• Home
  • Firm Blog
  • FDA Issues New Rules for Unique ID of Medical Devices and Implants

October 2nd, 2013

FDA Issues New Rules for Unique ID of Medical Devices and Implants

Use of medical devices and implants has skyrocketed over the last two decades. Pacemakers, artificial hips and knees are used widely. With increase in use comes issues such as defective products which cause premature failure and additional medical treatment including surgeries and rehabilitation.

Historically, identifying patients with a recalled or defective medical devices/implants was difficult. In the upcoming months and years, that problem may be relegated to the past.

Last week, the Federal Drug Administration issued new rules relating to the identification of medical devices and implants.

The UDI (Unique Device Identification) System is designed to help the FDA, patients and their medical doctors identify problems with products faster, especially when it comes to medical implant/device recalls. This overall improves patient safety.

The UDI will indicate the device and its version or model. The UDI will also include a production identifier, which will indicate at least the lot/batch number, serial number, expiration date, etc.

This new system will be phased in, depending on the type and class of medical devices/products. By 2020, implementation of the UDI System will be complete.

Medical Devices/Implants are Subject to Failure

Medical devices and implants are not impervious to failure. In fact, recalls of medical devices occur often. Just over the last four months, 21 medical devices have been recalled, including:

  • endotracheal tubes,
  • ventilators,
  • drug pumps, and
  • blood sets used for administration of blood and blood products.

Click here for a list of medical device/implants product recalls from the FDA.


If you or a loved one has questions about a recalled medical device/implant, please contact our Pennsylvania medical malpractice and surgical error lawyers for a FREE consultation. Click To Call

Our medical malpractice attorneys serve victims in the following areas: Allegheny County, PA; Berks County, PA; Bucks County, PA; Chester County, PA; Delaware County, PA; Lehigh County, PA; Montgomery County, PA; Northampton County, PA: Philadelphia County, PA; Atlantic County, NJ; Burlington County, NJ; Camden County, NJ; Cumberland County, NJ; Gloucester County, NJ; Salem County, NJ; New Castle County, DE; he County, DE; Atlantic City, NJ; Philadelphia, PA; Pittsburgh, PA; Newark, NJ; Doylestown, PA; Media, PA; West Chester, PA; Norristown, PA; Camden, NJ; Wilmington, DE; Newark, DE; Georgetown, DE; and New Castle, DE. Our lawyers can obtain special admission in other states on a case by case basis.

**This website does not provide legal advice. Every case is unique and it is crucial to get a qualified, expert legal opinion prior to making any decisions about your case. See the full disclaimer at the bottom of this page.