Medical Devices

Medical Device Event Reporting in Ophthalmic Settings - June 9, 2010

MedSun Education Webcast Transcript:

Wednesday, June 9, 2010
1:00 p.m. – 2:00 p.m. ET

Slide 1 - Medical Device Event Reporting in Ophthalmic Settings

Coordinator: Welcome and thank you for standing by. For the duration of today’s conference all participants are in a listen only mode. Today’s call is being recorded. If you have any objections, you may disconnect at this time. I would now like to introduce your host. We have Ms. Cynthia Bushee. Ma'am, you may begin.

Cynthia Bushee: Thank you. Good afternoon and welcome to this one hour MedSun sponsored Webcast, Medical Device Event Reporting and Ophthalmic Setting.

Slide 2 – Speakers (in order of presentation)

Cynthia Bushee, B.S.N. (Moderator)
Nurse Consultant
SightNet Coordinator
Division of Patient Safety Partnerships
Office of Surveillance and Biometrics

My name is Cynthia Bushee, and I am the moderator for this event. I'm a nurse consultant in the Office of Surveillance and Biometrics in the Division of Patient Safety Partnerships. And also, I am the coordinator for the SightNet subnetwork.

Slide 3


If participants have any questions or are having difficulty accessing the slides they can call MedSun at 1-800-859-9821.

Slide 4 – Nursing Continuing Education

One contact hour of nursing education credit is available  After this Webcast, those who registered may go to the registration site, fill out a short program evaluation and receive a certificate of participation with one contact hour of nursing continuing education credit. A link to the registration site can be found in your confirmation email.

Slide 5 - Agenda

  • Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH) overview
  • Current Ophthalmic Device Issues
  • Ophthalmic Device Reporting
  • Questions and Answers

During today’s discussion, we will present an overview of the Food and Drug Administration and the Center for Devices and Radiological Health, FDA and CDRH.

We will also discuss current ophthalmic device issues and ophthalmic device reporting. Lastly, we will answer a few questions that were submitted at the time of registration.

Slide 6 – Speakers (in order of presentation)

James Saviola, O.D., CAPT USPHS
Ophthalmic and Ear, Nose and Throat Devices
Network Leader,
Office of the Center Director

Bernard Lepri, O.D., M.S., M.Ed.
Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices
Office of Device Evaluation
SightNet Technical Advisor

And now I'd like to briefly introduce our speakers in the order that they will be presenting, Dr. James Saviola and Dr. Bernard Lepri.

Dr. James Saviola is currently the Ophthalmic ENT Network Leader for the Food and Drug Administration’s Center for Devices and Radiological Health. Previously he was the Vitreal, Retinal and Intraocular Devices Branch Chief in the Division of Ophthalmic and Ear, Nose and Throat Devices for 17 years.

Dr. Saviola is a graduate of Cornell University and the Pennsylvania College of Optometry. He is a Captain in the U.S. Public Health Service and holds consulting staff credentials at the National Naval Medical Center in Bethesda, Maryland.

Dr. Bernard Lepri has 12 years of clinical review experience with the FDA and excimer lasers, glaucoma drainage devices, intraocular lens implants, contact lenses and care products, retinal implants, refractive implants and ophthalmic viscoelastics.

Previously he has served as an Assistant Professor of Optometry and Director of External Clinical Training at Pennsylvania College of Optometry. Prior to joining the FDA, he was with Talbert Medical Group in Albuquerque, New Mexico. Dr. Lepri has a Doctor of Optometry degree and an M.S. degree in Vision Rehabilitation from Pennsylvania College of Optometry.

Slide 7 – Organization of FDA

  • FDA is comprised of several Centers
  • Three Centers deal with human medical products:
    • Center for Drug Evaluation and Research (CDER)
    • Center for Biologics Evaluation and Research (CBER)
    • Center for Devices and Radiological Health (CDRH)
      • MedSun
        • SightNet

I would like to begin by giving you some background information about FDA, CDRH, MedSun and SightNet and to let you know how they are related. The FDA is a large federal agency that has certain responsibilities for protecting public health.

Within the FDA there are three centers that oversee safety of medical products. These include Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

The MedSun project functions within two of the FDA centers, the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).

Slide 8 – Center for Devices and Radiological Health - Mission

  • Responsible for protecting and promoting the public health:
    • By assuring the safety, effectiveness, and quality of medical devices,
    • Assuring the safety of radiation-emitting products,
    • Fostering innovation, and
    • Providing the public with accurate, science-based information about the products we oversee.
  • Throughout the total product life cycle.

The mission of CDRH includes the responsibility for approving the use of medical devices and overseeing the manufacturing performance and safety of these devices.

Slide 9 - MedSun

  • An adverse event reporting program
  • Over 350 health facilities participate
  • The primary goal of MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.

CDRH at FDA learns about problems with medical devices through a variety of mechanisms. The Medical Product Safety Network, or MedSun, is a network of approximately 350 healthcare facilities that the FDA utilizes to obtain knowledge about problems experienced with the use of medical devices in the clinical community.

MedSun uses an internet-based system that is designed to be an easy and secure way to report adverse medical device events.

Slide 10 - SightNet

Participants from a variety of clinical settings work to identify, understand, and solve problems associated with ophthalmic devices.

SightNet is a specialty subnetwork within MedSun which is focused on the collection and sharing of information about potential and actual adverse events associated with medical devices used in the ophthalmic setting.
Working through MedSun and the subnetworks like SightNet is one of the ways that CDRH learns about problems and potential problems with medical devices.

