A Global Shortage of PPE

A Global Shortage of

Personal Protective Equipment

Mary C. Vrtis, Ph.D., MSN, RN, OCN, NEA-BC, FCN

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COVID-19: Guidance for Personal Protective Equipment

The pictures above in figure 1 are from one of the early guidelines published by the China Centers for Disease Control and Prevention (2020, February 17). Diagnosis and treatment, COVID-19 prevention and control. In March of 2020, as the pandemic was hitting the U.S., China’s CDC put out clear guidelines for COVID-19 in China Centers for Disease Control and Prevention (2020, March 12). Guidelines for personal protective equipment of specific groups from COVID-19. China CDC Weekly, 2, 19, 341-343.

As can be seen the personal protective equipment recommended included:

Nitrile or rubber gloves.
“Work clothes” defined as scrubs or disposable clothing.
Protective suit (note that the suit shown is disposable and has a hood.
Medical protective masks, powered air filter respirator, KN95, or an N95 respirator.
Work cap, disposable.
Work shoes or rubber boots.
Waterproof boot covers.

As the pandemic began to hit the U.S. hard starting in March of 2020, recommendations for personal protective equipment to be used when caring for a patient with confirmed or suspected COVID-19 included an N-95 (or higher) respirator, face shield, isolation gown, and gloves. Implementation of these standards of protection became extremely difficult, as it was almost impossible to purchase N95 respirators.

Figure 2 shows how rapidly the pandemic was expanding during this time period. The U.S. progressed from no cases of COVID-19 to over a half a million (578,268) by April 10 and to 1.7 million (1,716,078) by May 31, 2020. The U.S. had the dubious honor of over 30,000 deaths and was the world leader in both cases of COVID-19 illness and related deaths.

Given how quickly the SARS-CoV-2 virus was infecting humans throughout the world, the full protective garb recommended by China was most appropriate. Even in China, the virus spread country-wide very quickly. The Ebola virus was contained this way, and with careful use of high quality, transmission-based precautions and effective personal protective equipment, there were hopes that this situation could also be contained.

Due to the shortage of personal protective equipment, the U.S. CDC and the World Health Organization started to publish downgraded recommendations World Health Organization (2020, February 27). As shown in figure 3, the U.S also downgraded the recommendations. These downgrades, as shown in figure 3, were emergency modifications due to the shortages. Given the rapidly rising numbers of sick and dying, strengthening the recommendations for more protective equipment toward the initial China guidelines would have been the science-based response, whereas relaxing the guideline was clearly about triaging supplies to the areas of highest needs. The intention was to preserve respirators for staff caring for the sickest patients – usually in the hospitals.

U.S. Nurses on the Front Lines did NOT Have Adequate Protective Equipment

The worldwide shortage of personal protective equipment, including medical face masks, N95 respirators and other types of respirators had devastating consequences. Healthcare providers on the front lines were at very high risk for infection, especially those in the high-risk age groups, and providers with high-risk co-morbidities (obesity, asthma, respiratory disease, cardiac disease, hypertension, immunosuppression). Early in the pandemic, it was also known that African Americans and Hispanic/ LatinX healthcare providers were also at higher risk for contracting COVID-19 (Jain, 2020).

In the U.S., the protection needed to safely care for patients with active respiratory infections were in such short supply that one patient, one time use N95 respirators were being used continuously for long hours, reused for multiple days, and expired N95s were considered to be better than nothing (CDC, 2021, May. Situational update COVID-19 decontamination and reuse of filtering facepiece respirators) originally published October 19, 2020.

Multiple surveys of RNs caring for patients with COVID-19 infections were conducted. Figure 5 shows that when results of 9 different surveys were combined that 54,269 of the 117,437 nurses surveyed (46.2%) did not have an adequate supply of N95 respirators to provide the first line of defense against SARS-CoV-2. Six of these surveys asked if RNs were required to reuse N95s. Reuse of single patient, one time use of N95 respirators continued as late as April 2022. A total of 99,429 of 133,495 (79.5%) of RNs surveyed were still required to reuse N95s. (secondary analysis of results from Couper, et al., 2022, American Nurses Foundation, National Nurses United – see References Cited).

By April of 2022, the global supply had improved, and it was easier to obtain brand new N95s. The CDC had actually ended the emergency authorization use for reuse of N95s in May of 2021

The imbalance between supply and demand meant that patients infected with COVID-19 were being cared for in the healthcare system long before the necessary personal protective equipment needed was available to the staff providing care. The lack of adequate personal protective equipment put frontline clinicians who stepped up to provide direct care at extremely high risk for contracting this potentially fatal disease.

During the height of the pandemic the shortage of N-95 respirators and medical grade masks was so severe that clinicians caring for patients all over the world had to choose between reuse long beyond manufacturer recommendations or to have no protection at all. Countless nurses were forced to sew fabric masks for themselves and their colleagues. The results of the surveys and studies below show clearly that nurses and other healthcare professionals were not adequately protected and did get infected.

Nurse Surveys

National Nurses United Nurse Survey and Press Conference March 5, 2020

National Nurses United (NNU), the largest nurses’ union in the U.S. represented approximately 225,000 nurses. The union leaders held a press conference on March 5, 2020.

Executive Director Bonnie Castillo, RN, Cathy Kennedy, RN, Vice President, and Deborah Burger, RN, President, clearly articulated the concerns of nurses and the equipment and support the nation’s nurses needed in order to remain safe while they cared for patients with COVID-19.

