Deny The Problem Exists or Solve It?The solution Olympus has repeatedly fallen back upon is to stonewall and deny that a scope contamination problem exists, and, when they are forced legally or by a regulatory authority such as the FDA or to law makers like Senator Murray's Health, Education, Labour, and Pensions Committee (recall their statements last January 2016) they obfuscate with the best of their ilke and say they are meeting all regulatory rules and that the problems are related to user errors.
These scope contamination problems are not being solved (unless your health care facility is buying or has purchased a VP4); this is only the tip of an enormous iceberg.
Dr. Rutala's reported comments as per Terhune's article on the stand in Seattle should not go unnoticed: "“I found there was completely inadequate premarket validation testing. It was essentially nothing in my opinion,” William Rutala, an infection-control expert at the University of North Carolina, told the jury. Rutala has served as an expert witness for Olympus in the past during litigation involving other types of scopes. He said that the company asked him twice to testify on its behalf for this trial but that he refused because of the company’s failure to ensure patient safety. “I have been deceived. I thought there were meaningful data associated with [reprocessing] validation,” Rutala testified. “This device was intrinsically defective.”"
Again, don't forget that Olympus's redesign of their scope failed to solve the problem as previously reported in March 2017 and noted on the FDA Maude site: https://www.latimes.com/business/la-fi-olympus-scope-outbreak-20170322-story.html
Olympus is not alone to blame; but, they are the major player in the scope field, and they will deny, deny, deny...all scope contamination problems for duodenoscopes, cystoscopes, colonoscopes, gastroscopes, bronchoscopes....
until, perhaps:
1) They, or the company that acquires their scope business out of bankrupcy from the billions in individual and class action suits against them (?estimated cost 2-4 Billion in US suits alone), buys TSO3 so that they can solve and control their own problem, and can show regulators that they can be proactive to improve health care promoting this new VP4 solution (instead of stonewalling and reacting to problems they have ignored)
2) They decide to work or are told to collaboratively with TSO3 to honestly and develop changes to their scopes that ensure durable long term compatibility with the gold standard VP4 solution
3) Regulatory bodies including the FDA and government oversight Committees, such as Senator Murray's Health, Education, Labour, and Pensions Committee, mandate or legislate change, to the Spaulding Classification, for example, moving scopes from the semi-critical to the critical category.
I commend Rumble and TSO3 for going ahead and planning their individual device specific duodenoscope FDA submission for Olympus's duodenoscope without their assistance or endorsement. But, it should not be overlooked that TSO3 already has claims for a host of scopes that have been implicated in other scope contamination problems such as those reported in the AJIC in-press article regarding cystoscopes I referred to in an earlier post today.
TSO3 is taking the lead role in getting its story out regarding its solution and they must continue to do this, with or without Getinge's help. They must not wait for industry players like Olympus, or even Pentax, to cooperate or get their ducks in a row before showing the FDA and agencies such as that relevant Senate Committee what they can do and that TSO3 has the solution to this ongoing problem.
I only wish Terhune or Petersen or other reporters would give TSO3 some well deserved coverage and help get the word out so that more patients and health care providers are able to demand the TSO3 solution be made available in their communities.