Key Documents and Resources
Association for Advanced Medical Instrumentation (AAMI)
Association for Advanced Medical Instrumentation (AAMI) is comprised of professionals in engineering, medicine, nursing, the medical device industry, and governments with the common goal of increasing the understanding of and beneficial use of medical instrumentation.
- AAMI Foundation’s Healthcare Technology Safety Institute (HTSI) has released a number of white papers as part of the Institute’s “Safety Innovations” series, highlighting healthcare technology-related challenges (and solutions):
- Best Practices for Infusion Pump-Information Network Exchange
- Smart Pump Implementation: A Guide for Healthcare Institutions
- Nine Recommendations To Prevent Multiple Line Infusion Medication Errors
- Recommendations for Alarm Signal Standardization and More Innovation
- Using Data to Drive Alarm System Improvement Efforts, The Johns Hopkins Hospital Experience
- AAMI Report on Medical Device Interoperability to improve safety and effectiveness of connectivity for diverse array of medical devices and information technology.
- Preventing Misconnections of Lines and Cables
- Safety Precautions in the MR Environment
- Improper Use of Helical Tacks Can Harm Patients
- Sharps Safety and Needlestick Prevention
- Fire Safety and Oxygen: A Patient Guide
- Home Hemodialysis Safety: A Patient Guide
- Medical Device Safety Alerts Database This searchable database provides a review of the types of problems that have occurred with medical devices as well as the lessons learned over the past three decades. It focuses on the steps that medical device users can take to prevent or reduce medical device risks to patients and healthcare workers.
Food and Drug Administration (FDA) medical device safety
The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. Lists of medical device recalls may be found on the FDA website.
- The FDA also maintains a searchable database of medical device safety communications, and
- FDA medical device reporting requirements.
- FDA Public Workshop on Medical Device labeling, April 29-30, 2013
This workshop was held to encourage public comments regarding standard content and format for medical device labeling in a clear, concise, and readily accessible format for patients, caregivers, and healthcare providers.
- FDA Safety Communication for Cybersecurity for Medical Devices and Hospital Networks, June 2013
Medical device makers should take steps to protect their products from malware and cyberattacks.
- FDA Medical Device Recall Report FY2003 to FY2012 shows that the number of medical device recalls increased by 97 percent between fiscal 2003 and 2012.