No one likes to make a mistake; errors can make you look bad, cost you money or a job, and even be harmful for your health. In some industries, however, errors can be downright life-threatening.
Medical errors claim approximately a quarter million lives per year, making it the third leading cause of death in the U.S., according to a Johns Hopkins study. In a medical setting, many factors can contribute to errors, including the skill and training of the health-care provider, the quality and integrity of the drugs or devices being used, and even the packaging in which those implements are stored.
The importance of packaging and labels
In the past five years, the FDA has approved 239 medical devices, ranging from stents for a variety of purposes to breast implants, heart valves, corneal implants, surgical lasers and even a gel intended to temporarily plug blood vessels during surgery. Medical device packaging and labeling are critical factors in the usability of the staggering array of devices and products intended to help health-care professionals deliver better patient care.
Labeling that’s incorrect, hard to read or difficult to interpret can be a factor in misuse of medical devices — a situation that can harm patients. What’s more, one 2008 study found that medical device errors cost $1.1 billion per year.
Aiming to reduce medical errors, the FDA has begun the process of implementing a standardized identification system for medical devices that will require every label and device package to bear a unique device identification number. Until now, there was no standardized identification system, the FDA says. Some companies put National Health Related Item Codes (NHRIC) or National Drug Code (NDC) identifiers on their drug and device packaging.
The Unique Device Identification system (UDI) will replace the piece-meal ID methods drug and device makers have used until now, which has contributed to the risk of misidentification and medical errors. By creating a uniform identification system, the FDA hopes to help health-care practitioners and pharmacists quickly and accurately identify devices and drugs, and key information about how they can be used safely.
More time to comply
Although the FDA had initially intended to require all drug and device makers to fall in line with the new UDI system by Sept. 24, 2018, earlier this year the agency extended that deadline to Sept. 24, 2021. After hearing public comments and concerns on the possible impact of the original deadline on drug and device makers’ costs and supply chains, the FDA said it would delay final implementation of the rule.
Standardized identification of drugs and devices could help reduce the risks of medical errors, and continue to make progress for patient safety around the world.