At the time the settlement was made public, Attorney Andrew C. Meyer, Jr. was quoted:
“Much to Mass. General’s credit, they recognized the error and tried to do right by the family. They are in good faith trying to prevent the problem from occurring in the future. The family was appreciative.’’Now the FDA is getting involved by strengthening its review of medical devices before they go to market. According to this report in The Boston Globe...
"The agency is providing additional training on alarm standards and alarm safety to its reviewers, who are responsible for scrutinizing 4,000 applications a year from manufacturers seeking permission to sell their medical devices, including heart and oxygen monitors. Alarms on such monitors and on medication pumps, ventilators, and beds already blare endlessly in hospitals, and one of the FDA’s top device officials indicated that he wants to keep new products that do not serve an important function from needlessly adding to the cacophony."The article quotes Dr. William Maisel, deputy director and chief scientist at the Center for Devices and Radiological Health,
“The FDA could do everything right, but if the health care community is not doing its job, that won’t be enough.’’ Many of the patient safety lapses with ventilators are “not a malfunction of the alarm but the use of the alarm. Someone turned the volume down or didn’t hear it.’’For more follow up on the issue of alarm fatigue, see the article: FDA Working To Trim Hospital ‘Alarm Fatigue’
For Kowalczyk's investigative series, see: Alarm Fatigue series
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