# Presentation: 435904

## Ensuring the Safety of Marketed Medical Devices

**Dan Schultz, MD**
**Director, Center for Devices and Radiological Health**
**January 4, 2006**

## Outline 

**CDRH’s charge**
**Challenges to assuring postmarket safety**
**What we are doing today**
**What we will be doing tomorrow**

## Establishing reasonable assurance of the safety and effectiveness of medical devices  and of the safety of radiological products marketed in the U.S.

**Establishing reasonable assurance of the safety and effectiveness of medical devices  and of the safety of radiological products marketed in the U.S.**

**CDRH’s mission is:**

## CDRH also is responsible for:

**Monitoring medical devices and radiological products for continued safety after they are in use**
**Helping the public get accurate, science-based information needed to improve health**

## CDRH Postmarket Program:Challenges and Opportunities

## Medical Devices 

**Medical devices are critical to the delivery of health care in the U.S. **
**Medical Devices vary in complexity **
**From surgical sutures and contact lenses to prosthetic heart valves and diagnostic imaging systems**

## Profile of the Domestic Medical Device Industry

**Total Manufacturers***
**N = 14,937**

**Total 2004  Income**
**$320 Billion **

**Smallest Firms**

**Largest Firms**

**Employees**
**Per Firm***

*** Dun & Bradstreet 2004 Medical Device Firm Data**

## Challenges to Assuring Postmarket Device Safety

**Devices are becoming more complex and smaller -- less margin for error**
**Implanted devices are being used for longer periods of time and in younger population**
**Limited field resources**
**Difficult to communicate risk/benefit to multiple audiences in a way that is timely and balanced**

## Adverse Event Reporting Challenges

**Adverse events are widely under-reported by users**
**Numerous reports with inadequate information about how the device was used and what may have caused the problem **
**Difficulty in identifying the specific device involved**
**Health care providers generally do not document device use in patient records**
**Devices lack unique identifiers**
**Manufacturers continually produce modified versions of their products.  **
**Device firms are often purchased by other companies**
**Devices are often used “off-label”**
**Shift to home use**
**Non-professionals are using these products**

## What we are doing today

## We have established clear goals

**Access accurate and timely data about adverse events**
**Analyze and assess this information efficiently**
**Alert device users to up-dated risk/benefit information**

## We have aligned our FY 06 Priorities with those goals

**Increase our ability to identify, analyze and act on postmarket information **
**Increase communication of risk/benefit information to all of our stakeholders**
**Continue to implement and assess MDUFMA 1 and prepare for MDUFMA 2 **
**Advance the "critical path" for medical and radiological products**
**Invest  resources strategically to support the priorities of HHS, FDA, and CDRH**

## We are strengthening Condition of Approval studies

**We have:**
**Included epidemiology staff in PMA review to help design better postmarket studies **
**Transferred tracking and follow-up to postmarket staff (01/01/05)**
**Developed tracking system (01/01/05) **
**Issued guidance to industry on how to submit follow-up reports**

## We are improving medical device reporting 

**We are:**
**developing electronic reporting tools (eMDR)**
**improving access to additional sources of information (e.g., HRS)**

**CDRH receives about 180,000 reports annually. >1,125,000 total**

## We are improving targeted surveillance systems: MedSun 

**Improving the number and type of reports we receive from our 350 participating facilities**
**Increasing laboratory reports from the participating hospitals **

** ****MedSun is a national network of healthcare facilities trained to recognize and report problems in real time and benefit from rapid Agency feedback**

## We are focusing on Risk-Based Inspections

**Developing Risk Assessment Criteria that consider probability and severity of harm**
**Focusing our limited field resources on medical devices and manufacturers that present the greatest risk to public health**

## We are implementing Third-Party Inspections

**Issuing guidance - *****Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria***** (issued 10/04)**
**Publishing criteria for accredited persons - available at **_**[http://www.fda.gov/cdrh/ap-inspection/ap-inspection.html#list](http://www.fda.gov/cdrh/ap-inspection/ap-inspection.html#list)**_
**Selecting and training third-parties to participate in the program (currently 16)**
**Partnering with Canada to pilot implementation**
**CDRH’s Third-Party Inspection Programs**
**National/Domestic (MDUFMA)**
**International – Mutual Recognition Agreement (EU-MRA)**