One of the speakers read a letter from a nurse union member who became symptomatic while caring for a patient with confirmed COVID-19. The nurse was quarantined. At this time, the CDC was the only organization performing COVID-19 testing and the CDC refused to test the nurse because she was not sick enough. The test was requested from both her personal physician and the county health department. The writer indicated that returning a sick nurse to work while infected would put patients and staff at risk, but she was desperately needed at work if she did not have the infection.

Concern was also expressed because, as discussed above, the CDC had downgraded the recommendation that fit tested N95 respirators or higher equipment, such as powered air purifying respirators (PAPR) be used when caring for patients with confirmed or suspected infection. The new recommendations, as shown above, substituted a medical grade facemask and face shield instead of an N95 or higher filtration respirator with a face shield. Ms. Castillo also pointed out that downgrading made no sense when the infection rates were rising so quickly. Stricter protocols were needed, not less protection.

National Nurses requested that the Occupational Safety and Health Administration (OSHA) publish temporary emergency standards to protect everyone, nurses, as well as the general public – especially given that asymptomatic transmission of COVID-19 from one person to the next presented significant risks for providers (National Nurses, 2020 March 5). They pointed out that investigation of the severe acute respiratory syndrome (SARS-CoV) outbreak in Canada published in 2006 clearly showed the need for N95 respirators and personal protective equipment (Commission to Investigate the Introduction and Spread of SARS in Ontario, 2006, December 11).

National Nurses United surveyed 6,500 U.S. nurses who were members of the union in March 2020 and reported that the personal protective equipment required to safely care for patients with COVID-19 infections was not consistently available:

Only 63% of nurses had access to N95 respirators (37% did not).
Only 30% of nurses had enough personal protective equipment available to address a rapid surge in patients (70% did not).

Many nurses in the March 2020 National Nurses survey also reported that they did not feel that they had adequate education and training related to COVID-19 policies and procedures to guide them. When asked if they were aware of their employer’s policies related to suspected or known employee exposure to COVID-19, 43% of nurses did not know if the organization had a policy and only 19% reported that the employer did have a policy in place.

On behalf of union member nurses, NNU asked that employers provide policies and procedures for caring for patients with COVID-19 and employee exposures. Nurses also identified a need for education on the virus and donning and doffing personal protective equipment. There was a clear need for round-the-clock education as nurses worked in shifts for 24/7 coverage. National Nurses United requested governmental intervention to assure that nurses and other health care workers had the protective equipment available. They also asked that Congress provide funding for the emergency response and when available, provide vaccinations for COVID-19 for free (National Nurses United, 2020 March 5). Funding was provided.

The American Nurses Foundation Survey of 32,000 Nurses, May 2020

The American Nurses Association conducted a survey of 32,000 U.S. nurses in May 2020 and reported that:

43% had to make their own face masks.
14% had made their own hand sanitizer, goggles, or face shield.
79% were reusing disposable, one patient, one time use personal protective equipment for multiple patients for one to five or more days.

Hospital nurses reported the least severe shortages whereas long-term care and community health nurses faced the most severe personal protective equipment shortages. More than a quarter of nurses reported severe challenges in isolating patients exhibiting respiratory infection. The inability to quickly isolate patients infected with COVID-19 meant that they were not able to protect other vulnerable patients.

The vast majority of nurses, 87%, reported that they were afraid to go to work.

American Nurses Foundation (2020a, May). Personal protective equipment survey. https://www.nursingworld.org/~49cd40/globalassets/covid19/ppe-infographic-june-5-2020.pdf

American Nurses Foundation (2020b, May). What 32,000 nurses want you to know about treating COVID-19. https://www.nursingworld.org/~4987e5/globalassets/covid19/ana_covid19infographic_dataset1_20200424-final.pdf

The National Nurses United Survey, May 2020

Approximately 23,000 RNs participated in this survey from April 15 to May 10, 2020. The vast majority of nurses (87%) were re-using single use respirators and face masks when caring for patients with COVID-19 infections. At least 28% of nurses were reusing decontaminated respirators that had been used with patients with active infections. Isolation gowns were not available for most nurses as 72% reported caring for patients ill with COVID-19 with their own skin or clothing unprotected.

At least 500 of the surveyed nurses had tested positive for COVID-19 infections and another 500 were still waiting to be tested. Nurses expressed concern that they were not being notified when they were unknowingly exposed to someone who tested positive for COVID-19.

National Nurses United (2020, May 20). New survey of nurses provides frontline proof of widespread employer, government disregard for nurse and patient safety, mainly through lack of optimal PPE. https://www.nationalnursesunited.org/press/new-survey-results

The American Nurses Foundation Survey, August 2020

The American Nurses Association conducted a second survey on personal protective equipment shortages that was reported in August of 2020. There were 23,207 U.S. RNs who responded. The situation for nurses had not improved, and in reference to N95 respirators may actually have been worse.

The majority of nurses (68%) were “required to re-use single use items such as N95 respirators,” and reuse was encouraged but not required for an additional 20%. Nurses were required to reuse N95s respirators that the manufacturers recommended as one time use disposables for 1 full day to more than 15 days.

Figure 5 shows the number of days that nurses were required to use the same N95 respirator. There is no science to support such extended use. Forty four percent of nurses were required to use the same N95 for 5 days or more. Of those, 15% were using the same N95 for 15 or more days.

The most common method of decontamination was ultraviolet light (24% if methods), and the second most common was hydrogen peroxide vapor reported by 19% of respondents, see figure 4. Neither of these methods were used in the healthcare facilities, but rather by companies that picked up the contaminated masks and returned them disinfected.

