers can focus on patient care without endangering themselves or patients by unsafe PPE reuse or extended wear.
The COVID-19 pandemic has exposed PPE supply chain limits and weaknesses. On many levels, the industry was unprepared for a crisis of this magnitude. Assumptions based on established supply and demand patterns suddenly were obsolete. Supply chains that performed perfectly under the status quo were quickly strained. Upstream supplies of raw materials and chemicals were exhausted or out of reach. But as painful as these problems have been, each has provided an opportunity to change for the better.
For example, now healthcare institutions and their suppliers can evaluate their need for redundant supply sources. Even though no one knows exactly what type of PPE will be required for potential pandemics in the future, educated projections can be made. Professionals across the industry are viewing PPE procurement through a fresh lens, considering how multiple PPE products and styles might be capable of serving the same purpose. For example, a hospital’s future PPE pandemic playbook might allow for five pre-approved respirator styles instead of one. Or they might plan for a different mix of disposable and reusable isolation gowns.
This effort will include identifying alternative materials - and developing new ones - that can be effective for different PPE use cases. Healthcare procurement teams already are engaged in seeking more environmentally sustainable alternatives. Likewise, medical device manufacturers have been searching for eco-friendly alternatives to many chemicals and raw materials. Here is a golden opportunity to merge missions, investing in R&D and priming the procurement pipeline for the next generation of PPE.
Crisis planning extends to every supply chain process and activity. Take sterilization, for example. The COVID-19 crisis highlighted the need to reuse N95 respirators after they had been contaminated. Battelle was able to work with governmental entities and the healthcare industry to secure Emergency Use Authorization (EUA) for its Battelle Critical Care Decontamination System™. The system uses a vapor phase hydrogen peroxide process that appears to pose less risk for the environment and public health than ethylene oxide sterilization.3 Healthcare and government leaders will be studying the efficacy of this and other sterilization approaches applied during the pandemic. This holds promise for continued investigation of how different sterilization methods and new technologies might be leveraged both in future crises and under normal circumstances.
The goal: To get creative solutions to healthcare providers as rapidly as possible, enabling better patient care and potentially saving lives.
The complex and lengthy timelines to bring new medical devices to market have been a well-known issue. The COVID-19 crisis has demonstrated how parties across the healthcare ecosystem can work together to achieve much more efficient innovation.
For example, the U.S. Food and Drug Administration (FDA) is allowing expedited regulatory approvals for device developers who can demonstrate that they are adhering to guidelines and have strong supporting data behind new products. FDA also is issuing EUAs to allow quicker access to critical equipment needed at the front lines.
In addition, universities are offering advanced laboratory capabilities for PPE material testing, helping device makers to expedite material selection and product development. Healthcare clinical product specialists and their suppliers are working together to identify alternative PPE options and replenishment plans. Materials suppliers and device manufacturers are repurposing production lines, refocusing R&D and scaling up capacity to deliver much-needed medical products.
All these relationships can lead to great things if they are continued and nurtured post-pandemic. For instance, when college students return to their campuses, they could begin working alongside their professors and new industry partners on real-world healthcare solutions. Government agencies can determine which expedited review processes it makes sense to keep in practice after the emergency is over. A continuation of this accelerated innovation and collaboration will help to ensure that the healthcare industry and its PPE supply chain are as prepared as possible for the next challenge.
Out of great trials, opportunities for improvement emerge. The COVID-19 pandemic has exposed serious PPE shortages and challenges, but it also has brought healthcare stakeholders across the spectrum closer together, focused on common goals. Although the pandemic is not yet over, it is time to seize on the current momentum of innovation and partnership - to build on the collaborative framework forged in crisis.
Healthcare institutions, medical device suppliers, and government agencies can systematically continue the work of testing, validating, and qualifying alternative PPE materials, product designs, and supply sources.
Sustained efforts to develop creative PPE solutions promise to help healthcare institutions and their suppliers to be better prepared tomorrow than they were yesterday - and better equipped for the next pandemic than they were for the present one.
- “Strategies to Optimize the Supply of PPE and Equipment,” Centers for Disease Control and Prevention.
- Caitlin O’Kane, “Exhausted doctors and nurses post images of their bruised faces after long shifts wearing protective gear,” CBS News, March 31, 2020.
- “Delivering Critical Equipment to Hospital Systems,” Battelle.