05.08.2014

Infection Risks Posed By Damaged Sterile Packaging

A voluntary field safety corrective action has been initiated by Smith & Nephew for all batches of its RT-PLUS Modular Femoral Components manufactured since 2007.

The company said a packaging issue could lead to the component’s triple-pouch sterile packaging being damaged during shipping. 

The issue may result in a potential breach of the sterile barrier, which may lead to infection when fitted during knee implant procedures.

Smith & Nephew said the potential risk for contamination is minimal as the triple-pouch components are terminally sterilised and antibiotics are used to prevent infection before procedures take place.

It also stated that the area being operated on is washed out and revision surgery is carried out as a standard procedure.

Expert Opinion

While the likelihood of infection of patients undergoing knee replacements using RT-PLUS Modular Femoral Knee Components is minimal, it is vital lessons are learned by the manufacturer and steps are taken to improve packaging to prevent the potential for infection in the future. Ensuring packaging is safe for transport should for part of the manufacturer’s quality assurance procedures. <br/> <br/>“The manufacturer needs to investigate how this fault occurred and take action to prevent such problems in the future. <br/> <br/>“The safety of patients undergoing major surgery of this nature should always be the top priority and it is vital the devices being used to treat them meet the highest possible standards.” Kevin Timms - Solicitor