Robert Harrington is owner of the company PED-O-JET, maker of the military jet guns used on the troops. During a meeting with the FDA, VA and others, he states the jet injectors are safe, because the gun was wiped off after each injection.

Quote
MR. HARRINGTON:  Not necessarily.  It was used by the Army for 35 years and it was always wiped.  Never had an issue.  Good tracking system.  And there's nothing recorded in the world that says that it wasn't wiped.  It's in a study that was presented using a method that isn't approved, it was not wiped and it said oh, we can contaminate 31 out of 100.

This is supporting evidence- If the jet gun was not wiped off before it's use on you, add it to your claim.

www.fda.gov/ohrms/dockets/ac/99/transcpt/3527t1.rtf
SHDEPARTMENT OF HEALTH AND HUMAN SERVICES 
PUBLIC HEALTH ADMINISTRATION,
FOOD AND DRUG ADMINISTRATION 

GENERAL HOSPITAL & PERSONAL USE DEVICES PANEL 
 
 

OPEN SESSION 
 

Monday, August 2, 1999 
 

8:43 a.m. 
 
  

Food and Drug Administration

9200 Corporate Boulevard, Room 020B

Rockville, Maryland
 

C O N T E N T S
                                             PAGE 
 

Welcome and Introductory Remarks

     Martha T. O'Lone, Executive Secretary      4

     Dr. Charles E. Edmiston, Chairman          6 
 

Post-Market Surveillance

     Larry Kessler                             8 
 

Y2K Information

     Charles Ho                                17 
 

Issue:  Guidance for Review of Protected Sharps Systems 
 

FDA Presentation

     Tim Ulatowski, Director DDIGD -           23

       Overview

     Irene Naveau, Reviewer, Sharps            26

       Injury Prevention Guidance

     Lireka P. Joseph, Director OHIP           36 
 

Presentations by Users of Protected Sharps

  Systems

     Dr. June Fisher - Trauma Foundation,      41

       San Francisco General Hospital

     Toni Hughes, AORN                         55

     Mary Alexander, INS                       57

     Susan Wilburn, ANA                        61 
 

Open Public Hearing                            73 
 

Panel Discussion/Recommendation               84 
 

Afternoon Session                            141 
 

Issue:  Guidance Development for Jet Infectors 
 

FDA Presentation

     Tim Ulatowski, Director DIDGD            142

     Capt. Von Nakayama, Reviewer             145 
 

CDC Presentation

     Dr. Bruce Weniger                        153 
 
 
 

Presentation by Industry

     Glenn Austin, PATH                       173

     Bob Harrington, ANFIM                    186 
 

Open Public Hearing                           203 
 

Open Committee Discussion/Panel Summary       210

     and Recommendations

P R O C E E D I N G S

WELCOME AND INTRODUCTORY REMARKS

      MS. O'LONE:  Good morning.  Welcome to the General Hospital and Personal Use Devices Panel for the open session.  Thank you for coming.  If you have not signed in for this meeting, please do so.

      I am Martha O'Lone, the executive secretary of the General Hospital and Personal Use Devices Advisory Panel.  And before we have panel introductions and turn this portion of the meeting over to the panel, I have two items of business that I have to read into the record.

      The first is a conflict of interest statement.  It goes like this.  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 any impropriety.  To determine if any conflict existed, the agency reviewed the submitted agenda and all financial interests were reported by the panel participants.

      The conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employer's financial interests.  However, the agency has determined that participation of certain members and consultants, the need for whose services out-weighs the potential conflict of interest involved, is in the best interest of the government.

      Full waivers have been granted for Dr. William Rutala and Ms. Marcia Ryder for their interest in firms that could potentially be affected by the panel's decisions.  The waivers permit them to participate in all matters before the panel.  Copies of these waivers may be obtained from the agency's Freedom of Information Office, Room 12A-15 of the Parklawn Building.

      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.

      And the second item of business is appointment to temporary voting status.  Pursuant to the authority granted under the Medical Devices Advisory Committee Charter dated October 27, 1990, as amended on April 20, 1995 and October 10, 1997, I appoint the following person as a voting member of the General Hospital and Personal Uses Devices Panel for the duration of the panel meeting on August 2, 1999.  In addition, the following person will act as panel chair for August 2, 1999, and that's Charles E. Edmiston, Ph.D.

      For the record, this person is a special government employee and is either a consultant to this panel or consultant or voting member of another panel under the Medical Devices Advisory Committee.  He has undergone the customary conflict of interest review.  He has reviewed the material to be considered at this meeting.  And it's signed David W. Feigal, Jr., M.D., director, Center for Devices and Radiological Health on the 21st of July 1999.

      And the only other piece of business is that the future tentative date of this panel would be potentially November 16 for this year.  We don't have any other dates set aside at this time as tentative dates.  And to find out if we're having upcoming meetings, the phone number of the hotline is 800/741-8138 and the code is 12520.  That helps to get right to the General Hospital Panel to determine if there are any new messages on that line.

      I'll now turn the meeting over to Dr. Edmiston and we will begin the open session of the 34th General Hospital and Personal Use Devices Panel meeting at this time.  I'll introduce him.  He is an associate professor of surgery at the Medical College of Wisconsin and has been a consultant to our panel for quite some time and thank you very much for acting as chair today.

      DR. EDMISTON:  Thank you very much.

      At this time I'd like the rest of the panel members to introduce themselves, starting with my colleague on my right.

      DR. FOWLER:  Dr. Joe Fowler, a dermatologist at the University of Louisville, Louisville, Kentucky.

      MS. RYDER:  Marcia Ryder.  I'm a nurse consultant in vascular access and a doctoral candidate at the University of California at San Francisco in the Department of Physiological Nursing.

      DR. RUTALA:  Bill Rutala.  I'm director of hospital epidemiology, occupational health and safety at the University of North Carolina Hospitals and professor in the School of Medicine.

      MR. PALOMARES:  Salvodore Palomares, manager of regulatory affairs at ICU Medical.

      MR. DACEY:  Robert Dacey, consumer representative from Boulder and Longmont, Colorado.

      MR. ULATOWSKI:  Tim Ulatowski, director of Division of Dental, Infection Control and General Hospital Devices, FDA.

      DR. EDMISTON:  Thank you very much.

      Now at this time I'd like to invite Mr. Larry Kessler from the FDA to give us an update in postmarketing surveillance.

POST MARKET SURVEILLANCE

      MR. KESSLER:  Good morning.  I want to thank Dr. Edmiston and Martha O'Lone for having me here.  Let me tell you how this little presentation happened.

      About two years ago Dr. Alper asked me, as the director of the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health, to talk a little about postmarket surveillance in front of a meeting of the entire panel chairs in this very room.  At the end of that meeting, the panel chairs asked that we give such presentations to all the panels, to give you our perspective on postmarket surveillance, because you will see postmarket surveillance issues from time to time, even in your premarket review.

      I'm going to give you our perspective on how these relate to some of the work that we think you can play a very important role in helping us with the FDA mission.

      In the next 10 to 15 minutes I'll describe a few methods of device postmarket evaluation at the Center, present challenges in accomplishing postmarket evaluation, and describe the pivotal role that advisory panels can play in postmarket evaluation of medical products.