Our hope is that by providing educational programs like this, we can increase reporting about medical device problems, in particular, medical devices used in the ophthalmic setting. Now let me turn the program over to Dr. Saviola.

Slide 11 Agenda

  • FDA/CDRH Overview
  • Current Ophthalmic Device Issues
  • Ophthalmic Device Reporting
  • Questions and Answers

James Saviola: Thank you, Cynthia. Good afternoon, everybody. I'm going to discuss primarily three different ophthalmic device areas of particular interest to our center. But first I'll provide some additional overview to compliment the information that Cynthia has just provided.

Slide 12 – Medical Devices

Collage of images of medical devices
Promote and Protect the Public’s Health

Our center regulates a vast array of different types of medical devices. Some are relatively simply while others are more complex. Problems can occur at either end of the technological spectrum that these devices represent.
Often the simplest devices can generate a significant number of problems in reports that we receive.

Slide 13 - "Total Product Life Cycle” Vision

  • Ensuring the Safety of Marketed Medical Devices
  • Efficient, Effective, and Predictable Product Development
  • Enabling Technology and Innovation

Our view is that we have multiple roles in the regulation of devices throughout the total product lifecycle.

We use this term to describe a medical device from the concept phase to the development of protocols and generation of testing, the support, premarket review and approval, through commercialization of the product and ultimately obsolescence.

Our goals are that we do all these things so that we’re still able to ensure the safety of medical devices that are on the market to allow firms to be as efficient as possible by providing the predictable course and then navigate through the regulatory process, at the same time being supportive of all types of technological innovation for new devices.

Slide 14 – Managing Device Risk and Promoting Public Health

  • Quality System/Medical Device Design
  • Premarket Review Program
  • Postmarket
  • Research – strengthens science base
  • Membership standards groups
  • Ongoing patient education

Some of the ways that we fulfill the components of our mission are described on this slide. We manage risk at several points throughout the total product lifecycle.

For example, the quality system regulations apply during the concept and development phases as well as during the production phase of a device’s life. We review the Class II and Class III devices prior to clearing them to be marketed in the United States.

In the post market area we monitor device experience. This is the primary focus of today’s Webinar and Dr. Lepri will discuss the MedWatch and MedSun program shortly.

As the slide notes here, we also have a very active research program, which I'll touch on in a few minutes. We actively participate in standard development organizations to help establish and maintain a level playing field for manufacturers so that they are better able to characterize their devices and we’re able to evaluate the device’s performance.

We also have a variety of ways we provide ongoing education for patients and in some cases information for healthcare providers to maintain safe use of devices.

Slide 15 – What is important to practitioners

  • Products are safe and perform as labeled
  • Products with similar labeling meet minimal standards of clinical equivalence
  • Laws that protect patients enforced
  • Care providers and the products they use are treated (evaluated/regulated) fairly
  • Patient care is paramount

We do all these activities keeping in mind what is important to healthcare providers, such as yourself who work directly with patients. You expect the products are safe and that they perform as they are labeled and intended to.

The products of similar labeling meet minimum standards of clinical equivalence. We also expect that laws that protect patients' rights, welfare and safety are enforced.

And you, as care providers want the products you use to be evaluated fairly and evenly across the board. And of course, the well-being and care of your patient is always your highest concern, as it is ours.

Slide 16 – Medical Device Reports

Total Product Life Cycle (TPLC) Number of Reports for Contact Lenses, Excimer Lasers, and Intraocular Lenses (October 2007 to May 2010)

  • Contact Lenses = 855
  • Excimer Lasers = 1670
  • Intraocular Lenses = 9920

I'm going to spend the remainder of my time discussing initiatives in three different ophthalmic areas that we would like to emphasize the need for additional reports.

Some of the concerns that you hear may be obvious in terms of how soon these problems may appear relative to treating the patient, while others may not seem as obvious due to the later time frames and the problems coming to light.

The graphic on this slide is intended to give you a perspective of the relative number of events we receive for these three common ophthalmic devices which are contact lenses and their related products, excimer lasers and intraocular lenses.

Now the numbers that we have on this slide were generated from this relatively new tool that we have which provides a TPLC snapshot of device experienced.

The Website that is available to the external world is listed at the bottom if you would like to try and explore this tool on your own. I must make the point that the numbers of reports on this slide are not official numbers per FDA’s standpoint and if you do your own search you may come up with slightly different numbers than the ones you see on this slide.

And as I said, if you appreciate that we receive far more reports for IOLs than we do for contact lenses or for lasers then you get the point of this slide. I'm not going to go into specifics or the types of events that we receive for these different devices, other than to say that the vast majority of the IOL reports are events that occur prior to the lens being implanted - prior to the lens being implanted into the patient.
You can see that we have roughly twice the number of excimer reports as we do contact lens reports and somewhere between 10 to 11 times the number of intraocular lens reports as we have contact lens reports.

Slide 17 – Toxic Anterior Segment Syndrome (TASS)

  • Blurry vision
  • Corneal edema
  • Hypopyon
  • Conjunctival infection
  • Anterior chamber cell and flare
  • Fibrin formation
    (Top image of eyeball courtesy of National Eye Institute, National Institutes of Health; bottom image icon)

So the first ophthalmic topic that I will discuss involves a complication that can be associated with cataract surgery called Toxic Anterior Segment Syndrome or TASS. TASS is a non-infectious inflammation of the front segment of the eye.

