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Why medical manufacturers need to address risks early

The outbreak of the ‘superbug’ bacteria at the UCLA Health Center late last year, was linked to the use of the hospital’s duodenoscopes. The situation brought into sharp focus the need for proper sterilization of medical equipment. The subsequent lawsuits brought against the manufacturer of the medical scope, shows why medical manufactures need to address possible risks early, by reviewing current standards for sterilization.

Although the medical scopes were cleaned according to the specifications outlined by the manufacturer and the FDA, an outbreak did occur. This was due to the fact that the design of the machines makes them difficult to clean. Cleaning is usually done manually, as the machines are sensitive to high temperatures, and cannot be sterilized using an autoclave.

After the outbreak, the FDA issued a Safety Communication in February 2015, advising that the design of the endoscope may impede effective cleaning.

Consequent to the fallout from this case, both medical manufacturers, and health care facilities need to be proactive and implement procedures to minimize risk. There is no doubt that the public will be demanding more accountability from both parties. Therefore neither of them will be able to avoid culpability in these matters.

For their part, medical manufacturers need to re-evaluate the sterilization of these types of devices. Health care providers also have a role to play, because in the absence of a review, they need to put in place procedures that will ensure that medical devices are properly sterilized.   This is the only way that any potential risks will be identified and addressed early.

Medical manufactures or health care facilities that need legal counsel on this matter, can contact Nelson Hardiman, LLP, Los Angeles at 310-203-2800. You can also go online to http://www.nelsonhardiman.com/contact-us/.

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