More than half of surveyed individuals believe the FDA should maintain approval of devices or approve new devices that may harm some patients but still help others, according to results from the NEHI Innovation Barometer.
For the survey, the New England Healthcare Institute surveyed 500 "opinion leaders" to determine their perceptions of healthcare innovations. Thirty-six percent of respondents believe the FDA should still approve a product that later turns out to be harmful but still helps some patients, as long as it discloses those risks to physicians and patients. In addition, 22 percent believe the FDA should approve a new product if evidence suggests potential harm to some patients, as long as it still helps other patient and the risks are disclosed.
Other key findings from the Innovation Barometer include the following:
• If the FDA approves a product that later turns out to be harmful, it should leave it to physicians and healthcare providers to determine the best course of action for patients — 16 percent
• The FDA should not approve a product if it has any evidence that it will harm any patient — 14 percent
• If the FDA approves a product that later turns out to be harmful to some patients, it should withdraw its approval even if the product still helps some patients — 8 percent
• Not sure — 4 percent
To view the report in full, click here.
For the survey, the New England Healthcare Institute surveyed 500 "opinion leaders" to determine their perceptions of healthcare innovations. Thirty-six percent of respondents believe the FDA should still approve a product that later turns out to be harmful but still helps some patients, as long as it discloses those risks to physicians and patients. In addition, 22 percent believe the FDA should approve a new product if evidence suggests potential harm to some patients, as long as it still helps other patient and the risks are disclosed.
Other key findings from the Innovation Barometer include the following:
• If the FDA approves a product that later turns out to be harmful, it should leave it to physicians and healthcare providers to determine the best course of action for patients — 16 percent
• The FDA should not approve a product if it has any evidence that it will harm any patient — 14 percent
• If the FDA approves a product that later turns out to be harmful to some patients, it should withdraw its approval even if the product still helps some patients — 8 percent
• Not sure — 4 percent
To view the report in full, click here.
Related Articles on Device Safety:
Increased Attention to Sharps Disposal Led to Dramatic Drop in Sharps Injuries
White Paper Discusses Reusable Medical Device Cleaning Validation, Testing Requirements
Medical Device Interoperability Presents Patient Safety Challenges, Opportunities