In the short term of one to three days following anterior segment surgery such as for cataracts, the patient may experience blurry vision, while the clinician will see swelling in the cornea or the clear outer part of the eye, as well as internal inflammation with clinical signs of white blood cells to various degrees.

This can occur in discrete outbreaks for one particular location or spread out to many locations depending on the vector. It may be associated with instruments used for surgery that are re-sterilized or other devices used during surgery.

One suspected vector in the past has been the cushioning gel or ocular viscoelastic device that is used to protect the inside of the cornea during surgery. This viscoelastic is later rinsed out of the eye at the end of the operation.

Slide 18 – Proactive TASS Program

  • Assure relevant reporting of device related issues
  • Provide trend analysis of TASS occurrences
  • Allow for appropriate testing of suspected devices
  • Offer support for regulatory action when applicable
  • Facilitate prompt communication with the ophthalmic community

FDA initiated a proactive program to address past TASS in response to recurring outbreaks felt to last 5 to 10 years. The program is designed to coordinate the expertise within various offices of the center and to respond quickly to future outbreaks.

We would like to be able to ensure that relevant reporting of device-related issues is received in the agency. We also want to try to provide the trend analysis of occurrences.

We want to allow for appropriate testing of suspected devices and offer regulatory action support when that’s applicable such as in the event of a recall.

And another of our goals is to facilitate prompt communication with the ophthalmic community so they may be aware of an outbreak as it occurs.

Slide 19 – FDA Response to Future TASS Outbreaks

  • Created a fully equipped ophthalmic laboratory
  • Prepared to obtain and evaluate device samples when a significant increase in TASS rate occurs
  • Developed methods to test suspected device for contaminants
  • Test suspected device for contaminants using methods developed in this program
  • Take appropriate actions based on the results
  • Quickly communicate findings to minimize patient exposure to devices causing TASS

FDA has been monitoring the TASS rate within our internal database and has been working to determine a baseline level.
We’re also working to establish links to external TASS databases that are maintained by other organizations with the objective to establish an early warning system for TASS outbreaks.

In response to future outbreaks we've also created a fully equipped ophthalmic laboratory to allow us to obtain and evaluate samples of suspected devices when a significant increase in TASS rate occurs that is believed to be related to a device and develop methods to test suspected devices for contaminants and assess the contamination level using those response curves generated by the program.

We plan to take appropriate actions based on the results obtained as appropriate. And again, our goal is to communicate quickly our findings to the ophthalmic community in order to minimize patient exposure to devices causing TASS.

So again, since this is related to anterior segment surgery and it happens closely after the time of surgery, it goes along with the graphic I showed first where there’s a lot of reports for intraocular lenses because there’s more of a direct cause and effect coordination that clinicians can see.

Slide 20 – Contact Lens Care Product Recalls

  • Fusarium Keratitis

    May 06 B&L MoistureLoc
  • Acanthamoeba Keratitis

    May 07 AMO Complete MoisturePlus

This next topic is a little bit less obvious in some cases. I'm going to touch on two outbreaks that involved rare pathogens that resulted in corneal infection in contact lens patients.

These outbreaks involved different types of multi-purpose contact lens solutions, which are used for disinfecting, rinsing, cleaning and storing soft contact lenses.

Both products shown on this slide, the Bausch & Lomb Moisture Lock and the AMO Complete Moisture Plus were ultimately withdrawn from the market by the manufacturers and are no longer marketed anywhere in the world.

I'd like to provide you with a few reference points. There are approximately 34 million contact lens wearers in the United States. The type of corneal infection usually related to fungus or fungal keratitis is relatively rare in contact lens wearers and it counts for less than 5% of the cases of contact lens related microbial keratitis.

Likewise, the incidents that’s estimated for acanthamoeba keratitis is even less than that to fungal keratitis. It has been estimated to be roughly one to two cases per million contact lens users in the United States.

Now, of both of these outbreaks the CDC conducted a case control study to try to determine factors related to these infections. The FDA inspection of manufacturing facilities as well as CDC found that there was no evidence of contamination of either ones of these solutions that were associated with these outbreaks.

Instead, the solutions were thought to have insufficient anti-microbial effectiveness. Also in both outbreaks the practice of topping off a solution or re-using solution in the case and not using fresh solution each time the lenses needed to be disinfected also emerged as an important risk factor.

Now together these outbreaks raised the concerns about the safety of multi-purpose contact lens solutions.

Slide 21 – June 2008 Advisory Panel

Six main questions posed by the FDA:

  • Labeling directions and warnings
  • Clinical study design
  • Microbiology testing
  • Acanthamoeba as a test organism
  • Silicone hydrogel (SiHy) lens groupings
  • Cytotoxicity testing

As a result of the two outbreaks, we convened an ophthalmic advisory panel to consider ways to improve contact lens safety.

Our advisory panels are comprised of clinical experts across the country along with an industry representative and a patient advocate representative as well. At the meeting we held in June 2008, we sought input and recommendations from the panel on six topics.

We asked them for input on labeling directions and warnings for care products, for feedback on our clinical study designs, for input into the microbiology testing that’s currently being used for these types of products.

We asked them to give us the recommendations of whether they believe Acanthamoeba, even though it was a rare organism, should be added to the list of test organisms.

We asked them for a recommendation regarding ways to better characterize new types of soak and hydrogen lens materials that are on the market.

We also asked them for input on cytotoxicity testing to evaluate biocompatibility.