      This schematic is a fairly brief overview of the way in which we generally perceive our overall role at FDA.  From the left-hand side of the chart here--this is a time chart basically--design modification happened basically at industry and with the clinical community and patients telling industry what new products they need, what clinical needs need to be met.

      FDA gets more and more involved as we travel from design modification through testing and clinical testing to review.  On the right-hand side of the chart you'll see, under the postmarket evaluation part of this, at least five different mechanisms we have at our disposal to help evaluate and monitor products as they live and breathe on the market.  We have the Medical Device Reporting Program and two postmarket surveillance authorities--Section 522 in the postapproval or PMA authority.  I'll talk about these three in some detail.

      I won't today, because of time, talk about our epidemiology program or the large field inspection force we have running out of ORA with our contacts through the Office of Compliance, but they are a very critical part of postmarket evaluation.  I just won't get to talk about them today.

      While we're doing review and after we do postmarket evaluation, the FDA should have constant contact with the clinical community to find out what's going on and to communicate our findings and problems, something we need to improve on.  One of the ways in which we do contact the clinical community is our contact with advisory panels, and I'll say a little bit about how postmarket evaluation and advisory panel work should meet.

      Well, why bother with any of this at all?  Well, because there are a series of questions that we find often need to be asked in the postmarket period.  First and most obvious is long-term safety.  A number of products that reach the market do so on the basis of fairly modest or short-term studies.  Rather than wait for long-term studies to prove complete safety or effectiveness, some products will make it to the market where we will not have complete long-term data.

      This may be particularly true in terms of long-term implantables, where we would hesitate to wait, say, 10 years, which is what we might want to see for certain kinds of implantable performance, and we don't want to do clinical trials that last for 10 years, so we'll let something on the market based on a shorter period of time data and then look at it later.

      Other important questions come up often in the postmarket period.  For example, performance of device in community practice.  Often you will see products for review that are done in carefully designed clinical trials but products then move to community practice and we won't see the same effects and we will often see different patterns of adverse events that you will see in the premarket review.

      Sometimes effects of changes in user setting are important in product evaluation.  For example, a larger number of products than ever before are leaving the hospital doors and winding up in out-patient clinics and at the bedside at home.  Some of those products need professional training to be used properly and we get adverse events on a daily basis that show serious injuries, illness and death from products that went from the hospital to home either without adequate training or labeling or other kinds of problems that can be sometimes avoided.

      I'll talk for just a minute about the Medical Device Reporting Program because a number of people who know a bit about FDA and postmarket evaluation think MDR is where our postmarket evaluation begins and ends, and that's not the case at all but it is one of our most important programs.

      Since 1984, manufacturers must by law report deaths and serious injuries as well as malfunctions or near incidents to FDA.  Since 1990 with the Safe Medical Devices Act, all user facilities--every hospital, nursing home, ambulance, surgi-center--must report deaths to the FDA and serious injuries to manufacturers.

      Unfortunately, the User Facility Reporting Program in the country does not work nearly as well as it should.  The number of reports we get per year from manufacturers is roughly in the 80,000 to 100,000 range and only 5 percent of those reports of our total MDR system come from user facilities.

      Beginning about 1992 we were receiving over 100,000 reports of adverse events each year.  Information should include device specifics--the event description, event date, patient characteristics--with which we could see if there's a potential problem that needs rectifying in the postmarket period.  Unfortunately, reporting in the MDR program is often very limited--limited information.  It sometimes provides critical signals to FDA but sometimes we miss things because the information is poor.

      Part of this comes from the unfortunate litigious environment that we all practice in.  Often we'll hear manufacturers around this room tell you the reason our data are limited is when they call a hospital after a hospital has told them that their device may be involved in a death or serious injury, the hospital will say, "That's all I can tell you.  My lawyers tell me to give you no other information."

      Part of this has to do with the vast number of reports which are associated with use error, and hospitals are nervous about reporting out of their facility problems where their users may not have read the instructions, may not have followed the instructions so carefully or chosen to use products in ways that the manufacturer did not initially intend.

      But we do get a lot of mileage out of the 100,000 reports we get per year and here are some examples of things that reflect adverse event reports and actions taken prompted by the MDR program, related to products that involve this panel.

      For example, we get directed inspections of a manufacturer this year for blood leukocyte filters and hypotension and released a public health advisory related to leukocyte filtration.

      We've done product recalls in the past few years.  In fact, one explosion of an infusion pump puzzled one of our analysts.  We had outstanding collaboration from our Office of Science and Technology staff, who looked into the problem with us, and eventually convinced the manufacturer to do massive, 15,000 pump recall and reservicing.

      In the recent past infusion pumps have presented a lot of problems with free flow and we put out patient notifications about this problem.  This problem continues with a lot of pumps and we do all we can to try to minimize the problems that we see in free flow with infusion pumps, but it's a constant problem.

      I want to talk for just a couple of minutes about these two authorities because this is where you as panel members can be most influential and helpful to the FDA.

      Postmarket study authorities--there are two of them that we can invoke.  One is postmarket surveillance Section 522 and the other is the Postapproval authority.  Section 522 was originally mandated in SMDA '90 and changed in FDAMA '97.  And the changes were to reduce some of the scope of the original 522 act.

      Postapproval refers to PMA products only and is also sometimes called condition of approval studies.  Section 522 covers only Class II or III products whose failure may present a public health problem.  The language in the statute is more specific but this is the basic essence of that language.

      We see both authorities as a complement to the premarket role of the FDA and the role that you play.

      The criteria that we use for postmarket surveillance study in the requirements for manufacturers are whether we can figure out what the critical public health question is, and it can result from for-cause situations, new or expanded conditions of use or other reasons.  We have to consider whether other post-market strategies, such as the MDR program, give us enough information without requiring manufacturers to do additional study on their product in the postmarket period.  And we have to consider practicality and feasibility of the conduct of studies.

      We also try to figure out how will the data be used?  And I'll come to that in just a minute.

      Postmarket surveillance studies have a wide variety of approaches.  Our early foray into postmarket, earlier in this decade, was heavily weighted toward studies at the bottom end of the more rigorous type--randomized trials or case control studies.  However, recent guidance that we've published this year on postmarket surveillance studies suggests that we will be expanding the kind of approach that we would require manufacturers to apply, including detailed review of complaint history or the literature or nonclinical testing of the device, to help us resolve potential postmarket problems.

      But postmarket studies are challenging.  First of all, the rapid evolution of technology makes studies obsolete.  It is indeed wonderful that the medical device community revises their products on almost a weekly basis but it makes a postmarket study a particular challenge because by the time a study protocol is approved, fielded, data are collected and analyzed, it is often the case that the product is no longer marketed.  So is it still relevant?  It makes it a challenge.

      Second, in truth, there's a lack of incentives for the industry.  It is a rare situation where a postmarket study is going to give great good news to a company, so they're not excited about doing these, frankly.

      There's also a lack of interest in the clinical community.  Very few postmarket studies are sexy enough to be publishable, like the premarket stuff with the hot new technologies.  So that presents a big challenge.

      But by far we think the biggest challenge that we have faced, both in postapproval studies and in Section 522, is a lack of a clearly specified public health question.  What are we going to do with the data once it arrives?  Are you going to suggest a relabeling?  Are you going to suggest expanded or restricted indications for use?  Would you consider advising us of a product recall?

