Single-use flexible bronchoscopy (SUFB) use scopes which connect typically to a portable monitor allowing sterile procedures not limited by poorly mobile burdensome equipment (Fig. 1B, C). Scopes are for single use and completely sterile thus bypassing any risk of infection related to improper high-level disinfection or scope damage. Although not scientifically proven, it is hypothesized that SUFBs should reduce the risk of bronchoscopy-related infection [21•]. SUFBs have many other advantages including facilitating the procedure in and outside the ICU or bronchoscopy suite, eliminating the need for bulky and expensive processor, and monitoring requirement, storage space, and ongoing maintenance especially during pandemics and off hours emergency procedures [10].

Other advantages include reducing damage to the reusable bronchoscopes during training or its use through a rigid bronchoscope.

The FDA has made a recommendation to consider SUFBs where there is increased risk of spreading infection (for example, multidrug resistant microorganisms, immunocompromised patients, or patients with prion disease) or when there is no support for immediate reprocessing of the bronchoscope [22]. During the COVID-19 pandemic, several international bodies released consensus statements suggesting the use of SUFBs [23,24,25,26,27]. Upon recent internet search, up to 15 companies have either released or developed SUFB iterations.

Initial Development and ICU Data

The first scope was developed by Ambu® in 2009 for intubation, and subsequent developments have been associated with reports regarding intubation, percutaneous tracheostomy, bronchoalveolar lavage, and management of hemoptysis [4, 10]. However, data includes predominantly case series and retrospective studies without prospective trials with rigorous outcome analysis [28,29,30,31,32]. On assessment of the structure of the initial Ambu® aScope 1–4 designs, the handle of the scope was significantly different in design to standard flexible bronchoscopes (Fig. 1D). However, further scope development (including the Ambu® aScope 5 (Fig. 1D) by many medical technology companies have led to better design, suction, flexibility, and procedure capabilities [33].

Benchtop Comparisons

Scope development has included several benchtop comparisons [34, 35]. Our institution published a study examining the specifications, user ratings, and benchtop performance of SUFBs with CE approval between mid-2021 and 2022. Bronchoscopes included in the study were Ambu® aScope 4™ Large, Boston Scientific® EXALT™ Model B Large, The Surgical Company Broncoflex© Vortex, Vathin® H-Steriscope™ Large, and Pentax® Medical ONE Pulmo™. Scope channel diameters were 2.8–3 mm [33]. Testing included simulation tests on a low fidelity simulator (including intensive care and pulmonary physicians) and benchtop analysis including size and weight measurements, handle design, detailed analysis of scope flexion, extension, and turning angle with and without in situ devices. A pseudo-mucus liquid was also used to test suction capabilities with and without device in situ. Scopes differed in gender and hand size preference and maintenance of turning angle with device in situ. The Broncoflex© Vortex was preferred in simulation testing (without suction or image analysis); however, the Boston Scientific® EXALT™ Model B radically outperformed all other scopes including a reusable 3.2-mm channel scope in suction capabilities. Other benchtop and pilot studies have commented on BAL adequacy in comparison to historical controls [36]. Differences in benchtop and simulation testing should translate into clinical applications.

SUFB in Bronchoscopy Suite

Several studies have been published regarding SUFB use in the bronchoscopy suite [5,6,7].

The first was a prospective Spanish multi-center study of 300 patients using the AMBU® aScope 4 [7]. Thirty-six bronchoscopists participated, and most procedures were lavages or washings. Post procedure questionnaires were completed and sent into the primary center. Only 17 patients had a biopsy, and there were no needle aspirations, brushings, or any advanced techniques. Most procedures were satisfactory with reversion to a reusable scope in 5.7%. Reasons for changing the scope included scope damage, suction, and image quality. Our center subsequently published two prospective single-center studies regarding our experience [5, 6]. The first trial collected data prospectively on 139 procedures using the Surgical Company Broncoflex© range of SUFBs [5]. The majority were carried out for infection (45%) and malignancy (32%). Procedures included advanced bronchoscopy techniques such as transbronchial needle aspiration (TBNA), electrocautery, endobronchial and transbronchial biopsy, and cryobiopsy. Most were performed in the endoscopy suite, and 8% were COVID positive or suspected. Most procedures reported the highest score in satisfaction (83%) with technical limitations reported in 15% (predominately related to scope suction or inadequate image quality) reverting to a reusable scope in 3%. Our center also recently published our experience with the Boston Scientific® EXALT™ series of scopes [5]. Data was collected on 24 sequential cases including endobronchial, transbronchial biopsy, and cryobiopsy. Two debulking procedures were performed through a rigid bronchoscope including biopsy, mechanical debulking, argon plasma coagulation, and electrocautery using the 2.8 EXALT™ SUFB. In similar fashion to pre-clinical studies [33, 35], superior suction with impressive capabilities of managing hemoptysis was noted.

