General and plastic surgery devices panel medical devices advisory committee open session



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ATDEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

GENERAL AND PLASTIC SURGERY DEVICES PANEL
MEDICAL DEVICES ADVISORY COMMITTEE

OPEN SESSION

Wednesday, June 16, 1999


10:00 a.m.

Gaithersburg Hilton

Salons D and E

620 Perry Parkway

Gaithersburg, Maryland
PARTICIPANTS
Thomas V. Whalen, M.D., Acting Chairperson

David Krause, Ph.D., Executive Secretary


VOTING MEMBERS
Phyllis Chang, M.D.

Benjamin O. Anderson, M.D.

Susan Galandiuk, M.D.

David L. DeMets, Ph.D.


DEPUTIZED VOTING MEMBERS
Thomas B. Ferguson, M.D.

Blake Hannaford, Ph.D.

Michael D. Crittenden, M.D.

Mark A. Talamini, M.D.

Nancy N. Dubler, LLB.

Cedric F. Walker, Ph.D., PE


NONVOTING MEMBERS
Maxine F. Brinkman, RN, Consumer Representative

James W. Burns, Ph.D., Industry Representative


C O N T E N T S
Conflict of Interest and Opening Remarks,

David Krause, Ph.D. 4


Panel Introduction 7
Update Since Last Meeting, Stephen Rhodes 10
"Postmarket Evaluation at FDA's Center for Devices

and Radiological Health, Larry G. Kessler 12


Presentation of Award, Mr. Jim Dillard 30
Applicant Presentation, Intuitive Surgical Incorporated:
Introduction, Michael Daniel 32
Technology, Fred Moll, M.D. 34
Statistical Analysis, Dan Bloch, Ph.D. 40
Clinical Study and Results, Barry Gardiner, M.D. 49
FDA Presentations
Preclinical and Technical Aspects, Dwight Yen 98
Clinical Aspects, Roxi Horbowyj, M.D. 101
Statistical Aspects, Harry Bushar, Ph.D. 110
FDA Questions, Dwight Yen 119
Panel Deliberations
Preclinical Overview, Blake Hannaford, M.D. 121
Clinical Overview, Mark A. Talamini, M.D. 131
Statistical Overview, David L. DeMets, M.D. 138
Discussion of FDA Questions by the Panel 159
Concluding Panel Deliberations and Vote 184

P R O C E E D I N G S

Conflict of Interest and Opening Remarks

DR. KRAUSE: I would like to get the meeting started, please. Good morning, everyone. We are ready to begin this meeting of the General and Plastic Surgery Devices Panel. My name is David Krause. I am the executive secretary of the panel. I am also a reviewer in the Plastic and Reconstructive Surgery Branch in the DGRD.

I would like to remind everyone that you are requested to sign in on the attendance sheets, which are outside the door, on the tables. You may also pick up an agenda, a panel meeting roster and information about today's meeting there. The information includes how to find out about future meeting dates through the advisory panel phone line and how to obtain meeting minutes or transcripts.

Before I turn the meeting over to Dr. Whalen I am required to read a number of statements into the record. I have three statements to read. One is the deputization of temporary voting members. The second is deputization of acting chair, and the third is the conflict of interest statement.

This is the temporary voting status: Pursuant to the authority granted under the Medical Devices Advisory Committee Charter, dated October 27th, 1990, as amended on April 20th, 1995 and October 10th, 1997, I appoint the following people as voting members of the General and Plastic Surgery Devices Panel for this meeting on June 16, 1999: Blake N. Hannaford, Nancy A. Dubler, Mark A. Talamini, Cedric F. Walker, Thomas B. Ferguson and Michael D. Crittenden.

For the record, these people are special government employees and are consultants to the Center for Devices and Radiological Health under the Medical Devices Advisory Committee. They have undergone customary conflict of interest review. They have reviewed the material to be considered to this meeting. And, it is signed by Dr. Elizabeth Jacobson, Acting Director, Center for Devices.