Slide 22 – Panel Recommendations

  • Agreed with the professional organizations – current products should be used only with rubbing directions
  • “Consider performing a ‘rub and rinse’ lens cleaning method, rather than a no-rub method …”
    • American Academy of Ophthalmology
    • American Academy of Optometry
    • American Optometric Association
  • In the future, after new standardized test methods and performance criteria are developed, “no rub” technologies should meet the same new “higher bar” level of biocidal effectiveness as “rub” products

The feedback that we received from the panel included the following:

The panel agreed with different professional organizations that recommended using the rubbing directions for care products rather than just a rinse-only type of approach.

Both the American Academy of Ophthalmology, the American Academy of Optometry and American Optometric Association have at the times of the outbreaks and since, have all recommended to their membership that their patients consider performing a rub and rinse cleaning method, rather than simply rinsing lens only to disinfect the product.

And the panel gave us the recommendation in the future after we’re able to develop new standardized test methods and performance criteria and a no rub technology should be evaluated with a higher bar of effectiveness compared to rub products.

Slide 23 – Panel Recommendations

  • Revise warning statements in labeling:
    • Topping off or reuse
    • Avoiding water exposure
    • Providing a discard date after opening
  • Endorsed development of separate categories for SiHy lenses to be included with conventional hydrogels in both clinical and cytotoxicity testing

The panel also recommended revising warning statements from the labeling specifically to address risks such as topping off or re-use of disinfecting solution, of water exposure to contact lenses which can carry pathogens and also providing a discard date after opening so that solutions do not get contaminated.

An endorsement of developing of separate categories for silicone hydrogen lenses so they can be better characterized both in clinical study and in biocompatibility testing area.

Slide 24 – Panel Recommendations

  • A “real world” microbiology test, which challenges the care product with microbes in the lens case with the contact lens
  • Add Acanthamoeba as a challenge organism. (No detailed discussion of methodology or performance criteria)

The panel recommended a real world microbiology test, which challenges the care product with microbes in the lens case with the lens present.

Current standard test methods to ensure the effectiveness of disinfecting solutions to kill microbes involve challenging the solution directly with the organism, but not with the contact lens being present.

And it’s possible that the contact lens material can interact with the disinfecting agent, so we’re interested in working with that. Also they recommended adding Acanthamoeba to the panel of challenge organisms. Although we did not discuss at this meeting the methodology or performance criteria in order to do that.

Slide 25 – Contact Lens Standards

Continue work within standards process

  • ANSI

    American National Standards Institute
  • ISO

    International Organization for Standardization

Now the test methods that are used to evaluate these types of products or develop these processes are part of our involvement in the standard development organizations. And the two main ones that we deal with here are the American National Standards Institute as well as the International Organization for Standardization or ISO.

We have an active role of membership and participation in these groups. And in order to generate data to support development of new testing methods, we are involved in an active contact lens research plan.

Slide 26 – FDA Contact Lens Research Plan

  • Develop robust analytical procedures to characterize the various components (preservatives, surfactants, and additives) of care product solutions
  • Generate data to help categorize SiHy lens materials into functional sub-groups groups to better predict interactions with the care products solutions
  • Assess the interactions of lens materials with care product to determine if biocidal effectiveness is variable, and to what degree
    • Acanthamoeba test method development

Our contact lens research plan intends to develop more robust analytical procedures to characterize the various components of care products. We want to look at the effect of the interaction of the contact lens material and the care product so that we can evaluate depletion of the active ingredients and see how that affects the ability to become microorganisms.

We also have developed analytical methods to characterize the amount of preservative that can be measured in contact lens solutions. We are also interested in generating data to help better categorize the silicon hydrogel lenses with more functional subgroups so that we were able to better predict interactions with care products and solutions.

In order to assess the interactions and new material care products as we start to look at the biocidal effectiveness. We are also looking at criteria involved in Acanthamoeba testing in order that we may be able to better design an effective Acanthamoeba test to change solutions with.

Now all this research is going on within our Office of Science and Engineering Laboratories. Once they have generated data we will use this to support both new guidance for the industry and for participation in the standards development process with the different standards organizations.

Slide 27 – LASIK Regulation FDA’s Role

FDA regulates the sale of medical devices

  • Premarket:
  • Postmarket: FDA monitors the ongoing safety and effectiveness
    • MedWatch/MedSun
    • Post-Approval Studies (sometimes)

The last device area that I will want to discuss is the use of ophthalmic lasers for refractive surgery. The procedure known as LASIK, or laser-assisted in situ keratomileusis, is a common procedure with over 700,000 people treated each year in the United States.

The agency has some specific roles that expand all types of devices and that includes these specific devices. FDA basically regulates the sale of medical devices. In the premarket area, the manufacturers must get approval from FDA to market these types of Class III laser devices.

And as part of the review in the premarket area, they must provide reasonable assurance of safe, device safety and acceptance for the particular indication for use. In the postmarket area, FDA does monitor the ongoing safety and effectiveness. To help assure continued safety of these devices, Dr. Lepri is going to address the MedSun/MedWatch in just a few moments.

We also have the ability to implement post market studies. Postmarket studies can help assure continued safety and effectiveness of an approved device. We may require these as conditions of approval when the firm has cleared the marketed device.

The post approval study can be either clinical or non-clinical and it’s intended to gather specific information to address questions about the postmarket performance or experience with an approved medical device.

