More Adverse Events Reported for Surgical Waste System
More Adverse Events Reported for Surgical Waste System
The US Food and Drug Administration (FDA) warned today that clinicians must be properly trained before using 2 models of a surgical waste management system related to a number of patient injuries and deaths.
The devices in question are the Neptune 1 Silver and Neptune 2 Ultra systems from Stryker. They feature a high-flow, high-suction vacuum to collect waste fluids in operating rooms and surgical facilities. The Neptune 2 Ultra also can remove surgically produced smoke. However, when used improperly, the devices can damage soft tissue, muscle, and vital organs as well as cause hemorrhaging.
The company issued a class 1 recall of other versions of the products in June 2012 after it received 2 reports of serious tissue damage, one of which resulted in a patient's death. In that case, a healthcare worker attached the Neptune 2 Ultra to a passive chest drainage tube after an operation. At the time, the instructions did not warn against connecting the device when passive drainage is needed.
In September 2012, Stryker expanded the recall to include the Neptune 1 Silver and Neptune 2 Ultra, both of which lack FDA approval. The FDA soon issued a safety alert recommending that clinicians not use either system unless an alternative device was not available. Facilities that had no choice but to use the recalled Stryker products were instructed to complete a Certificate of Medical Necessity and send it to the company.
On March 12, 2013, Stryker announced that it had received an FDA warning letter for marketing the 2 devices without agency clearance, failing to notify the agency about a recall, and falling short of quality-control standards.
In today's safety alert, the FDA said that it had learned of more injury and death reports related to the incorrect use of the surgical waste management systems by improperly trained personnel. The agency reminded facilities that still must use the recalled devices to complete the following steps as required by their Certificate of Medical Necessity:
The FDA said that Stryker has suspended production of the Neptune 2 Ultra. The company no longer makes the Neptune 1 Silver, but it will maintain and support it until March 1, 2014, for customers granted a Certificate of Medical Necessity.
A Stryker spokesperson told Medscape Medical News that the company has asked the FDA to approve the Neptune 2 Ultra, but that it is not seeking an approval for the Neptune 1 Silver.
More information about today's safety alert is available on the FDA Web site.
To report problems with Neptune waste management systems, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
The US Food and Drug Administration (FDA) warned today that clinicians must be properly trained before using 2 models of a surgical waste management system related to a number of patient injuries and deaths.
The devices in question are the Neptune 1 Silver and Neptune 2 Ultra systems from Stryker. They feature a high-flow, high-suction vacuum to collect waste fluids in operating rooms and surgical facilities. The Neptune 2 Ultra also can remove surgically produced smoke. However, when used improperly, the devices can damage soft tissue, muscle, and vital organs as well as cause hemorrhaging.
The company issued a class 1 recall of other versions of the products in June 2012 after it received 2 reports of serious tissue damage, one of which resulted in a patient's death. In that case, a healthcare worker attached the Neptune 2 Ultra to a passive chest drainage tube after an operation. At the time, the instructions did not warn against connecting the device when passive drainage is needed.
In September 2012, Stryker expanded the recall to include the Neptune 1 Silver and Neptune 2 Ultra, both of which lack FDA approval. The FDA soon issued a safety alert recommending that clinicians not use either system unless an alternative device was not available. Facilities that had no choice but to use the recalled Stryker products were instructed to complete a Certificate of Medical Necessity and send it to the company.
On March 12, 2013, Stryker announced that it had received an FDA warning letter for marketing the 2 devices without agency clearance, failing to notify the agency about a recall, and falling short of quality-control standards.
In today's safety alert, the FDA said that it had learned of more injury and death reports related to the incorrect use of the surgical waste management systems by improperly trained personnel. The agency reminded facilities that still must use the recalled devices to complete the following steps as required by their Certificate of Medical Necessity:
Ensure that all users of the Neptune 1 Silver and Neptune 2 Ultra are properly trained;
Implement the Neptune pre-use check list;
Appoint someone in each facility to ensure that the check list is consistently used; and
Follow the recommendations in an updated FDA safety communication to reduce the risk for harm, such as not using the devices for respiratory-tract suction.
The FDA said that Stryker has suspended production of the Neptune 2 Ultra. The company no longer makes the Neptune 1 Silver, but it will maintain and support it until March 1, 2014, for customers granted a Certificate of Medical Necessity.
A Stryker spokesperson told Medscape Medical News that the company has asked the FDA to approve the Neptune 2 Ultra, but that it is not seeking an approval for the Neptune 1 Silver.
More information about today's safety alert is available on the FDA Web site.
To report problems with Neptune waste management systems, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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