Skip to main content

Data quality plays pivotal role in medical device compliance

Richard Jones Archive

In the rapidly evolving world of medical devices, government intervention makes it more difficult for manufacturers to meet their many needs. They strive both to make better, faster devices that will improve patient care and save lives, and to meet a stringent set of federal regulations.

Data quality plays a primary role in this effort. Because the Food and Drug Administration recently released a "final rule" requiring that medical devices distributed in the United States carry a unique device identifier, or UDI, manufacturers of health-related products need to pay extra attention to accurate data. They use these identifiers to improve medical device adverse event reports and develop stronger relationships with the industry, the clinical community, patients and consumer groups.

Striving for UDI compliance
According to Information Management, it has become simultaneously more important and more difficult to maintain compliance in the world of medical devices. Kelle O'Neal, managing director of First San Francisco Partners, says that managing data quality is an important component in doing so.

"Lack of data quality management results in inconsistent and inaccurate data, which leads to poor decisions," O'Neal stated. "Poor decisions, in turn, can lead to inefficiencies, errors, additional costs or loss of business. The inability to successfully manage data quality may also result in fines or other regulatory actions when compliance needs cannot be met within required time frames."

Mistakes in the production of medical devices can prove particularly costly. These mishaps can lead to products being recalled, legal actions being taken and long-term damage being done to companies' reputations. Manufacturers can avoid all of these adverse effects by paying closer attention to data.

How mistakes happen
Mistakes in medical device data quality come in a variety of ways. One of the most common types of errors is a lack of completeness - if not all appropriate information about a device is readily available - say, if some values are missing or listed in an unusable state - companies can get themselves into trouble.

Problems also arise with conformity. If data is listed in one format in one department's system, that format should be applied uniformly across the board. Inconsistencies can lead to hiccups in a company's operations.

There are plenty of other ways that difficulties can arise. Inaccurate data, duplicated entries, dishonesty in recording and lack of timely information are all among the various types of data errors that can hamper companies' operations.