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Recalls of Defective Medical Devices

Update April 12, 2017
The attorneys at TheLawFirm.com often sue the manufacturers of defective medical devices. But, sometimes, patients are injured or killed not from a defective medical device but through misuse of a medical device. Patients in various health care settings receive their health care treatment through various medical devices. Many of these medical devices connect to each other.

Medical devices are often packaged either in tubing sets or together with another medical device. (Tubing sets include all the parts patients need to use the tubing). Connectors attach tubes to other parts of the set or other devices.

Patients use medical devices that must be connected to each other in their homes and other health care environments. Patients often need different medical devices at the same time. Each device has its own connections.

Medical device misconnections occur when one type of medical device is mistakenly attached to another type of device that performs a different function. Patients can use connectors with various medical devices. Problems arise when patients mistakenly connect unrelated systems to each other. This can result in delivery of medication or other substances through the wrong tubing to the wrong area of the patient’s body.

A misconnection can injure or even kill a patient. The FDA provides examples of potential misconnections, case studies of errors, and ways to prevent them on its “Examples of Medical Device Misconnections” page on its web site, here.

Medical device misconnections can occur for various reasons, including:
• the similar design, sizes and shapes of many connectors, and
• human error arising from various conditions, including:
• multiple connections on one patient,
• poor lighting,
• lack of training,
• time pressure,
• fatigue, and/or
• high-stress working environment.

Manufacturers and health care facilities try various ways to prevent medical device misconnections, including color-coding, labels, tags, and training. However, none of these methods solves the misconnection problem by itself. Why? For two reasons: 1) they are not consistently applied, and 2) they often do not prevent misconnections.

The ways in which devices connect may be changing, thus reducing misconnection risk. For example, new design standards for tubing connectors are being developed. This new design will prevent unrelated devices from being able to connect to each other.

The FDA is working with standards organizations, professional societies, advocacy groups, patients, and others to address and reduce medical device misconnection. Its efforts include:
• Participating in international consensus standards development;
• Developing draft and final guidance;
• Evaluating medical device adverse event reports that result from medical device
misconnections; and
• Communicating with patients and others to help them understand the impact of new connector designs.

It is important that all parties, including the FDA, hospitals, doctors, patients, and others in the health care system recognize: 1) the importance of misconnections, and 2) the need to reduce and prevent misconnections to the extent possible.

Medical device recalls are initiated when a particular medical device is defective and/or otherwise could pose a risk to its users’ (patients’) health. A recall can also be initiated if a medical device needs to be checked, adjusted, or fixed.

A defective medical device recall does not always mean that its users/patients must stop using the particular device or return it to the company.

Examples of medical device recalls include:
• Inspecting the medical device for problems,
• Repairing the device,
3) Adjusting device settings,
4) Re-labeling the device,
• Destroying the device,
• Notifying patients of a device defect, and
• Monitoring patients who are or have been exposed to the defective device or are using the medical device for personal health issues.

Implanted Medical Devices
Recalling a medical device that is implanted in a patient does not always require removal of the defective device from such patient(s). When an implanted device has the potential to fail unexpectedly, the device’s manufacturer or seller often asks doctors to discuss with their patients the risks of removing the device compared to the risk of leaving it in place.

Recalling a Defective Medical Device that is Part of a Group of Medical Devices
Sometimes a company knows of a defect within a group of medical devices, but does not know and cannot predict which particular device(s) in that group are defective. The company may address the defect by recalling an entire lot of the particular defective device or line of devices.

Voluntary Medical Device Recalls
Usually the company that manufactures, distributors, or sells a particular defective medical device will voluntarily recall that defective medical device. When a company learns that its medical device violates FDA requirements, it will recall the defective device and notify the FDA of the defect and its recall.

Mandatory Medical Device Recalls: FDA Recall Authority

The FDA has legal authority to require a company to recall a particular defective medical device when a company refuses to recall the particular defective medical device which is associated with significant health problems or even death. However, the FDA rarely uses this mandatory recall authority to require a defective medical device recall.

The FDA and Medical Device Recalls: Degrees of Risk
When the FDA learns about a company’s medical device recall, it: 1) reviews the company’s proposed strategy to recall the defective device, 2) assesses the health hazard posed by the defective device, 3) determines if the device defect violates FDA requirements, and 4) if appropriate, the agency classifies the recall.

The FDA uses three classifications for medical device recalls to indicate the defective medical device’s relative degree of risk (Classes I, II, and III), as follows:
Class I: when there is a reasonable chance that a medical device will cause a patient serious health problems or death.
Class II: when a medical device may cause a temporary or reversible health problem or when there is a slight chance that a medical device will cause serious health problems or death.
Class III: when a medical device is not likely to cause any health problem or injury.

Once the FDA classifies a medical device for recall, it monitors the recall to ensure it is effective. The FDA only terminates a recall when it is assured that a recalled defective medical device no longer violates the law or presents a health hazard to its users.

The FDA’s Medical Device Database
When a company recalls a defective medical device, the FDA posts information about the defective medical device recall in its Medical Device Recall Database, which can be found at here.

The FDA updates this Medical Device Recall Database twice: first, after it classifies the recall, and second, after the recall ends.

Public Notice about a Defective Medical Device
The FDA notifies the public about defective medical device recalls by posting information about each recalled device, including a company’s (such as a device manufacturer’s) press releases, other public notices. and and/or warnings to users and potential users of that defective medical device medical device, about the significant health risks health risks that the particular defective medical device may potentially present to them as users or potential users of that defective medical device. It also notifies the public about defective medical device recalls in its weekly Enforcement Report.

The agency also posts information about all Class I as well as some Class II and Class III medical device recalls on its web site to inform and alert patients and potential patients who may use the device about its significant health risks. This helps to increase current and potential future patients’ awareness of the serious potential health risks posed to them if they are use the particular defective medical device.

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