I would now like to read the appointment of the temporary panel chair person. I appoint Thomas V. Whalen, M.D. to act as temporary chairperson for the duration of the General and Plastic Surgery Devices Panel meeting on June 16th, 1999. For the record, Dr. Whalen is a special government employee and is a voting member of the General and Plastic Surgery Devices Panel. Dr. Whalen has undergone customary conflict of interest review. He has reviewed the issues to be considered at this meeting. It is signed by Dr. Feigel who is the present Director of the Center for Devices.

Finally, I would like to read the conflict of interest statement. The following announcement addresses conflict of interest issues associated with this meeting, and is made part of the record to preclude even the appearance of an impropriety. To determine if any conflict existed, the agency reviewed the submitted agenda and all financial interests reported by the panel participants. The conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employers' financial interests. However, the agency has determined that participation of certain members and consultants, the need for whose services outweighs the potential conflict of interest involved, is in the best interest of the government.

The agency took into consideration matters regarding Drs. Cedric Walker, Blake Hannaford, Susan Galandiuk and Benjamin Anderson. These individuals reported financial interests in firms at issue, but in matters not related to the topic to be discussed by the panel. The agency has determined, therefore, that they may participate fully in today's deliberations.

In the event that the discussions involve any other products or firms not already on the agenda for which an FDA participant has a financial interest, the participant should excuse him or herself from such involvement, and their exclusion will be noted for the record.

With respect to all other participants, we ask in the interest of fairness that all persons making statements or presentations disclose any current or previous financial involvement with any firm whose products they may wish to comment upon.

At this time, I would like to turn the meeting over to Dr. Whalen.



Panel Introduction

DR. WHALEN: Thank you, Dr. Krause. My name is Thomas V. Whalen, and I am head of the Division of Pediatrics Surgery at Robert Wood Johnson Medical School at Camden, where I also hold the role of Associate Professor of Surgery and Pediatrics.

Today, our panel will be making recommendations to the Food and Drug Administration on a premarket approval application. Our next item of business is to introduce our panel members, who are giving of their time to help the FDA in these matters, and the FDA staff who are here at this table. I would like to ask that each person introduce him or herself, stating his or her specialty, position title, institution and his or her status on the panel as voting member, industry or consumer representative or deputized voting member. I would like to ask Dr. Burns to begin and we will go around the table.

DR. BURNS: I am Jim Burns. I am Vice President of Biomaterial and Surgical Products Research at Genzyme Corporation, and I have a Ph.D. in bioengineering, and my expertise is in biomaterial science.

MS. BRINKMAN: I am Maxine Brinkman, Director of Women's Services, from Mercy Medical Center in Mason City, Iowa. I have an RN and a masters in public health.

DR. WHALEN: Could you each mention your status on the panel?

DR. BURNS: I am the industry rep. for this panel.

MS. BRINKMAN: I am the consumer rep.

DR. DEMETS: My name is David DeMets. I am a biostatistician, University of Wisconsin, and I am a voting member of the panel.

DR. FERGUSON: I am Tom Ferguson, Cardiothoracic Surgery, Washington University School of Medicine. I am a deputized voting member.

DR. HANNAFORD: My name is Blake Hannaford. I have no middle name, which is what the "N" stands for I think   

[Laughter]

I am a Professor of Electrical Engineering at the University of Washington, in Seattle. I am also Adjunct Professor of Bioengineering and Adjunct Professor of Surgery, and I have a Ph.D. in electrical engineering and computer science. I am a deputized voting member of the panel.

DR. GALANDIUK: Susan Galandiuk. I am a colorectal surgeon and I am an Associate Professor of Surgery at the University of Louisville, and I am a voting member of the panel.

DR. CRITTENDEN: I am Mike Crittenden. I am a cardiothoracic surgeon at the West Roxbury VA, and affiliated with the Harvard Medical School. I am a deputized voting member.

DR. ANDERSON: I am Ben Anderson. I am an Associate Professor of Surgical Oncology at the University of Washington, in Seattle. I am the Medical Director of the Breast Care Program there, and a member of the Fred Hutchinson Cancer Research Center.