When asked if the N95 masks fit properly, 64% of RNs said YES, but 24% said NO, and the remaining 11% of respondents said they were not sure.

Of great concern is the notation that 48% of nurses required to reuse single use N95s did not know the methods used for decontamination. These respirators were placed over the fragile skin of the face. The other question, of course, is whether the used respirators were actually decontaminated at all!

It is important to recognize that 55% of the nurses who responded did not feel safe with being required to reuse single patient, one time use equipment over and over and over again. And the nurses who felt like that had very good reasons. Colleagues were getting infected, and in some nurses had died.

Shortages of other types of protective equipment continued. Face shields were reported as hard to find by 23% of nurses in August, which was just slightly lower than the 27% reported in May of 2020. Shortages of isolation gowns decreased from 27% to 22%. Surgical masks were more readily available in that only 16% of nurses reported being unable to obtain these or difficulties in obtaining these, compared to 25% in May.

American Nurses Foundation (2020, August). Personal protective equipment (PPE) Survey 2 results. https://www.nursingworld.org/practice-policy/work-environment/health-safety/disaster-preparedness/coronavirus/what-you-need-to-know/ppe-survey-2/

Reuse of N95’s: The Science Did NOT Support Practices

Although there is some data to support decontamination and reuse, for example, the Fischer, et al. (2020) study, we were unable to find any scientific evidence to support the length of time nurses were required to reuse the same N95 respirators, see figure 4.

The ability of an N95 to filter effectively decreases with prolonged reuse, and it is questionable that reuse for 5 days or more was even safe.

The Fischer publication contains the following statements: “Our results indicate that, in times of shortage, N95 respirators can be decontaminated and reused up to 3 times by using UV [ultraviolet] light and HPV [vaporized hydrogen peroxide] and 1–2 times by using dry heat. Following nationally established guidelines for fit testing, seal check, and respirator reuse is critical. We recommend performing decontamination for sufficient time and ensuring proper function of the respirators after decontamination using readily available qualitative fit testing tools.”

Fischer, R. J., et al. (2020). Effectiveness of N95 respirator decontamination and reuse against SARS-CoV-2 virus. Emerging Infectious Diseases, 26, 9, 2253-2255. DOI: https://doi.org/10.3201/eid2609.201524

National Nurse United Surveys March and September 2021

National Nurses United surveyed 9,200 RNs in March of 2021 and 5,000 RNs in September of 2021. Nurses were still having to reuse single use protective equipment, including N95 respirators. Although more N95s were available, 80% of hospital nurses reported that they were still reusing respirators that were designed for one-time, single patient use. Between March 2021 and September 2021, the percentage of nurses who had access to N95s for all patients with active COVID-19 infection decreased from 80% to approximately 60%. In addition, only 40% of nurses were using full protection, including N95 respirators for patients under investigation for COVID-19.

The reason that there was a decrease in the ability to have maximum protection was not reported. It is possible that availability of N95s decreased as reuse was phased out when new, single patient use respirators became easier to acquire. Clearly, caring for patients under investigation without adequate personal protective equipment was not acceptable, as patients are contagious for at least 2 to 4 days prior to emergence of symptoms and positive test results.

National Nurses United (2021, March 10). National RN survey highlights continued hospital failures to prioritize nurse and patient safety during pandemic. https://www.nationalnursesunited.org/press/fifth-survey-of-national-nurses-highlights-continued-hospital-failures

National Nurses United (2021, September). National nurse survey reveals that healthcare employers need to do more to comply with OSHA emergency temporary standard. https://www.nationalnursesunited.org/press/national-nurse-survey-reveals-health-care-employers-need-to-do-more-to-protect-workers

Inadequate Protective Equipment: Nurses at Risk

Nguyen, et al. (2020) calculated the hazard ratio for developing a positive COVID-19 test for clinicians who reported adequate protective equipment, inadequate supplies, and reuse of personal protective equipment. The sample included 99,795 front line healthcare workers in the U.S. and U.K. and 2,627,695 U.K. plus 182,408 U.S. general public participants. Responses were collected through a COVID-19 Symptom Study smartphone app. Data was collected from March 24 to April 23, 2020. Results were as follows:

Front line healthcare workers with INADEQUATE personal protective equipment were 1.31 times more likely to contract the infection (HR 1.31, 95% CI 1.10-1.57) when compared to staff with adequate equipment.
Front line healthcare workers who reported REUSING personal protective equipment were at 1.46 times higher risk of COVID-19 infection (HR 1.46, 95% CI 1.21-1.76) than workers who reported adequate equipment was available.
Front line healthcare workers caring for patients with CONFIRMED COVID-19 infections with INADEQUATE personal protective equipment had a hazard ratio of 5.91 times the risk of those who had adequate equipment and were NOT caring for patients with COVID-19 (HR 5.91, 95%, CI 4.53-7.71).
Front line staff working with patients with CONFIRMED COVID-19 who had to RE-USE equipment had a hazard ratio of 5.06 when compared to those with adequate equipment and were not caring for patients with COVID-19 (HR 5.06, 95%, CI 3.90-6.57).
Front line healthcare workers caring for patients with ADEQUATE equipment and CONFIRMED COVID-19 had a risk of 4.83 (HR 4.83, 95%, 3.99-5.85) when compared to workers not caring for patients with suspected or confirmed infections.
Inpatient front line healthcare workers had a risk of contracting COVID-19 that was 24.30 times that of the general public (HR 24.30, 95% CI 21.83-27.06).
Front line nursing home workers had a risk of 16.24 (HR 16.24, 95% CI 13.39-19.70) when compared with the general public.
Inpatient front-line staff were at highest risk and 24.30 times more likely than the general population to develop a positive COVID-19 test (HR 24.30, 95% CI 21.83-27.06).
Nursing home staff were also at very high risk of contracting the infection with HR 16.24, (CI 95% 13.39-19.70) and 16.9% of these staff members reported inadequate personal protective equipment.

