Guidance for the NHS and Health Care Providers on Appropriate Testing of Disposable Incontinence Products
Download Guidance for the NHS and Health Care Providers on Appropriate Testing of Disposable Incontinence Products Document and Product Testing Checklist
The AHPMA has created this guidance document for use by the NHS and health care providers to aid understanding and consistency of appropriate testing and evaluation of disposable incontinence products.
How Disposable Incontinence Products are Tested
There are four basic types of test that can be used to assess the performance of disposable incontinence products:
1. Laboratory testing carried out to a defined standard or rationale – including proving compliance to published standards or specifications.
2. Biocompatibility testing to show that the products perform as intended without causing any adverse or harmful effects for patients or users and they mitigate any risks posed by the device. This includes dermatological testing carried out in a laboratory on both wet and dry products to measure skin tolerance.
3. Clinical assessment (clinical testing – including clinical trials, in use evaluations and case studies). The scale of a clinical study will be dependent upon the nature of the product, the associated claims and its classification under regulatory standards.
4. Usability testing (carried out by individuals to simulate an aspect of user experience – including practical function tests and table top simulation in aspects of performance).
The main international standard for the laboratory testing of disposable incontinence products is ISO 11948-1 / Rothwell test method which measures the total absorption capacity of a pad in a laboratory environment. In this test product features such as elastics which help to reduce the risk of leakage are cut off and the product is weighed before starting the test. It is then placed on a drainage tray with the absorbing surface face down and then immersed in a solution of distilled water and sodium chloride. The product is left for 30 minutes so that it can absorb as much liquid as possible.
The drainage tray is then lifted out of the water and allowed to drain for 5 minutes. The pad is folded and placed in a beaker that has already been weighed together with any excess fluid which is still on the drainage tray and weighed. The ISO result is made by subtracting the dry product weight from the wet product weight to calculate the total absorption capacity of the pad.
The test method does not reflect the way in which urine is passed into the product in use and when used to assist in purchasing decisions it should not be used as the main criteria for measuring product performance. Different product categories and designs of products will have different product features that will have an impact on how products perform in use in relation to leakage protection e.g. leakage barriers and fixation tapes.
All four types of product testing, together with a risk analysis may form significant elements of a product’s technical file. This type of file provides evidence that products comply with the regulations and suitability for use.
Published tests do not exist for all aspects of product performance or suitability in use. There are aspects relating to product use which are subjective, e.g. ease of use, legibility of labelling, clinical efficacy and outcomes and safety in use. These aspects are considered by a manufacturer during their risk analysis process and are designed to minimise the risk of the product in use. Output from the risk analysis will be reflected in the instructions for use.
For a disposable incontinence product to be placed on the market in the UK and anywhere in Europe it is required to be CE marked.
The CE mark shows that the manufacturer has ensured that the product satisfies the requirements essential for it to be fit for its intended purpose, complies with EU safety, health and environmental requirements. To prove this, the manufacturer has to compile a technical file that includes a clinical evaluation report based on some or all of the types of testing described above.
It also includes:
• A detailed risk analysis
• Proof of compliance with standards
• Intended use
• Instructions for use
• Proof of product claims
• Clinical information
Incontinence products sold in the UK and the rest of Europe are regulated under the Medical Device Directive which will be replaced by the Medical Device Regulations by May 2020. Compiling supporting literature for any disposable incontinence product is a regulatory requirement and forms part of the product evaluation carried out by suppliers. In addition post market surveillance and post market clinical follow up are required, to show continual evaluation and monitoring of a product’s performance in use.
Strengths and Weaknesses of Product Testing
Each type of product testing has characteristic strengths and weaknesses, which must be considered when disposable incontinence products are assessed. Comparative assessments need to consider laboratory testing, usability testing and clinical outcomes to reach a balanced conclusion – all of which need to be appropriate to the clinical settings and patient groups involved.
Type of testing
Laboratory testing is reproducible. It can compare products from one occasion to another and from one test centre to another. It has a low potential for bias and is complaint to accepted standards and test methods.
All test methods and materials are clearly defined.
It can have a low relevance to clinical practice and the in use experience of the user and does not always correlate with the required clinical outcomes.
This is the manufacturer’s responsibility as part of the product technical file and CE marking of products.
When well designed, clinical studies and in use evaluation can provide realistic evidence of patient outcomes that have a low potential for bias. The results can also be transferable.
When clinical studies are used to compare products, it needs to be considered that certain factors will influence the patient’s continence profile e.g. diet and medication.
