Ambu® aScope™ 4 Cysto

Product / Technology Description

The Ambu® aScope™ 4 Cysto  is supplied by Ambu Limited. It is described as a single-use, sterile cystoscope, designed for and used in various flexible cystoscopy procedures for diagnostic, therapeutic or surveillance purposes.

Detail Provided By The Supplier

Website: https://www.ambu.co.uk/endoscopy/urology/cystoscopes/product/ambu-ascope-4-cysto

Additional links:

IPS Review/Comments

How It Will Be Used

Combined with the portable 12.8” HD Ambu® aView™ 2 Advance monitor, the aScope™ 4 Cysto offers consistent image quality. With a brand-new cystoscope for every procedure, there is no risk of damage or deterioration affecting image or bending quality. The clear and sharp images make it easy to identify anatomical structures. The high bending angles of 210°/120° and varied stiffness of the insertion cord enables the Urologist to manoeuvre and navigate smoothly in the urethra and bladder. The Urologist can advance and completely retroflex the cystoscope to inspect the bladder neck even with the forceps inserted. In addition, the lightweight and ergonomic design makes aScope™ 4 Cysto easy to use. The single-use aScope™ 4 Cysto eliminates the need for reprocessing and costly repairs. The aScope™ 4 Cysto is always available and portable, making it easier for Urologists to manage their schedule and deal with in-house consult procedures, minimising the significant risks to patients resulting from equipment and workflow delays.

Advantages Of This Product

Guaranteed sterility every single time is the most significant advantage of the system, eliminating the risk of patient cross-contamination and patient-to-patient infections. The aScope™ 4 Cysto is part of a single-use, flexible, ready-to-go cystoscopy solution that improves safety and productivity. The endoscopes are sterile straight from the pack, always available with no risk of cross-contamination. Portable, intuitive, lightweight, and ergonomic. No handling, zero reprocessing, nothing to repair. A single-use solution that improves patient safety.

Given the nature of the product, the review has been conducted using a PESTLE framework.

PESTLE

 

Benefits of the product

Potential Issues/Concerns

Political

 

·       Supports increased clinical throughput per list, helping meet UK imperatives to increase activity to ‘catch-up’ the pandemic backlog.

·       Facilitates cystoscopy at the point of clinical decision in a range of departments, rather than waiting for a place to become available on a list.

·       UK and global commitment to reduce carbon emissions, but carbon will be generated during the acquisition of raw materials and during the manufacture of these devices.

Economic

 

·       Less staff time required than would be the case for the reprocessing of reusable devices. This includes reduced time required for training staff in reprocessing techniques, and competency checking practice.

·       Costs for reusable endoscope repairs, processing chemicals and associated devices will be eliminated or reduced.

·       Cost of waste disposal of these devices is only included in one of the published economic evaluations provided and must be factored into any economic evaluation by users to ascertain the overall cost/cost benefit. Evaluations published that do not include the costs of waste disposal should be viewed with caution.

Social

 

·       A brand-new sterile device, opened from its packaging is likely to be viewed positively by patients, and to give them confidence that the procedure is clean and safe.

·       Staff may prefer the ease of a device which can be immediately disposed of, rather than one which requires complex decontamination.

·       The device weighs just 158 grams, and the compatible aView 2 Advance HD monitor weighs just 2.7 kilos, meaning they can be transported by a single staff member easily to wherever they are required.

·       Patients or staff members who have strong views on the environment and avoiding unnecessary waste may fundamentally object to this product for routine use due to the environmental impact.

Technological

 

·       These products provide up-to-date technology, which can easily be improved as and when there are technological advances in relation to these procedures. This compares to reusable devices which have a minimum life-cycle time in use before replacement.

·       Following the UK exit from the European Union, this product will need to meet the requirements of changing British legislation including UKCA marking and other MHRA requirements.

Legal

 

·       Providing the sterile packaged products are stored and handled correctly (temperature range 10-40’C), they will provide a sterile product for use. This is a greater degree of decontamination than achieved with reusable products which are usually subject to high-level disinfection.

·       Use of this product will help organisations to demonstrate compliance with their legal requirements under the Health & Social Care Act - Codes of Practice (England, Wales) as well as similar regulations in Scotland and Northern Ireland. 