The authors also reported that 23.7% of inpatient staff were required to reuse PPE (Nguyen, et al. 2020).

The Consequences of Failure to Protect Healthcare Providers

By the end of June 2023, nurses, and other healthcare workers (including nursing home staff) had experienced 2,752,931 COVID-19 infections. Secondary analysis CDC COVID-19 data tracker – cases and deaths among health care personnel, and CDC COVID-19 nursing home data. We will discuss the mental health consequences and impact of long COVID/ post-COVID syndrome on the nursing workforce in another chapter.

Approximately 5,906 U.S. healthcare workers died in the U.S. from COVID-19 infections by the end of June 2023, see figure 6.

Secondary analysis CDC COVID-19 data tracker – cases and deaths among health care personnel, and CDC COVID-19 nursing home data.

We can NEVER allow this to happen again!

Disruption of Global Personal Protective Equipment Supply Lines

Prior to the pandemic, healthcare providers went to the supply closet and restocked. Items needed were ordered from the contracted supplier and the items requested arrived within a few days. If an item was back ordered, a comparable substitute product was usually available.

The spread of COVID-19 occurred so quickly that available supply and existing production methods could not even begin to meet demand, especially for N95 and filtering face piece respirators such as genuine KN95s. Before the pandemic, little consideration was given to where products were produced, or the effort that was required to obtain an item like a NIOSH-approved N95 respirator or an isolation gown. End users had little need for questions when the supply chain worked. Historically, medical supplies in the U.S. were obtained through reputable companies that addressed demand and supply issues with minimal disruptions.

During the pandemic, organizations that had long-standing relationships with mainstream suppliers could not get supply orders filled as all types of personal protective equipment were on backorder. What little was available through pop-up medical suppliers was cheaply made and counterfeits were flooding the market. Individuals with connections to overseas producers began direct marketing supplies at significantly higher prices than usual for very low-quality products (personal observation).

The COVID-19 pandemic emphasized the fact that a large proportion of medical supplies used throughout the world are produced in China, the country that was initially most affected by lockdowns and restrictions on workers. As shown in figure 6, before 2020 47% of personal protective equipment purchased in the in the U.S., 50% of personal protective equipment used in Europe, and 43% of that used in the rest of the world was imported from China. The remaining 53% of personal protective equipment used in the U.S. was produced in the U.S. or elsewhere (Bown, 2022). When China could not manufacture and/ or rapidly ship supplies fast enough, the entire global supply chain collapsed.

Another factor that contributed to the U.S. shortage of personal protective equipment is that healthcare organizations minimize costs for these items by maintaining a minimal base inventory and then ordering supplies of equipment “just-in-time.” Personal protective equipment is a requirement for staff protection, but the cost cannot be passed on to consumers or third-party payors (Cohen & Rodgers, 2020), so many healthcare organizations keep a bare minimum and monitor staff usage.

This widespread form of containing the budget worked relatively well under normal circumstances but failed miserably in the face of worldwide shortages during the rapidly growing pandemic. The supply issues were infinitely worse as more and more countries experienced disastrous conditions. Factory closures, shipping delays, and border restrictions worldwide translated to unsafe conditions for healthcare providers.

Emergency Authorization for Use of Non-NIOSH-Approved Respirators in the U.S.

U.S. hospitals, nursing homes, outpatient facilities, home health, hospice and organizations that provide personal care aides were all scrambling for the same scarce supplies of personal protective equipment.

Downgrading of recommendations for personal protective equipment started on February 4, 2020, when the U.S. had identified the first 16 to 26 patients with COVID-19. The U.S. Health and Human Services Secretary had already declared an emergency use authorization for alternative, non-NIOSH-approved respirators (CDC 2020, July 16).

The table in figure 7 shows respirators used in other countries that the emergency use authorization identified as essentially equivalent to the NIOSH approved N95 to N100 series. Whereas the N95s are tested and then approved by NIOSH, none of the alternatives listed go through the NIOSH testing process. The left side of figure 8 show examples of counterfeit respirators that did not fall under the emergency authorization.

By the time that the World Health Organization published Rational use of personal protective equipment for coronavirus disease 2019 (COVID-19): Interim guidance on February 27, 2020, the global shortage of personal protective equipment was already at crisis state. Obviously with a respiratory virus, medical masks and respirators were the most critical forms of personal protective equipment required for staff safety – and these items were the most difficult to obtain. The World Health Organization identified that the following factors contributed to shortages:

Rapidly rising numbers of COVID-19 cases.
Insufficient supplies in the global personal protective equipment stockpiles.
Panic buying and stockpiling.
Limited ability to expand production of personal protective equipment.
Inappropriate use of personal protective equipment.

The U.S. CDC and WHO recommended similar strategies to reduce the need for personal protective equipment as follows:

Wear the same N95 or FPP2 respirator for extended time periods and multiple patients without removing it.
Plan to perform multiple patient care activities together to reduce entries into the room.
Avoid use of personal protective equipment for asymptomatic patients.
Restrict visitors for patients with active disease.
Use telemedicine instead of face-to-face encounters whenever possible.
Construct glass or plastic barriers in locations such as triage areas, registration desks, pharmacies, etc.
Monitor utilization by calculating the burn rate.
Control distribution and use of personal protective equipment by staff (WHO, 2020 February 27; CDC, 2020 July 16; CDC, 2020 December 29).