DR. CHANG: I am Phyllis Chang. I am an Associate Professor in the Department of Surgery, Section of Plastic Surgery, with a joint appointment in the Department of Orthopedics Surgery for Hand and Microsurgery, in the University of Iowa, College of Medicine. I am a voting member.

DR. TALAMINI: Mark Talamini. I am an Associate Professor at Johns Hopkins University School of Medicine. I am a general surgeon, gastrointestinal surgeon primarily, and Director of Minimally Invasive Surgery at Hopkins, and I am a deputized voting member.

MS. DUBLER: I am Nancy Dubler. I am Director of the Division of Bioethics at Montefiore Medical Center, and a Professor of Bioethics at the Albert Einstein College of Medicine, and I am a deputized voting member.

DR. WALKER: Cedric Walker, Professor of Biomedical Engineering at Tulane University, in New Orleans. I am a deputized voting member.

DR. WITTEN: Celia Witten, Division Director of DGRD in ODE in CDRH and FDA. I am a representative of FDA, not a panel member.

DR. WHALEN: Thank you. I would like to note for the record that the voting members present constitute a quorum, as required by 21 CFR, Part 14.

Next, we are going to hear from Mr. Stephen Rhodes who will give the panel an update since our last meeting in November. Mr. Rhodes?

Update Since the Last Meeting

MR. RHODES: Thank you. I am Stephen Rhodes. I am the Branch Chief of the Plastic and Reconstructive Surgery Devices Branch. In November the panel made recommendations on the classification of five wound dressings, gauze, hydrophilic wound dressings, hydrogel wound dressings, occlusive wound dressings and porcine wound dressings.

The FDA is working on a final rule classifying four of those wound dressings, the gauze, the hydrogel wound dressings, the occlusive wound dressings and the hydrophilic wound dressings, as Class I exempt devices. These are products that do not have any drugs, any biologics or any animal source materials in them. We are still working on classifying the porcine wound dressings. We appreciate your assistance in helping us to classify these products, and we are pleased that we are reaching closure on classifying all these important classes of products.

Other activities in the branch    we have completed a guidance document on surgical meshes. We are working on updating several guidance documents, a guidance document for breast implants which was developed in 1995, and we are also updating the guidance documents for interactive wound dressings and noninteractive wound dressings. We are also developing a new guidance document for sutures. Lastly, we are working on a final rule, calling for PMAs for safety and efficacy data for saline filled breast implants for mammary prostheses. We are expecting that that final rule will be published this year, and we are looking forward to the panel's participation in the discussion of those PMAs in the future.

That concludes my update. Thank you.

DR. WHALEN: Thank you, Mr. Rhodes. We will next hear from Mr. Larry Kessler regarding postmarket evaluation at FDA's Center for Devices and Radiological Health. Mr. Kessler?



"Postmarket Evaluation at FDA's Center

for Devices and Radiological Health"

MR. KESSLER: Good morning. My name is Larry Kessler. I am the Director of the Division of Surveillance and Biometrics at FDA. I am not a voting member..

[Slide]

Around two years ago, maybe a little less, Dr. Susan Alpert, who is the Director of the Office of Device Evaluation, asked me to give a brief presentation to a group of the panel chairs who collected together to review issues and common to panels. And, I talked a little bit about postmarket evaluations at FDA and a number of the panel chairs asked me to come, give presentations to the members of the panels, not just the chairs.



So, Dr. Tom Gross, who is the head of my Division of Postmarket Surveillance, and myself have been going around this year to give presentations to all the panels, trying to give you a little flavor for how we work on the postmarket side. So, in 15 minutes I am going to describe everything we think you need to know, in a brief primer, on postmarket evaluation.

As I am going to show you in a minute, there are a variety of different mechanisms which use similar names and may sometimes get confusing to you, as panel members, and are even sometimes confusing to FDA staff who work with them on a week to week basis.

[Slide]

I am going to describe a few of the methods of device postmarket evaluation at the Center. I am going to present the challenges we face in accomplishing postmarket evaluation roles, and just try and describe the pivotal role that you, as the advisory panel, can plan in helping us accomplish the goals for making sure that devices are safety and efficacy, not only as they reach market but as they spend time on the market.



