Medical Device Link.

Originally Published IVD Technology July 2003

IN PERSON

Louis J. Dunka Jr., PhD, is chair of the American Association for Clinical Chemistry industry division and professional affairs officer for Lifescan Inc. (Milpitas, CA). He can be contacted at LDunka@LFSUS.JNJ.com.

Last year, the American Association for Clinical Chemistry carved out a permanent space for IVD companies by establishing an official industry division. The division was created to be a forum in which IVD manufacturers could network with other AACC members, and a vehicle through which common concerns could be addressed. Additionally, the division was established to enhance communication between division members and clinical laboratorians to encourage cooperation and promote synergies. 

The early actions of the division have taken the form of educational workshops. Goals for further educational and collaborative activities will be created around the industry needs that are voiced at the division meeting during the 2003 AACC Annual Conference. Conference attendees can register for the industry division annual meeting on-line at http://www.aacc.org/2003AM/register.stm. 

To receive an update on the evolution of the industry division and its role in serving the needs of the IVD industry, IVD Technology editor Richard Park spoke with Louis J. Dunka Jr., PhD, chair of the AACC industry division and professional affairs officer for Lifescan Inc. (Milpitas, CA). In this interview, Dunka discusses relations between the industry division and the more laboratorian-focused divisions of AACC, the most recent industry division educational activities, and the importance of membership and participation in division activities. 

IVD Technology: How has the industry division been progressing since it became an official AACC division last year?

Lou Dunka: It has been coming along fine. We have put together several programs primarily focused around membership activities. 

How has the industry division been received by those in industry?

The division has received a significant level of support. Industry sees a need for representation within AACC. We are one of the main financial supporters, via booth fees and attendance, at the annual meeting, and we are the driving force behind what goes on in the laboratory.

Why do you believe it is important to join the industry division?

We discuss and address those issues that affect the industry. We provide education and activities. Currently, our efforts are geared primarily around meeting the requirements of the IVD Directive, and members benefit by participating in the networking and educational opportunities we provide.

Recent Activities

What programs has the industry division been involved in?

We participated in a workshop at the National Institute of Standards and Technology (NIST; Gaithersburg, MD) on calculating statistical uncertainty in relation to the price of bloater (ph) requirements in the European Union. 

I, along with a couple of folks from FDA and several statisticians from NIST, determined how to calculate uncertainty. We accomplished this task to help both FDA and industry come to a consensus about how uncertainty will be presented once the IVD Directive requirements become law in December 2003. The results of this workshop will soon be available on the Web at http://www.nist.gov. 

How much progress has the industry division made in accomplishing its previously stated goals?

We have met our goals for the year through educational workshops. The NIST workshop fulfilled one of those and we are also putting on a workshop on traceability at the annual AACC meeting. The primary goal of the division has been education to this point. At the AACC business meeting, we will work at broadening our goals beyond that.

Besides traceability, what are some other issues that you’re planning on addressing?

Labeling under the IVDD is a significant issue since each country in the EU can require that labeling be done in its language. So the division has been working with AdvaMed (Washington, DC) to get symbols officially recognized. So far, we have had some success in getting FDA to recognize 19 symbols. 

Initially, FDA indicated that they would accept the symbols with terminology inside. That was counter to the purpose of using symbols, which was to avoid the use of words. 

Through AdvaMed, symbols were printed up and tested on a group of laboratorians to see whether they could recognize the meaning of the symbols. The test was highly successful, and FDA has indicated that they will recognize 19 of those symbols without the accompanying language.

Will attendees from the industry, who are not necessarily members, have any input at that meeting?

They will. It’s open to everyone, and that’s basically how the strategy is decided upon. We receive input from the attendees, do a prioritization, and then figure where we can focus our efforts best.

Tackling the IVD Directive

What issues has the industry division been focusing on? 

This year, the IVD Directive and how it is going to affect all our products is the number-one subject.

What aspects of compliance with the IVD Directive has the industry division identified as priority issues?

Traceability, labeling, and self-certification for most of the IVD products. 

Most IVD companies are going to self-certify their products, which indicates that their products meet the requirements of the IVD Directive. This is a big issue because IVD manufacturers suspect that the first time there is a problem with a product that has been placed on the market, there may be a call for changes in the IVD Directive. These changes would probably include the requirement for a more formal review of product technical specifications than the review that is currently required under the IVD Directive. 

In order to sell their products in the United States today, IVD manufacturers file a 510(k) with FDA. However, for marketing and sale in the EU, IVD manufacturers submit their technical files for review by the competent authorities and approval under the IVD Directive. Most IVDs will be reviewed in this manner, except for a few self-testing products and some high-risk products like HIV tests. 