      If one of those actions doesn't occur to you and you're just interested in the question, then it probably isn't a good candidate for a postapproval or postmarket study.  But if you can help us with a clearly specified public health question and what you think you might do with the answer to that question, it'll help us formulate the appropriate protocol and hold the manufacturer responsible to conduct that protocol and bring results here back to the panel, which we rarely have done.

      So that's my challenge for you.  When considering a postmarket study, whether postapproval or 522, and that's an issue that we can work out at FDA and you needn't be concerned with, please ensure that the question you're asking is of primary importance, help specify that question and note the clinical or regulatory relevance of answering the question.  What will we do with the data?  That'll help us formulate the question; it'll motivate the company; it'll motivate the clinical community to contribute data, answering the question; it'll help us address potentially important postmarket surveillance problems.

      The 100,000 events that we get every year represent thousands of deaths and scores of thousands of serious injuries that occur because of medical devices sometimes being used improperly, being handled improperly or sometimes failing.  Our job is to try and minimize that and we hope you'll help us in that mission.

      Thank you very much.  I'd be glad to take any questions.

      DR. EDMISTON:  I think in the interest of time, we're going to move on.  Thank you very much, Mr. Kessler.

      Our next presenter will be Mr. Charles Ho, who will give us a presentation on Y2K.

Y2K INFORMATION

      MR. HO:  Good morning.  I'm Charles Ho. It is my honor to be here to talk before the General Hospital and Personal Use Devices Panel to discuss with you the year 2000 problem.

      Yes, medical devices are subject to the year 2000 problem.  Susceptible devices can be found in the microprocessor or PC-controlled products, software applications, device interfaces to databases and recordkeeping systems and also in embedded chips for date display or recording.

      What is the year 2000 problem?  It's the failure of a computer system to properly process a display face due to representing the year using only two digits or other date-related problems, such as failure to recognize the leap year.  For example, list of confusion between the 2000 and 1900.

      An example of a year 2000 failure.  A chemical in a clinical laboratory test has an expiration date in the year 2000.  However, the testing device reads this date as a in the year 1900 and did not allow the test to proceed, since the testing device thought the chemical was out of date.

      So how do we define the year 2000 compliance?  For the purpose of a database, year 2000 compliant means, with respect to medical devices and scientific laboratory equipment, that the product accurately processes and stores date/time data, including but not limited to calculating, comparing, displaying, recording and sequencing operations involving date/time data during, from, into and between the 20th and 21st centuries and the years 1999 and 2000, including correct processing of leap year data.

      So what is the FDA requesting of the panel?  Please provide us with advice regarding problematic devices from the panel's domain of expertise.  Please identify types of devices which because of their use of dates, could present risks to patients if not addressed.  Please provide suggestions to CDRH regarding actions to reduce risks from year 2000 problems.

      What has the FDA done regarding the year 2000 problem?  Since 1996 we have made internal assessments of potential impact and vulnerable devices.  In June 1997 we sent a notification letter to manufacturers to advise them of the problem.  FDA will address the year 2000 problem in premarket reviews.  New submissions are not required for repairs which are only date-related.  Repairs/updates before impact will not be classified as recalls.

      In addition, we are also participating in the Biomedical Equipment Working Group.  This is a group of federal users of devices and scientific equipment.  The work group is chaired by the Department of Health and Human Services.  We send a consolidated request for information in January 1998.  We think that the public and the private health care organizations have the same information needs.

      We established a website in the spring of 1998.  We sent out a guidance on FDA expectations in June of 1998.

      The address of the FDA product database can be found at www.fda.gov.  Please select the year 2000 item.

      The Biomedical Equipment Database.  This is an FDA-operated World Wide Website.  The data are provided voluntarily by the manufacturers.  It is a certification by the manufacturers.  The data are continually updated, searchable and downloadable.

      What does the project database show us?  Well, many companies have not yet reported.  Presumably assessments are still in progress.  Most noncompliant products involve date display or date recordings.  They usually record date-stamping.

      A limited number of products have significant operational problems, such as the problem of the expiration date that I talked to you about.  PC-based problems and PC-type problems, such as recording and date-stamping.

      Manufacturers are providing a number of solutions, such as software upgrade, patches or complete replacements.

      Major additional letters to manufacturers.  In January 21, 1998 we sent out a letter on the year 2000 impact on biomedical equipment.  This was followed by the June 29 and September 2, 1998 letters.  Then September 21, 1998 we sent a letter on manufacturing process concerns.  May 26, 1999 we sent a guidance on MDR reporting.  June 18, 1999 we sent out a year 2000 readiness survey.

      Major additional communications to health facilities and consumers.  December 29, 1998 we sent a letter on computer date problems on medical devices on January 1, 1999.  This is about the rollover from 1998 to 1999.  May 26, 1999 we sent a guidance on MDR reporting.  And most recently, on July 16, 1999 we sent out a Y2K planning.

      The future CDRH/FDA activities.  We have already established a Biomedical Equipment Clearinghouse.  We are expanding the database to include complaint as well as noncompliant devices.  We are continuing to do outreach communications with industry, clinicians and consumers.  We are pursuing rigorous action on products which present significant risk.  We increased inspectional emphasis on Y2K.

      Health care facilities.  We recommend that health care facilities do the following.  Inventory and assess devices used; obtain information on device status; test devices for Y2K compliance; check interconnected or networked devices; check device information system connections; plan for or develop workarounds, upgrades or replacements; and finally, develop contingency plans.

      If you have any comment, please give your comments to the panel executive secretary or to Dr. Tom Shope at the address listed.  You can also send comments to him via e-mail at Tbs@cdrh.fda.gov.

      DR. EDMISTON:  Thank you very much, Mr. Ho.

      At this time we'll move into the main presentations but before we do that from the FDA I'd like to make a statement.

      The charges of this panel today are twofold.  This morning we're going to discuss guidance for review of needleless systems and this afternoon we're going to discuss and make recommendations to the FDA for guidance in the development of jet injectors.  That will be the focus of today's presentations.  We will try to keep on task and try and keep on time.  These are two extremely important areas that need to be discussed.

      I also want to point out again that anyone who comes to the podium, please speak directly into the microphone.  Identify yourself and your affiliation.

      For those members in the audience, representatives from industry and from private organizations, we would like you to state not only your name and affiliation but we wish you would also state what, if any, financial interest you may have in the medical device industries.

      At this time I would like to ask Mr. Tim Ulatowski, the division director for Dental, Infection Control and General Hospital and Personal Use Devices, to provide an overview of this morning's topic.

ISSUE:  GUIDANCE FOR REVIEW OF

PROTECTED SHARPS SYSTEMS

FDA PRESENTATION

      MR. ULATOWSKI:  Thank you, Mr. Chairman, and welcome to the panel.  Thank you for taking the time out of your busy schedules to come in and have this discussion with us today about these important devices.

      There's somewhat of a misnomer in the agenda this morning.  We're discussing protected sharps devices, not needleless systems per se.

      But at any rate, today's discussion is a somewhat different panel session for a panel session.  Usually we discuss premarket submissions, premarket approval applications, investigational applications in closed session or sometimes premarket notifications, so-called 510(k)s.  But today we're having a discussion about guidance documents, either current ones or future ones, and there will be no voting today, as there usually is when we talk about a premarket submission.

