Faulty medical devices not only endanger the lives of users, but can also mean the collapse of a company. After the recall of their products, there were bankruptcy cases for large companies. If such incidents can topple multinational companies, imagine what can happen to smaller manufacturers.
Statistics have shown that companies see an average drop in their stock prices of 10% after a recall. Some events can lead to a bad corporate image and further depreciation. In the past decade, poor quality medical equipment has caused tens of thousands of deaths.
According to some medical experts, a device malfunction leading to death and complications has become an industry crisis. When a device manufacturer detects problems with devices, they will be removed or corrected as appropriate.
To correct this, the company addresses the problem in the same place it is used or sold. On the other hand, removing involves fixing the problem by removing it from such places. When a manufacturer recalls a product, it means it has violated FDA law.
A recall does not necessarily mean that you must stop using or returning it. Here is a list of medical devices that are commonly recalled when negligent acts in the manufacture and distribution of products are discussed:
- Medical monitors
- Diagnostic equipment
- Medical laboratory equipment
- Therapeutic machines
How technology is revolutionizing the product recall scene
Due to the increase in the number of medical device recalls, the FDA has asked manufacturers to ensure the traceability of their products through unique device identification. As the number of devices on the market increases, better tracking and tracing of medical devices becomes more important.
If there wasn’t an effective record of equipment, there would be a lot of chaos and many human lives at risk if a manufacturer realizes that a product is defective and decides to recall it. Today, advances in technology have made it easy for companies to comply with new regulatory requirements for tracking medical devices.
You can find many Unique Device Identity platforms. As with other healthcare industries, the process of tracking involves getting real-time information about your inventory and asset locations. Without a UDI label, device manufacturers cannot sell their products in the United States. In addition to putting the label on a device, businesses need to make it useful to healthcare companies.
A doctor can use a handheld scanner to scan a UDI barcode on a medical device. In this way, they will receive all relevant information, including special instructions and callback notifications. Such tools have eliminated the need for manual data entry of medical device identifiers into the EHR.
UDI platforms ensure the accuracy of the information by bringing it up to date. By using these platforms, healthcare providers can be assured that a device is safe to use. Since the identifiers can be 25 characters long, it is easy to make mistakes when recording the data manually. In the event of a recall, errors can have serious security consequences.
Direct connections to the EHR mean high accuracy as the correct device information is tied to a patient. Reviewing patient records will help a doctor find the correct device information, the date of the implant, and the latest information about it.
Common reasons for medical device recall
Aside from the fact that a manufacturer is defective, they can recall a device for several reasons. First, it can happen due to insufficient information among users. The manufacturer must inform users of the potential risks of using equipment, installation procedures, and maintenance requirements.
Another common reason for callbacks is the rush to test. Companies invest millions of dollars in product development. As a result, they may be tempted to speed up the testing process to get their inventions out as early as possible and recoup their investments.