Medical Device Description:
Insulin pens are pen-shaped injector devices that contain a reservoir for insulin or an insulin cartridge. These devices are designed to permit self-injection and are intended for single-person use. Insulin pens are designed to be used multiple times, for a single person, using a new needle for each injection. Insulin pens must never be used for more than one person.
Instructions when purchasing the Medical Device:
1. Ensuring that the store is licensed.
2. Ensuring that the Insulin Pen has marketing authorization from Saudi Food and Drug Authority.
3. Ensuring to have an invoice.
4. There are many types available in the market, and you should consult a doctor or a specialist about the type of device that is suitable for the diseased condition.
5. Make sure that the Insulin Pen has a warranty and services are to be provided such as maintenance.
6. Make sure you have the instruction booklet in Arabic to learn how to use and take care of the device.
7. Talk to your healthcare practitioner about any questions or concerns you have about the correct use of insulin pens.
8. Knowing the number of insulin injections the body needs, you can estimate the amount of pens you need.
9. Check the expiration date and estimate according to usage.
10. Select the best needle for the insulin pens according to the comfort and safety they provide to you as per the following:
• Needle sharpness
• Needle length
• Clock (counter) needle.
• The color of the needle cap
• Needle cap dimensions
• Needle cap strength
• The strength of the ligament of the needle
• Sterilization of the needle
The Safe Use of the Medical Device:
1. Read the instructions booklet and the direction for use of the Insulin Pen
2. Insulin pens should be clearly labeled with the person’s name or other identifying information to ensure that the correct pen is used exclusively on one individual.
3. Put a new needle on the tip of the pen each time of the injection.
4. Make sure to use the appropriate type of insulin and needle for the type of pen.
5. Check the expiry date of your insulin, needle and the pen.
6. Make sure that the insulin pen needle you intend to use is still sterile and capped.
7. For unused pens, be sure to keep them refrigerated. For pens currently are used, they should be kept at room temperature. Extreme temperatures or cold should be avoided.
Warnings when using Insulin Pens
1. Never share your insulin pen or syringe with other people, even if the needle has been changed. You may cause a serious infection to others or get a serious infection from them.
2. Do not use needles, pens, or insulin injections after expiration, which can be allocated on the label or on the pens box.
3. Keep all insulin pens and needles in a safe place and out of reach of children.
4. Follow the instructions that show where and how to dispose the empty pens and used needles to avoid spreading infection or health risks to others.
5. Dispose needles immediately after use by placing them in a sturdy, lockable container or order puncture-proof containers from your health care provider.
6. Do not throw used needles in the regular wastebasket at home.
7. Put label on the container to warn people of its danger.
8. Keep the used needle container out of the reach of children.
9. Always keep the container covered.
10. If someone is accidentally pricked with your insulin needle, contact a health care provider.
To report problems related to medical devices, please visit the website of the National Center for Medical Devices Reporting:
Or contact us through the number 19999