INSIGHT REPORT
Vol 5  No. 5
May
2002

INSIGHT REPORT

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Insight Report Vol.  5  No.5  

The Olympus Recall - A lesson to be learned

It would appear that when misfortune occurs there is always a lesson to be learned. If we take the time to learn these lessons, then maybe we can avoid similar problems in the future.

Recently there was a major recall of bronchoscopes by the Olympus Corporation. On the surface, the announcement appeared to be a recall like any other, that may have been the result of a design or a manufacturing defect or even of misuse by a doctor.

However, a closer look at this recall situation reveals several lessons to be learned. Let’s review this situation and see what can be done to avoid similar problems.
 

The Olympus Recall

On March 5, the Associated Press announced that Olympus had recalled its bronchoscopes. These instruments are used to inspect a patient’s lungs and take tissue samples. The recall was due to a loose value that could trap bacteria which in turn could prevent complete disinfection and lead to possible cross contamination.

The article also stated that Olympus might have spread potentially life-threatening bacteria to patients, in that they knew the equipment was defective in September 2001, but did nothing about it for two months.

In Olympus’ press release, from their Japanese headquarters, they provided a time-line of their actions. It showed that on 9/17/01, they received a report on cross contamination inside a Tennessee hospital. They then initiated their investigation.

While pursuing their investigation, during the week of November 20th, they suspected that the maintenance of the sterilization process was not being performed in the proper manner. They then did their own testing in Japan. The results of this test showed that there was negative contamination even though the scope had a loose channel inlet.

On Dec. 8, they could not completely deny that the loose channel inlet was the cause of the contamination and they filed a recall for their bronchoscopes with the FDA, considering the patient safety as the reason. This was over two months after their first report of cross contamination.

There is one aspect that must be determined - can the company defend this time-line? This is the major question that will be asked should an investigation be conducted by the FDA, or even by the company’s own Regulatory Affairs department. (By the way, we were told that this recall was classified by the agency as a Class III recall.)
 

Let’s continue with the recall facts:

Olympus sent recall letters to 2,361 facilities in the USA notifying them of the recall of 4,418 scopes. Olympus subsequently recalled the sample scopes in Japan.

On Feb. 5, 2002, (approximately 2 months after the recall was initiated) Johns-Hopkins Hospital in USA, reported to Olympus America that they had detected pseudomonas virus in 9 bronchoscopes in their hospital. On Feb. 12th, Olympus America received an investigation request from the FDA regarding the Johns-Hopkins Hospital contamination issue, and Olympus responded with a report to the FDA with an explanation.

On Feb. 28, Olympus America received a report from Johns-Hopkins Hospital that two patients died on Feb. 28th. Olympus America immediately took the following actions:

1. February 28th, they tried to contact the person at the Johns-Hopkins hospital, but the person was not available.
2. On the same day they spoke with the FDA.
3. March 1st they contacted Johns-Hopkins Hospital, spoke with the person in charge and confirmed the following points:

a. To report to the FDA about the incident at the hospital and provide one of the scopes that was used at the hospital.

b. To retrieve 2 scopes from the hospital.

c. Johns-Hopkins informed them that they would check the patient’s history and run another investigation.

4. March 1st, Olympus informed the FDA the 3 items above.
    

So what happened here and what could we learn from this situation?

First of all, did Olympus wait too long between the first complaint in September and their final decision to recall the product in December. Having been involved in many recall decisions, I know this would depend on many factors. The decision to recall is quite serious as well as very expensive. Most companies will try to hold off on making such a decision until they are pushed to do it, either by the FDA or potential liability for not making such a decision. Many companies will do an extensive investigation of the situation after the original complaint. Of course this investigation should include a review of their other complaints and a service and repair trend analysis to determine if there was either a developing trend that should require a corrective action or an isolated incident that did not require immediate follow up?

Was the situation an isolated incident which nevertheless was completely unanticipated and still deserved a possible recall?

For most companies issuing a recall based on one complaint or unexpected repair is a very strong action to take, and would not be the usual course of action.

So when does a company decide to take that “recall” action? In the real world the recall decision is usually made either when the company finally determines that there is a problem with the product that could either be hazardous to the patient or the user and/or when the situation is such that it makes more sense to recall the product and make the necessary repairs than to wait until the product could possible fail. Such a failure would probably cause more problems and involve larger expenses as well as exposing the company to possible liability issues.

In either case, it is probably the hardest decision for a company to make.

A recall has many more implications then just the recalling of the product. In a recall the size of Olympus’, the logistics would include the notifying the companies, then getting the devices back to the facilities for repairs, in some cases supplying loaner scopes while the defective devices are being returned, dealing with your company’s reputation and lastly, the potential for law suits and even a class action suit against the company.

One can only speculate as to what occurred prior to the final decision in this. To really find out what happen would one would have to speak to all the people involved in the decision making process.

But, why didn’t Johns Hopkins learn about the recall until over two months after the recall action was taken? Who is at fault here? And why did it take Olympus several weeks to respond to Johns Hopkins’ initial inquiry in early February? This points to an apparent problem with the Olympus response team.

Let’s speculate that Olympus in fact did conduct their Class III recall and notified the initial consignee (where the unit was shipped to) of the recall. That they had return receipt mail receipts as well as notification that the recall information was received. Would notifying the receiving dock at a hospital of a recall seem reasonable in this case?

The shipping clerk doesn’t use the unit so what is his/her responsibility to the Hospital to notify the appropriate hospital staff? Did Olympus expose themselves to potential liability issues by not making sure that they notified the responsible people in the hospital of the potential problem of cross contamination?

I did discuss this with a liability attorney and he explained that without a doubt Olympus could be consider to be at fault for not making sure that the notification was made to the most appropriate individual in the hospital. This would have assured that the problem was transmitted to the proper hospital personnel thus preventing any future problems.

But, in fact, Olympus did what they were supposed to do according to the FDA regulatory requirements? Isn’t that enough? It maybe have been enough under the FDA but will it be enough in a court of law? In the long run it would appear that dealing with the FDA is kid’s stuff compared to dealing with the liability issues.

So, what is the moral to this story? What can be learned from this situation? First, it would appear that mere compliance with the agency requirements does not guard against future liability issues. Second, mere compliance with the FDA requirements may not always be the smart way to proceed. You have to remember that the FDA requirements are the minimum or the basic standards. You have to determine what is necessary for your situation, to assure the safety of your end user and to avoid future problems.
 

Let’s look as these questions:
 

• Should Olympus have notified the bronchoscope doctors of the problem and not relied wholly on the initial contact?
• Should Olympus have at least notified the Risk Managements in the hospital so that they could take the appropriate actions necessary to avoid potential problems?
• Should Olympus have posted the recall on their website to at the very least notify people who visited their website of their recall actions?
• Could any of these have prevented future liability issues?
   

These are things that you should remember when you are in a similar situation. You should check your recall procedures and make sure that they address all potential issues and remember that complying with the FDA regulatory requirements may not always be enough to assure patient safety.

If you want to discuss this Insight Report or your recall strategies please email us at info@mdiconsultants.com. We would be glad to chat with you and see how we can address your concerns.
 

The next Insight Report – To Be Announced

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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