Clinical Evaluation Report
Period: May – Sep 2019
Client: NOT DISCLOSED
Subject: Class III (Drug Device Combination)
Povidone Iodine Non-adherent Dressing (Antimicrobial Non-adherent Wound Dressing)
Our Task Was
Povidone Iodine Non-adherent dressing contains 10% povidone iodine (PVP-I), equivalent to 1% available iodine. The PEG-based ointment is non-adherent to the wound bed, so it allows easy removal without pain or trauma. In addition to this, it provides a moist environment for the wound, which promotes faster healing. Upon contact with wound exudates, the iodine is released from the PEG base, offering a broad range of antimicrobial activity against gram-positive and gram-negative bacteria, MRSA, yeast, and fungi. The PEG-based ointment is water-soluble, so it can be easily removed from the skin or wound surface. The dressing is also non-adherent to the wound bed, so it can be removed without pain or trauma to the newly formed epithelial tissues.
Challenges
As per MEDDEV 2.1/3 rev. 3 (borderline products, drug-delivery products, and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative), the technical file is submitted to the notified body, which prepares a usefulness report to seek a scientific opinion from one of the competent authorities designated by the Member States or the EMEA. The Povidone Iodine Non-adherent Dressing has Povidone Iodine integrated as the medicinal substance, which has been well-established worldwide as an antimicrobial agent or antiseptic for more than 20 years in different formulations such as solutions, ointments, dry sprays, or dressings. Povidone iodine is monographed in the European Pharmacopoeia as well as in the British Pharmacopoeia and the US Pharmacopoeia.
- How safe is povidone-iodine wound dressing for humans?
- How effective is wound dressing with povidone iodine in the treatment of wounds in humans?
- Does povidone iodine dressing cause any adverse reactions or side effects in people?
- What are the risks of using wound dressings with povidone iodine in people?
- What are recent developments in the treatment of wounds?
- What is the impact of residual risks on the safety and performance of the device?
- Is the amount of iodine absorbed from the dressing within the safe limits?
- Title/Abstract Screening
Result
It can be concluded from the various literature and tests that the benefits of povidone-iodine dressing outweigh any risks posed by it. Hence, when weighed against the medical benefits to the patients, the risks are acceptable.
An analysis of the performance of povidone-iodine non-adherent dressing through a literature review and various tests conducted establishes that the device is efficient in its application based on its intended use as a wound dressing.
Hence, it can be concluded that povidone-iodine non-adherent dressing, when used as instructed by the manufacturer, can protect the wound from infection and aid in its healing, and that the side effects are acceptable.
Conclusion
So, the overall clinical evidence demonstrates that:
- The literature references cited are related to the clinical safety and performance of the product and have very well established the intended use of povidone iodine non-adherent dressing.
- The medicinal product impregnated on the dressing is povidone iodine, which has been used efficiently for the treatment of wounds for many decades now with proven benefits to patients.
- Information from the scientific literature shows positive feedback about the clinical performance and safety of the device among the European population.
