US Food and Drug Administration Seeks Input From Healthcare Technology Management Community on Medical Device Supply Disruption During COVID-19 Pandemic

Abstract

The US Food and Drug Administration (FDA) is currently seeking information from the clinical community about existing and anticipated disruptions in the supply of medical devices related to COVID-19. This information is important to FDA's fulfillment of its mission to ensure that healthcare providers and patients have continued access to safe and effective medical products. Insights from the clinical community, including clinical engineers and biomedical equipment technicians, bring device supply issues experienced on the front lines to FDA's attention so that the FDA can develop effective strategies to prevent and mitigate medical device supply concerns in its continued response to the COVID-19 public health emergency. Here, we describe the public health impact of the clinical perspective and the type of information that the FDA is seeking regarding current or anticipated medical device supply concerns. Information about how to have your voice heard on this important matter is included at the end of this article.

The US Food and Drug Administration plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. In the face of the COVID-19 global pandemic and the resulting increase in demand for certain medical devices, such as personal protective equipment, respiratory support devices, and dialysis machines, the FDA is aware that there has been disruption in the supply of a range of medical devices that are essential for the care of COVID-19 patients and protection for healthcare workers. In addition, COVID-19 continues to spread, oftentimes in unanticipated rates across different geographic areas and patient populations. Simultaneously, the management of COVID-19 patient care continues to evolve as healthcare workers gain understanding of the course of the disease and as treatment strategies evolve. Together, these changes have implications that can cause downstream disruption in the supply of medical devices that are needed by hospitals and other healthcare facilities to diagnose, treat, and prevent COVID-19.

Critical to FDA's mission to protect the public health is a comprehensive understanding of existing or anticipated disruption in the supply of medical devices.¹ In an effort to stay apprised of shortages from medical device manufacturers, the FDA issued a June 2020 Final Guidance Document,² requiring manufacturers of medical devices “to notify FDA of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States” for the duration of the COVID-19 public health emergency. However, in addition to notification from medical device manufacturers, the Agency considers the impact and experiences of a range of relevant stakeholders to the medical device and healthcare community, including clinical engineers and biomedical equipment technicians (BMETs), to gain comprehensive knowledge of supply concerns as the Agency takes efforts to prevent and mitigate supply disruptions.

With a frontline perspective and the responsibility for managing a range of medical devices throughout hospitals, clinical engineers and BMETs can contribute to FDA's comprehensive understanding of medical device supply disruptions, especially as they relate to capital equipment, such as ventilators, hospital beds, infusion pumps, hemodialysis machines, monitoring equipment, and many others.

How Is Supply Disruption Information Used by the FDA?

When the FDA becomes aware of supply disruptions or limited availability of medical devices, the Agency may take a range of actions to prevent or mitigate the disruption in supply. As an example, emergency use authorizations may be issued to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.³ As of July 2020, FDA's Center for Devices and Radiological Health had issued hundreds of emergency use authorizations to prevent and mitigate supply disruptions for devices, including respiratory assist devices, ventilators and their accessories, infusion pumps, hemodialysis devices, blood purification devices, and personal protective equipment.³

In addition, when aware of a strain on the supply chain, the FDA can take proactive measures to help manufacturers of medical devices to bring more products to market. For example, through the final guidance document, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic,” the FDA temporarily modifies regulatory reporting requirements for medical device manufacturers with the purpose of allowing manufacturers to shift focus to product development and production to help with supply disruption.⁴

We Need to Hear From Members of the Clinical Community

To monitor supply concerns across the United States on a continuous basis, the FDA is engaging with hospitals, hospital systems, state hospital associations, and other entities to gain a clear understanding of supply disruptions that hospitals are currently experiencing, supply disruptions that are anticipated to occur, and the impact that these supply disruptions are having on hospitals, patients, and healthcare workers. Because supply disruptions can have serious implications for our nation's healthcare system and public health, and because critical information about supply disruptions is needed from a range of stakeholders in the medical device ecosystem, the FDA has initiated a voluntary survey to understand medical product supply disruptions related to COVID-19.

This voluntary survey is being conducted pursuant to US Department of Health and Human Services Secretary Alex Azar's waiver from the requirements of the Paperwork Reduction Act (44 USC §3501 et seq.) as a result of the public health emergency caused by COVID-19. Through this effort, and with the help of the clinical community, including clinical engineers and BMETs, the FDA will collect information to support its response to the COVID-19 public health emergency.⁵

What Are Examples of Devices That the FDA Wants to Know About?