Slide 28 – CDRH LASIK Plan

  • Developed in response to the feedback from the public and LASIK experts
  • Consists of:
    • Quality Of Life (QOL) Project
    • Recognition of ANSI LASIK Standard
    • Labeling Guidance
    • Communication
    • Outreach Activities
    • Inspections and Enforcement

Now I'm going to give you a little bit of background about LASIK. Going back about five to six years, CDRH had received complaints from patients regarding symptoms such as dry eyes, glare, halos, starburst and double vision which significantly affected their quality of life after LASIK.

In light of the great popularity of the procedure and its potential significant impact on public health, the Center convened an action team to conduct an assessment of the postmarket LASIK data and compare this with the premarket data we had available to us. The team found that both postmarket and premarket satisfaction surveys showed a high level of satisfaction.

Postmarket data that was available and the literature failed to suggest any widespread quality of life problems. However, there was no valid basis for statistical comparison of these patient reported outcomes in the postmarket literature with those in the premarket studies.

And this was due to several factors. Primarily there was limited number of relevant articles and there were differences in scoring methods that patients had used to report their symptoms. So the team was unable to perform a valid comparison of the premarket literature with the post market information.

They did determine that rare, severe events were not adequately evaluated and they recommended to center management that FDA further consider evaluation of postmarket quality of life in the clinical setting.

We also had convened in April, 2008 at an ophthalmic advisory meeting. At this meeting we listened to patient experiences and we also received panel recommendations on how to improve information for patients and physicians.

We received input on FDA tools that we have to improve patient safety such as patient labeling, our LASIK Website and information about the ANSI standard and with the MedSun SightNet Program.

The center has developed a LASIK plan that includes several components. We've developed a response to the feedback from the public and the LASIK experts and the quality of life study is a major component of this.

We've recognized the ANSI LASIK standard for clinical studies of these types of devices. We’re developing additional labeling guidance. We have ongoing communication. We've conducted outreach activities, as well as inspection and enforcement activities.

I'm not going to go into detail about all of these different components of the plan, but I will touch on a couple. Our Website for LASIK is one of the most popular FDA Websites. After the panel meeting, we made several significant improvements to the site.

There is a ‘Report a Problem’ button on the homepage which a patient can click and be taken directly to the reporting Web links. This simplifies the ease of patient access to our system. We also have a latest on FDA’s LASIK Program page that we keep updated as events change.

Slide 29 – LASIK Quality of Life Collaboration Project

Collaboration with FDA, National Institute of Health (NIH), and Department of Defense (DOD)
Project’s Ultimate Goal:

The quality of life study is a planned interagency collaboration between FDA, the National Institutes of Health and the Department of Defense. The project’s ultimate goal is to determine the percentage of patients with significant functional limitation after LASIK surgery assessed by patient reports themselves. And also to identify factors associated with these poor outcomes.

We issued a press release about this endeavor in October of last year and in the meantime have been working to get the study up and running.

Slide 30 – LASIK Quality of Life Collaboration Project

  • Phase 1 – design and implement a Web-based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK
  • Phase 2 – evaluate the quality of life and satisfaction following LASIK as reported by patients in a select population at a DOD Refractive Surgery Center
  • Phase 3 – a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population

There are three phases to this project. The first phase is to design and implement a Web-based questionnaire to assess patient reported outcomes and evaluate the quality of life issues of LASIK.

The second phase is to evaluate quality of life satisfaction following LASIK as reported by patients in a select population at a Department of Defense Refractive Surgery Center. And the final phase is envisioned to be a national multicenter clinical trial which will study the impact of the procedure and the quality of life in the general population. We plan to update information about the study at our Website as our process proceeds forward.

Slide 31 – Inspections and Enforcement

  • FDA letters to ambulatory surgery facilities (ASF) about adverse event reporting systems – October 2009
  • FDA letter to care providers on false and misleading advertising – May 2009
  • Article in Federation of State Medical Boards newsletter on FDA concerns – August 2009
  • FDA links placed on Federal Trade Commission (FTC) Website – Oct 2008
  • Worked with FTC to revise their website/marketing guide

We've also taken a number of actions in the compliance area. We issued a number of letters to ambulatory surgical facilities about the inadequacy of their adverse event reporting systems starting October, 2009.

We have issued letters to the care providers regarding false or misleading advertising in May of last year. We partnered with the Federation of State Medical Boards and through their newsletter expressed our concerns about LASIK procedures and practices to their membership.

And we've worked with the FTC collaboratively to place links to each other’s web pages and work with them in revising the marketing guide on their Website.

Slide 32 – Inspections and Enforcement

October 15, 2009 Announced Warning Letters Issued to LASIK Facilities

The inspections at ambulatory facilities involved in LASIK were highlighted in that same press release I mentioned just a moment ago in October. We found that there were inadequate adverse event reporting systems at these ASF stops, which is part of their regulatory responsibility to report to us.

The inspections did not identify problems with use of LASIK devices themselves, but primarily focused on reporting requirements including having written protocols to report adverse events.

Since the inspections were conducted and the warning letters issued, we have followed up with education efforts targeting organizations with ophthalmic surgeons to help them better understand their responsibilities associated with mandatory reporting within ambulatory surgical facilities.

I hope that you have gained some insight into the familiarity of potential issues with these three different types of ophthalmic devices. And now I'll pass the microphone to Dr. Lepri who'll discuss the next segment of the presentation.

Slide 33 – Agenda

  • FDA/CDRH Overview
  • Current Ophthalmic Device Issues
  • Ophthalmic Device Reporting
  • Questions and Answers

Bernard Lepri: Thank you, Dr. Saviola. Good afternoon and welcome. I'm going to speak to you about ophthalmic device reporting this afternoon and then we'll have some questions and answers.