As you well are aware, most of the time a device is in use is postmarket, not premarket, and that is the bulk of our concern. I believe you have handouts on this in case you want to take notes, and I hope you have questions.

[Slide]


This is a brief schematic of how we view the world. This is the world of the Center for Devices viewed from the context of the Office of Surveillance and Biometrics.

For the most part, from design through clinical testing the bulk of this work, the best majority of this is done by manufacturers, clinicians, their patients and not by the FDA. This is where the bulk of the work is done in the premarket phase. FDA gets increasingly involved as any device or modification of a device goes through lab and bench testing and clinical testing. Once it reaches FDA review, we have the clinical community that we hope we are interacting with a lot. The advisory panels are one mechanism for that. Once a device is cleared for market, we have a variety of tools that we can use in the postmarket period to evaluate continued safety and effectiveness issues during the postmarket period.

I am going to talk quite a bit about the medical device reporting program, and then about postmarket surveillance authorities and postapproval studies. You are probably most familiar with postapproval studies but I will try and talk about all three and weave them together a little bit. I am not going to talk very much about our epidemiology program or field inspection program, which are also important components of postmarket evaluation but I don't have that much time today and I can always come back if you are interested.

[Slide]


What do we care about in the postmarket period? Clearly, long term safety is one issue that matters to us, matters to you, matters to everybody involved. We are also very interested in the postmarket period about looking at performance of a device in community practice. You will see premarket applications that frequently come from well controlled studies, clinical settings where there may be device experts; there is a great deal of attention to protocol. Once devices get out into the community they don't achieve the same level of performance often, and sometimes you see problems you would not have seen.

In a minute I will tell you a little bit about the MDR program, but if you think you can imagine everything that can happen to devices you clear, you can't. You must see these reports. It is amazing what people would think about doing when devices have been approved and cleared for market.

Effects of change in user setting    as you well know, an enormous amount of product has left the hospital walls and moved to the bedside, and it has been particularly true over the last 16 years since the imposition of DRGs by HCFA and the insurance world. People are trying to move patients out of hospitals faster and faster.

Some of this is very positive from a therapeutic standpoint, but it means increasingly sophisticated technologies making it to the bedside. We, on the postmarket end, tend to see an increase in the different kinds of problems that we see. This includes serious injuries and deaths from a variety of products that you would not tend to see in a hospital setting but you will see in a home at bedside because you have people who are less expert and who don't have the resources to deal with problems once they arise. So, whether in fact some piece of technology should move from the hospital to the bedside is something that we will often ask in the postmarket of a product.

[Slide]

One of our most quoted and used mechanisms for looking at product problems is the Medical Device Reporting Program. Manufacturers must by law report deaths and serious injuries, if a medical device may have caused or contributed to the event, as well as malfunctions. Now, in the European Union these are called "near incidents." A product that fails that did not happen to cause a death or serious injury but could if it occurred without such fortuitous circumstances is a mandated reportable event by a manufacturer.



Since the Safe Medical Devices Act of 1990, all user facility in this country    all hospitals, all nursing homes, ambulances, surgical care centers, they are supposed to also report all deaths to the FDA, and all deaths and serious injuries to manufacturers of devices if they know the manufacturer of a product.

We get roughly 95 percent of our 80,000 reports from manufacturers and less than 5 percent come from hospitals, nursing homes, etc., and most of the events we get from manufacturers are happening in hospitals, nursing homes, etc. So, we get the reports from manufacturers. Many of the manufacturers you see here stand up before you are critical components of our ability to monitor postmarket data. Hospitals and nursing homes    some of them do well and many do not.

[Slide]

Beginning in about 1992, we were receiving at FDA over 100,000 medical device adverse events a year. We were really swamped with work. It was really a challenge because we had roughly 15 analysts to look over 100,000 reports and it was really a daunting task.



Information in these reports is supposed to include device specifics, event description, event date, patient characteristics, etc., but these reports often have limited information. Sometimes a manufacturer will come to us and they will say, "I'm going to send you a report but it's not complete." By law, they are supposed to complete all the information they can get. We will ask them why not. They will call the hospital who will tell them, "my lawyer tells me not to tell you what really happened." I am sorry for the legal guys out there; it's just something that happens in the walls of the hospital, and it sometimes is a challenge for us.