Although the FDA would like to hear from the clinical community about supply disruptions for any medical product, there are several device types that are essential for the diagnosis, treatment, and prevention of COVID-19. We want to hear from the clinical community to learn about any existing disruptions in supply, as well as any disruptions in supply that are anticipated to occur in the near future across a range of essential medical devices, many of which are managed directly by hospital clinical engineering and biomedical engineering departments. Table 1 includes a range of medical device types that may be essential for the diagnosis, treatment, or prevention of COVID-19, along with examples of devices in those categories. For many of these essential devices, such as infusion pumps, ventilators, and dialysis machines, the operation of the device itself depends on the availability of accessories, components, or disposables. A supply disruption for a critical component or accessory of a device, especially in cases where there is no suitable alternative for the component or accessory, may be equally important to bring to FDA's attention.

TABLE 1.

Medical Devices That May Be Essential During the COVID-19 Pandemic

Blood purification devices, including accessories, disposables, or components

Examples: continuous renal replacement therapy (CRRT) devices, hemodialysis devices

Infusion pumps, including accessories, disposables, or components

Respiratory devices, including accessories, disposables, or components

Examples: respiratory assist devices, ventilators, breathing circuits, breathing systems, spirometers, pulse oximeters

Cardiac devices and monitoring equipment, including accessories, disposables, or components

Examples: defibrillators, stethoscopes, cardiopulmonary bypass equipment, electrocardiograph equipment, extracorporeal membrane oxygenation devices, patient monitoring devices

General hospital devices, including accessories, disposables, or components

Examples: urine collectors, syringes, needles, hospital beds, infusion pumps, catheters, stretchers, isolation chambers, blood access devices

Sterilization equipment, including accessories, disposables, or components

Examples: steam sterilizers, ethylene oxide gas sterilizers

Radiological devices, including accessories, disposables, or components

Examples: x-ray equipment, computed tomography equipment, personal protective shields

Personal protective equipment

Examples: masks, surgical apparel, drapes, gloves, face shields, barriers, N95 respirators

Diagnostics

Examples: blood gas tests, serological reagents, blood specimen collection devices, swabs, viral transport media, molecular diagnostic tests, antigen diagnostic tests, serology tests

Other medical devices

Examples: obstetrical monitors, intracranial pressure monitors

What Is the Impact of the Supply Disruption on Hospitals, Patients, and Staff?

If there is a current or anticipated supply disruption for any device within any of the categories listed in Table 1, it is important that we understand the real or potential impact of the supply disruption on hospital operations and procedures. Importantly, the FDA would like to know whether and how hospitals have changed or modified procedures to accommodate or mitigate the disruption in supply, along with any plans or strategies that would be needed if a supply disruption that is anticipated were to occur. For example, changes may have been made to typical hospital procedures, such as additional training, workarounds to adapt to unavailable equipment, and purchasing of alternative devices and equipment. Although such strategies may be necessary to maintain hospital operations, patient care, and staff safety, insights to the strategies that have been executed or developed by hospitals helps the FDA understand the impact that a particular supply shortage has on the availability of safe and reliable medical devices. The clinical community, with first-hand knowledge to a range of hospital supply concerns, can help patient safety on a national scale by providing this key information to elucidate the downstream effects that supply disruptions can have in the hospital setting.

The FDA also wants to understand the impact that any medical device supply disruption has or may have on patient care or staff safety. Through learning about the specific potential or real implications and consequences that are faced during the course of patient care, the FDA can more easily prevent or mitigate the supply concern. As healthcare workers care for COVID-19 patients spanning a range of treatment needs and disease severity, a disruption in the supply of a critical medical device may have severe adverse effects on the patient, the healthcare worker, support staff, hospital operations, and, ultimately, public health as a whole. Again, the clinical community's engagement with the FDA can provide a clear picture, not only of a particular device in limited supply but also of the potential public health consequences that have taken place or may take place as a result.

I Want to Help. What's Next?

As the COVID-19 pandemic continues to evolve, we are collecting supply disruption information on a recurring monthly basis. To have your voice heard and contribute to this important public health effort, you can access the survey directly by following this link: https://www.surveymonkey.com/r/HGGGMBK. Alternately, you may contact us by emailing MedSun@fda.hhs.gov, using the subject line “Supply Survey,” or schedule a time to tell us about your supply disruption or related concerns by phone at (800) 859-9821. Feedback from the clinical community is always welcome, and as a reminder, supply disruptions or shortages of medical devices can also be emailed to DeviceShortages@fda.hhs.gov, which is a monitored mailbox.