Slide 34 – Why Does FDA Need Reports from User Facilities?

  • To learn more about how marketed devices perform
  • To identify devices that are adulterated or misbranded
  • To identify devices that are not safe and effective for their intended use

FDA needs to receive your reports because we need to know how devices are performing in the marketplace. We need to know if devices are being used legally for the intended purposes for which they were approved or marketed.

Many times problems with devices result because they are adulterated or misbranded. It all comes down to finding out if medical devices in the marketplace are safe and effective for their intended use.

Slide 35 – Data Flow and Reporting Timeframes

  • User Facility – Deaths all), Serious Injury (when manufacturer unknown – 10 work days to FDA
  • User Facility – Death and Serious Injury – 10 work days to Manufacturer
  • Other Sources – Deaths and Serious Injuries – Product Problems/Malfunctions to Manufacturer
  • Importer – Deaths, Serious Injury and Malfunctions – 30 calendar days to Manufacturer
  • Manufacturer – Remedial Action with unreasonable risk harm or FDA requested – 5 work days to FDA
  • Manufacturer – Death, Serious Injury and Malfunction – 30 calendar days to FDA

Typically, user facilities and importers report problems directly to the manufacturer. The manufacturer processes these reports and informs the FDA of deaths and serious injuries or malfunctions within approximately 30 calendar days of receiving them.

MedSun on the other hand provides an important conduit for the flow of information about adverse events and medical devices in the marketplace. MedSun participants from user facilities can report deaths and serious injuries directly to FDA. This is especially helpful if the user facility does not know who the manufacturer is.

This avenue of reporting gets the information to FDA faster; actually within 10 days and it is unfiltered by the manufacturer. Otherwise, the same information may take up to 30 days if reported solely by the manufacturer.

So double reporting helps facilitate the process for events that are typically very time relevant.

Slide 36 – MedWatch and MedSun

  • FDA’s safety information and adverse event reporting program
  • Monitors medical product experience after FDA approval or clearance
    • Medical products (drugs, biologics, and medical devices)
  • Adverse event reports from manufacturers, user facilities, health professionals, and patients/consumers

MedWatch is FDA’s safety information and adverse event reporting program.

MedWatch is used to monitor medical product experience after FDA approval or clearance, which include drugs, biologics and medical devices. MedWatch receives adverse event reports from manufacturers, user facilities, health professionals, as well as patients and consumers.

Slide 37 – Types of Medical Device Reporting

  • Mandatory Reporting to FDA
    • Medical device manufacturers: adverse events such as deaths and serious injuries, and some malfunctions
    • User Facility: (hospitals; ambulatory surgical centers; nursing homes; outpatient treatment centers; outpatient diagnostic centers; emergency services; and home health care services): deaths to FDA and manufacturer and serious injuries to manufacturer
  • Voluntary Reporting to FDA:
    • Reporting of any medical device adverse event by health care professionals and consumers

There are two broad categories of medical device adverse event reporting, mandatory and voluntary. Medical device manufacturers and user facilities are mandated to report adverse events.

Manufacturers report events such as deaths and serious injuries and malfunctions that have potential for serious adverse events. User facilities such as hospitals, ambulatory surgical centers, nursing homes, outpatient treatment centers, outpatient diagnostic centers, emergency services and home health care services are required to report deaths to FDA and the manufacturer and serious injuries to the manufacturer.

Health care professionals and consumers are the only individuals who can voluntarily report medical device adverse events to FDA.

Slide 38 – How Reports Are Submitted

  • Online
  • Phone
  • Fax
  • Mail

(Images of a telephone and a computer screen)

You’re probably wondering how these reports are submitted. Well, there are various ways of transmitting your information to FDA.

The most common method of reporting is through our online program, but of course it can also be done by mail, fax or phone, whatever method works best for you, as long as you get the information to us.

Slide 39 – Types of Medical Device Programs to Report

  • Instructions/labeling
  • Packaging
  • Manufacturing defects
  • Software problems
  • Failure to work as intended/malfunction
  • Interactions with other devices
  • Problems encountered with off-label use
  • Human factors issues

Basically, we have two categories of events to be reported, medical device problems and medical adverse events, the events resulting from the use of medical devices.

Medical device problems include problems with instructions and labeling errors, packaging - such as damaged products, manufacturing defects, software problems - as with lasers and topographers, failure to work as intended and other malfunctions.

There are problematic interactions with other devices in the medical environment and problems that are encountered with off label use and of course there are always human factors, our own errors.

Slide 40 – Ophthalmic-Specific Information

  • Time elapsed since implantation of the device?
  • OD (right eye), OS (left eye), OU (both eyes)?
  • Preexisting ocular conditions?
  • What care products or lenses were used?
  • Baseline, post-treatment; post adverse event best corrected visual acuity (BCVA)?
  • Intraocular pressure (IOP): baseline, post-treatment, post-adverse event?

If you were participating in SightNet, FDA’s newest subnetwork, which is designed specifically to address adverse events and medical device problems in the eye care field, there are specific pieces of information needed when making a report to SightNet.

We'd like to know the time elapsed since implantation of the device, as in the case of an IOL, an intraocular lens. Was it the right eye, the left eye or both eyes? Are there any preexisting ocular conditions?

What care products or lenses were used for contact lens related events? We would like to know what the best corrected visual acuity is at baseline, after treatment and after the adverse event.

