Patient Safety Advocates Urge FDA to Adopt Medical Device ID System

A coalition of stakeholders in patient safety matters recently urged the FDA to approve a proposal to create a unique device identification system to help doctors and hospitals quickly and accurately identify medical devices.

In a letter to the FDA, the Advancing Patient Safety Coalition (APSC) stressed that a unique device identification (UDI) system is vital to improving patient safety and putting into action reforms of electronic medical records and delivery systems that were part of the recent health care reform legislation.

The group includes the American Hospital Association, American Heart Association, the Federation of American Hospitals, American Medical Association and the American Nurses Association, among others.

Saving Money and Making Health Care Safer

The APSC says implementation of a uniform UDI system would save billions of dollars health care providers could reinvest in improving services.

The group says a UDI system would help minimize confusion in hospitals when a patient is admitted with a medical device that might have been the subject of a recall. With more than 600 medical device recalls issued annually, hospital personnel can miss critical health problems brought on by defective devices.

Medical devices can include pacemakers, replacement heart valves, breast implants, intra-bone implants, cerebral stimulators and others. They can also include surgical needles and instruments, x-ray machines, infusion pumps, wheelchairs and other devices.

Reducing Medical Errors

The APSC says with a UDI system, practitioners would be able to reduce medical mistakes and improve the safety of their patients by accurately identifying medical devices before and after use.

It would also help doctors and hospitals proactively identify medical device compatibility issues before they become problems implanted in patients or used in patient care.

The group also says a UDI system would also reduce surgical errors and help doctors track contaminated surgical instruments or equipment to patients.

If you or a family member has been harmed by a medical device or negligent health care involving a medical device, contact a Pennsylvania medical malpractice attorney to receive an assessment of the case. A medical malpractice lawyer can assist in obtaining full compensation for patients hurt by preventable medical errors.