CDC provided a Burn Rate Calculator to help healthcare organizations project for reality-based needs (CDC, 2020 July 16) and continuously provided many opportunities for healthcare provider and leadership education. Recommended strategies to optimize personal protective equipment were divided into three levels of options that could be implemented sequentially if and when the shortages became more problematic.

Downgrading the recommendations was not the correct response when the number of patients with and dying of COVID-19 was increasing at unprecedented rates worldwide. Downgrading caused healthcare workers to be less safe! There is no evidence of efforts to increase the manufacture of protective equipment, and that is what was desperately needed.

Changing Standards of Care for Staff Protection

Conventional Capacity strategies were those already in place before the pandemic. Plans for temporary surges in patient volume were included in most healthcare infection control plans. Routine annual, and just-in-time fit testing of employees for respirators was an OSHA requirement.

The next level, Contingency Capacity strategies were implemented during periods of personal protective equipment shortages. It was already extremely difficult to obtain adequate personal protective equipment through regular channels after the first patients with COVID-19 were diagnosed in the U.S. (by January 28, 2020). So, U.S. health care facilities and agencies were in contingency mode very early in the crisis.

Contingency strategies included selectively cancelling elective and non-urgent surgeries, procedures, and converting scheduled face to face appointments with healthcare providers to virtual communications. Patients with COVID-19 infections were sent home as quickly as possible to reduce the need for personal protective equipment. Annual fit testing for respirators was waived temporarily. N95 respirators that were beyond their expiration dates were approved for use in training and fit testing.

The third level of strategies to reduce personal protective equipment use were for Crisis Capacity. These were allowed along with a shift to Crisis Standards of Care. All elective and non-urgent procedures and appointments were canceled. Respirators could be used for direct patient care beyond their expiration dates, for extended time periods and with multiple patients – far beyond manufacturer recommendations for single patient, one time use. Re-use of N95 respirators became acceptable when there were no other options until they became grossly contaminated or fell apart.

When no respirators or facemasks were available, a face shield that covered the sides of the face and to the chin or below was recommended. Isolation gowns were to be prioritized for healthcare providers and used for extended periods of time and for multiple patients – beyond manufacturer recommendations for disposal after single patient, one time use.

Face shields and goggles for eye protection, and medical gloves could be used beyond the expiration date and for extended periods of time. In addition, respirators approved for use in other countries could be used in U.S. care settings and information on how to evaluate equivalence was provided, see figure 7 (CDC, December 29, 2020).

Centers for Disease Control and Prevention (2020, December 29). Summary for healthcare facilities: Strategies for optimizing the supply of PPE during shortages.

CDC-2020-December-29.-Summary-for-healthcare-facilities-Strategies-for-optimizing-the-supply-of-PPE-during-shortages Download

Consequences of Required Prolonged and Reuse of Disposable PPE

As noted above, Fischer, et al. (2020) demonstrated that acceptable filtration of used N95 respirators could be achieved after treatment and decontamination for up to 2 to 3 times. Decontaminated N95s could then be reused (Fischer, et al, 2020).

Reuse of previously used N95s after decontamination was approved as an emergency use authorization by CDC and NIOSH in March of 2020. The source document was reviewed for 2023.

There were specific requirements for reuse in the guidance document. As discussed above in the nurse surveys, the reuse recommendations were not followed. Interviews with critical care nurses who were required by facilities to reuse N95s stated that the decontaminated respirators they were given had been used by other healthcare providers. The nurses who relayed this information did become ill with COVID-19, some more than once.

The emergency use authorization guidance was as follows:

“Data suggest limiting the number of reuses to no more than five total uses (five total donnings) per device by the same HCP [healthcare provider] to ensure an adequate respirator performance.”

“During times of crisis, practicing limited re-use while also implementing extended use can be considered. If limited re-use is practiced on top of extended use, caution should be used to minimize self-contamination and degradation of the respirator.”

“If no manufacturer guidance is available, a reasonable limitation should continue to be five total donnings regardless of the number of hours the respirator is worn. An example of this scenario is: An HCP wears a respirator during the first 3 hours of their shift, removes the respirator to eat lunch, and puts it back on after lunch. This would count as two uses or donnings. Some N95 respirators might be worn after more than five donnings, but the structural and functional integrity may be compromised.”

Centers for Disease Control and Prevention, NIOSH (2023, May 9, last review). Strategies for conserving the supply of N95 filtering facepiece respirators. https://www.cdc.gov/niosh/topics/pandemic/strategies-n95.html#print

As noted above, Nguyen, et al. (2020) reported that frontline healthcare workers caring for patients with COVID-19 who had to reuse protective equipment had a higher risk of contracting COVID-19 than healthcare workers who had adequate equipment.

Galanis, et al. (2021) conducted a meta-analysis of 14 studies that included a total of 11,746 health care workers from 16 countries. In light of global shortages of equipment, during the first year of the pandemic, health care workers in many settings frequently wore the same mask or respirator, eye protection, and gowns for extended periods of time – up to 6 to 8 hours or more. The publications discussed common adverse reactions from reuse and prolonged use of disposable personal protective equipment include (but are not limited to) acne, rashes, itching, dermatitis, and allergic reactions.

