Incoming Quality Inspection (IQI) for Medical Consumables
Kingphar Medical Group New’s 06/10 2026 No results See all results Table of Contents Incoming Quality Inspection (IQI) for Medical Consumables: Complete Guide Procurement Quality ·
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18/4 2026
Foam dressings are among the most widely specified advanced wound care products — yet procurement orders frequently specify only "foam dressing" without defining adhesive type, MVTR, or exudate level suitability. This guide explains the two key performance mechanisms (absorption and MVTR), compares the four main foam dressing types, covers EN 13726:2023 testing, and provides a complete procurement checklist.
Foam dressings were introduced to wound care in the 1970s and have become the most widely used advanced wound care category globally, primarily for moderate to heavily exuding wounds including pressure injuries, leg ulcers, and post-surgical wounds. Their core advantage is the combination of high absorption capacity and moisture vapor management — maintaining a moist wound environment while preventing exudate from accumulating to the point of maceration.
For procurement managers, the critical decision points are: adhesive vs non-adhesive format, the MVTR of the backing film (which determines total fluid handling capacity), and confirmation of EN 13726 test data. "Foam dressing" as a purchase order specification is incomplete — it describes the material but not the performance. This guide provides the specification language needed for precise procurement. For related wound care procurement context, see our Non-Adherent Dressing Types Guide.
Foam dressing performance is governed by two distinct but interrelated physical mechanisms. Understanding both is essential for procurement, because a dressing optimised for only one mechanism will underperform in certain clinical scenarios.
Exudate is drawn from the wound surface into the open cells of the polyurethane foam structure through capillary action. The foam retains the absorbed fluid within its cellular structure — it does not liquefy or break down, and leaves no particulate matter in the wound. Absorption capacity is determined primarily by foam porosity: the greater the volume fraction of micropores, the higher the absorption capacity.
Water vapor evaporates from the fluid absorbed within the foam, passing through the semi-permeable polyurethane film backing layer to the external environment. This evaporative loss contributes to the dressing's total fluid handling capacity — a dressing with a highly permeable backing can handle significantly more total exudate than the foam absorption alone would allow.
Research testing commercially available polyurethane foam-film dressings found that total fluid handling capacity (absorbency + evaporative loss) ranged from approximately 7 to 26 grams per sample — a nearly fourfold difference. The variation was largely driven by film backing permeability (MVTR), which ranged from approximately 2,000 to 20,000 g/m²/24h across products in the same category (Lee et al., Biomaterials Research, 2016). This means two foam dressings with similar absorption capacity can have dramatically different total fluid management performance based on their backing film — a parameter that is frequently absent from supplier datasheets. Always request MVTR data alongside absorption capacity when evaluating foam dressing suppliers.
EN 13726:2023 includes MVTR as a required test parameter for foam dressings but does not currently specify pass/fail minimum values. This means a supplier can claim "EN 13726 compliant" for a foam dressing with very low MVTR — which may be clinically inadequate for heavily exuding wounds. When requesting EN 13726 test reports, ask for the actual measured MVTR value, not just a compliance statement. Compare MVTR values across candidate suppliers to select the appropriate product for your wound type mix.
