Lancing Devices

• Types of Lancing Devices
  
• FDA's Role in Regulating Lancing Devices

Sharps Disposal

• Sharps Disposal Containers
  
• Needle Destruction Devices

Lancing Devices

Types of Lancing Devices

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

Automatic Lancing Devices
Most automatic lancing devices consist of a hand-held tube with a spring-loaded lancet. To obtain a blood sample, hold the device against your skin and press a button to release the lancet. Most lancing devices come with different lancet covers to allow different amounts of skin penetration. Before the next use, you must clean and reset your 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.

For more information about lancing devices, use the following link:

FDA Clears First At-Home Laser for People with Diabetes
http://www.fda.gov/bbs/topics/NEWS/NEW00667.html

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FDA's Role in Regulating Lancing Devices

Manufacturers of lancets and other non-powered lancing devices 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. For information about how FDA regulates medical devices, use these links:

CDRH General Information on Medical Device Regulations - 510(k) and Premarket Approval (PMA)
http://www.fda.gov/cdrh/consumer/geninfo.html

Overview of Medical Device Regulations
http://www.fda.gov/cdrh/devadvice/overview.html

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Sharps Disposal

Sharps Disposal Containers

According the American Diabetes Association, an easy way to get rid of used 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). For a copy of this document, (in PDF format) use the following link:

Guidance on the Content and Format of Premarket Notification [510(k)] for Sharps Containers
http://www.fda.gov/cdrh/ode/895.pdf

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.

For more information about OSHA regulations for sharps disposal, use the following link:

Occupational Safety and Health Administration (OSHA)
Regulations on Bloodborne Pathogens, 29 CFR Part 1910.1030
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&
p_id=10051&p_search_type=STANDTEXTPOLICY&p_search_str=1910.1030&
p_text_version=FALSE#ctx1

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.

To search FDA's 510(k) database for sharps disposal containers, use the following link:

FDA 510(k) Database Search (Sharps Disposal Containers)

For more information about sharps disposal, use the following link:

Handle with Care: How to Throw Out Used Insulin Syringes and Lancets at Home: Booklet for Young People with Diabetes and Their Families. U. S. Environmental Protection Agency.
http://www.epa.gov/cgi-bin/claritgw?op-Display&document=clserv:epacinb:0598;&rank=4&template=epa

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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). For a copy of this document, use the following link:

Guidance on the Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA."
http://www.fda.gov/cdrh/ode/guidance/891.html

In its review, FDA looks at the following safety issues

• 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 devices 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.

For more information on needle-destruction devices approved for home use, use the following links:

Medical Device Approvals: Q-103 Needle Management System
http://www.fda.gov/cdrh/mda/docs/p980020.html

Medical Device Approvals: Disintegrator Insulin Needle Destruction Unit
http://www.fda.gov/cdrh/mda/docs/p010040.html