Environmental Impact

The environmental impact is an ongoing concern as the medical field moves further toward single-use devices. It is pertinent to evaluate the environmental implications of SUFBs. A comparative study published in 2018 evaluated the carbon dioxide (CO2)-equivalent emissions and resource consumption from a single-use bronchoscope (Ambu® aScope™ 4) versus RFBs. This study noted that the use of personal protective equipment (PPE) along with washing and drying processes for the RFBs contributed significantly to the environmental burden. If one set of PPE was used per RFB reprocessing, this had an equivalent or even higher environmental impact than SUFBs. However, the authors noted that reprocessing practices for RFBs vary highly and so could not conclude as to which device had a more significant environmental impact overall [37]. Further environmental impact assessments are needed, but it is reassuring that this initial study did not find that SUFBs were inferior from an environmental viewpoint.

Role in Training

SUFB has great potential in their role for training and in particular simulation-based learning. Given the high cost of RFBs including the reprocessing and repairs, it is not economical to use RFBs as training devices. Our institution has published on the use of single-use bronchoscopes coupled with a low-cost bio-simulator ALFIE™ as a training tool. This model allowed trainees to improve their scope handling techniques and for simulated procedures such as endobronchial biopsy and brushing [38].

Cost Comparisons of Single Use and Reusable Bronchoscopes Table 1 Table 1 Cost-effective analysis including systemic reviews and meta-analysis of single use in comparison to reusable bronchoscopes

If a healthcare system is considering switching from RFBs to SUFBs, one of the most important factors is the cost. Several cost-effective analyses have been published including meta-analysis and systematic reviews (Table 1) [21, 39,40,41,42].

Multiple factors other than cost of the equipment need to be considered. While comparing SUFBs and RFBs, less staff are required for SUFBs [28, 42]. Furthermore, SUFBs reduce the risk of infection to staff, delays between the procedures, and reliance on staff and logistical support associated with repair, reprocessing, microbial surveillance, and maintenance of accreditation/certification of reprocessing rooms [42].

One analysis estimated the cost of SUFB at €232 per procedure, similar to that reported elsewhere in the literature [42]. They concluded that SUFBs were associated with a significantly higher cost, and the reason their analysis differed to other published literature was likely the result of the economy of performing large number of procedures (1500 bronchoscopies annually). Their estimated cost of €78 per procedure with RFBs at their institution may be less than other centers. The authors concluded in a hospital performing less than 328 bronchoscopies a year, the use of SUFBs could become economically viable. However, the authors highlighted that assessing SUFBs from a cost viewpoint alone does not factor in many other organizational factors such as risk of infection, simplified institutional processes, staff stress, ease of access during an emergency, teaching opportunities, risk to infection to the staff, and the impact on high-risk patient groups [42]. Two more recent studies mirrored these findings [39, 41]. Another analysis concluded that in a larger academic institution with high procedural numbers, SUFBs may be more expensive. Cost comparison depends on a number of annual procedures, cost and incidence of scope-related infection, and cost of SUFBs [39]. The other identified no difference in cost [41].

While considering cross-contamination and potential follow-up infections, a previously published cost-effectiveness study of SUFBs in a typical intensive care unit (ICU) in the USA showed that implementation is cost-effective and linked to improved patient safety [43].

A unique systematic review of sixteen studies sought to calculate the risk of cross-contamination or infection following using RFBs in any clinical setting [21•]. Further, it determined the cost of treating the clinical consequences of such infections. In this cost-effectiveness analysis, the effect measure was the averted risk of infection while using SUFBs instead of RFBs. To represent a more accurate estimate, the risk of infection and cross-contamination was calculated using a weighted average with a fixed-effect model. Since no incidents of cross-contamination with SUFBs have been recorded to date, the risk is anticipated to be 0% [21•]. Their systematic evaluation showed the risk of patient infection following bronchoscopy with a cost per use of an RFB of £249 and a cost per use of a SUFB of £220. However, if a 2.8% risk of bronchoscopy-related infection is included with added costs of treating an infection, this cost-effectiveness analysis increased the cost per patient usage of £511 for RFB compared to £220 cost per use of SUFBs.