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PK7300
With capacity for 300 specimens per hour, this is the latest model in the PK series. Enhanced support for medical GMP requirements have been built into this system from the design stage. It provides a stable testing environment through internal temperature and humidity control. All items, including microplates, reagents and diluted liquids, are identified by barcodes, providing enhanced traceability for test results. The photograph shows a PK7300 in use at the Hokkaido Red Cross Blood Center. |
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| The PK7300's data management screen provides easy access to test data records, storage, and connections to external systems. |
We have shipped 350 PK Series systems worldwide. Each year they are used to process tests for 20 million people. These figures add up to an awesome responsibility. If we expand into the Chinese market, we anticipate that the number of tests will increase to 25-30 million. When we create a new product, we want to show our customers that we can still improve our accumulated technology. We look forward to the continuing cooperation of the Hokkaido Center for this reason, too.
And we look forward to working with you.
Olympus systems are used throughout the world, including the major markets of North America, Europe, as well as South Africa, Iran and Finland. We also have markets in Asia, including China, Taiwan, Thailand and Malaysia.
This is a reflection of the reputation that Olympus has built. However, needs are changing. In medical fields, such as blood transfusions, we must be aware of the demands of good manufacturing practice (GMP).
Patients' lives depend on blood transfusion services. Obviously, the equipment used must be reliable.
Olympus has many overseas subsidiaries, but confidence in products made in Japan is extremely high. We become immediate aware of this when we go overseas. This contrasts with the harsh views that we sometimes hear from our customers in Japan. Yet it is precisely because our products meet the demanding criteria of Japanese users that we are trusted throughout the world.
Some manufacturers have moved into the Japanese market, only to retreat because the market was so demanding. Japanese users always want perfection.
The standards are different. I think there are also differences in the ways in which equipment is used.
One of the issues relating to the way equipment is used is the handling of subtypes. (Note Subtypes are blood group variations that are difficult to type, because they do not produce proper reaction patterns in normal testing.) Because subtypes produce weak agglutination patterns, accurate automatic typing is very difficult. Some say that systems that cannot do this are unacceptable. But it's not clear whether such rigorous testing is really necessary for actual blood transfusions.
That's a scientific question rather than an equipment problem.
From a transfusion practice perspective, I don't think such rigor is really necessary.
In Europe, such concerns are generally regarded as hair-splitting, provided that there have been no actual cases of transfusion side-effects. But it's different in Japan. It may seem strange to worry about such subtle details, yet perhaps medical technologists regard the achievement of perfection as necessary to the fulfillment of their professional duties.
Hair-splitting is not necessarily a bad thing. It may lead to important discoveries. That's important.
From a practical perspective, PK Series systems are used in all blood centers in Japan. Given this situation, I would suggest that our approach should be to work with those who are focused on perfection to consider how our systems should be administered.
Dr. Kato, you understood the capabilities of the system, and you went one step further by suggesting ways to achieve even better results. But few users were so supportive. Generally, they would just tell us that the system was unacceptable. That made our work as manufacturers very difficult. You encouraged us by telling us that the system was already good enough to be useful, provided that users employed it intelligently.
From what you are saying, it seems in one sense that we need to offer not only improvements to our systems, but also new ways to perform tests.
That's a very important concept.
What we need is a mass-screening system. If there are specimens that cannot be tested on such a system, they can be handled separately by medical technologists. The question is where to set the standard. If the standard is too rigorous, the reject ratio will rise, causing testing efficiency to fall. We need to consider the characteristics of the system carefully so that we can truly understand the aims of automation and the reasons for using these systems.
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