But often the reports are very useful and we use them to prompt a lot of actions. What I have done is select a couple of products that are relevant to this panel where we have taken some actions based on the data from the MDR program. For example, we get reports of operating room fires with ESUs frequently. It is a common problem. You may have seen a piece that I think "20/20" did about a year ago, and it is something that we see repeatedly, and we think it is a problem that can be reduced by more Public Health action and we proposed to take some actions this year to make clinicians and the public aware of how we can reduce fires related to ESUs.

More recently, in 1997, a product was approved by FDA, I believe through the 510(k) program, for a collagen impregnated synthetic sling. We noticed some increased reports in 1998 and conducted several inspections with the manufacturer who eventually, upon more careful examination of their complaint data and our MDR reports, decided to recall the product in January of this year, and they will no longer market or manufacture the device.

DR. TALAMINI: Excuse me, sir   

MR. KESSLER: Yes?

DR. TALAMINI:    as a surgeon, I have to know what an ESU is.

MR. KESSLER: Electrosurgical cautery unit.

DR. TALAMINI: Sorry.

MR. KESSLER: We are talking about things that are used in a very rich oxygen environment around drapes.

Based on the MDR system, we will also conduct directed inspection of facilities, and we will also conduct postmarket studies. We did one on polyurethane foam coated breast implants a few years ago    successful.

[Slide]

I am going to spend a couple of minutes on these two authorities because these two will probably interest you more than anything else. The Safe Medical Devices Act passed Section 522 postmarket surveillance. We have had this authority for about nine years now. We also are allowed to call for postapproval studies under the PMA. Both of these are mandated by law. Postapproval refers to PMA products only, whereas, Section 522 covers, as modified by FDA in May, 1997, Class II or III products whose failure may present a public health problem. I have stated that quite generally; the statutory language is a little more specific.



We have two mechanisms at FDA for calling for or requiring manufacturers to conduct studies in the postmarket period. These are principally done for safety concerns. They don't have to be done only for safety concerns; we can ask effectiveness questions but the principal spirit of the postapproval and postmarket and studies is for safety issues but there are effectiveness and performance questions which are sometimes asked as well, and sometimes they are not separable for a certain kinds of device; its safety is its effectiveness issue. We see both authorities as complementary to postmarket.

[Slide]


To call for a study, we need to figure out what are the criteria to ask for such a study because studies in the postmarket period are quite challenging, and I will explain that in a minute. First of all, we need to understand the critical public health question, and these postmarket study requests can either occur from "for cause" situations or new expanded conditions of use or an evolution of technology.

We have to consider before we actually require a postapproval or postmarket study other mechanisms we might use to collect the same relevant data. This could include the Medical Device Reporting Program, secondary database analysis of, say, the HCFA data that we have in house, etc.

I want to talk for a bit about practicality and feasibility on my next slide and, most importantly, how will the data be used? Before we ask for a postmarket study, we need to figure out what we are going to do with it. Are we going to modify the label? Are we going to ask for a recall? Change the way we approve a device? What about communication to the public, health professionals, etc?

[Slide]


There is a wide variety of study approaches that we should use in the postmarket period. With the institution of required or discretionary postmarket surveillance after SMDA, FDA tended to use a fairly heavy approach to postmarket studies and asked for things at the bottom end of this list. We were asking for randomized, case control or well documented trials, and we had a lot of problems getting those accomplished.

With the recent FDAMA, the clear signal from Congress was to expand the kinds of things we might allow manufacturers to do to provide valuable postmarket data. So, in our recent Federal Register notices about our postmarket program we have expanded the kinds of designs that we might ask for not only from detailed randomized studies, but also possibly something as simple as detailed review of complaint history in files of manufacturers or literature, as well as non clinical testing of devices.