Variations in patient levels and types of incontinence, continence assessment, clinical settings, clinical skills and environmental factors e.g. manual dexterity problems may all lead to variable outcomes. Clinical studies can be costly to carry out and may involve ethical considerations. The end point of in use evaluations can vary depending on the evaluation criteria, external factors and patient compliance.
e.g. table top testing
Has relevance to user experience in relation to assessing certain product aspects such as simple to understand packaging, ease of opening, safe storage and an intuitive design which helps to make the application of the product easy.
Methodologies can lack standardization and so have poor reproducibility and low comparative values. There is significant potential for bias.
Testing is often subjective and can include non-scientific protocols. It is also open to influence by individual personal experience or preferences. If the technical abilities of participants in designing and conducting tests is limited, selection of the test criteria and the subsequent lack of “weighting” between critical and non-critical aspects can misrepresent products.
Critically there is little relevance to clinical efficacy, patient needs or overall product costs.
Table Top Testing – Further Information
Table top testing is a form of usability testing often carried out as an adjunct to procurement activities.
Results from table top testing need to be used in an informed manner, due to the following characteristics of this type of testing:
- Methodologies can lack standardisation and so reproducibility e.g. the amount and temperature of the fluid being poured into products to evaluate leakage protection and dryness is often not reflective of an in use experience and there are no guidelines for how much water should be used and at what intervals the water is added to the pads. Assessing for wetness / rewet when water has been poured into a pad is a personal experience and how do you measure this and how is it completed? With subjective outcomes, this can invalidate results. The testing can demonstrate usability, but cannot be used for comparative purposes or to define suitability for a specific clinical need.
- Working absorbencies are not reflective of the in use experience and there is no national guidance on what percentage of the ISO value is a working absorbency.
- Tester’s experience and knowledge of local, technical and regulatory requirements may be limited.
- Table top testing is appropriate for checking the usability such as ease of opening the packaging, removing the pad and unfolding the product.
- Table top testing is not appropriate for assessing disposable incontinence product characteristics such as wear time, time before the pad should be changed, leakage performance or skin dryness in relation to skin health, patient comfort, ease of fit and removal. This can also apply to laboratory testing which can produce results that do not correlate with clinical outcomes e.g. ISO values.
- Lack of relevance to clinical practice – a product that may be easiest to handle in table top testing may well not be the best for patient experience or outcomes e.g. in use experience in the all-in-one product category is also dependent on the individual patient’s body shape and size and if the product does not fit closely to the body the risk of leakage will be increased. Nor may it offer the best economic value.
- Comparative studies like these, that do not use recognized standards, or are selective on non-critical criteria, can misrepresent products and result in misinformed product choices.
- Product scoring systems often used in table top testing risk over simplification of product performance and can then be detrimental to both patient outcomes and healthcare costs.
Reliance can be placed on the CE mark to demonstrate safety and efficacy for the intended use.
Comparative studies need to consider an appropriate combination of laboratory testing, user testing and clinical evidence to reach a balanced conclusion. These all need to be relevant to the clinical settings, patient groups and continence assessment.
Table top evaluations have little value when comparing the clinical performance of disposable incontinence products to the in use experience. They have a role in the assessment of packaging, handling, ease of application and nursing convenience. They offer little validity in other areas and might lead to sub-optimal product choices if used in isolation and without a review of supporting clinical evidence.
Over simplification of disposable incontinence products is likely to be detrimental to a patient’s quality of life, outcomes and healthcare costs.
Industry provides innovative, cost effective products to healthcare providers to help meet the challenges of increasing health costs and works together with clinicians to provide evidence based solutions and educate health care practitioners to advance the technology and design of incontinence products.
Basic Protocol for Comparative Testing of Disposable Incontinence Products for Urinary Incontinence
1. Visual cues
Intuitive patient application – ease to understand how to how to fit the product
Secure closure systems e.g. all-in-one products
2. Pouring water into disposable incontinence products needs to be reflective of both the average individual voiding episode (and thus the time interval in between) and the type of incontinence.
3. Patient Experience
I. Wear time.
Episodes of leakage and time between changes.
Product weight before and after use should also be considered.
II. Product design that promotes independence. This should be evaluated by product category.
III. Skin friendly – prevents wetness against the skin and reduces the risk of Incontinence Associated Dermatitis.
The patient’s skin condition should be checked before the start of the evaluation. If skin is compromised or damaged potential causes should be evaluated e.g. changes in diet can have an impact on this.
IV. Odour protection.
V. Fixation system.
VII. Instructions for use.
VIII. Ease of opening the packaging.
IX. Instructions for correct disposal of the products.