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determination of the appropriate remedy after such notification is a decision that should be left to the manufacturer and the purchaser. Replacement or reimbursement are matters which should not be left to the Secretary. In many instances, the question of whether

a product is defective is ultimately decided by a jury in a court of law. The Secretary has other mechanisms to ensure that products whose use may result in a hazard to health are removed from the market. These mechanisms and notifications by the manufacturer should be sufficient to protect the public health and S. 2368 should be modified accordingly.

The Secretary is authorized to use existing classification panels and the conclusions reached by these panels in the classification of devices. The criteria used in establishing existing panels and developing panel conclusions were not the same criteria provided for in S.2368. Individuals with actual production experience are not voting members of existing panels. For these reasons, existing panel findings should not be adopted unless reviewed by new panels established in accordance with S.2368.

In the definition of the term "adequate scientific evidence" which will be required for products to obtain pre-market clearance, emphasis is placed on the use of "sufficient well-controlled investigations." Based on the historical use of the term by the Secretary in evaluating drugs, it can be anticipated that the Secretary will require wellcontrolled studies in all cases requiring scientific review. requirement is inappropriate for many medical devices. S.2368 should be amended so that the Secretary is required to accept as adequate scientific evidence clinical experierce, tests, studies and other scientific data which could be used by experts qualified by scientific

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training and experience in evaluating the safety and performance

the device involved.

6. S.2368 provides for the classification of devices, and would allow to the maximum extent practical, an opportunity for interested persons to submit data and views on the classification of a device We would urge that manufacturers be given the right to provide such input.

7. S.2368 also provides that panel members possess adequate skills in the "use of or experience in the development, manufacture, (and) perfection" of devices they are considering. We urge the Sub-Committee to consider making it mandatory that individuals who have "experience in the development, manufacture, (and) perfection of devices" be members of such committee.

8.

S.2368 would allow the Secretary to assess the cost of assembling an independent advisory committee to the person requesting referra to that committee. As stated previously, many of the manufacturer of medical devices are small in comparison to manufacturers in other health related activities. The cost of assembling an advisory committee could be considerable and may act as a deterren to a small manufacturer. He may decide to drop a product rather than incur the additional expense.

HIA appreciates the opportunity to present our views on medical device legislation to the Sub-Committee. We have made a number of suggestions which would require amending S. 2368, and we are prepared to discuss these in detail. Thank you for the opportunity to present

this statement on behalf of the members of the Health Industries

Association.

Mr. WHITLOCK. The next association, gentlemen, is the Medical-Surgical Manufacturers Association, represented by Mr. James Lierman. STATEMENT OF JAMES D. LIERMAN, EXECUTIVE VICE PRESIDENT OF C. R. BARD, AND PRESIDENT OF THE MEDICAL-SURGICAL MANUFACTURERS ASSOCIATION; ACCOMPANIED BY JAMES HULSE OF BECTON-DICKINSON CO., AND RICHARD FLINK, FROM C. R. BARD

Mr. LIERMAN. I am James D. Lierman, executive vice president of C. R. Bard, a major manufacturer of medical devices and the president of the Medical-Surgical Manufacturers Association (MSMA). I have with me this morning Mr. James Hulse of the Becton-Dickinson Co., and Mr. Richard Flink from C. R. Bard.

MSMA is a trade association representing manufacturers of medical and surgical devices. Founded in 1903, MSMA is the only trade association in the United States representing solely the manufacturers of these products. Our present membership totals 105 companies, which range in size from an annual sales volume of less than $1 million to annual sales in excess of $1 billion. An examination of our membership would show that approximately 65 percent of them qualify as small businesses as defined by the Small Business Administration.

These small manufacturers, as has been noted many times before, play an important and indeed a vital role in the medical device industry. I am here to speak in large part on their behalf.

First, I would like to endorse and support the statements made by our spokesman, Mr. Whitlock. I sincerely hope that this subcommittee will carefully consider the recommendations that he has made. If the quality of health care, here in the United States, is to continue to improve at the same rate as in the past, these recommendations must be accepted.

There is one other area, not covered by Mr. Whitlock, due to the limited time allotted-that is the provisions of S. 2368, which are addressed to standards for medical devices.

