Equity, guidelines, and respiratory devices

Increased dependence on devices in a time of supply chain challenges

Medically complex individuals with chronic respiratory conditions are becoming increasingly dependent on specialized respiratory technologies. These patients include those with obstructive sleep apnea, chronic obstructive pulmonary disease, amyotrophic lateral sclerosis, and other neuromuscular disorders and conditions that impair sleep, breathing, and secretion mobilization. Advances in medical technology in the past few decades include continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP), and invasive mechanical ventilation for sleep-disordered breathing and chronic respiratory failure. Mechanical insufflation-exsufflation (MIE) is also used for secretion clearance from the lungs. Patients with chronic respiratory conditions who rely on respiratory technologies are treated in a variety of locations, including their homes, assisted living facilities, emergency departments, and inpatient hospital units, and their care is managed by a team of medical practitioners that includes family physicians, respirologists, nurses, and respiratory therapists. Given Canada’s vast geography, patients may live far from specialty clinics, which are typically based in urban areas and associated with academic health centres.

While the specific benefits depend on the underlying condition and the type of technology used, in general these devices have been shown to reduce mortality and to improve survival, perceived quality of life, and markers of cardiovascular health, in addition to reducing hospital admission and length of stay.^1-6 In many conditions, individuals are completely reliant on respiratory technology for survival. Moreover, there is evidence that use of these devices may decrease health service use and reduce health care costs,⁷ and that they are cost-effective.^8,9 Based on evidence of efficacy, these devices have become an integral component of medical care for these individuals and are included in clinical practice guidelines.^10-17

The increasing number of patients who are dependent on respiratory technologies makes it increasingly important to ensure an adequate supply of devices. Even for specialized interdisciplinary teams experienced with complex clinical evaluations, prescriptions, and funding for devices, delivering patient care that meets current standards depends on ongoing research and development, sustainable manufacturing and supply chains, and agile and efficient processes within Health Canada to evaluate and approve novel medical devices.

Over the past few years, clinicians providing care for medically complex individuals with chronic respiratory conditions have faced increasing challenges obtaining the equipment necessary for their patients. This is due to multiple factors, which have included recalls and equipment scarcity, particularly during the COVID-19 pandemic; a global recall of ventilators and positive airway pressure (PAP) devices; and a recent discontinuation of ventilator and MIE devices.¹⁸ These supply chain disruptions have highlighted the risks of relying on a small number of industry partners.

Barriers caused by the manufacturing process

In Canada, most ventilators and PAP devices are supplied by only 2 manufacturers, and only 1 MIE device was approved by Health Canada until recently. The Canadian health care community has struggled to find and fund other equipment as the global demand for these devices soared. In most situations, patients who were dependent on a recalled ventilator or PAP device to breathe were advised to continue to use the potentially defective device because of limited, if any, alternatives. When alternative devices did exist, the process to switch was slow, in part due to reduced product availability.¹⁹ The authors estimate that in Alberta, this affected nearly all of the approximately 4000 patients who are ventilated or treated with noninvasive ventilation, while in Ontario it affected nearly all of the 7500 children and adults who are ventilated. These numbers do not account for the tens of thousands of patients affected by recalls of CPAP and BiPAP devices across the country. Since the 2021 global ventilator recall, a manufacturer providing 1 of the few ventilators not affected by the recall, and notably the only approved device for use in children weighing less than 5 kg, announced the discontinuation of the product in the United States, with a further phase-out expected in Canada in the coming years.

Historically, a single MIE device from 1 manufacturer was approved by Health Canada, limiting options for clinicians and patients. The tipping point for MIE devices occurred as a result of manufacturing issues secondary to supply chain shortages and subsequent product discontinuation. As a result, many patients were unable to access an MIE device. While the full extent of MIE lack of access has yet to be quantified, individuals who are dependent on this therapy were subject to an increased risk of respiratory deterioration and hospital admission. However, even when multiple devices are approved by Health Canada, there are ongoing barriers that include provincial regulatory processes to test new devices, obtaining sufficient stock of the devices and the associated required disposable components, and procuring sufficient funds to purchase the equipment. The challenges experienced for PAP and MIE are analogous to recent drug shortages. These challenges highlight the fragility of the health care system and the negative impact on patients of a system that operates with limited reserve capacity and relies too heavily on a small number of manufacturers for life-sustaining medical therapies.

Financial barriers

Financial constraints continue to be a barrier for Canadians because many devices are not funded by provincial health care systems. This leads to high upfront costs for patients, in addition to ongoing costs for consumable supplies. These barriers are even higher for those with low socioeconomic status and those with low health literacy. Accessing respiratory technology can be costly and often requires coordination between multiple organizations and groups, including care teams, funding bodies, and vendors.^20,21 Furthermore, patients living in remote areas often have less access to services than those living in urban centres, further exacerbating existing barriers.^22,23 The number of patients with chronic respiratory conditions who may benefit from advanced technologic support continues to rise, adding further stress to this process.^24-26 Exact numbers of Canadians treated with respiratory support are difficult to estimate, as much of the technology is not publicly funded and no studies report on the prevalence of respiratory technology use in Canadians. Due to this lack of data, the total cost associated with respiratory support is also unknown, although costs of treatment often fall on individuals and there is variability across the country regarding coverage of respiratory technology.²⁷

Given that patients with chronic respiratory conditions who benefit from respiratory technology are seen in all areas of the health care system (home, assisted living, emergency departments, inpatient hospital units), the lack of access to these devices affects all areas of health care and all health care providers. Without these devices, patients may have respiratory decline and poorer outcomes when they deteriorate. These scenarios result in increased health care use (including outpatient visits to family physicians and specialists, emergency department visits, and hospitalizations), ultimately increasing costs to an already overburdened health care system.

Recommendations for improved access to devices

Within the Canadian health care system, there exists a tension between the regulation of medical technology and policies that support innovation, development, and implementation of new technology. The current system relies on manufacturers to produce and test new devices, and to submit to Health Canada for review and licensing approval. This process is designed to rigorously evaluate the data of each medical device, with a review period quoted of up to 90 days, although it is unclear if these timelines are being met.^28,29 Given that Canada has a relatively small market for respiratory equipment compared to other countries, there may not be a sound financial reason for manufacturers to engage in this process, despite the importance to this growing population of individuals dependent on these life-sustaining technologies.

As clinicians, we rely heavily on manufacturers and regulatory bodies such as Health Canada to ensure that patients have access to high-quality medical devices. The Canadian health care system needs efficient processes that support manufacturers to bring products to market while maintaining high standards for quality and safety. An adequate and affordable supply of devices is a prerequisite to addressing the many other barriers impacting access to life-saving medical devices for all patients. We encourage the provincial and federal governments to collectively support programs and processes that facilitate adequate barrier-free access to life-and health-sustaining therapies, which would include the following:

• Proactively seeking out alternative devices to ensure that gaps due to manufacturing or supply chain issues do not affect patient care.

• Developing processes to facilitate expedited review of devices already approved by similar agencies including the Food and Drug Administration and European Medicines Agency.

• Refining processes for review of new medical technologies to facilitate a more agile system that can respond rapidly to medical technology advances.

• Improving transparency of processes and timelines and increasing involvement of clinicians.

• Improving the provincial processes to sustainably fund a variety of respiratory devices, thereby avoiding dependence on single manufacturers and devices.