Once IVD manufacturers put together a technical dossier, they can file it away in a drawer, and they have essentially successfully satisfied the requirements for self-certification. However, if manufacturers with self-certified products must initiate a recall, the process of self-certification will be called into question. Self-certification saves manufacturers time and money, so the threat of withdrawing self-certification as a viable method of approval is on the minds of many division members.

How can IVD manufacturers go through the self-certification process in a manner that will allow them to avoid recertifying in a more formal manner in the future?

Manufacturers could bring in third-party auditors to inspect their quality systems and their technical dossiers. This additional step would give manufacturers an added level of assurance. Thus, if they were required to go through a more rigorous recertification process in the future, they will know they could survive the scrutiny.

I think that larger organizations may have enough expertise internally to do audits, but smaller organizations may be unable to sustain the expense of an external audit. Although an external audit can ensure that a manufacturer will survive a rigorous inspection, I’m not sure that a lot of organizations can afford to take advantage of one.

Working with Laboratorians

How have the relations been between industry members and the vast majority of AACC members?

Benign neglect. I’m not trying to be flip, but most AACC members see us as necessary. The issues that we deal with are often not issues that they deal with, so we are somewhat different than the other divisions.

Could you give some examples of those differences or where they may stem from?

The industry division’s concerns are related to either our viability as an industry or our ability to serve the laboratories. For example, AACC membership is composed mostly of American laboratorians, and the IVD Directive means nothing to them. The directive is a huge issue to the industry division because we want to manufacture the same product for Europe, Asia, and the United States.

Can the industry division and AACC members find common ground on issues of mutual concern?

Some of the issues around reimbursement affect us all equally. If a lab doesn’t get paid appropriately then they’re not going to make money, and if they won’t get paid, they’re not going to use our test. Most common issues are those that are related to the financial health of both sides, and we work on those together. Competitive bidding will have a huge impact on both industry and on the labs.

How do you believe the industry should handle issues about which laboratorians and manufacturers disagree?

In the end, we should both consider how to best serve the patient. Issues of traceability and uniform calibration are important to all of us because at one point or another, every one of us will be in a hospital and will want to get a correct result when we’re tested. 

An area of conflict is over point-of-care tests (POCT) versus testing in the central lab. My view is that whatever opinions laboratorians hold about POCT, it’s here to stay. It’s growing at a rate that’s about five times the rate that central-lab testing is growing. The devices are becoming more sophisticated, more comprehensive, and the laboratory has an important role in making sure that POCT is done properly and that the results are appropriately credentialed and communicated. 
If laboratorians try to stand in the way of POCT, they’ll probably be left behind when, instead, they could play an important role in making sure POCT progresses in a valid and effective manner. 

A couple of years ago, the connectivity industry consortium, which created the universal connectivity standard for point-of-care, specifically included the ability to communicate results from testing done in nursing homes, from distances, and from patient homes in their standards. Laboratorians can contribute to the advancement of POCT by insisting that, if they’re going to be responsible for processing testing conducted outside of the laboratories, the testing must be done with appropriate calibration, when calibration is required. 

They can insist that control testing is done and that information is provided that verifies that the test has been conducted in an appropriate manner on the correct patient. Wherever the testing is done, a certain amount of information is required to appropriately credential the data. Laboratorians can demand that testing be done properly, either by requiring that manufacturers design products that prevent end-users from doing the testing when insufficient information has been entered, or by making sure that results aren’t posted to a laboratory information system unless all of the required information has been provided.

Future Directions

It seems that the IVD Directive was the real hot topic for this past year. Any speculation in terms of what the next hot topic will be?

The whole concept of evidence-based medicine is emerging. Evidence-based medicine involves putting algorithms together to provide clinicians with advice on what they should do, based upon laboratory results. This type of medicine is a growing issue within AACC, and I think that the industry division could get involved in and hopefully have an impact on this technology.

What is evidence-based medicine?

When a person goes into a hospital emergency room with chest pains, they receive a battery of tests for cardiac markers. One application of evidence-based medicine would be if a doctor could generate recommendations for the course of action based on the laboratory test results. 

For instance, an expert group of cardiologists could come together to determine the combination of component myoglobin and CKMD that would allow a person to be sent home, the combination that would put them into the hospital for observation, and the levels that would send them to the cardiac test labs. Once the cardiologists come to a consensus, that information could be incorporated into software, so that as the results came back from the laboratory, the software would generate recommendations based on the expert system. They may generate a recommendation that 97 percent of the time, people with this combination, when sent home, were sent home safely. That’s evidenced-based medicine.

How do you envision the industry division getting more involved?

We could put on a symposium, bring in some of the leading experts in the area, and give examples of how the technology could be applied. 

What else does the industry division have planned for the coming year in the short term, and, long term, into the future?

The industry division will actively address the needs of its members and make them known on a more frequent basis. We may set up more educational audio conferences and other activities that would make it easier for more members to participate.

Copyright ©2003 IVD Technology