      We are talking about different devices from the morning to the afternoon, somewhat different--protected sharps devices in the morning and jet injectors in the afternoon.  Certainly they're somewhat different but they're related in terms of the problems they're trying to address.

      In the morning session we are revisiting our 1996 guidance on protected sharps and what we intend to do is to update the guidance based upon your comments and post it under our new good guidance practice procedure, which came into effect a couple of years ago.

      Now we're not here to discuss worker safety policy or current events that are driving an interest in protected sharps per se.  That's certainly an important issue.  We're here to talk about a guidance document and how to update that guidance document to the benefit of the agency.

      This guidance we're talking about does not address some devices that fall under the aspect of worker protection, sharps containers and some other devices.  We are talking about primarily protected syringe devices, but there are many other devices that come under the purview of our guidance that we'll be discussing today.

      As I was considering having this as a discussion item, I think one of my concerns, my critical concerns was as we move forward with clearing products, as FDA moves forward and people are relying upon our clearances across the country, we want to make our evaluations of these devices certainly up to date and pertinent, relevant to what's going on today in terms of what people think we ought to be doing in terms of product evaluations.

      I think some people out there think we get products and we're fidgeting with them and testing them on ourselves, trying to stick ourselves and what-not.  We don't really do that.  We do get samples and we do fiddle with them, as we are engineers and nurses and what-not and physicians, and we love to fiddle with things, but primarily our focus is upon the documentation contained in the documents and the testing that's done by the manufacturers or the people they bring in to evaluate the products or to whom they send products for evaluation.

      I'm primarily concerned about the clinical survey aspect in our guidance document as we discuss things this morning.  I know that there's various organizations and institutions who have their own surveys for their purchasing purposes or whatever, and each has its own scheme of questions and answers and approaches and how many products are tested and what controls are run.

      I think there's a place for everyone doing their own thing to a certain extent but as far as FDA's purposes, I want to try and reconcile some of those differences in approaches and see where we need to be doing perhaps a more comprehensive job in some cases and where we can leave some other evaluations as people feel it's necessary in their own institutions.

      So that's my reflections today and Irene Naveau is going to bring us up to date in a little more detail on the guidance document.

      DR. EDMISTON:  While we're waiting let me ask Mr. Ulatowski one question.  Do you prefer that in the course of this morning that when we refer to these systems we refer to them as protected sharps systems?  Would you prefer that?

      MR. ULATOWSKI:  I think that's more generally the scope.  There are some needleless or blunted needle-type systems but more generally it's protected sharps.

      DR. EDMISTON:  Fine.  Thank you.

      MS. NAVEAU:  Good morning.  The guidance document under discussion this morning is entitled Supplementary Guidance on the Content of Premarket Notification Submissions for Medical Devices with  Sharps Injury Prevention Features.  The document is intended to assist manufacturers, distributors or importers in preparing 510(k) submissions for medical devices or accessories with sharps injury prevention features, as well as to facilitate the 510(k) review in a consistent manner.

      I plan to include in my discussion today a brief background of the existing guidance document, as well as a review of working definitions of those types of medical devices to which this guidance document pertains.  The desirable performance characteristics of these devices will be identified.  Elements of the guidance document will be addressed and then a brief summary.

      Finally, I'd like to present a list of questions that were previously submitted to the panel to review for subsequent discussion and recommendation.

      The earliest medical device with a sharps injury prevention feature was reviewed in 1984 as an accessory to an IV administration set.  In 1985 a shielded syringe was reviewed.

      Since that time, the General Hospital Devices Branch has reviewed over 225 sharps injury devices with safety protective features, with the largest number of devices reviewed in 1991 and 1992 and in 1996 and 1997.

      It should be noted here that other divisions in the Office of Device Evaluation also review various medical devices with safety features.  Therefore a comprehensive list of these devices is not currently available.

      In 1994 a supplementary guidance document, the precursor of the guidance for review today, was presented to panel.  At the conclusion of that particular panel meeting, we acknowledged the comments and recommendations of the panel, as well as the public, specific to the performance data section and sample size recommendations for studies being conducted.  The revised draft supplement guidance in effect today has been used by the agency and industry since March 1995.

      The guidance document is used in our review for various types of safety devices and include the blunt or blunted needles of stainless steel or a plastic material, the prepierced septum devices of various configurations, reflux valves, which are sometimes referred to as bidirectional valves, vial adapters, those devices that provide needleless access to a drug vial for reconstituting and withdrawing medication, retractable needles, shields and guards associated with syringes, and recessed needles.

      These devices are integral components of an existing device or may be marketed alone.  For example, a reflux valve can be marketed alone for use as a heparin lock type of device used in conjunction with an IV catheter, an IV administration set or a syringe.

      What are we talking about when we refer to devices with safety features?  There are any number of definitions for devices with safety features but for our purposes today I'd like to read two working definitions of these devices.

      A medical device with a sharps injury prevention feature is a device designed with a component or attachment, either active or passive, that protects the user from a sharps injury.

      Sharps injury prevention features are found in devices such as but not limited to piston syringes, hypodermic single lumen needles, IV administration sets, intravascular catheters, vacuum tube holders, as well as blood collection devices.

      These features can be a component of a finished device, such as a sheathed or shielded syringe, while some safety feature products are marketed separately as accessories that are attached to devices by the user at the time of use.

      For regulatory purposes, accessories to a device are classified in the same class as the devices to which they are assembled.

      The second definition:  a needleless system is one that provides repeated access to a patient's vascular system without the use of sharps.  Fluid flow through the system may be unidirectional or bidirectional, with the latter allowing the user to administer or withdraw fluids or medications.

      An example would be a prepierced septum and blunt canula.  With this type of septum, a blunt canula connected to a syringe or secondary IV administration set can be inserted into the prepierced septum on a Y site of an IV administration set, an adaptor or other secondary IV or extension set.

      Another example is a valve connector, sometimes referred to as a reflux valve.  It prevents fluid flow through the device in either direction when not activated.  However, when a male or mating lower connector is inserted into the prepierced septum at the end of the valve's housing, the valve is activated in various ways, depending on the valve configuration.  This activation opens the fluid flow pathway for the infusion of IV solutions or medications and for the withdrawal of blood samples.

      In the next two slides I've listed a number of desirable performance characteristics that we believe should be considered by industry in conducting their simulated clinical and actual clinical studies in the evaluation of safety devices.  Evaluation of these characteristics may require actual use of the device and by targeting questions to health care workers who may or may not have had any experience with the device.

      These characteristics can usually be assessed with visual inspection of the device or by simple manipulation of the mechanism and should include:  hospital personnel are shielded from the needle before, during and after disposal.  The protective mechanism can be used equally well, regardless of hand preference or for hand size, for that matter.  If additional steps to the usual procedure are necessary to activate the protective mechanism, they would be few.  And they do not interfere with the usual nonprotected procedure.

      It is not necessary for the user to place either hand near the needle during a procedure and the hands should remain behind the needle at all times.

      In addition, the protective shield or retracted needle reliably locks securely into place with little effort.  The protective mechanism is designed in such a way that the user is always aware of its status; that is, whether or not the device is engaged or locked into place.