And finally, intraocular pressure is also very important. Once again, we need to know the recordings from baseline, immediately after treatment and after the adverse event.

Slide 41 – Viscoelastics, Phacoemulsification, Intraocular Lenses

  • Viscoelastics
    • TASS
    • Significant endothelial cell density (ECD) losses
    • Corneal decompensations
    • Intraocular pressure spikes/elevations
    • Cataractogenesis
      • Cataract development
    • Phacoemulsification
      • Corneal/Scleral burns
      • Phacoemulsification tip fractures
        • Metal fragments
      • Phacoemulsification system malfunctions
    • Intraocular Lenses
      • Endophthalmitis
      • Explants
      • Significant BCVA losses
      • Retinal detachments

As you can imagine, it is next to impossible to predict every type of event that may occur in patient care, especially surgical care. However, we've attempted to identify some of the most significant adverse events that are encountered.

This slide presents some typical adverse events associated with cataract surgery which involves intraocular lenses, phacoemulsification tools and viscoelastics. You may be the first to notice these events in your post surgical follow-ups.

Keep in mind that although some of these sequelae are not unanticipated, it is important for FDA to discern whether or not they were related to the actual device or human error. So even though it may seem common to you, what you are seeing may be occurring nationwide and part of a much bigger problem.

This is why it’s so important to report these events. Your participation in MedSun or SightNet will give you a direct method for reporting these occurrences.

Slide 42 – Glaucoma Implants

  • Device extrusions – the device dislocates
  • Intraocular pressure decreases
    • Glaucoma implants can lower the IOP too much
  • Significant endothelial cell density (ECD) losses
    • These cells are the lining of the cornea and are a major player in the physiology of the cornea
  • Corneal decompensations
    • Losses of ECD cause the cornea to fail, become cloudy
  • Significant BCVA losses –
    • Cloudy corneas from corneal decompensation cause losses of best corrected visual acuity

On this next slide, we see some of the potential adverse events that may accompany the use of glaucoma drainage implants. Glaucoma implants have specific events associated to their use that should be reported. For example, glaucoma implants are known to dislocate.

Sometimes they cause drastic decreases in intraocular pressure which is an emergency situation for the patient and their eye.
Because of their location in the anterior chamber of the eye, there is risk of major losses of corneal endothelial cells and subsequently loss of vision and potentially the need for a corneal transplant.

Slide 43 – Contact Lens; Refractive Lasers

  • Contact Lenses
    • Infectious keratitis
    • Corneal ulcers
    • Significant losses of BCVA
  • Refractive Lasers
    • Abnormal trends in post-operative topography
    • Glare, haloes, sunbursts, dry eye beyond the 6 month post-operative period
    • Endemic cases of diffuse lamellar keratitis
    • Significant losses of BCVA

Contact lenses and refractive lasers have specific adverse events associated with their usage also. In particular, contact lenses and contact lens care products have been in the news the past few years with the outbreaks of Fusarium keratitis and Acanthamoeba as discussed by Dr. Saviola.

So, corneal ulcers and infectious keratitis are of utmost importance to report. One case may not seem unusual to you; however, your one case may be part of a reported trend that has major significance to public health.

Likewise, the presence of DLK (Diffuse Lamellar Keratitis) and abnormal topographies may be significant when combined with reports from around the country indicating a potential problem with a device or method of usage of the laser.

And obviously any loss to best corrected visual acuity of two lines or more that persists throughout and beyond the postoperative period is of major concern. And we've learned that the subjective complaints of glare, halos, dry eyes and pain of LASIK can be some of the most important side effects of LASIK.

Slide 44 – Punctal Plugs; Retinal Temponades

Punctal Plugs

  • Surgical removal of plugs
  • Extrusions
  • Infections
    • Canaliculitis
    • Dacryocystitis
    • Preseptal cellulitis
    • Orbital cellulitis

Retinal Tamponade Complications and Failures

  • Cystoid macular edema
  • Light toxicity from diagnostic devices
  • Retinal detachments

On this next slide, we see a listing of other adverse events associated with the use of punctal plugs and retinal tamponades. Some examples for punctal plugs are surgical removal of the plugs, extrusions and infections associated with the use of the plugs.

For retinal tamponades used to actually secure the retina in place when there’s a detachment - partial or full, are cystoid macular edema and light toxicity from the diagnostic devices that are used extensively in these procedures and additionally, other retinal detachments.

While many of the adverse events identified here today are not considered to be unanticipated, they must be reported because you’re one case may be part of a major wave of adverse events of similar nature.

When this occurs we have a major public health concern that must be addressed and addressed promptly and efficiently. FDA compiles and collates these reports on a daily basis in a major effort to identify public health problems and respond to them efficiently.
And please be assured that FDA is not monitoring you or your medical practice, but the products and their quality of performance because FDA is not authorized to regulate the practice of medicine.

Slide 45 – Report Example

Case Study

• SightNet facility reported an issue with trephine blades used during corneal transplants.
• The center black ring used to advance the blade was repeatedly detaching from the blade during procedures.

Cynthia Bushee: Thank you Dr. Lepri. Now let me briefly discuss a report that was received from a SightNet participating facility. This site submitted three reports which were related to the blade of a trephine used during corneal transplants. The black ring that was used to advance the blade apparently was not adhered properly and became detached from the trephine during the procedures.

