Faulty medical devices not only endanger the lives of the users, they may also mean the collapse of a company. There have been cases of bankruptcy for large organizations after the recall of their products. If incidents like these can cause the fall of multinational companies, imagine what may happen for smaller manufacturers.
Statistics have shown that organizations record an average 10% decline in their share prices after a recall. Some events can result in a bad corporate image and a further drop in value. In the past decade, low-quality medical devices have caused tens of thousands of deaths.
According to some medical experts, device malfunctioning resulting in deaths and complications has become a crisis in the industry. When a device manufacturer notices problems with equipment, they go for removal or correction, depending on the prevailing circumstances.
For correction, the company addresses the problem in the same place it’s used or sold. On the other hand, removal involves tackling the issue by removing it from such places. If a manufacturer recalls a product, it means it has violated FDA law.
A recall doesn’t necessarily mean you must stop using or returning it. Here is a list of medical devices that are usually recalled when talking about product production and distribution acts of negligence:
- Medical monitors
- Diagnostic equipment
- Medical laboratory equipment
- Therapeutic machines
How Technology Is Revolutionizing the Product Recall Scene
Because of the increase in medical device recalls, the FDA responded by requiring manufacturers to ensure their products’ traceability through unique device identification. As the number of devices increases in the market, better medical device tracking and tracing are becoming more important.
If there’s no effective device record-keeping, there would be a lot of chaos, and many lives would be at risk if a manufacturer realizes a product is defective and decides to recall it. Nowadays, technological advancements have made it easy for companies to comply with new legal provisions for medical device tracking.
You can find many Unique Device Identity platforms. Like other industries, in healthcare, the process of tracking involves getting real-time information about your inventory and your asset locations. Without a UDI label, device manufacturers cannot sell their products in the U.S. Other than putting the label on a device, organizations must make them useful to healthcare firms.
A medical professional can use a hand-held scanner to scan a UDI barcode on a medical device. By doing so, they can get all of the relevant information, including special instructions and recall notifications. Such tools have eliminated the need for manual data entry of medical device identifiers into the EHR.
UDI platforms ensure the accuracy of information by ensuring it’s up to date. By using these platforms, healthcare providers can rest assured that a device is safe for use. Since the identifiers can be 25 digits long, it’s easy to make errors while recording the data manually. In the event of a recall, errors may lead to dire safety consequences.
Direct links with the EHR means high accuracy as the correct device information is tied to a patient. When a medical professional reviews the patients’ records, they will find the correct device information, the date of the implant, and up-to-date information about it.
Common Reasons for Medical Device Recall
Other than being defective, a manufacturer may recall a device due to several reasons. First, this may be done due to inadequate information about it among the users. The manufacturer must inform the users about the potential risks of using equipment, installation procedures, and maintenance requirements.
Another common reason for recalls is rushing to test. Organizations invest millions of dollars in developing a product. As a result, they may be tempted to rush the testing process to release their inventions as early as possible and recoup their investments.