      The design of the protective mechanism allows appropriate visualization during device use.  The user is not exposed to the needle during disassembly and the mechanism is compatible with the sharps disposal system used in the facility.

      In September 1998 OSHA published a request for comments from a number of health care organizations related to occupational exposure to blood-borne pathogens due to percutaneous injury.  The FDA responded by submitting the preceding list of desirable performance characteristics that are found in the guidance document.

      Five similar performance characteristics were listed in OSHA's recent executive summary as suggestions from researchers for selecting safer medical devices.  However, it has not yet been determined how OSHA will incorporate these suggestions in their revised standard.

      This may be an opportunity for FDA to meet with OSHA and consolidate recommendations regarding the characteristics of devices with injury prevention features.

      The performance characteristics on the previous two slides are listed in this table.  They were compared with those characteristics outlined in the evaluation forms the three other organizations use; that is, the Service Employees International Union, the SEIU, from their guide In Preventing Needle Stick Injuries in 1998; the New York State Department of Health, the NYSDOH, from their study of needle stick prevention devices in March of 1992; and the Training for the Development of Innovative Control Technologies, the TDICT, from their Safety Feature Evaluation Form found on their website.

      The results of this comparison indicate that similar evaluations are being used by these organizations and in most cases concur with our characteristics.  For instance, we all agree that the user should be protected from needle stick injury before, during and after use, that the safety feature may be activated with either hand, and the user be able to visualize the fluid and the fluid level during preparation and use.

      We have included a statement indicating that the device with safety features should be compatible with the sharps disposal system in the facility.  The statement may be included in their evaluations, but it was not evident in the material that I had access to.

      The guidance document does not include a list of targeted questions, as do these organizations, but it does contain recommendations to industry regarding their report forms that would include this information.

      Apart from the section that addresses appropriate device description and labeling, much of the guidance is directed to device specification and performance test specific to sharps injury prevention.  What it does not address are sharps containers which are addressed in their own guidance document and needle recappers.

      In essence, the guidance provides overview information to applicants to aid in the analysis of performance characteristics of these devices and contains recommended types of tests that can be performed.  Again only recommendations are suggested to industry.  Therefore the document does contain a checklist or a to-do list for manufacturers to follow.

      In this document we refer to five main types of performance testing for devices with sharps injury prevention features.  Those include bench testing, biocompatibility data, preclinical, simulated clinical and actual clinical studies.

      The guidance also contains factors that should be considered before conducting a simulated clinical or actual clinical study; for example, how a device is equivalent to other similar devices, and microbiological issues.

      Typically, needleless systems present a contamination concern addressed with simulated testing in a microbial challenge test, whereas the sharps devices present a needle stick concern addressed with simulated clinical and actual clinical study data.

      In summary, we have established that the 1994 revised draft guidance document has served as a working document for FDA reviewers and industry alike for the past five years.  The document includes recommendations to industry, especially related to design features and performance characteristics that should be included in their studies prior to 510(k) submission.

      Several types of surveys are in progress by industry during their preparation in introducing their safety devices into the marketplace and by organizations dedicated to the protection of health care workers and others that use devices with protective features.

      In light of public health issues that have arisen and emerging new technology, we are revisiting our document.  We recognize that it may need revision for the following reasons:  for consistency in our reviews and to assist the manufacturer in assembling scientific information, especially microbiological and performance data to determine substantial equivalence.  There may be other areas in the guidance, as well, which you may offer your suggestions for change.

      I'd like to read now the following questions that were previously submitted to the panel.  I understand that the questions will then be considered separately for discussion and recommendation.

      Number one, "Our current guidance document allows sponsors to perform either a simulated clinical use study or an actual clinical use study to evaluate the performance of the sharps injury prevention feature.  In most cases, sponsors have provided information from simulated clinical studies.  When would it be appropriate for FDA to consider data from actual clinical use versus simulated clinical use?

      "Are there minimum criteria in terms of sample size, independence of the evaluators and number of sites that FDA could consider for both the simulated clinical and actual clinical use studies?

      "In addition to the survey format, are there any other methods that the FDA should consider when evaluating the performance of these types of devices?

      "Are the evaluation criteria listed in the guidance document appropriate and inclusive?

      "How could the results of these evaluations be presented to users?  Should the results be included in the labeling?"

      And two, "Currently sponsors submitting applications for needleless access devices are asked to demonstrate that their device is substantially equivalent by providing nonclinical bench data to demonstrate that their device does not increase the risk of microbial contamination of the fluid pathway, validation of the cleaning method, and instructions for use.  What additional types of information should be considered for our premarket review?"

      Three, "What mechanism does the panel recommend to the FDA to increase user awareness of the safe use of these devices?"

      And four, "Is there a need for educational programs for the use of sharps injury prevention devices?  If so, what content should be included in the educational programs to encourage the safe and effective use of these devices?"

      And five, "Are there other areas of the guidance document that should be revised?"  Thank you.

      DR. EDMISTON:  Thank you very much.

      Do the members of the panel have any questions for Ms. Naveau?

      [No response.]

      DR. EDMISTON:  That being the case, I'd like to invite to the podium Dr. Joseph, director of the Office of Health and Industries Program at the FDA.

      DR. JOSEPH:  I'll say good morning while we get ready and we appreciate your being here and thanks to the division for including us today.

      As was stated, I'm Dr. Joseph, the director of the Office of Health and Industry Program in the Center.  The office has several activities in which we engage on behalf of the Center, one of which is outreach and educational activities.

      What I'm going to talk about today is a little bit about to put our educational activities in a context.  I think it's really important to briefly review what our mandate is in terms of the FDA mandate relative to devices.  And because there are other sister agencies who also, as Irene said, have an interest in this area, I thought we'd briefly take a little snapshot of what OSHA's mandate is and see how we can blend our activities and then get your advice on that.

      Okay.  The mandate of the FDA in terms of medical devices is to really focus on our regulatory activities on the product features and product aspects, and that's again to ensure the safety and effectiveness of those devices.  So we pretty much look at the labeling requirements, the performance test methodology, good manufacturing practices and quality systems.

      Whereas the Occupational Safety and Health Administration has a deep interest in sharps injury prevention devices, as well, and from their mandate you can see that they're tasked with ensuring that workplace conditions are safe and healthful for employees, and they do this by enforcing their standards developed under their act, as well as collaborating with the states to ensure that those conditions are met and providing research, information, education, training in occupational safety and health.

      And as Irene said, recently OSHA issued their request for information and comments on a number of items to reassess their blood-borne pathogen standard.  They asked specifically for information on 16 items.  I've just listed three here, which has sort of some interesting possible overlap with where our interests are, and that's in training and education in the safe use of medical devices and any effect on reducing injury rates and the impact on the delivery of patient care.

      But we've, as I said, we do have a role and there are things we can do.  Irene mentioned we cleared in excess of 200 devices with some sharps injury prevention features.  We have cosponsored several meetings with CDC, OSHA, NIOSH, NIH and the most recent one was last August relative to the prevention of transmission of blood-borne pathogens.

      We have issued three safety alerts or notices, all of which went to the health care community, two of which pertained to recommendations on the safe use of safety prevention technology relative to administration sets, and most recently, the one we issued in February of this year, on capillary tubes.  I think that was probably the first alert that we issued that was jointly sponsored by OSHA, NIOSH and ourselves.

