FDA's new regulations strictly check the quality of defibrillators
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Recently, the US Food and Drug Administration (FDA) said that after receiving approximately 45,000 reports of equipment failures in the past seven years, it plans to propose new regulatory rules to improve the reliability of emergency defibrillators.
The agency said that its proposal will require manufacturers to provide clinical data or other evidence that their equipment is safe and effective, can be approved or stay on the market.
Many public places in the United States are equipped with self-defibrillators, including airports, stadiums, schools, shopping centers, and office buildings. After a simple training, whether on-site bystanders, emergency rescue personnel or police officers, can operate this instrument correctly and win valuable rescue time for patients with heart attack. According to statistics, the survival rate of cardiac arrest cases occurring outside the hospital is only about 5%. If the automatic defibrillator can be used within 5 minutes of the disease, the survival rate can be increased to 75%.
The FDA proposal will also require manufacturers to provide inspection reports and submit details about any changes to the equipment. The agency stated that most of the reported issues are "preventable and corrective." "The most common problems involve the design and production of equipment, as well as poor control of parts purchased from other suppliers."
Manufacturers of emergency defibrillators include Physio-Control Inc, Zoll Medical and Philips Medical Systems, a subsidiary of Philips Electronics.
Rachel Bloom-Baglin of Philips said that the company has not yet seen the written version of the FDA proposal. However, based on previous discussions with the FDA, she believes that more reviews will not lead to disruptions in the supply of defibrillators or accessories.
She said she believes that the increase in equipment failure reports is due in part to the fact that more defibrillators are placed in public places and that more people use them.