-9

the Congress for the past ten years. The IUD hearings held by our Subcommittee established that legislative inaction in this field has impaired the willingness or the ability of FDA to regulate IUDs and other medical devices. As a result, public health protection has suffered.

It is important that Congress take definitive action this session to enact medical device legislation which is urgently needed.

Thank you.

Senator KENNEDY. I will now ask Mr. Goldhammer of the subcommittee staff to demonstrate several of the defective devices which might have been recently recalled from the market. These might never have been shipped or produced had there been good manufacturing practices and quality control requirements for medical devices.

Mr. GOLDHAMMER. Mr. Chairman, I do not know whether you can see this

Senator KENNEDY. Can we have your complete name?

STATEMENT OF GILBERT S. GOLDHAMMER, CONSULTANT TO THE SUBCOMMITTEE ON INTERGOVERNMENTAL OPERATIONS OF THE HOUSE COMMITTEE ON GOVERNMENT OPERATIONS

Mr. GOLDHAMMER. My name is Gilbert S. Goldhammer. My title is consultant to the Intergovernmental Relations Subcommittee of the House Committee on Government Operations.

I hope you can see this transparent plastic device [indicating]. It is an adapter that is used in tracheotomies or situations where air has to get down into the lungs and the body itself is not capable of transporting that air. This is the shape of a "T." It has a horizontal tube and a vertical tube. The air comes in through this horizontal tube, then goes down to the vertical tube, except in this particular device, there is a blockage at the point where the air is to turn to go down the vertical tube.

There is a plastic diaphragm over it which should have been stamped out at the time this was manufactured. This could be lethal, if that defect is not discovered before use.

Senator KENNEDY. Why?

Mr. GOLDHAMMER. It means that it is impossible for air to reach the lungs and the patient would either be injured or die of asphyxiation. There was such an occurrence actually-not a death but an injury—to a patient right here in our National Institute Clinical Center. Senator KENNEDY. How do we know that was not 1 out of 10,000? Mr. GOLDHAMMER. There were examinations made, I believe, in Los Angeles and several other places where stocks of this device were available.

Senator KENNEDY. All similar to that?

Mr. GOLDHAMMER. All similar to this, yes. A significant number of the individual devices either were completely plugged up or were partially blocked. In either case, this could be a lethal weapon.

Senator KENNEDY. In other words, even a very simple device can be life-threatening, and in such cases, the device ought to be adequately inspected?

Mr. GOLDHAMMER. This could have been avoided, I think, if there had been instituted in the factory where this had been produced an adequate quality control program.

In other words, by good manufacturing practices, which would include a quality control program, this would probably be caught.

Now quality control programs and good manufacturing practices are not capable of eliminating every last accidental production of defective merchandise. But we know from the experience in the enforcement of drug provisions where GMP's are required, many instances

are uncovered in the laboratory and the merchandise never gets out into the field. That is No. 1. I should say all of these exhibits were obtained from the Food and Drug Administration, which has quite a chamber of horrors illustrating hazards.

Another rather serious defect which could have disastrous effects is in this device which is known as a Miller-Abbott tube. This is 10 feet long, and at the end it has a little balloon. This balloon is collapsible. Let me see if I can collapse this. This says "balloon" and I could collapse it with this [indicating]. This is operating properly.

But let me explain first what this device is. This is inserted through the nose down the esophagus and penetrates to the lower digestive tract and lower bowel. It is used in the maintenance of patients who have had to be treated for perhaps intestinal obstructions. This is 10 feet long and it is composed of two tubes. The inner tube is to take compressed air and inflate the balloon, which must be inflated at all times during this operation. Then there is an outer tube which has six holes in it very close to the balloon. This outer tube is to suck out the gases and liquid content from the lower intestine and take them out of the body.

Now this one operates properly; there is nothing wrong with it. It has, as you see, a Y-shaped contraption up here. One of these is marked "balloon" and the other one is marked "suction."

The balloon is to take the compressed air, and if I blow through this with compressed air-I have the bad one. This is on "balloon" and I am trying to inflate it and I cannot. Why? Because they have these reversed.

The balloon terminal is for suction. Now I have the balloon here, and I am sucking.

Senator KENNEDY. Wait until someone reads this testimony. [Laughter.]

Mr. GOLDHAMMER. The suction you see takes the compressed air, so what is the effect of all of this? When you use this on this defective one and apply compressed air to the balloon and suction to the one marked suction, you actually get compressed air coming through the outer tube, where the suction should have been into the intestine, causing great distress and damage. When you try to inflate the balloon with compressed air, nothing happens.

So that this could be disastrous and actually there was a case of injury on the west coast. There was a death. It could not be established that this device was the prime cause of death, because the fellow had very serious surgery, but it does not take much imagination to realize the great damage which could be done to the patient.

Senator KENNEDY. I think the point is well made but in the manufacturing process, what would you do, change the top of it so it is more clearly identifiable to people who are trained to use these? I suppose the manufacturer's point of view would be that this wouldn't happen if the operator knows what he is doing?

Mr. GOLDHAMMER. No; he would be guided. Whoever uses this would be guided by designations on the tube. If it should be suction, they would apply compressed air

Senator KENNEDY. It is mislabeled. The point is because it is mislabeled, anyone following the instructions on the label could cause irreparable harm.

