From the Guidelines
Regulatory reforms should prioritize a risk-based approach to oversight, adopting a tiered review system and harmonizing international standards to streamline compliance processes without compromising patient safety. This approach is supported by recent guidelines, such as the 2024 eacts/eactaic/ebcp guidelines on cardiopulmonary bypass in adult cardiac surgery 1, which emphasize the importance of establishing a safety culture within hospitals to minimize adverse events. Key reforms include:
- Implementing electronic submission systems with standardized formats to reduce administrative burden
- Utilizing real-world evidence and post-market surveillance to supplement traditional clinical trials
- Adopting adaptive licensing pathways for staged approvals based on evolving evidence
- Providing clear guidance documents and enhanced communication channels to help companies navigate requirements efficiently
- Encouraging manufacturing companies to comply with regulations, perform long-term studies, and report safety-related data promptly and transparently to regulatory authorities, as recommended in the joint diabetes technology working group of the European Association for the Study of Diabetes and the American Diabetes Association 1. By prioritizing these reforms, regulatory agencies can maintain rigorous safety standards while reducing unnecessary delays and costs, ultimately improving patient access to beneficial treatments and technologies.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Regulatory Reforms for Streamlining Compliance Processes
To streamline compliance processes without compromising patient safety, several regulatory reforms can be considered:
- Implementing a risk-based approach to compliance, focusing on high-risk areas and processes 2
- Enhancing governance and leadership in healthcare organizations to promote a culture of patient safety 2
- Improving communication and reporting of adverse events, allowing for timely identification and addressing of safety concerns 3
- Streamlining regulatory requirements and reducing administrative burdens, enabling healthcare providers to focus on patient care 2
Key Strategy Domains for Risk Management
The following strategy domains can be utilized to manage risk and improve patient safety:
- Transformational leadership
- Patient engagement
- Human resources management quality
- Innovation technology
- Skills certification
- Education in patient safety
- Teamwork
- Effective communication 2
Beta-Blockers in Patients with Myocardial Infarction
The use of beta-blockers in patients with myocardial infarction and preserved left ventricular ejection fraction is a topic of ongoing debate:
- Some studies suggest that beta-blockers may not significantly reduce mortality or recurrent myocardial infarction in this population 4, 5
- Other studies indicate that beta-blockers may reduce the risks of all-cause mortality, major cardiovascular events, and myocardial reinfarction in patients without heart failure following acute myocardial infarction 6