Demonstrate the state-of-the-art performance

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Reference no: EM133504655

Review protocol - First Aid Dressing (Non-Sterile Bandages)

Background

Kays Medical Ltd has not conducted clinical investigations with the device under evaluation. No studies were identified in the literature search which addressed the performance of First Aid Dressing or its similar devices.

The use of First Aid Dressing to:
• Holding dressings in place.
• Treatment of sprains and strains and in other conditions requires light support.
• Providing rigid support, which is good for immobilising joints.
• A multipurpose, conformable paper tape that allows air to circulate.
• Treatment for soft tissue injuries, sports injuries, dislocations and sprains.
• Gives even radial support and pressure for weakened joints and muscles.
• Aiding rehabilitation after the removal of plaster of casts.

Objective
The literature search will identify clinical data relevant to the device under evaluation. This systematic search of scientific literature will be carried out with the following objective:
To identify and assess literature to demonstrate the state-of-the-art performance and safety of the device under evaluation and similar First Aid Dressing (Non-Sterile Bandages) as intended by the legalmanufacturer.

Review question

Provide the full review question in sentence format, and then break up the question according to the PICO framework (or other frameworks as appropriate).

Methods: The literature review will follow the guidance of MEDDEV 2.7.1 Rev 4. The literature search will identify published clinical data that are not in possession of the manufacturer and that may assist the manufacturer in assessing state-of-the-art performance and safety of First Aid Dressing (Non-Sterile Bandages) to give input to the assessment of acceptable benefit/risk ratios.
To identify studies and guidelines likely to answer the review questions, it is essential to define the population of interest, the interventions, comparators, outcomes and study designs (PICOS) that will be eligible to provide data for the review. These eligibility criteria are described in Sections 2.1 to 2.4 and summarised in Table 1 and Table 2.

Population The eligible population will be patients of any age, gender and from any country.
Intervention The use of First Aid Dressing to:
• Holding dressings in place.
• Treatment of sprains and strains and in other conditions requires light support.
• Providing rigid support, which is good for immobilising joints.
• A multipurpose, conformable paper tape that allows air to circulate.
• Treatment for soft tissue injuries, sports injuries, dislocations and sprains.
• Gives even radial support and pressure for weakened joints and muscles.
• Aiding rehabilitation after the removal of plaster of casts.

Comparison • Reliance
• Stenoplast
• HYPA Safety First Aid
• St John Ambulance
• Crest- Blue Dut
• Qualicare

Search strategy

Databases
List the bibliographic databases to be searched.
- MHRA
- FDA
- HTA
- ICTRP
Search terms
What are your key search terms? Pick out the keywords and think about alternatives you will need to include in your search.
- Non-sterile bandages
- Non-sterile plasters
- Non-sterile wound care
- Non-sterile Elastic Adhesive Bandage
- Non-sterile Zinc Oxide Tape
- Non-sterile Microporous Tape
- Non-sterile Cohesive Bandage
- Non-sterile Fabric Tape
- Non-sterile Tubular Bandage
- Non-sterile Gauze Swabs
- Non-sterile Conforming Bandage

Identifying other useful sources
Outline any other ways you will find useful sources, such as hand-searching contents lists of key journals, looking at relevant websites, and looking at references and citations for relevant articles.

- WHO
- BfArM
- Healthy Canadians
- Swiss Medic
- EUDAMED

Data extraction& synthesis
Outline the procedures you intend to use to analyse and summarise thestudy results, including whether or not you intend to carry out meta-analyses. How will you extract the data and how will it be analysed and summarised (statistical or narrative)?

Attachment:- First Aid Dressing.rar

Reference no: EM133504655

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