Neptune waste management systems made by Stryker are used in operating rooms across the country to clean up surgical fluid waste. Some models of the Neptune waste management system can even get rid of smoke that may accumulate inside surgical operating rooms that can come about from laser or electrocautery devices.

In 2012, the Food and Drug Administration, or FDA publically announced a Class I recall. Recalls at the Class I level are issued when devices are deemed to likely cause serious health effects or consequences because of their use.

While the recall applies only to two specific models of the Neptune waste management system, it also questions whether all Neptune models could be dangerous due to a lack of understanding by the surgical personnel who use them. If the system is used incorrectly, hemorrhaging, soft tissue, vital organ, and muscle damage can also occur.

In some cases, the improper use of the Neptune 1 Silver and Neptune 2 Ultra System caused serious health effects and injury. The recall was prompted by reports of injury and at least one instance of death related to the use of the Neptune waste management system.

Because of the recall of the Neptune Systems, the FDA was left concerned about health related effects and injuries occurred due to inadequate education and training regarding the Neptune Waste Management systems.

As a result of the recall, hospitals were left questioning whether they should either replace their waste management systems or add additional oversight and training.

Many hospitals decided to implement additional internal education and training by incorporating and requiring a Certificate of Medical Necessity, acquired and earned by the hospital medical staff. Other hospitals decided to stop using the Neptune waste management system completely.

The FDA, however, removed its recall in February 2014. Safeguard mechanisms and system improvements such as a “hands-on continuing education programs,” was introduced.

The hands-on education program includes a workshop in the correct use of the Neptune waste management system, lessons on healthcare professional responsibilities, safety measures and precautions in the use of suction devices and applications, and the “science of volumetric pressures”.

Occurrences in device or system recalls illustrates and provides a great reminder that an important part in assuring the safety of patients is the proper education of all medical and hospital staff who use the device.

Patients who have suffered injuries related to use of the Neptune waste management system may be able to seek compensation for their injuries. A consultation with an experienced medical device attorney can apprise such a patient of all their legal options.