We seriously question the language of section 513 (a) (1) wherein it is stated that standards may relate to the composition, construction, properties, and uniform identification of a medical device. It should be kept in mind that the overall objective of any medical device bill is to help assure the reasonable safety and effectiveness of medical devices.

We ask that the authority to set standards be limited to standards establishing the performance criteria necessary to achieve reasonable safety and effectiveness and that the bill not attempt to define the particulars or details which may go into the development of a standard. Such detail, in my opinion, is not necessary. We can anticipate that granting authority to establish specifications for types of materials would unduly restrict the development and manufacture of medical devices. It should suffice for a standard to set forth performance criteria or efficacy criteria, leaving for the manufacturer the manner in which his device meets this criteria.

If a standard were to allow only for the use of a specific material, an occasion might arise where new technology brings to the market a

new material which has equal or better properties, yet this material could not be used in the manufacture of a medical device without amending the standard. Amendments to standards take time; time which could be very detrimental to a patient in need of a medical device.

Senator KENNEDY. Last Friday we had testimony about the materials used in the construction of heart valves in particular on the struts of one valve. It was pointed out that the materials had a brittle characteristic, and therefore some of them broke off. We heard that four deaths could be attributed to the breaking off of these various struts.

Now as I understand your testimony, you feel the legislation should cover only the characteristics of the particular device, not the materials that go into it.

I am wondering how we should handle this situation. The materials that went into the valve had defective characteristics and because there had not been adequate review of these characteristics deaths resulted at least in some cases. How do we handle that?

Mr. LIERMAN. It seems to me the way that is handled is to specify the strength of that particular object. It seems to me that a specification should be written around that certainly the product is nontoxic, that it is nonirritating. Certainly the specification should indicate the diameter of the product, possibly the strength of it, the length of it, but I think allowing the manufacurer to use materials of his choice that meet those specifications can provide, I believe, more rapid improvement of the product as new materials are brought to the marketplace. I guess I could relate it possibly as an example by using the automobile seat belt. It seems to me that the requirement for a seat belt is strength, possibly the width of the seat belt. Perhaps that is not a good example, but that again allows the manufacture of seat belts, for example, to use materials that are more economical or materials that will provide better protection to the user.

Senator KENNEDY. Would you have objections to having detailed performance standards?

Mr. LIERMAN. I think we are talking mainly about the types of material that are specified. We endorse the requirements and the properties of the requirement, but allowing the manufacturer, the clinical investigator to come up with improved materials without having to go through and get the specifications changed, because these can be quite lengthy.

I can visualize these requiring a period of a year or so to get a specification changed on a product. But I think we are all interested

Senator KENNEDY. Would we not meet both of our goals if we had detailed performance standards for these various devices?

Mr. LIERMAN. That is right. The key to the whole subject is performance. That is what we are all after. How is the product going to perform? I think that is what we are after.

Senator KENNEDY. You go ahead.

Mr. LIERMAN. Innovators and developers of medical devices must have complete flexibility to blue-sky the problem in order to find the best solutions. They must not be unduly inhibited with restrictive

standards that specify material and design characteristics. Do not needlessly stultify these many thousands of dedicated individuals who are daily trying to bring new and better devices to our Nation's sick and wounded.

I submit, Mr. Chairman, that in today's modern technology, it is possible to set out in great detail just what a medical device must do, or not do, in terms of performance required to insure reasonable safety and effectiveness. It can then be stated what those tests are that the device must meet to insure performance.

It is difficult for me to conceive of an instance where performance type standards will not be adequate. However, there may be times when other types of standards are required. Therefore, I recommend that the sentence "to the maximum extent possible, standards for medical devices will refer to performance criteria" be inserted into this section at the appropriate location.

I would make one final point. Medical devices are inanimate objects; they do not treat or cure disease on their own initiative. They are nothing more than the tools that are used by the professional, or paraprofessional. The finest surgical blade in the hands of an unskilled person, becomes a dangerous weapon. On the other hand, when used by a skilled surgeon, it becomes a lifesaving instrument.

As you design controls for one instance don't overlook the other. Don't tie the hands of the skilled surgeon with more controls than are absolutely necessary.

Thank you, Mr. Chairman.

[The prepared statement of Mr. Lierman and other material supplied for the record follows:]