During some procedures, up to five devices were used before properly functioning device was found, this lead to a delay during the procedures as well as potential increase in cost. At the time that these reports were submitted, this was the only MedSun site reporting this issue.

Slide 46 – Report Example Continued

  • Following report submissions, an investigation was conducted by the FDA.
  • Investigation included follow-up with the site and the manufacturer.
  • As a result, manufacturing improvements and design changes were made to the device to rectify the problem.

As a result of the report, an investigation was conducted by the FDA. Investigations such as this may include one of the following. Follow-up with both the reporting site and the manufacturer. Following this investigation, the manufacturing process was improved and design modification was made to the device to rectify this problem.

This report example illustrates the kind of impact to medical device safety that can be achieved through your reports. While this did not lead to a large scale recall action, it still led to an improvement and the safety of a medical device.

Slide 47 – Agenda

  • FDA/CDRH Overview
  • Current Ophthalmic Device Issues
  • Ophthalmic Device Reporting
  • Questions and Answers

Now we will proceed to the question and answer portion of the presentation and as previously mentioned.

Slide 48

Questions and Answers

These questions were submitted at the time of registration.

Slide 49 – Questions and Answers

Where can I find information about FDA recalls, new product approvals and clearances, and safety information relating to ophthalmic devices?

Our first question is, "Where can I find information about FDA recalls, new product approvals and clearances and safety information relating to ophthalmic devices?" Dr. Lepri, would you like to address this question, please?

Bernard Lepri: Of course. Information is useless unless you have access to it when you need it.

Slide 50 – Safety Information Websites

So FDA has several Web sites at your disposal for you to obtain patient and medical device safety information as listed here on these slides and the next one.

Slide 51 – Safety Information Websites

They include one page descriptions of new device approvals, public health notifications, patient safety news and Websites for both professionals and consumers on contact lenses and products, including LASIK and phakic IOLS. So I strongly urge you to utilize these resources.

Slide 52 – Questions and Answers

“Does FDA have a list of recommended products for purchasers to review before buying new medical devices?”

Cynthia Bushee: Thank you. The next question is, "Does FDA have a list of recommended products for purchasers to review before buying new medical devices?" Dr. Saviola, would you please address this question?

James Saviola: Yes I will, Cynthia. FDA is responsible for regulating companies that manufacture, repackage, re-label and import medical devices that are sold in the United States.
We do this through scientific review of premarket data that’s submitted by medical device manufacturers to establish the device’s safety and effectiveness. And once on the market, we monitor medical device adverse event reports to detect and correct device related problems in a timely manner.

It’s important to note that because the FDA’s scope of work is to regulate the medical device industry, we cannot and do not recommend specific medical devices for use.
That type of action would conflict with our purpose of getting safe and effective medical devices on the market and monitoring them once they are on the market.
And as the point was made earlier, we do not regulate the practice of medicine either. So I'm sorry, there is no list of best buys that we can put out for people to look at.

Slide 53 – Questions and Answers

  • Why should we take the time to report problems?

Cynthia Bushee: Okay, thank you. The next question is, "Why should we take the time to report problems?" Dr. Saviola, would you please address this question?

James Saviola: Yes, I will. Again, we really appreciate the fact that your organizations are participating in MedSun and that you allocate resources to submit reports to us on a regular basis because it is part of your responsibility to do so many other things besides interact with us.

As Dr. Lepri mentioned earlier, one case can be very important. In Cynthia’s case study example, there weren't a lot of reports we received in that one either.

So similar to reporting experiences with other types of regulated products, which are drugs or biologics, we do feel that it is important for you to take time to report serious adverse events or product quality problems to us, so that we may associate any of your experiences with other people’s with the same type of device.

In order to keep effective medical products available on the market, we rely on these types of voluntary reports of events from practitioners, as well as mandatory reports that companies must send us in. We use this data to maintain our safety surveillance of these products.

Your report may be the critical action that prompts a modification in use or design of a product and improves its safety profile that leads to increased patient safety. So again, thank you for your efforts in this area.

Slide 54 – Questions and Answers

  • If I am not sure if something is related to use of the device, should I report the problem?

Cynthia Bushee: Thank you. Our final question is, "If I am not sure if something is related to the use of a device, should I report the problem?" Dr. Lepri, would you please address this final question?

Bernard Lepri: Yes. By monitoring reports about problems and concerns before a more serious event occurs, FDA, manufacturers and clinicians can work together to proactively prevent serious injuries and death.

You may not see how this information fits together, but it’s important since the problems you notice may not be unique to your facility. If you report to the company voluntarily, the company will apply their complaint handling model and they may determine that they do not have to file a mandatory report to FDA, so we might not hear about it.

When we hear from you directly, we can compare information with what we receive from other places to tell how widespread the problem is. We can investigate and it may lead to a product recall or a notification on how to better use the device safely.

Cynthia Bushee: Thank you. This will conclude our program today. On behalf of the FDA, I'd like to thank all of the participants who attended today’s presentation.

Slide 55 – Contact Information

Cynthia Bushee

James Saviola

Bernard Lepri

Again, let me remind you that certificates of participation with one nursing continuing education contact hour are now available to staff from participating MedSun sites.
You may go to the registration Website listed on your confirmation e-mail, complete a short evaluation and print a copy of the electronic certificate. We have included our contact information here if you should have any questions.

Slide 56



Additionally, if you know of others at your MedSun organization who would like to receive a replay of this presentation and the associated nursing continuing education contact hour, please call MedSun at 1-800-859-9821. Again, thank you for attending this day’s presentation.


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