On average, 78% of health care workers studied experienced adverse effects, with a range among studies of 42.8 to 95.1%. Headaches were the most common reaction, reported by 55.9% of providers. Dyspnea was also experienced by over half of workers (53.4%). Pressure injuries developed for 40.4% of the combined participants. Another 31.0% had dermatitis. Dry skin was reported by 54.4%, itching by 39.8%, and hyperhidrosis (excessive sweating) by 38.5% of health care providers.

The risk of adverse events increased for health care workers who also had diabetes, obesity, or smoked. Additional factors that increased the risk of adverse events were due to wearing protective equipment during shifts over 4 to 6 hours, and on consecutive days, and for hospitalstaff with heavy workloads due to patient severity.

Higher grade personal protective equipment, necessary for safety, increased clinician discomfort and adverse effects. Dyspnea, especially with respirators was reported by over half of participants, and the researchers suggested that the anxiety and stress of caring for such seriously ill, infected patients may have added to the dyspnea. Skin reactions that disrupted the normal protective flora and skin barrier put clinicians at high risk for other types of infections (Galanis, et al., 2021).

Rapidly Rising Costs and Price Gouging

As the need for all types of personal protective equipment increased along with the number of patients with COVID-19 infections, shortages were even worse due to rapidly rising demand. Worldwide production could not meet demand and this situation was further complicated by ongoing issues related to transporting equipment from factories to medical care providers. There were breakdowns at every step of the process from manufacturer to end user.

Prices increased dramatically. Proffitt (2022) noted that the cost of personal protective equipment for a dental aerosol generating procedure increased from 30 pence to £8 to 13 (1 British pound sterling = 100 pence). This translates to a jump from approximately 4 cents to $9.9 to $16.10, secondary analysis using a currency converter. The cost of one FFP2 (comparable to N95) respirator increased from 3 pence to 60 pence and the price for one FFP3 respirator (equivalent to an N99) jumped to £5 to £10 (Proffitt, 2022).

Unscrupulous profiteers who rushed in to take advantage of unprecedented opportunities to make money bought up huge quantities of legitimate, high-quality personal protective equipment with the intention of price gouging. By March 23, 2020, just over two and a half months after the virus was first discovered, Amazon, one of the largest online retailers in the US, informed sellers of actions being taken to deal with those attempting to profit from the pandemic. In a statement entitled “price gouging has no place in our stores,” Amazon listed actions taken:

Automated and manual monitoring of prices.
Removal of bad actor sellers.
Deletion of offers with high prices or excessive shipping costs.
Collaboration with federal, state, and local law enforcement agencies.
Coordination with states attorneys general in all 50 states.

Amazon had already suspended the accounts of 3,900 price gouging sellers (Amazon, 2020).

Cabral, et al (2021) evaluated the effect of seller reputation on price gouging on Amazon during this time by looking at pricing for 14 different 3M brand masks and respirators and 17 different Purell brand hand sanitizers. Sellers and overall prices during the seven months prior to the pandemic in 2019 were compared to those at the beginning of the pandemic. Amazon, the primary seller on the site, only increased prices for these items by 3 to 4% percent, though the items were frequently out of stock.

For third-party sellers, prices for 3M masks and respirators increased by 60 to 141%. For hand sanitizers, the increase was 72%. Third-party sellers new to the marketplace after onset of the pandemic charged approximately twice the prices as sellers on the site in 2019, before COVID-19, for masks and respirators. The researchers suggested that incumbent third-party sellers, those who were already selling in 2019 had a reputation to maintain, whereas those sellers new to the marketplace set prices as high as possible. However, the researchers concluded that the desire to maintain a reputation alone was not enough to prevent price gouging and that some form of regulation during a crisis is needed to control costs (Cabral, et al, 2021).

Opportunistic price gouging for personal protective equipment was a worldwide phenomenon. Sefah, et al. (2021) surveyed a total of 131 community pharmacists from six African countries (Ghana, Kenya, Namibia, Malawi, Nigeria, and Zambia) and three Asian countries (Bangladesh, Pakistan, and Vietnam) from March to June 2020. A convenience sample of pharmacists were contacted via email, telephone, or personal contact and asked about prices, availability, and usage patterns for specific medications and personal protective equipment. From the limited data the authors were able to obtain during these early days of the pandemic there were shortages of personal protective equipment in all nine countries (Sefah, et al., 2021).

The situation in India was complicated by high co-payments for COVID-19 tests, which resulted in low testing rates. When Hague, et al. (2021) surveyed 111 pharmacies from early March to May 2020. They found that 88.3% of stores experienced shortages of personal protective equipment and marked price increases (Hague, et al., 2021).

The authors reported on additional challenges faced by nurses and other healthcare providers in India and developing countries who were doing their best to care victims of the SARS-CoV-2 virus:

“India faces ongoing challenges with preventing the spread of COVID-19, including issues with social distancing in big cities with crowded streets, lack of access to clean water, lack of regular hand washing facilities in an appreciable number of households, lack of physicians, lack of hospital beds (at 0.5 to 0.7 beds per 1,000 compared with 4.3 per 1,000 in China) and ICUs vs. higher income countries, just 20,000 ventilators in the country, and a lack of personal protective equipment (PPE) among healthcare professionals.”

“There are also challenges with high co-payments for treating existing infectious and non-infectious diseases, which will be exacerbated by diverting expenditures towards prevention and management of COVID-19, as well as purchasing basic necessities if incomes are reduced as a result of the pandemic.” (Hague, et al., 2021). Unfortunately, the World Health Organization report that showed 182,143 people had been infected with COVID-19 and that 5,164 had died as of May 31, 2020, was probably a low estimate (WHO, Situation Report 132, May 31, 2020). The situation is likely to have been much more severe than was reported.