      We've also issued eight guidance documents on injury prevention aspects, of which three were directly related to sharps prevention devices, the primary one being the one that you'll be discussing the morning; the other two are supplementary to it.

      Irene mentioned we responded to the OSHA request for information by providing them with the human factors desirable performance characteristics that we look for and feel would assist and go a long way in preventing any injuries.

      And I failed to mention under the safety alerts that we also are currently developing a new notification on use of devices with sharps injury protection features and we're just now trying to determine the direction or if those will be interval notices.

      But we've also been planning an educational teleconference with several federal agencies on sharps injury prevention activities and devices.  We've been communicating with OSHA in trying to determine if they're willing to take the lead in this venture and we certainly are willing to collaborate with them on that.

      And as Irene read to you, there are three questions that we would appreciate response from you as guidance for the future, since the office has been tasked with doing some additional educational or outreach activities and before moving too much further along, we thought it would be helpful if we could get your guidance on the mechanism that the panel could recommend for us to increase user awareness of the safe use of devices.

      If indeed there is a need for educational programs for use of sharps injury prevention devices, should you respond in the affirmative to that, then what should the content be included in those programs that would encourage the safe and effective use of those devices?

      And in the interest of being very brief, that's all I'll say this morning.  And I look forward to whatever information or guidance you can provide us.  Thank you.

      DR. EDMISTON:  Thank you very much.

      Are there any questions from the panel members for Dr. Joseph?

      [No response.]

PRESENTATIONS BY USERS OF PROTECTED SHARPS SYSTEMS

      DR. EDMISTON:  That being the case, we're going to move on to our presenters, the users of protective sharps systems.

      Before I do that, I'd like to reiterate again when you come to the podium, please speak clearly into the microphone.  Also it's very important for you to identify the organization you're part of.  We need to know what, if any, financial interest you may have in the medical device community.

      And I should also emphasize that we're trying to run a tight schedule today because we're going to have some significant discussion regarding this particular guidance documentation.  I want to encourage our next presenters to limit their comments to 15 minutes.

      The first person I'd like to call to the podium at this time is Dr. June Fisher, who's a clinical associate professor of medicine at the University of California and is director of training and development for innovative controls and technology.  Dr. Fisher.

      DR. FISHER:  I would like to make the comment that I am thankful for the invitation to speak here today and that I really am very excited to see that the FDA is addressing the issue of health car worker health and safety.

      I know there's a mythology out in the general community that there's an oppositional thing between patient safety and health care worker safety and I know that in institutions these are weighed.  I think that this has been proven repeatedly that this is an erroneous approach to patient care.

      As a clinician, that is my primary concern but I do know that the health care worker who has a safe environment can provide much better care.  The most obvious example is if you think about in terms of back injuries.  I do not want to be lifted in a hospital but if I had to be there, by somebody who has had a back injury and is not supplied with the appropriate devices to lift people.

      I think that this certainly goes for the needle stick area and I really welcome this kind of--the FDA is vigorously approaching the issue of health care worker safety in their desire to improve patient safety.

      I am not going to talk specifically about needleless systems.  It'll be a little bit more of an overview, which will be consistent with some of the presentations that went a little earlier.

      [Pause.]

      I have a lectureship in engineering but I must say that I'm totally baffled when we have anything like this.  I think it's every speaker's nightmare to not have your slides available.  Since your time is a little pressed, I will try to speak a little extemporaneously and then hopefully the slides will be projected.

      The Training for Development of Innovative Control Technology is a program that was started in 1989 and has been funded for almost 10 years by the National Institute of Occupational Safety and Health and it's a program that brings together product designers, industrial hygienists and users.  And most of my discussion will be really based on user-driven technology.

      You're going to have to bear with me.  They were organized.

      This is our logo for our slide.  I hope I'll have a few more minutes.

      DR. EDMISTON:  Of course you will.

      DR. FISHER:  As all presentations that I do around this topic, I always use this dedication slide.  This is a group of health care workers who--the first group are still alive and the bottom group are people who have died from occupational exposure to blood.

      I have to make the point that these are all in one city.  And when I do speak around the country, I hear from many people that probably the same numbers do exist, so that as important as the CDC numbers have been, most of us feel that these numbers are very, very limited.  And I don't have time to discuss that, so we have to remember that there is a real human face and there are serious outcomes for this.

      I was asked to talk a little bit by people earlier today so I put this slide in.  Coming from California, we have a particular circumstance that we now have legislation mandating the use of safer devices, which will change the whole direction in California and will have impact or already has had impact nationally.

      We have the blood-borne pathogen standard, which is OSHA.  We have a Cal/OSHA standard now, which is working under an emergency order, which mandates the use of engineering controls.  If this is not passed by the board, the emergency standard will continue so that this will be in effect regardless of what--in California we have a political board.  The assumption is that they will pass this.

      There's legislation in Tennessee, Maryland and I think in 20 other states--somebody may speak for that--and there's federal legislation pending on it.  So we have, although we don't want to deal with the political issues, we do have a political driving force.

      As I said, our project is a project that brings together the industrial hygienists, product designers and health care workers.  And, as far as I know, this is unique for any area in health care.  And I would certainly recommend that this kind of collaboration exist for many areas in device development.

      I do know, as an aside, because I have a lectureship in engineering, I have 48 product designers usually a year running around the hospital and there are major, major issues that need to be addressed, not just in these devices, that could be improved by bringing together the user and the product designers.

      Why bring the health care workers to it?  This is from a modification of Warren Estrine from HEMAS because they have a familiarity with new existing devices, the knowledge of the medical device procedure and protocol and an understanding of the environment in which the devices will be used and intimacy with the concerns of the actual user and an advocacy that goes on.

      The manufacturers do try to have this but in my only experience with them, they really don't fully understand the line user.  I suppose the best example is when I was a resident at Stanford.  The  hospital was built by talking to the chiefs of medicine.  The building didn't work, and it was the first instance we made it very clear that you have to go to the person who's doing the job.

      Our project involves a large group of institutions and this is an old slide and it can be expanded now because we have national involvement with both dental areas and with some of the other hospitals in the country.

      This slide, and it's upside down and it's supposed to go later--it's showing you when we do simulation studies.  I think we'll have to forego that.

      Our methods developed our review of data on needle stick injuries, an appraisal of the health care workers who are doing the observational studies, failure analysis of devices.  And I really want to emphasize that that is very important, to do failure analysis and simulation studies with the devices and joint brain-storming sessions and multi-center health care worker testing.

      One of our first things we did was to provide a tool for health care workers to assess devices and you got some of that when the chart was presented before.  If there's a consistency with the SEIU it's because they adapted their devices from ours, so I wouldn't say that independently this occurred.

      And we have now 14 devices where we have the tools--I don't know if I can focus this any better--and you can get these tools on our web page, which give guidance to the health care worker in evaluating the device.  And I chose the one for needleless systems for IV connectors today.

      The interesting thing about these devices, I'm not going to go over the specifics within 15 minutes but we can provide you with those, all of them.  I don't know Martha, if you were able to get that off the web.  We could provide that for the committee.  I have a copy here.

      These were the first written criteria for now 14 types of safety devices.  They provided a means for involving health care workers and most of these have been validated in multiple institutions.  This is an old slide.  The 14 are now in the 1999 AHA document.