## We are communicating risk/benefit information 

**Patient Safety News **_**[www.fda.gov/psn](http://www.fda.gov/psn)**_** **
**Public Health Notifications **_**[www.fda.gov/cdrh/safety.html](http://www.fda.gov/cdrh/safety.html)**_** **
**One Pagers - New Device Approvals            **
**	**_**[www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/mda/mda-list.cfm?list+1](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/mda/mda-list.cfm?list+1)**_
**Listservs - Breast Implants **_**[www.fda.gov/cdrh/bicl](http://www.fda.gov/cdrh/bicl)**_
**Websites:**
**	****FDA & You **_**[http://www.fda.gov/cdrh/fdaandyou/index.html](http://www.fda.gov/cdrh/fdaandyou/index.html)**_** **
**	****Diabetes **_**[http://www.fda.gov/diabetes/](http://www.fda.gov/diabetes/)**_** **
**	****Heart Health **_**[http://](http://www.fda.gov/hearthealth/)**__**[www.fda.gov/hearthealth](http://www.fda.gov/hearthealth/)**__**[/](http://www.fda.gov/hearthealth/)**_** **
**	****Consumer website **_**[www.fda.gov/cdrh/consumer/index.html](http://www.fda.gov/cdrh/consumer/index.html)**_** **

## We are refining our communication strategy  

**Working with AdvaMed and the Heart Rhythm Society to explore opportunities to improve Product Performance reports, PMA Annual reports, standardized Dear Doctor letter format**
**Using the Total Product Life Cycle (TPLC) model of regulating implantable defibrillators, automatic external defibrillators and pacemakers by convening a Defibrillation Working Group**
**Improving our automated information systems**
**Developing easy-to-use databases of CDRH-regulated products, e.g., Devices@FDA is available at **_**[http://](http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/)**__**[www.accessdata.fda.gov/scripts/cdrh/devicesatfda](http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/)**__**[/](http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/)**_** **
**Developing methods of collecting and disseminating (“pushing out”) CDRH news, e.g. ****GovDelivery Email Subscription Management (available since 12/12/05) **
**Improving CDRH web pages, e.g., adding FAQ’s (available 01/06) **

## What we will be doing tomorrow

## Postmarket Safety Inventory

**We will assess the impact of our postmarket safety program and pinpoint areas that are in need of improvement. **
**We will look at the tools we use to identify problems, analyze problems and take action, either regulatory, information dissemination or both ******** ****Postmarket Report**
**We will examine ways to better coordinate our efforts so we can increase our understanding of how devices  perform in the market ******** *****Action Steps***

## Action Steps 

**We will take steps to strengthen the CDRH postmarket program**
**Develop a “Culture of Collaboration” on Postmarket Safety within the Center**
**Develop World Class Data Sources and Systems**
**Enhance Risk/Benefit Communication Efforts**
**Improve Enforcement Strategies for Postmarket Issues**

## 1. 	Develop a Culture of Collaboration

**Place more emphasis on the importance of our postmarket effort**
**Place more emphasis on collaboration in identifying and solving postmarket problems, both within the Center and with outside constituencies **
_**What we will do**_
**Establish a Senior Matrix Execution Team (MET)**
**Senior CDRH Leadership**
**Steve Niedelman (ORA) **
**Dr. Elizabeth Jacobson (Ex-FDAer; currently a Management Consultant)**
**Dr. Jeff Brinker (Cardiologist at Johns Hopkins Univ)**
**Use the MET team to set priorities and oversee implementation**

## 2. 	Develop World Class Data Sources and Systems

**Explore new ways to gain access to richer health care data**** **
_**What we will do**_
**Champion unique device identification**
**Develop an electronic reporting system**
**Explore opportunities to partner with other external groups and organizations **
**Develop ways to routinely and systematically search the professional literature and the popular media to find and share reports of adverse events**

## 3. 	Enhance Risk/Benefit Communication

**Maximize our ability to communicate information clearly and quickly to practitioners, patients and consumers**
_**What we will do**_
**Assess the communication tools we currently use**
**Partner with outside professional groups**
**Use popular media to multiply message**
**Create easier access to Center information**

## 4. 	Improve Enforcement Strategies for Postmarket Issues

**Improve the coordination, consistency, quality and timeliness of inspections, reporting and enforcement actions**
_**What we will do**_
**Facilitate cooperation and discussion among the Center’s Office of Compliance and Center components, ORA headquarters, and ORA field**** **
**Assess the effectiveness of current enforcement strategies and tools for postmarket programs**** ****and recommend improvements **

## Components of CDRH’s Postmarket Program

**Postmarket Problem**
**Identification**

**Postmarket Public**
**Health Response**

**Postmarket Problem**
**Assessment**

## Ensuring the Health of the Public Throughout the Total Product Life Cycle – It’s Everybody’s Business

**Ensuring the Health of the Public Throughout the Total Product Life Cycle – It’s Everybody’s Business**