Informed Clinical Decisions

KEY POINTS

• Medical devices play an important role in furthering public health through the treatment and diagnosis of illness and disease. However, it is important to understand that in addition to the benefits that medical products provide to patients and healthcare providers, all medical products—no matter how well-designed and thoroughly tested—also have potential risks associated with their use. As part of FDA’s premarket review, the agency carefully considers the benefit-risk profile of devices by weighing the probable benefit to health from the use of the device against any probable risk of injury or illness from such use.
• Medical device labeling sets forth the conditions of use under which a product has been FDA cleared or approved. A medical device’s labeling is the primary tool used to communicate the important information needed to help ensure that the device is used safely by the device’s user for the device’s intended purposes.
• Medtronic is committed to ensuring that patients and physicians have the most up-to-date information regarding our products to ensure that their decision-making process is based on an accurate understanding of the therapies’ benefits and risks.

Overview

1. Benefit-Risk in Medical Devices
   
   

   FDA imposes strict requirements on manufacturers to ensure that medical devices are safe and effective for their intended uses. However, it is important to understand that in addition to the benefits that medical products provide to patients and healthcare providers, all medical products— no matter how well-designed and thoroughly tested —also have potential risks associated with their use. Even common, household medications, such as aspirin and ibuprofen, can have potentially serious adverse effects. In fact, as part of FDA’s premarket review and FDA’s determination of a device’s safety and effectiveness, the agency carefully considers the benefit-risk profile of devices by weighing the probable benefit to health from the use of the device against any probable risk of injury or illness from such use.

   The fact that use of a medical device or therapy is associated with certain potential risks does not mean that the device is defective or dangerous. Medical therapies used to treat certain life-threatening conditions such as cancer also may be associated with greater risks than therapies used to treat less severe ailments such as headaches. Factors such as whether the medical therapies address an a life-threatening or irreversibly debilitating disease or condition and patient preference information are taken into consideration during FDA’s premarket review when FDA weighs these important benefits against the risks of the device.

   The fact that medical products have risks in addition to the benefits of the product underscores the importance of continued evaluation of the device as well as informed medical decision-making by physicians and patients. Trained healthcare professionals play a critical role in helping patients choose the best treatment options for their individual needs. When evaluating treatment decisions, healthcare professionals look to the benefit-risk profile of the device or therapy, comparing the benefits offered with its potential risks in the context of the specific disease or condition at issue. As discussed below, Medtronic is committed to the continued evaluation of the safety of products after FDA approval or clearance so that patients and physicians have the most up-to-date information regarding our products.

2. Medical Device Labeling
   
   

   Medical device labeling sets forth the conditions of use under which a product has been FDA cleared or approved. A medical device’s labeling is the primary tool used to communicate the important information needed to help ensure that the device is used safely by the device’s user for the intended purposes. The labeling accompanies the device and provides directions and information for the intended user on how to use the product safely and effectively under the device’s conditions of use. Medical device labeling can be supplied in many formats, including user manuals, instructions for use, and patient information booklets. The labeling contains key information for the intended user such as a device’s intended use, frequency and duration of administration, and risk information.

   Manufacturers have an obligation to update a device’s labeling as needed to ensure that it is not false or misleading. For example, after FDA approves a device, a manufacturer may need to add a warning to label based on new data collected about the device. Depending on the type of labeling change, the manufacturer may be required to receive approval or clearance from FDA for such change.

3. Medtronic’s Commitment to Information and Data-Sharing
   
   

   Medtronic understands that a device’s benefit-risk profile may change as more information is generated by a device through the clinical use of the product. Therefore, Medtronic’s commitment to safety continues after our products are approved or cleared for patient use. Medtronic is committed to ensuring that patients and physicians have the most up-to-date information regarding our products so that healthcare decisions are based on an accurate understanding of the device’s benefits and risks.. This commitment includes conducting post-market surveillance, monitoring and evaluating the safety of our products and, when appropriate, communicating new information to physicians and patients. Medtronic will take the appropriate steps to ensure the safety information is effectively communicated to the user, including making the necessary updates to the device labeling.

   In addition, Medtronic strongly supports efforts to enhance data transparency and, to that end, has committed $5 million to help improve information sharing throughout the healthcare industry. In partnership with the Patient Safety Movement Foundation, Medtronic also has pledged to allow access to all available acute clinical data generated by their products used in hospitals and in outpatient practice settings to interested parties that want to use them to help minimize preventable patient complications and death.¹

See also:

• Safe and Responsible Product Development
• Responsible Promotion and Compliance
• Medical Device Regulations