      And while they were originally used for a tool for health care worker evaluation and selection, it became the industry benchmarks.  So it is very important to develop these criteria that are user-based because it does drive the industry.

      That was the surprise to us, a picture showing--this is when our team was living down in the emergency room.  Here is a product designer actually who is now trying to do laboratory failure analysis of the device.  This is a picture--actually the woman in white is a product designer, industrial hygienist and nurse who is guiding another nurse in testing of the devices, using the criteria sheets.

      One of the things that we did is also we do design evaluation courses for nurses.  When you're talking about education, this is one of the things that actually we want to include.  We're hoping now to be able to develop a program with the American Nurses Association where we will hope to develop 400 master trainers around the country so that we could emphasize the training.

      Training is essential.  When the question was asked for health care workers, you cannot just coldly go in.  This is one of the slides for our course.  We're not expecting the nurses to be product designers but we were trying to help them develop a language so they could talk to product designers and manufacturers in a constructive way.

      The importance of it is that out of this course, not only did they learn something but we learned a lot.  And what we got out of that course was a user-based performance standard for design evaluation selection of medical devices.

      And a performance standard is different than benchmarks and it should not stifle innovation.  We were very aware that the manufacturers have to have that kind of freedom where they can develop new devices.

      We are still in the early stages of development.  It should be user patient-based.  You give a framework for evaluation.  And we need a national task force to develop consensus on performance standards and this is one of the things that I was talking about with Tim for a long time, that if the FDA could take the lead in promoting this kind of census, it may not be something that you can do yourself but if you develop that national consensus, that will be furthering things.

      And performance standards versus criteria performance are generalized.  It's procedure-based and encompasses the product life cycle versus the point of use only.  Before, I was talking about the specific criteria.

      It's a rather extensive document.  We can also give you copies of that that can be made, but these are the areas that they cover.  Obviously patient care and quality care came first.  User safety, user fit and satisfaction, we felt, came before patient fit and satisfaction.  And product life cycle, which we're talking about sharps boxes, administrator's fit and satisfaction.

      One of the other things that came out of there was the issue of scenarios, which you call simulation and we're calling them scenarios.  It's the ability of the actual user to test-drive new products and it approximates real-life situations and it draws attention to unforeseen difficulties.  It's a very systematic way of doing that.

      These are the variables that we identified and that impacted on the use.  Some of them may sound silly to you.  Why lighting?  Well, that's labeling and packaging.  Noise?  Why noise, people ask us, because a lot of the engagement of the devices depends on sound.  And crowding, condition of hands, visibility.  Some of these, I think, are included in your document, also.  So we feel these are the variables to be considered for the sharps devices.

      And here is the way we rank them.  You choose what is applicable to your clinical situation and then develop the device.  This chart shows how you put them all together.

      And, as an aside, I just have to say we tested that at UCSF and I think the system works because a door was open in the room when we were doing the simulation and one of the nurses was acting as a patient who was having some difficulties and the intern ran in and said, "Can I help you?"  So I knew that we had a good scenario.  We just closed the door.

      What came out of that is that we needed a user-based design and that users should be involved from the very beginning of need-finding and they should be involved throughout the whole process.  Rarely are they.  This is really the process that goes on.  If you don't believe me you don't have to, but we've gone to manufacturers who've all told us this is, in reality, what happens.  And we would push that the user be involved from the beginning.

      One of the other things I just want to put in, what we really are aiming for is to have the PEST.  That is passive, easy, simple and throughout.  That's the summary of what we think is desirable in a device.

      I would like to go over briefly the overheads.  I have to apologize for the overheads because they're handwritten.  There was a power failure as I was trying to use my computer and I couldn't wait any longer because I had a plane waiting for me.  As a physician, my handwriting is not very good but I think you can read that.

      These are the recommendations for FDA, to participate in the promotion of primary prevention of occupational exposure to blood.  I know that there's a lot of emphasis and there should be and people do get stuck but I think we have to think about primary prevention so we don't even have to think about post-exposure treatment.

      The first thing, some of these are very specific and some are more general.  One is labeling of all sharps devices.  At present, the only sharps devices that are labeled are those that have the safety feature.  We believe that the ones with nonsafety features need to be labeled, also, and they clearly need to be labeled.

      There are going to be instances where you have to use a standard sharp device but you should be very aware that it is a standard sharp device, so we think that they should all be labeled.  They should not be treated differently.

      I think it's interesting that previous speakers from FDA brought this up, to actively solicit device failure inadequacy from end users.  I think you may have to redefine things.  I don't want to think about death or serious injury.  I think any needle stick, and we have probably 900,000, should be analyzed and FDA should be having their handle on.  I'm not asking you to look at all 900,000 but that there should be more awareness of what's going on there.

      There should be promotion of criteria for systematic pilot-testing of market-available devices.  I didn't talk about that because of the time but what I presented before, we consider are just screening tests.  That pilot testing systematically is a very urgent issue.  And from my experience, both in my institutions that I've been in and now I've been in many institutions talking around the country, pilot testing is--at best I could call it a joke.

      Generally you give the device to people and you come back two months later and ask them, "Did you like it or you didn't like it?"  That is not pilot testing.  There needs to be a very systematic approach to doing it and to actively collecting the data.

      And I think if there were criteria for this that you would be getting better pilot testing and actively collect failure inadequacy data obtained from pilot test.  If you had good pilot tests, that would really give you postmarket data that is really not available now.  So we're recommending that there really be an emphasis on the pilot testing.

      And there should be expanded requirements for simulation testing.  From what I can gather, the simulation testing is left to the manufacturer to define what they are and I think that that causes a great deal of variability.  There should be standards.  I'm not saying that you specifically say you have to do this and this and this, but put the benchmarks out there, the standards for the variables to be included in that testing.

      And to require, before you even do the testing, a user-based work task analysis.  Define what variables you want in that test.  If you're going to go in the emergency room and you're going to use some standards that you devised for the out-patient department, that doesn't give you much detail.  Or if you just bring a group of people together that doesn't represent the spectrum of work and say, "Well, try this," and sit in the room, which has no clinical bearing at all, so I think that you should have user-based work task analyses and require testing for failure.

      That sounds very strange but in our own experience if you just go to a naive health care worker, they know what their problems are but they don't know how to look at it.  They're so grateful that you have a new device that they say, "Oh, it's fine."  And you look at them and you say, "That is fine?"  So they have to understand how to go to failure, to do all those mistakes.

      Our trained users will throw things on the floor, will do bad practice because they know that's what they have to look at, because that's what you're going to get in reality.  And to require the inclusion of trained users in the testing process.  This is why we're excited about our collaboration with the ANA, to train these kinds of resources around the country, but I think that should be required by the FDA in your simulation testing, that you've had some trained users who can foresee.

      And my last slide is that our performance standards and our criteria and some discussion scenarios are all available on our website, which is here.  Thank you for allowing me to speak.  I think I've covered the 15 minutes.

      DR. EDMISTON:  You're right on time, believe it or not.  You're right on time.

      Are there any questions from the panel for Dr. Fisher?

      [No response.]

      DR. EDMISTON:  Dr. Fisher, I have one question.  When you use the word "pilot," are you referring to bench testing or to simulated clinical testing?

