Harsh-Med Dressing Set - 40g

Usage Guidelines: To use the Dressing Set by Harsh-Med, which is fully compliant with the medical device's directive, follow these steps. Firstly, ensure that the set is properly sterilised and intact. Open the packaging and arrange the contents for easy access. The set includes a 3-compartment tray, which can be used to organise the various items. Use the dressing forceps, of which there are two, to handle the sterile items and prevent contamination. Next, take the five cotton balls and use them for cleaning or applying antiseptic solutions to the affected area. The four gauze swabs can be used for wound dressing or as a primary or secondary dressing. Make sure to discard any unused swabs after use to maintain sterility. The yellow limpet bag is provided for proper disposal of any contaminated items or waste generated during the dressing procedure. Place used materials in the bag and seal it securely for safe disposal. Additionally, use the hand towel to maintain a clean and dry working environment. It can be used for hand drying or as a protective barrier during the dressing procedure. The patient drape is included to create a sterile field around the affected area. Unfold the drape and place it over the patient, ensuring that it covers the surrounding area, creating a clean and sterile surface for the dressing. Finally, utilise the sterile field to set up the required instruments and dressings needed for the procedure. Arrange the items within the sterile field, ensuring they do not come into contact with non-sterile surfaces.

Remember to follow proper aseptic techniques throughout the dressing procedure to minimise the risk of infection. Dispose of all used items appropriately and adhere to local guidelines and regulations for medical waste management.

Certification/Claims: 

1. MDA: To ensure that this disposable Dressing Set is MDA (Medical Device Authority) certified and compliant with regulatory requirements, it is important to verify the certification or approval markings on the packaging or labelling of the product. Look for the MDA logo or any other indication that confirms compliance with the relevant medical device regulations When using an MDA-certified Dressing Set, follow the instructions provided by the manufacturer, which may be included in the packaging or available on their official website. Adhere to any specific guidelines or precautions mentioned to ensure safe and effective use of the set.
   
   
2. GDPMD: To ensure that the Dressing Set is GDPMD (Good Distribution Practice for Medical Devices) certified and compliant with regulatory requirements, you should verify the certification or approval markings on the packaging or labelling of the product. Look for the GDPMD logo or any other indication that confirms compliance with the relevant medical device distribution regulations. When using a GDPMD-certified Dressing Kit, follow the instructions provided by the manufacturer, which may be included in the packaging or available on their official website. Adhere to any specific guidelines or precautions mentioned to ensure safe and effective use of the set. It is also important to check the expiration date of the Dressing Pack. GDPMD certification ensures that the product is distributed according to the approved practices, but it is essential to use it within the specified shelf life indicated by the manufacturer. Expired products may not guarantee the same level of sterility or effectiveness. If you have any concerns or questions about the proper use of the GDPMD-certified Dressing Set, consult with a healthcare professional or reach out to the manufacturer or supplier for clarification and guidance. They should be able to provide you with the necessary information to ensure the safe and effective use of the dressing set in compliance with GDPMD standards.
   
   

Storage Instruction:  To store the Dressing Set by Harsh-Med in a warehouse or clinic, it is important to follow proper storage procedures to maintain the quality, sterility, and usability of the items. First, designate a dedicated storage area that is clean, well-ventilated, and free from direct sunlight, excessive heat, moisture, and dust. Ensure that the area is secure to prevent unauthorised access and minimise the risk of contamination.

Organise the Dressing Sets in a systematic manner, using shelves or storage racks, to facilitate easy access and inventory management. Keep the sets in their original packaging, which provides an additional protective barrier. Ensure that the packaging remains intact and undamaged.

Maintain a consistent temperature and humidity level within the storage area, as specified by the manufacturer's recommendations. Extreme temperature variations and high humidity can compromise the integrity of the dressing set components.

Regularly inspect the storage area for any signs of pests or environmental hazards that may pose a risk to the dressing sets. Implement pest control measures if necessary and promptly address any issues to maintain a clean and safe storage environment.

Label the storage shelves or racks with clear identification, indicating the contents and expiry dates of the Dressing Sets. This will assist in proper rotation and timely disposal of any expired or damaged sets.

Establish a regular inventory management system to monitor stock levels, track expiration dates, and ensure timely replenishment. Regularly check the Dressing Packs for any visible signs of damage, such as torn packaging or compromised sterility indicators. If any sets are damaged or have expired, remove them from inventory and arrange for proper disposal following appropriate waste management guidelines.

By adhering to these storage practices, you can ensure that the Dressing Set by Harsh-Med remains in optimal condition, ready for use when needed, in both warehouse and clinic settings.

Packaging Information: 

Overview of Dressing Set

The Dressing Set by Harsh-Med is a comprehensive medical device package designed to meet compliance with industry standards. This set includes essential items required for dressing procedures and wound care. It contains a 3-compartment tray for organising the various components, two dressing forceps for sterile handling, five cotton balls for cleaning or applying antiseptic solutions, and four gauze swabs for wound care. Additionally, it includes a yellow limpet bag for proper disposal of waste, a hand towel for maintaining a clean environment, a patient drape for creating a sterile field, and a sterile field for organizing instruments and dressings.

The Dressing Set is packaged in a white airtight sealed packaging, ensuring the integrity and sterility of the contents. The packaging dimensions are approximately 30 cm x 54 cm x 38 cm (11.81 in x 21.26 in x 14.96 in), making it compact and convenient for storage. Each unit weighs approximately 40g (1.41 oz), and a carton contains 100 packets. For larger quantities, a 20ft container can accommodate up to 300 cartons.

With a shelf life of 48 months, the Dressing Set offers an extended period of usability. It is manufactured in Malaysia, adhering to quality standards and regulatory requirements. The set provides healthcare professionals with the necessary tools to perform dressing procedures effectively and safely, ensuring patient care and infection control.

Dressing Set Specifications

- Includes 1pc of a 3-compartment tray, 2pcs of dressing forceps, 5pcs of cotton balls, 4pcs of gauze swabs, 1pc of a yellow limpet bag, 1pc of a hand towel, 1pc of a patient drape, and 1pc of a sterile field
- Packed in a white airtight sealed packaging, ensuring the sterility and integrity of the contents
- Has dimensions of approximately 30 cm x 54 cm x 38 cm (11.81 in x 21.26 in x 14.96 in)
- The weight of 1 unit of the dressing set is approximately 40g (1.41 oz)
- Each carton contains 100 packets of the dressing set. A 20ft container can accommodate up to 300 cartons
- Has a shelf life of 48 months
- Manufactured in Malaysia

Application: Procedural and Wound Management 

- Full compliance with the medical device’s directive
- Cleaning and dressing clean surgical wound and Contaminated-infected wound
- Hospital, Office and Home Base Procedures, i.e. removal of tubing, drainage, catheter, cannula, cleaning and change of dressings
- Two forceps for application confidence reduce cross-contamination risks and safety
- Sterility (EO) is guaranteed unless the package is damaged or opened