·       As this product does not require decontamination, its use will reduce the exposure of staff members to harmful chemicals. Use therefore improves compliance with COSHH regulations and avoids use of harmful substances in line with the HSE hierarchy of controls (eliminate, rather than use of PPE).

·       Risks of an inadequately reprocessed device being used on a patient will be eliminated by use of this product, with benefits to patient safety as it will eliminate the risk of cross-infection from the cystoscope.

·       Some risk of cross-infection may remain if ancillary items used with the device are reusable.

Environmental

 

·       Use of this product means that chemicals harmful to people and the environment do not need to be used for reprocessing, as the device is thrown away after use.

·       Ambu globally has committed to developing its business to become fully sustainable and has so far eliminated phthalates from its products.  

·       There is possible detrimental environmental impact because of the single-use model: manufacture-use once-throw away. Potentially increased use of scarce raw materials, increased water usage during production, and a potential increased carbon footprint through both production and disposal.

·       There will be increased hazardous waste volume, weight and disposal costs by using this product. Additional departmental collections may be needed at local level.

·       It is unclear whether these devices would need to be disposed of under the Waste Electrical and Electronic Equipment Regulations, in addition to classification as Hazardous Waste. This would likely increase costs further.

 

 

IPS Conclusion

From an infection prevention perspective, this product has much to offer from a patient and staff safety aspect, as well as operational advantages and improved legal and regulatory compliance. Use of this pre-packaged sterile device would eliminate cross-infection risks due to inadequate decontamination of reusable cystoscopes.

However, the environmental impact of this single-use product may be significant, especially if these products are used routinely for large numbers of patients. The costs and logistics of disposal of these items, especially in large quantities, is an area which requires further clarity in the commercial and professional published literature.

Implementation of the product for rapid ‘point-of-diagnosis’ cystoscopy in a variety of settings would appear to be a major advantage of this product. Routine use to replace reusable cystoscopes in high-throughput settings such as endoscopy lists would require careful local cost-benefit evaluation, to include disposal costs.

Ambu Limited supplied a range of published literature to support the submission to the Industry Insights Panel. Publications considered as part of this Industry Insights Review are referenced below. 

References

Assmuss M et al (2020) Direct to cystoscopy: A prospective quality assessment of patient preference. Can Urol Assoc J. 14(4):118-21. http://dx.doi.org/10.5489/cuaj.6013

Borja Bruges CN et al (2022) Willingness-to-pay and preferences of patients undergoing a cystoscopy: results from a large survey-based study in Spain. Value In Health. S216

Canales BK et al (2007) An Independent Analysis of Flexible Cystoscope Repairs and Cost. Journal Of Urology. 2098-2102

Oderda M et al (2020) Cost-effectiveness analysis of a single-use digital flexible cystoscope for double J removal. Urologia Journal. 87(1) 29–3

Patel M & Andrews J (on behalf of Ambu Ltd) (2022) Clinical Whitepaper: Clinical performance of the single-use cystoscope aScope™ 4 Cysto: A user evaluation based on initial perceptions from Urologists in the UK and Ireland.

Pietropaolo A et al (2020) Comparison of ureteric stent removal procedures using reusable and single-use flexible cystoscopes following ureteroscopy and lasertripsy: a micro cost analysis. Cent European J Urol. 73: 342-348

Sorbets E et al (2019) An outbreak of Pseudomonas aeruginosa urinary tract infections following outpatient flexible cystoscopy. AJIC. 47. 1510-1512

Wong A et al (2021) The first UK experience with single-use disposable flexible cystoscopes: an in-depth cost analysis, service delivery and patient satisfaction rate with ambu® ascope™ 4 cysto. JELEU. 4(1) e29-e44   https://jeleu.com/index.php/JELEU/article/view/120

The following references have been submitted post review and have not therefore been considered by IPS but appear for information: 

Boucheron T et al (2022) Cost and Environmental Impact of Disposable Flexible Cystoscopes Compared to Reusable Devices. Journal of Endourology. https://doi.org/10.1089/end.2022.0201

Hogan D et al (2022) The Carbon Footprint of Single-Use Flexible Cystoscopes Compared with Reusable Cystoscopes. Journal of Endourology. 2022. https://doi.org/10.1089/end.2021.0891