      DR. FISHER:  No, I'm actually--thank you for asking that.  I think they should be bench-tested.  I think there should be evaluation before you even do a simulation, at least for the evaluation.  For the manufacturers, they should then go to simulation.

      And then the pilot testing is actually postmarket pilot testing by the institutions.  And I think most places say they do that.  They're going to decide if they're going to buy a device or not and they bring it on the unit and look at it.

      DR. EDMISTON:  So you're defining pilot testing really as product evaluation within the institution.

      DR. FISHER:  Yes.  And I think that that's a very valuable area that FDA could use for a postmarket details without having to wait for the death, which may come a year later.  So I think that that data could be extremely valuable.

      DR. EDMISTON:  Well, thank you very much.

      Our next presenter is Ms. Toni Hughes, a perioperative nurse who is representing the Association of Operating Room Nurses.

      MS. HUGHES:  Good morning.  Thank you for the opportunity to submit a statement on behalf of AORN to this Federal Drug Administration advisory panel.

      My name is Toni Hughes.  I'm a registered nurse with a bachelors of science degree in nursing and a certification in operating room nursing.  I'm a perioperative nurse at Anne Arundel Medical Center in Annapolis, Maryland.  I have been a perioperative nurse for 19 years and a surgical department manager for the past two, a member of AORN since 1981.  I was the chair of the AORN National Practices Committee from 1998 to 1999 and am an active member of the Maryland Nurses Association and the American Nurses Association.

      Organized in 1949 with a current membership of 43,000, AORN, the Association of Perioperative Nurses, is the professional organization of perioperative registered nurses, whose mission is to promote quality patient care for providing its members with education, standards, services and representation.

      AORN supports the development and use of products, such as safe needle devices, to prevent unnecessary exposures of perioperative personnel to hazardous blood-borne infections.  Perioperative nurses are acutely aware of the potential dangers associated with use of needles and other sharps in caring for perioperative patients.  Although only 13 percent of the sharp injuries in the operating room are due to hollow bore needles, needle stick injuries are even more significant risks than the preoperative and postoperative patient care arenas.

      Eighty percent of all blood-borne exposures are the result of needle stick injuries.  One study has found that a needle stick injury prevention strategy eliminating 100 percent of needle sticks and not costing more than 36 percent of the cost of needle devices would not increase overall costs.

      As participants in product evaluation and purchasing teams, perioperative nurses recognize the complex challenges encountered when trying to identify the most effective and affordable products available.

      As health care employers begin to acknowledge the hazards and risks associated with direct delivery of health care services and begin to seek safe needle devices for workers, manufacturing standards should be established to ensure that truly safe and effective devices are available in the marketplace.  The FDA's role in supporting the development and manufacturing of high quality, safe, affordable and effective devices is critical to achieving a truly safe working evidence.  AORN supports the FDA's efforts in collaboration with manufacturers and users to build a safer health care working environment.

      DR. EDMISTON:  Thank you very much.

      Does the panel have any questions for Ms. Hughes?

      [No response.]

      DR. EDMISTON:  In that case, thank you very much.

      Our next presenter will be Ms. Mary Alexander, who is the past president of the Intravenous Nurses Society.

      MS. ALEXANDER:  Good morning.  I'd also like to thank the panel for allowing INS to make a statement.

      My name is Mary Alexander.  I'm the chief executive officer of the other INS, with the Intravenous Nurses Society.  We're a national nonprofit member organization that was founded in 1973.  INS is the largest organization for the IV specialty and exists to promote excellence in intravenous nursing through standards of practice, education, public awareness and research.  The organization's ultimate goal is to ensure that patients receive safe, high quality, cost-effective nursing care.

      The Intravenous Nurses Certification Corporation is also affiliated with INS.  However, it is a separate corporation established in 1983 to ensure the clinical competency of intravenous nurses.  INCC achieves this goal by administering certification exam and recertification programs.

      A registered nurse who passes the certification exam and meets the experience criterion receives the certified registered nurse intravenous credential.  This credential is maintained by continuing to practice the IV specialty and completing continuing education requirements or retaking the exam.

      INCC exists to benefit and protect the public through assessment, validation and documentation of the clinical eligibility and continued competency of nurses delivering intravenous therapy in all practice settings.

      INS understands the inherent dangers involved in administering IV therapy.  Vascular access devices, needles and sharps are fundamental to the practice of IV therapy.  INS members are the frontline health care workers who provide IV therapy to patients in a variety of practice settings, which are now extending beyond the acute care setting and including but not limited to the home, physicians' offices, skilled nursing facilities, subacute facilities and ambulatory infusion centers.  As well as our members, more practitioners are involved and their competency and skill levels differ widely.

      INS supports engineering and work practice controls that eliminate or minimize exposure of the health care worker to blood-borne pathogens.  In 1997 INS wrote a position paper on safety products which appeared in the Journal of Intravenous Nursing.

      INS supports research and development activities on IV products and medical products and devices to improve patient care and protect the health care worker, education and compliance with commonly accepted principles of infection control and basic practices, choice of products based on engineering design that accomplishes the prevention of transmission of blood-borne pathogens and improvement in patient outcomes, safety and risk management based on professional responsibility and clinical standards of practice, and blood collection design characteristics which result in effective safety device, which include the elimination of the need for the clinician's hands to be placed in front of a sharp needle tip, integration onto the device's design and not an accessory, activation before disassembly in that it remains in effect after disposal, and simplicity in utilization, preferably a passive system.

      Requiring all health care facilities to use needleless systems and sharps with engineered protections, such as retractable needles, and instituting training and education in the use of safer medical devices provides an effective means of preventing percutaneous exposure incidents and reducing the needle stick injuries each year.

      INS contends the best way to reduce the risk of accidental needle sticks to health care workers is through ongoing education, training and competency testing, use of vascular access devices that minimize the risk of needle stick injuries, in compliance with OSHA's blood-borne pathogen standards.

      Frontline health care workers should not have to risk their lives while saving the lives of their patients.  INS applauds and supports your efforts to positively impact health care worker safety.  Thank you.

      DR. EDMISTON:  Thank you, Ms. Alexander.

      Are there any questions from the panel members?

      [No response.]

      DR. EDMISTON:  Thank you.

      Our final presenter will be Susan Wilburn, the president of the American Nurses Association, who will address the panel.

      MS. WILBURN:  Good morning.  Thank you very much.  It's a pleasure to be with you here today and thank you for taking a look at this issue that is of critical importance to the American Nurses Association and the two and a half million registered nurses around the country that we represent.

      My name is Susan Wilburn and I'm the senior specialist for occupational safety and health at the American Nurses Association, so my work is to work with you to protect nurses from needle stick injuries and the subsequent illness and death, as Dr. Fisher described.  And I wanted to start today to talk a little bit about our members and the impact in recent years of needle stick injuries on their lives.

      The American Nurses Association is the professional association representing nurses in the United States with our 200,000 members and as the professional association, we develop the code of ethics for nurses; we establish standards of practice; we develop standards for certification and certification testing of basic nurses and nurses in specialty practice, including advanced registered nurse-practitioners.  And as the largest union representing nurses in the country, we also, in 28 states across the country, represent nurses for the purposes of collective bargaining and the advancement of the economic and general welfare of registered nurses.  And my role as the occupational safety and health specialist falls in all of those areas.

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