# Presentation: 028825

## Gaps in Your Postmarket Safety Net for Medical Devices

- Larry Kessler, Sc.D.
- Director, Office of Surveillance and Biometrics
- Center for Devices and Radiological Health
- DIA January 8, 2001

## Today’s Objectives

- Describe methods of device postmarket surveillance
- Challenges in assessing adverse events
- The complicating factors of medical error
- The holes in the Safety Net
- A vision of the future

## What you might not know...

- Medical devices are ubiquitous in health care (from Exam Gloves to In Vitro Diagnostics to Implantable Cardioverter Defibrillators to Magnetic Resonance Imaging Machines)
- Recognition of device errors or adverse events presents a series of challenges
- Under-recognition, under-reporting, and the “blame game” continue to act as obstacles

## From Design to Obsolescence:  Medical Devices and Center for Devices and Radiological Health, FDA

- Design,         Lab/Bench     Clinical     FDA     Postmarket
- Modification     Testing       Testing     Review  Evaluation
- 							***MDR Program***
***	******	******	******	******	******	******	******Postmarket Surv***
***	******	******	******	******	******	******	******Epidemiology***
***	******	******	******	******	******	******	******Field Inspection***
***	******	******	******	******	******	******	******Postapproval (PMA)***
- ‘Design’		Device evolution		‘Obsolescence’

- Clinical Community

- Clinical Community

***{Industry/Customers}***

## Questions of Interest in the Postmarket Period

- Long term safety
- After clinical trials, performance of device in community practice
- Change of user setting    (e.g., hospital to home)
- Unusual pattern of adverse events not requiring product recall

## Adverse Event Reporting:FDA’s MedWatch Program

**Mandatory Reporting:**
**Manufacturers must (by law) report deaths and serious injuries or malfunctions (near incidents) if a medical device may have caused or contributed to the event**
**All user facilities (hospitals, nursing homes, etc.) must report deaths to FDA and serious injuries to manufacturers**
**Voluntary Reports encouraged from health professionals**

## Slide 7

## Example of MDR Report - DeathManufacturer Report

**Mfr 22-FEB-2000: FOLLOWING A LEFT HEART CATHETERI-ZATION PROCEDURE, AN ANGIO-SEAL DEVICE WAS DEPLOYED IN THE RIGHT FEMORAL ARTERY WITHOUT REPORTED DIFFICLUTIES. APPROX 5 DAYS LATER, THE PT BECAME UNSTABLE. A FEMSTOP WAS APPLIED TO THE FEMORAL ARTERY, FLUID VOLUME REPLACEMENT WAS GIVEN, AND PLATELET RED CELLS ORDERED TO REPLACE VOLUME LOSS. THE VASCULAR SURGEON WAS CALLED TO ASSES THE EVENT. THE PT WAS TAKEN TO SURGERY, THE FEMORAL BLEED WAS REPAIRED AND A RETROPERITONEAL HEMATOMA WAS EVACUATED...REVEALING AN OPEN PUNCTURE SITE IN THE RIGHT ILIOFEMORAL ARTERY. SUDDENLY, THE PT DEVELOPED SEVERE HYPOTENSION, DEEP CYANOSIS, AND THEN AGONAL RHYTHM AND THE PT EXPIRED. IT SHOULD BE NOTED THAT THE PHYSICIAN HAS STATED THAT AN ERROR IN DEPLOYMENT WAS MADE BY THE OPERATOR; IT WAS NOT A DEVICE FAILURE, BUT AN OPERATOR FAILURE.**

## Unique Aspects of Device Events

- Lack of standard nomenclature for devices
- Often, these events represent numerators, with no clear denominator available
- Operator involvement and human factors issues inherent in virtually every event
- Complex multi-device situations are common leading to complex evaluation
***Information in reports often limited***

## The St. Jude Silzone Heart Valve

- Mechanical valve:  silver coated to reduce incidence of a known complication: endocarditis
- Already 30,000 have been distributed
- High rate of thromboembolic events in one U.K. clinical center
- Alert by U.K. Medical Devices Agency
- Available data has significant flaws
- What should FDA do?