| Parameter | Non-adhesive flat | Adhesive bordered (acrylic) | Silicone bordered | Cavity / filler |
|---|---|---|---|---|
| Adhesive type | None | Acrylic adhesive border | Soft silicone border | None (inserted into cavity) |
| Secondary dressing required | Yes — bandage or tape | No | No | Yes — to cover and secure |
| Repositionable after application | N/A | No — acrylic adhesive bonds on application | Yes — silicone allows careful repositioning | N/A |
| Atraumatic removal | Good — no adhesive to periwound skin | Good — foam non-adherent to wound bed; adhesive border may traumatise fragile skin | Best — silicone minimal trauma on removal | Good if changed per manufacturer guidance |
| Exudate level suitability | Moderate to heavy | Low to heavy (product-specific — check manufacturer data) | Low to heavy (product-specific) | Moderate to heavy (cavity wounds) |
| Under compression | Preferred — no adhesive; compatible with compression bandaging | Not recommended — adhesive border creates pressure differential | Generally not recommended under compression | Not applicable |
| Cost tier | Lower | Medium | Higher | Medium–high |
| Application complexity | Higher — requires secondary fixation | Low — peel-and-apply | Low — peel-and-apply, repositionable | Higher — clinical assessment required for correct packing depth |
EN 13726:2023 is the current European test standard for wound dressings, published in September 2023. It replaced the previous EN 13726 series from 2002–2003. Key changes relevant to foam dressing procurement:
Request the EN 13726 test report for each product with actual measured numeric values for: (1) Free swell absorption capacity (g per 100 cm²); (2) MVTR (g/m²/24h); (3) Fluid retention under compression if the product will be used under compression systems. These values allow objective comparison across suppliers. A supplier who can only provide "meets EN 13726" without numeric values has likely not commissioned full testing — or is withholding performance data that is unfavourable compared to competitors.
| Layer | Material | Function | Procurement relevance |
|---|---|---|---|
| Wound contact surface | Heat-treated PU foam or perforated soft silicone (silicone-contact versions) | Non-adherent contact with wound bed — allows exudate to enter foam without tissue adhesion | Silicone contact layer = more atraumatic; standard PU surface = adequate for most wounds |
| Absorbent foam core | Polyurethane foam — open-cell structure | Absorbs and retains wound exudate within porous cellular structure; provides cushioning | Foam thickness and porosity determine absorption capacity — request actual absorption data |
| Backing film | Semi-permeable polyurethane film | Allows water vapor to evaporate (MVTR); prevents liquid water and bacteria from entering from outside; waterproof outer surface | Film MVTR is the key differentiator between products — request MVTR value |
| Adhesive border (bordered types) | Acrylic or soft silicone adhesive on film extension | Secures dressing to surrounding skin; provides seal against exudate leakage around dressing edges | Acrylic = stronger hold; silicone = more atraumatic removal. Specify adhesive type for fragile-skin populations |
| Clinical scenario | Recommended type | Key consideration |
|---|---|---|
| Pressure injury (sacrum, heel) | Silicone-bordered or adhesive bordered (sacral/heel shape) | Anatomical shape ensures complete coverage; silicone adhesive for fragile surrounding skin in pressure injury patients |
| Venous leg ulcer under compression | Non-adhesive flat | No adhesive border — compatible with compression bandaging; flat format conforms to limb under compression |
| Post-operative wound | Adhesive bordered or silicone bordered | Self-contained; no secondary dressing required; convenient for ward and outpatient dressing changes |
| Diabetic foot ulcer | Adhesive or silicone bordered (fenestrated) or non-adhesive depending on offloading device | Confirm compatibility with offloading footwear; fragile peri-wound skin common — consider silicone bordered |
| Deep wound / cavity | Cavity/filler foam | Must fill dead space from base — flat foam dressing bridges cavity and leaves dead space which hinders healing |
| Tracheostomy stoma | Fenestrated foam (tracheostomy shape) | Pre-cut central aperture for tracheostomy tube; soft foam reduces pressure on stoma site |
| Heavily exuding wound | Non-adhesive or adhesive bordered — verify high MVTR backing | High MVTR backing essential for heavy exudate management; request MVTR data before specifying for high-exudate wounds |
Under EU MDR 2017/745, standard polyurethane foam dressings without antimicrobial components are classified as Class I medical devices. For sterile foam dressings, the designation is Class Is — the sterility aspect requires notified body involvement even for a Class I device. For procurement and GCC supply:
Kingphar manufactures polyurethane foam dressings in non-adhesive, adhesive bordered, and silicone bordered formats — CE-certified under EU MDR 2017/745, EN 13726 tested with batch MVTR and absorption data, ISO 13485, with SFDA registration support and Arabic labeling for GCC institutional supply.
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