Counterfeit Personal Protective Equipment Floods the Marketplace

Other profiteers started mass producing counterfeit supplies that on the surface appeared to be legitimate. Respirators of the N95 to N100 type, and KN95s, and filtering face piece respirators (FFP2). When CDC authorized use of KN95s to substitute for N95 respirators that had become nearly impossible to source, the counterfeit market was flooded with fakes. Fit testing should be done for each employee at least once a year and whenever changing a respirator brand or design. As outlined in OSHA (2004). Appendix A to § 1910.134 – Fit Testing Procedures (Mandatory). https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134AppA

There is also a 12 minute OSHA Fit Testing video: https://www.youtube.com/watch?app=desktop&v=D38BjgUdL5U

A trained fit tester uses specific equipment and a detailed process to assure that the respirator brand fits snuggly over the face and nose, and that the employee cannot smell the test solution while talking, bending over, grimacing, etc. If an adequate seal is present, there will be no leaks around the mask after it conforms to the face, the employee will not be able to smell the test solution. If the fit test fails, the odor can be detected within the hood with the respirator on, and that means viruses and bacteria could also get through.

As cheap knockoffs do not provide the respiratory protection of real N95s and KN95 FFP2s, many of these were recognized as counterfeit when it was not possible to obtain an adequate seal during fit testing. Unfortunately, many American companies that purchased the fakes were not aware that the equipment did not meet the rigid National Institute for Occupational Safety and Health (NIOSH) testing standards (Ippolito, et al., 2020). Wearing a respirator with a failed fit test would give a false sense of protection, especially with prolonged use. Specific numbers are stamped on genuine N95 or higher filtration respirators, but these can also be faked, see figure 8. Genuine N95s have elastic straps that go around the head, they do not have ear loops as these do not create an adequate seal.

Because faking respirators was big business during the height of the pandemic, NIOSH put out a series of guides to help buyers determine whether products sourced were genuine and a certified equipment list. See details at How to Tell if your N95 is Approved @ https://www.cdc.gov/niosh/docs/2021-124/pdfs/2021-124.pdf

International Fraud

There were an endless number of scams that used email and internet contacts to offer quality personal protective equipment that did not actually exist. Most scams were limited in scope, but not all. A large number of these have required involvement with international law enforcement.

A European Scam

One of the biggest scams occurred three months into the pandemic. German Health Authorities contracted with two sales companies to obtain face masks worth 15 million Euros. Delivery via 52 trucks with a police escort was planned, but the deal fell through. The initial communications came via emails from sales companies in Zurich, Switzerland and Hamburg, Germany offering to obtain the face masks from a company in Spain (the conspirators faked a website that appeared to represent a real company in Spain using a legitimate email address that was compromised).

When the initial deal fell through, the buyers were referred to a “trusted middleman” in Ireland who required an upfront payment of 1.5 million Euros for 1.5 million masks to be picked up in the Netherlands. Immediately before delivery was requested, the buyers were required to send an additional 880,000 Euros via wire transfer.

The money was sent, but the masks were not delivered. The Dutch company the buyers thought they had worked with had no record of the order. The website of the legitimate Dutch company had also been faked. The bank notified Interpol and they were able to freeze the 1.5 million Euros in an account in Ireland. Some of the 880,000 Euros had been sent to the U.K., and all of the money was intended to go to accounts in Nigeria. Two suspects had been arrested, but it was still an active investigation at the time that this article was published (Interpol, 2020 April 14).

A U.S. Scam

The state of Maine purchased over 2 million N95 respirators intended for nurses and other healthcare workers in need. These were billed as genuine 3M brand N95s. Unfortunately, it was a totally counterfeit operation. A Department of Homeland Security investigation had uncovered the scam and seized the respirators when they arrived in Maine in June of 2021.

Investigators had been working with the 3M company after they were alerted to suspected counterfeits purchased by hospitals and government organizations. There were approximately 6,000 possible buyers from 12 states that purchased the products from illicit dealers.

When 3M uncovered the counterfeit operation, they notified the hospitals and medical facilities that they may have purchased fake respirators and to contact Homeland Security. The $3.6 million spent by the state of Maine for the counterfeits was recovered. There have been at least 12 additional investigations into counterfeit N95s bearing 3M labeling initiate by the company has their own fraud team.

In addition to Homeland Security, numerous law enforcement agencies are involved in anti-counterfeiting activities related to personal protective equipment. Federal investigations are conducted by the Federal Bureau of Investigation, the U.S. Department of Justice, Immigration and Customs Enforcement, the U.S. Postal Inspection Service, Food and Drug Administration, and the Internal Revenue Service. States Attorneys from most jurisdictions, and state as well as local law enforcement agencies have also been involved (U.S. Immigration and Customs Enforcement (2021, June 29).

The companies that lost money purchasing counterfeit N95s and other protective equipment were victimized. But it was the end users of the counterfeit N95s, the nurses and other healthcare providers who believed they were protected who were the real victims.

The Situation in Other Countries

Pandemics are global situations and will continue to grow whether the population has many resources or few resources to combat it. With an extremely contagious virus that readily mutates to overcome the obstacles humans develop to prevent spread, what happens in one part of the world can affect everyone in the rest of the world very quickly. Inadequate supplies of critical protective equipment is a global issue.

