Lancets & Lancet Devices - Diabetic Lancets, Diabetic Lancet Devices

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Lancets & Lancet Devices

Lancing Devices & Sharps Disposal

Ascensia Microlet Lancets and other Ascensia Microlet Automatic Lancing Device are sharp blades or needles used to obtain blood samples for glucose testing. Manufacturers often provide lancing devices as part of glucose monitoring kits. After you use a Gentle Draw Lancing Device, you must dispose of it in a safe container to prevent needle sticks.

Lancing Devices

Types of Lancing Devices

E - Z Ject Lancets are fine sharp-pointed blades or needles used to get a sample of blood for glucose testing. There are many types of FreeStyle Sterile Lancets; some have protective caps or other special features.

Automatic Lancing Devices
Most automatic Invacare Lancing Device consist of a hand-held tube with a spring-loaded Invacare 30 Gauge Lancet. To obtain a blood sample, hold the device against your skin and press a button to release the lancet. Most BD Lancing Device come with different lancet covers to allow different amounts of skin penetration. Before the next use, you must clean and reset your One Touch Penlet Plus Lancing Device.

Laser Skin Perforators
Laser skin perforators work like lancets to perforate the skin to draw blood. These devices produce a single pulse of laser light, which makes a small hole in your fingertip. Cell Robotics' Lasette is a first-of-its-kind portable laser. FDA cleared Lasette for marketing in December, 1998. This device can be used at home by both adults and children. Clinical testing shows that trained patients can use Lasette as accurately as a lancet. Lasette is available by prescription only.

FDA's Role in Regulating Lancing Devices

Manufacturers of Monolet Lancets and other non-powered Accu Chek Soft Touch Adjustable Lancet Device do not need clearance from FDA in order to market them. These products are regulated by FDA and must follow certain requirements. However, FDA does not review any safety or effectiveness data about these products before they are sold.

Companies that want to sell laser skin perforators must show FDA that their devices are "substantially equivalent" to skin lasers already for sale.

Sharps Disposal

Sharps Disposal Containers

According the American Diabetes Association, an easy way to get rid of used One Touch UltraSoft Lancets or needles is to put them in a heavy-duty plastic or metal container with a tight-fitting lid (such as an empty laundry detergent bottle). When the container is full, you dispose of it according to your local waste-disposal rules.

A sharps disposal container, which is any container that is intended to be used for sharps waste disposal, is a FDA-regulated medical device. Manufacturers must obtain premarket clearance before marketing the device to the public.

FDA describes the type of information and data that are needed for marketing clearance of sharps containers in the document, Guidance on the Content and Format of Premarket Notification [510(k)] for Sharps Containers (October 1993).

The information is based on Occupational Safety and Health Administration (OSHA) requirements for sharps disposal containers. The container must be

� closable

� upright and stable during use

� puncture resistant

� leakproof at sides and bottom

� properly labeled with the biohazard symbol and legend or color coded

The label on the container should clearly inform the user that the container holds sharps waste. Either a recognized symbol, the phrase "Infectious Sharps Waste," or a similar warning must be clearly visible on the container label.

Reusable sharps disposal containers are used primarily in healthcare facilities. The reusable container label should give instructions for decontaminating the device and the number of times the user can safely reuse it. The manufacturer must support these claims with data demonstrating that the containers can undergo repeated use and decontamination and still perform as well as the original unused container.

Needle Destruction Devices

Devices or containers with mechanisms that bend, break, incinerate (destroy by high heat), or shear needles are called sharps needle destruction devices. These medical devices must receive FDA premarket approval (PMA) before they are marketed to the public.

FDA describes the type of information and data that are needed for premarket approval of a sharps needle destruction device in the document, Guidance on the Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices (January 2001).

� toxic fumes

� noise

� heat

� sparks

� infectious aerosols

� electromagnetic interference with other medical devices

� completeness of needle destruction

� contamination of the surrounding environment

The manufacturer is responsible for testing needle-destruction Accu Chek Softclix Lancet Device to show that they are safe and effective. The labeling may make a claim that use of the device reduces the risk of needle stick injury. However, the labeling may not claim that use of the device will prevent disease, destroy organisms, or prevent or reduce needlesticks. If the manufacturer demonstrates that the remaining needle nub is no longer a sharp, then the labeling may claim that the device serves as an effective substitute for a conventional sharps container. Unistik2 Capillary Blood Sampling Device, Accu Chek Soft Touch Lancets, Accu Chek Softclix Lancets, Ultra-Fine Lancet, Unilet Comfortouch Lancet, Unilet ExecLite Lancet.

Lancets & Lancet Devices, Diabetic Lancets, Diabetic Lancet Devices, Diabetic Supplies, Diabetic Testing Supplies.