Draft:QuickChange Wrap
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|  |
| Type | Absorbent wrap |
|---|---|
| Manufacturer | UI Medical LLC |
The QuickChange wrap (formally QuickChange Urinary Incontinence Penile Wrap) is a disposable absorbent product designed for the management of male urinary incontinence. Developed by UI Medical LLC, it was introduced in 2018 as an alternative to traditional incontinence products such as adult briefs, pads, and catheters. The wrap features a one-size-fits-all design that folds around the penis to collect urine at the source, minimising skin contact and requiring minimal movement during changes. The product received a dedicated HCPCS code (T4545) from the Centers for Medicare & Medicaid Services (CMS) effective January 1, 2019.[1][2]
Overview
[edit]The QuickChange wrap consists of absorbent material that folds around the penis, forming a 360-degree barrier to wick away urine from the skin. It is primarily intended for nonambulatory or minimally ambulatory men with moderate to heavy urinary incontinence.[3] A 2018 WOCN Society consensus statement recommended the use of disposable wraps for such patients.[4]
History and development
[edit]UI Medical LLC developed the product to address limitations in existing male incontinence options, particularly for patients with retracted penises or those at risk of skin breakdown. Following a commercial launch in March 2018, the company received FDA Class I exempt status and ISO 13485 certification.[2]
Design
[edit]The wrap has four layers:
- A soft, non-irritating coverstock
- An acquisition layer to distribute urine
- A superabsorbent core (887cc capacity)
- A breathable moisture barrier
The design supports skin integrity, accommodates anatomical variation, and requires no lifting for application.[2][3]
Clinical use
[edit]A 2019 Mayo Clinic observational study (n=39) found lower rates of skin complications among users of the QuickChange wrap compared to briefs. While unpublished, the study is cited in the NICE briefing.[3]
The WOCN consensus recommended the wrap as an adjunct to briefs or pull-ups in patients with moderate to heavy incontinence.[4]
Safety and testing
[edit]Independent tests found no evidence of cytotoxicity, skin irritation, or sensitisation, following ISO protocols.[2]
Economic impact
[edit]Independent guidance from the National Institute for Health and Care Excellence (NICE) noted that the QuickChange wrap may have economic implications beyond unit cost, particularly in relation to staff time, ancillary product use, and management of complications such as pressure injuries or incontinence-associated dermatitis.[3][1]
According to manufacturer documentation, the product may reduce:
- The time and staffing required to change incontinence products
- The use of associated supplies such as wipes, barrier creams, and underpads
- Incidents of skin breakdown that may require additional care or treatment
UI Medical has estimated potential institutional cost savings based on these factors; however, these figures have not been independently validated in peer-reviewed economic analyses.[2]
Regulatory status
[edit]- FDA Class I exempt device (21 C.F.R. § 876.5920)
- ISO 13485:2016 certified
- HCPCS code T4545 assigned by CMS in 2019[1]
References
[edit]- ^ a b c CMS HCPCS Application Summary, June 2018
- ^ a b c d e UI Medical LLC. Final Draft Dossier, 2019.
- ^ a b c d National Institute for Health and Care Excellence. Medtech Innovation Briefing: QuickChange Incontinence Wrap, 2020.
- ^ a b Gray, M. et al. (2018). Assessment, Selection, Use, and Evaluation of Body-Worn Absorbent Products for Adults With Incontinence. Journal of Wound, Ostomy and Continence Nursing, 45(3), 243–264.
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