## Potential Actions for FDA

**Judge problem of no significance**
**Have company notify**
**Release an FDA Advisory/Alert**
**Collect more data under regulatory authority**
**Force off market:**
***Summer 2000: St. Jude performed recall***

## The Fundamental Problem?

**For many devices, the lack of systematic data in the postmarket period hampers reasonable, science-based decision-making**

## THE MEDICAL DEVICE SURVEILLANCE NETWORK (MeDSuN) WHY CHANGE USER REPORTING?

**Underreporting / lack of quality data**
**Lack of connection to clinical facilities**
**FDA’s current system is dominated by manufacturer reporting **
**Food and Drug Modernization Act 1997**

## Sentinel ReportingFDA’s Pilot Program

- “Sample” of user facilities committed to reporting
- Well educated and well monitored
- Regular feedback on performance or device information

##  Reporting Barriers

**LIABILITY**

**FEEDBACK**

**CONFUSION**

**BURDEN**

- Recognition

## FDA:  Management, Analysis, and ActionCoordinating Center:  Maintain uniformity and quality control;  Materials development;  Advisory Group

- Recruit probability
- sample of facilities
- within each region - 50
- per region;  Data to
- Coord. Ctr; Grassroots
- voluntary reporting

## Global Harmonization Task Force

-  Study Group 2

- _22* Members_
- 10 Industry
- 10 NCAs
-  2 Other
-     - EC
-     - ECRI

- Canada

- European Union

- United Kingdom

- Germany

- France

- Belgium

- Switzerland

- Australia

- Japan

- United States

## SG2 Activity Highlights

**The NCAR/Vigilance Report Exchange Program-**
- A successful pilot project for AE exchange: going global**	**

**SG2 N21 Manufacturer Reporting Guidance-**Universal agreement on what is reported to NCA

**Key Projects-**
- -N 32:Mfr. Universal Dataset
- -N 33:Mfr. Report Timeframes
- -N 36:Mfr. Trending of AEs
- -N 31: Use Error Reporting

## Integrating the Pieces of the Postmarket Puzzle

**Immediate concerns**
**after approval**

**Rare events**
**and unusual**
**problems**

**Long term **
**concerns**

**Common and**
**known problems**

**Unknown**
**problems, use error,**
**use in clinical settings**

**Integrating the Pieces of the Postmarket Puzzle**

## A Few Interesting Research Questions

- What are optimal strategies for postmarket monitoring of devices?
- For rare but known events, since MDR won’t pick up modest excesses, what mechanisms can fill this gap?
- What are useful metrics for weighing risk vs. benefit for devices?  How does this reflect changing knowledge over time?

## Postmarket Study Authorities:Postmarket Surveillance (Section 522) and Postapproval (PMA)

- Two types of regulatory mechanisms
- Provide FDA the opportunity to ask key surveillance questions of “high risk” devices or where failure may cause death or serious injury
- Used with considerable caution

## Postmarket Surveillance Study Design Approaches

- Detailed review of complaint history/literature
- Non-clinical testing of device
- Use of existing data sets, e.g., Medicare
- Telephone or mail follow up of patients
- Use of product registries
- Case control studies
- Randomized trials

## Frustrations in the Postmarket Period

- Rapid evolution of technology make studies obsolete
- Lack of incentives for the industry
- Lack of interest in the clinical community
- Lack of clearly specified public health question

## Vision for the Future

**Developing a new system of reporting **
**for a selected sample of well-trained and**
**motivated hospitals;  electronically based**
**Expand system to include all medical products**
**Expand access to different data sources, e.g., registries**
**Improved knowledge of medical products in clinical settings**
**Focus on lifecycle of the product (feedback to premarket)**
**Prevention of error, improved patient safety **