Mr. GOLDHAMMER. Absolutely. This could have been caught had there been a good quality control program in effect.

Mr. FOUNTAIN. Mr. Chairman, I am also pleased to note that all three bills contain a requirement for the standardization of devices. Such a provision, if enacted, should result in safer and more reliable medical devices and instruments.

Mr. Goldhammer will demonstrate several examples of defective devices which were removed from the market because of serious hazards. These devices probably would not have been marketed if standardization and preclearance requirements had been in effect.

Mr. GOLDHAMMER. This is a sterilizer used in hospitals to sterilize equipment. It is a portable sterilizer. The trouble with this device is that if someone were to touch the cover of the sterilizer, while at the same time brushing a nearby medical instrument or other medical object which is grounded, the operator could suffer a lethal electrical shock. Obviously, if there were standardization, this could perhaps be avoided.

Another example is this small eyepiece to an instrument, which is known as a resectoscope. It is for the purpose of viewing the internal organs of the body. This happens to be made of metal. Now the resectoscope transmits a rather high voltage when used, and the body of the device is shielded to protect the patient. But there is no protection to the viewer, to the physician looking through it, and he could get one jolt from this some doctors have actually been injured by it—their eyes and brows have been singed by it.

This is composed of metal. Obviously, with standardization, they could control the kind of materials that make up the product so that they are safe.

Now this is the last one, and this is shown from the standpoint of device preclearance. Congressman Fountain mentioned the Majzlin Spring intrauterine device. I have one here. This is a small thing. tightly wound. I am not sure whether any of you can see this. This is inserted into the uterus. It is just about the size of a clip, only it is a spring.

If I release the pressure on it, it opens wide. It is tightly wound when it is inserted into the uterus, and when it gets into the uterus, it opens wide. It is made of metal. It came into being in 1968, just about the same time that Mr. Goodrich was urging that IUD's be regarded as new drugs. This device turned out to be a fiasco.

Its intent was to overcome the spontaneous rejection or expulsion of IUD's, which was so troublesome with the other devices. This being a spring, it was thought it would be held more tightly in the uterus and not be spontaneously expelled. That is what made this an "instrument of the devil," as one physician said. Its ability to hang onto the uterus was so great that when the time came to remove it, it could not be removed. It was imbedded in the uterus and a number of uteri had to come out along with it. This turned out to be a disaster which could have been avoided, had FDA back in 1968 followed Mr. Goodrich's recommendation and required preclearance of this device.

Senator KENNEDY. When was that brought to the attention of the Food and Drug Administration?

Mr. GOLDHAMMER. The injuries came about a year after the device had been in use. The Food and Drug Administration by 1971 had

ample evidence that this was a dangerous device and causing serious injury. So by 1971 they knew all about it.

Senator KENNEDY. Why did it take so long to get it off the market? Mr. GOLDHAMMER. Well, I think it was because they felt that this was no different from all the other IUD's. As a matter of fact, there is a letter to the effect that all IUD's give you this injury, and there was a reluctance to single this one out, when all the others were equally implicated or almost equally implicated.

Mr. FOUNTAIN. Mr. Chairman. I realize your time is limited and I have another appointment, sir, so I am going to conclude with another brief observation.

Mr. Chairman, bills to regulate medical devices have been before the Congress for the past 10 years. I do not know why no action has been taken. Maybe no one has shown enough interest. Maybe the FDA and the FTC have not followed through adequately because they have recommended this sort of thing, but I think it is more unfortunate that in a well developed scientifically and medically competent country like ours something had not been done about it. The IUD hearings held by our subcommittee established that legislative inaction on this bill has impaired the willingness or the ability of the FDA to regulate IUD's and other medical devices.

As a result, public health protection has suffered.

I think it is important that Congress take definitive action at this session, as you have indicated, to enact medical device legislation which almost all or maybe all who are familiar with the facts know to be urgently needed.

Thank you, Mr. Chairman.

Senator KENNEDY. Thank you very much, Congressman. Yours is very helpful testimony, particularly because you have given the subject matter so much attention. I think it is very valuable to benefit from your experience and your concern.

I want to thank you and Mr. Goldhammer very much for your appearance here.

Mr. FOUNTAIN. I might say Mr. Goldhammer was with the Food and Drug Administration for over 30 years and retired. We have, as you know, quite a bit of experience in Mr. Goldhammer.

Senator KENNEDY. Thank you very much, Congressman.

Our next panel of witnesses, representing the Administration, consists of Dr. Charles Edwards, Assistant Secretary for Health, Department of HEW, and Dr. Alexander M. Schmidt, Commissioner of the Food and Drug Administration. We have had the privilege of hearing from Dr. Edwards many times, both in his present capacity and in his former capacity as Commissioner of the FDA. Dr. Schmidt, prior to becoming FDA Commissioner, was dean and professor of medicine at the University of Illinois College of Medicine from 1970 to August 1973.

I had the opportunity of meeting him when we were out having some hearings on the health care crisis in Chicago just about 2 years ago. Dr. Edwards, we want to welcome you, and I want to express at this time a very warm sense of appreciation that we on this committee have for the kind of cooperation and help that we have received from the Administration in helping us develop legislation.