[Slide]

But postmarket challenges have been very frustrating. They are frustrating for at least these four reasons: First, rapid evolution of technology make the studies that we are doing sometimes obsolete. By the time we get a protocol in house, the manufacturer goes and asks clinicians for data, they begin to collect data, they are already on the second or third generation of that product and it is questionable of what utility the postmarket study might be.



It is not true of all medical device products but it is true of some. I still remember    I spent, I guess, ten years at the National Cancer Institute working in cancer prevention and control, and when I arrived in 1984 one of the first things I was told there is, "the Pap smear is about to become obsolete, guys. It's been used for thirty years and we have much greater technology that's coming down the road, and it's going to be all gone by the time you hit 1990." As you all know, it is still one of our major tools for cancer prevention and detection. It is true for devices. We hear things are going to be obsolete but you would be surprised at how long they hang on.

There is a lack of incentives for industry. The plain fact of this is when we ask industry for postmarket studies, it is generally not good news and their interest in helping us with those data is relatively minimal. It is unlikely that the end of the postmarket market study is going to be "what a wonderful product." It is more likely to be "we've discovered some problem and we want to tell you about them." Although this may be good marketing in the long run, for industry it is not exciting news generally. So, they are generally reluctant. Some of them have dragged their heels on some of the postmarket studies we have asked them for.

There is a general lack of interest in the clinical community. Those of you at Hopkins and the Fred Hutch and Washington U don't make a lot of publications off products that are already marketed, but it is nice to have sexy new technology for which you can help get information out in the literature. So, getting the clinical community interested in postmarket studies has been a frustrating challenge not only for us but also for industry. They find it hard.

Finally, sometimes on both ends, industry and the FDA end and on the advisory panel end, we have not clearly specified the public health question of importance for which to conduct a postmarket study.

[Slide]

That is the challenge I will leave you with. When considering postmarket studies, whether postapproval or 522    and FDA can figure out the right mechanism to use; they each have different strengths and weaknesses. Postmarket studies under 522 can be done for 510(k) products. Condition of approval only apply to PMA products. We need to ensure that this is of primary importance, that it is not a secondary question. I reviewed, in 1997/8, almost a dozen panel recommendations for postapproval studies or for PMA products. For half of them a postapproval study was asked for, and in most of those I could not detect clearly specified the question the panel was asking for us to ask a manufacturer, and that is a real challenge for us. So, if you are going to ask for a study, you really need to specify what you are trying to answer. That is critical.



Try and figure out what the clinical or regulatory relevance is for the question. What are you going to do with the data? Are you going to suggest we change the label? Are you going to suggest we put out a public health advisory to the clinical community, the lay community, hospitals? Who is going to get this information? Will we conduct a recall? If you discover, say, a long term safety problem that was above some threshold, tell us the issue that you are interested in; clearly specify the question that will help us specify the question and work with the company to develop a design that makes sense. If you can do that, you can help us a lot.

[Slide]


Finally, I hope the future of the Medical Device Reporting program and postmarket surveillance    I haven't talked a lot about the future of MRD, it is less relevant here    we are trying to use a wider variety of design approaches to give the industry more flexibility and us more flexibility to answer the right question correctly. We work in collaboration with the industry and the clinical community, and we are trying to obtain expanded access to different data sources, including registries, and we are beginning to hold a variety of workshops and conferences with industry and with the academic community to get better data in the postmarket period. Our data are somewhat limited, but with better specified questions, better specified studies and increased access to wider data sources which exist in the public domain we think we can answer the questions that we need to fill our mission in monitoring postmarket safety and effectiveness of devices.

Thank you for your time. I will take questions if you have any.

DR. CRITTENDEN: I have two questions. Could you talk about off label use, and the second question is, there seem to be 100,000 adverse events per year and I just want to know how close that is to what the estimates are in terms of the actual number.

MR. KESSLER: I will answer the second question first because it is easy. We have lousy estimates    let me go to the first question and then I will come back because the second one I have a longer answer for. Off label use    we don't explicitly track off label use in terms of studies unless you or we suggest what we should look for. However, that is one of the great things about the Medical Device Reporting program.