In countries with fewer financial resources than the high-income countries, healthcare providers were even more at risk of contracting COVID-19. Inadequate or non-existent personal protective equipment was not the only issue nurses in low-income countries faced. In countries where money for healthcare is scarce, with the population spread out over large geographical areas, access to even basic healthcare is quite limited.

Nurses and others in some of the low-income countries had minimal to no personal protective equipment. The healthcare providers were also faced with additional obstacles that made caring for patients with COVID-19 infections extremely difficult. Their lives were often at risk, and we have no idea how many healthcare providers were ill, disabled, and or died worldwide during the pandemic. The last estimate from the World Health Organization was in 2021.

Chersich, et al. (2020) documented that nurses in several African countries had little to no protective equipment. Additional impediments that challenged nurses in these countries were:

Limited or non-existent water supplies for handwashing.
Unstable power supplies.
Overcrowded primary health clinics.
Shortage of critical care beds.
Severe shortage of healthcare providers.
High mortality rates for healthcare workers who were infected.

The World Bank has a map that shows world countries ranked by income, The World Bank (2022). As we attempt to find long-term solutions to help prevent future pandemics, it will be important to look at the issues holistically and cross-culturally.

Moving Toward Solutions:

Acceleration of Personal Protective Equipment Production Worldwide

Throughout the year 2020 manufacturers worldwide attempted to increase production of personal protective equipment to meet global needs. The equipment had to get from the point of manufacture to the nurses and others in need in the U.S.

To accelerate delivery to the US, the Federal Emergency Management (FEMA) and Health and Human Services (HHS) created an “air bridge” for flights from Asia starting at the end of March 2020. FEMA covered the costs of flights containing PPE, reducing delivery time from months to days, and distributors who received the products agreed to send 50% of the supplies to hospitals, nursing homes, and healthcare facilities (FEMA, 2020 April 7).

Defense Production Contracts: General Motors and the Ford Motor Company

General Motors and Ford Motor Company both contracted with the U.S. Department of Health and Human Services to start making ventilators under the Defense Production Act in April of 2020. (CDC, 2023, March 15).

General Motors made 30,000 ventilators in 154 days (General Motors, 2020; Ventec Life Systems, n.d.). General Motors also adapted another plant to temporarily produce medical grade face masks (General Motors, 2020).

Ford also manufactured personal protective equipment, including face shields, gowns, medical grade face masks, N95 respirators, and powered air purifying respirators (PAPRs). In partnership with 3M and with General Electric, Ford helped to produce over 50,000 ventilators (Ford Motor Company, 2020; Ford Motor Company, 2020, March 24). The U.S. government contract with General Motors and Ventec was for $489 million and the contract with General Electric and Ford was for $336 million (LaReau, 2020, September 1).

A Return to Conventional Capacity Standards of Care

As of May 2021, the CDC provided new guidance and stated that the supply of NIOSH approved N95 respirators was adequate and that crisis capacity strategies were no longer needed. Healthcare facilities and organizations were instructed to discard previously used and/ or decontaminated respirators and to return to purchasing and using only NIOSH approved personal protective equipment (CDC, 2021. May).

NIOSH, in combination with the CDC and the National Personal Protective Technology Laboratory NPPTL currently maintains a regularly updated list of NIOSH approved N95 respirators. This list provided healthcare decision makers responsible for purchasing respirators for clinicians a place to start when trying to determine if supplies offered through alternative channels were genuine or counterfeit NIOSH, CDC, NPPTL (2022, December 2).

A Sustainable Public Health Supply Chain

The difficulties involved in obtaining critical personal protective equipment supplies raised concerns about U.S. dependency on international manufacturers. Efforts to increase production of critical supplies such as N95 and other filtering facepiece respirators, isolation gowns are under way. Immediately after taking office, President Biden initiated a deep dive effort to identify the issues underlying the failure to protect U.S. healthcare personnel with adequate personal protective equipment through Executive order 14001 A sustainable public health supply chain (Biden, J., 2021, January 21).

Recommendations:

It is obvious by the number of nurses and other healthcare professionals who became infected, and the losses to death that we MUST take better care of our clinicians. Personal protective equipment is the barrier between life and death for clinicians. Last minute ordering during a crisis does not work. All clinicians caring for patients with a contagious infection need access to high quality protective equipment. They should never, ever have to sew their own or feel like they are begging for equipment that could save their lives.

Equipment does have expiration dates, for a reason, and outdated equipment that has an elastic band that breaks in the middle of a procedure is not acceptable. Healthcare organizations need to be ready for an infection control crisis and maintain an adequate supply of equipment at all times. Expired equipment in state and national stockpiles needs to be removed and replaced in the same manner that healthcare organizations are expected to do for their supply closets.

In the future, we need to start at the beginning of an outbreak with the highest level of personal protective equipment. That includes the use of powered air filter respirators for staff caring for patients in critical care units with viral, bacterial, or fungal infections that are airborne or transmitted via droplet. These patients are most likely to undergo intubation, mechanical ventilation, and aerosolizing procedures. Recommendations should be downgraded only if science shows it is appropriate to do so. Never again should this type of decision making be due to lack of supplies.

Post-acute care providers in nursing facilities, assisted living, and home health need access to the same kinds of protective equipment recommended for inpatients if they are sent to their residences while infected. In addition, it is important to understand that a family member who has been exposed and is quarantined poses just as much risk to the staff as the patient with the diagnosed infection. Full personal protective equipment needs to be used in home settings as well as facilities for infected patients. We can never put our healthcare providers at risk again!

Please see the Kindness of Strangers chapter for information on donations!

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