Insufficient evidence to recommend routine screening for cognitive decline. Changes to FDA approval process needed to improve safety
1. USPSTF finds insufficient evidence to recommend routine screening for cognitive decline
The United States Preventive Services Task Force (USPSTF) found insufficient evidence to recommend routine screening for cognitive decline in older adults in the primary care setting. Dementia affects up to 5.5 million Americans and its prevalence increases with age. Mild cognitive impairment (MCI) is a decline in cognitive function that is not severe enough to interfere with independence in daily life. Early detection of MCI may help patients and their caregivers make both short- and long-term diagnostic and treatment decisions. In 2003, the USPSTF found insufficient evidence to recommend for or against routine screening for dementia in older adults. To update its review, the USPSTF commissioned a systematic review of the evidence on screening for cognitive impairment, including dementia and MCI. Evidence on benefits, harms, and test performance of screening instruments and the benefits and harms of commonly used treatment and management options for older adults with MCI or early dementia was included in the review. The researchers found insufficient evidence to assess the balance of benefits and harms of screening for cognitive impairment.
2. Changes to FDA approval process needed to improve safety of high-risk medical devices - Current system allows approval of modified devices without clinical data
Premarket approval, or PMA, is the process by which the FDA assesses the safety and effectiveness of new devices. When modifications to existing devices are made, a less rigorous process known as a PMA supplement is employed. This process does not require clinical data and researchers are concerned that clinicians and patients may be subjected to unknown risks, especially when devices have multiple PMAs. The authors of a commentary being published in Annals of Internal Medicine cite two examples where devices that had undergone changes after the original approval had to be recalled after the devices failed or caused patient deaths. They say changes in the process are required to ensure patient safety and that the FDA's Unique Device Identification program is not enough. With the understanding that device improvements require rapid approval, the authors say clinical data, even on a limited basis, must be included in PMA supplements that are not cosmetic or packaging changes. Clear labeling and publicly accessible data registries that record ongoing clinical outcomes and adverse events for all device recipients would also help clinicians make informed decisions about devices.