We get routinely evidence of off label use, and I will give you a great example    it is not so much relevant for this panel, although I am sure we have dozens of them for you. It is an example I presented to the panel chairs. Soon after coronary stents were developed and started to be used, we would get reports of deaths or serious injuries related, and one of the egregious uses of stents is one clinician, wanting to keep a large part of an artery patent used 27 stents stringed in a row. They were labeled single stent only. Stringing a few of them together was something some clinicians were starting to do but one clinician got carried away, let's say, and the patient did pass away. The patient may have passed away anyway; it may not have been directly related to the use. But the MDR system is rife with those examples, and those are some of the ones on which we act. We will see a use that was not intended by the manufacturer which will provoke death or serious injury, and we will use public health advisories and safety alerts to the clinical community to tell them what we think is going on. So, that is the answer to the first question.

The second answer, the General Accounting Office made an estimate about a decade or so ago that we get about one percent of the real events that are happening. So, if we get 100,000 events there are a million, and I think that estimate could be plus or minus, another factor of five or ten, quite frankly. It could be way up or way down. It is not very good. We have lousy denominator data, and even if we ask manufacturers to supply it, which we were going to do in 1996 but have walked away from it for a variety of reasons, it is not clear we would get good numerator data. You need both.

[Slide]

So, Congress, in its wisdom, supported the FDA by providing the legislative mandate for FDA to begin conducting a sentinel or device surveillance network program. We did a pilot study two years ago, which just ended last year, where we used 24 facilities and concentrated on those facilities in getting them to report faithfully, and we can get much better tracking of what is going on. The new sentinel system is supposed to begin in the next year or two, depending on the appropriations. We have been directed in statute to develop a sample user facility system so we can have a lab where we can look at good estimates of adverse events and denominator uses. Right now we don't have that. That is where we are going, and you will be hearing more and more about this system over the years provided Congress can find the wherewithal to appropriate the funds. But that is the way we need to go. It is a really exciting program for us, and we think it is going to make a big difference in being able to find out how devices are really used.



DR. CRITTENDEN: Thank you. You have partially answered my question, but if you had all the data you wanted do you have the resources to really evaluate it properly at this stage?

MR. KESSLER: If we got 100 times the reports? No, no. If we got all the reports I wouldn't need to. I will just tell you about something we have done in the past two years, and give you a flavor for how we can work around this. We get 100,000 reports, but many of them are absolutely repetitive. It is the same thing over and over. The best example that relates to you is capsular contracture of breast implants. Once we get the first few hundred of those, the next 20,000 are not very interesting.

Now, I have to say this, and I am glad there is a consumer advocate here, we have a problem convincing women with breast implants and some of their associated legal counsel that more MDR reports of capsular contracture aren't a scientific way to help us evaluate a problem. So, what we have done is to move to a program that we call summary reporting. Once we see a problem over and over, we work with the industry, we work with the advisory panels, we work with the clinical community and try to figure out is there something to be done. When there isn't we have the wherewithal to either have reports sent in, in a summary fashion so we get, say, one table four times a year of the same kind of complaint and, in that way, you can get a thousand complaints reviewed in a minute. So, that is one avenue we have taken. We can also give an exemption to companies    don't report that. Keep it in your complaint file and in your quality system reporting and we can handle it there.

But the magic behind the sentinel system is that if we can get a good sample of between 5 10 percent of the hospitals in the country, the way the National Nosocomial Infection Surveillance System does in CDC, you can track the real problems fairly fast and you don't need a 100 percent sample. So, if we can get a good 5 or 10 percent of the hospitals reporting, and the rate in the sentinel pilot was 20 times current report rates, we would get a lot more reports but from a much smaller sample. So, then we could handle it. I have 15 outstanding analysts. Almost all of them are nurses; one is not, but they are fabulous, and they pick up really unusual problems. They find needles in haystacks    really unusual.

Other questions?

DR. WHALEN: Thank you, Mr. Kessler. Before proceeding to the next listed item on the agenda, for an important unlisted piece of business I turn the floor back to Dr. Krause.

DR. KRAUSE: Sometimes we have the fun activity of handing out plaques and things. So, Jim?

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