# Presentation: 737087

## Closing Gaps in Our Postmarket Safety Net for Medical Devices:It’s Everybody’s Business!

- Larry Kessler, Sc.D.
- Director, Office of Surveillance and Biometrics
- Center for Devices and Radiological Health
- FDLI, April 18, 2001

## 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

## Integrating the Pieces of the Postmarket Puzzle

- Immediate concerns
- after approval:
- COA or Sec 522

**Report Card for CDRH: The Sum total of PM**

- Rare events
- and unusual
- problems:
- MDR

- Long term concerns:
- Epidemiology, Sec.
- 522, Special studies

- Common and
- known problems:
- QSR and the Mfr.

-          Unknown
- problems, use error,
- use in clinical settings:
-          **MeDSuN**

**Integrating the Pieces of the Postmarket Puzzle**

## What can “go wrong” and how we find out

| A rare but catastrophic event (e.g., explosion) | Medical Device Reporting (MDR) System |
| --- | --- |
| Common and known problems (e.g., infection) | Quality System Requirements (Mfr.) |
| Long term concern (e.g., failure over time) | Epidemiologic studies, 522/PMS, Registries |
| Immediate concern after approval | Condition of Approval, 522/PMS |
| Use error; use in clinical settings | Medical product Surveil-lance Network (MedSuN) |

## Holes in the Safety Net

**MDR may not be able to detect increases in rates of known events; heart valves and perivalvular leak**
**Specific disincentives to reporting, e.g., use error and bed rail entrapment**
**MDR not a good mechanism for certain product classes, e.g., IVDs**
**New technology and the learning curve, e.g., AAA Stent Grafts**

## The Fundamental Problem?

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

## Fixing the Holes in the Net

**Medical Product Surveillance Network (MedSuN)**
**Global Harmonization Task Force: SG2**
**Postmarket Surveillance Authorities (Section 522; Condition of Approval)**
**Registries; implant retrieval**

## Medical Product Surveillance Network (MedSuN)

**What**:sample of medical facilities specifically trained in device reporting. Includes “potential for harm” reports.
**Objectives**: improved decision making about device problems; improved signal detection; improved patient safety.
**Impact:** better understanding of device problems such as human factors, new devices and clinical circumstances surrounding use.

## 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
- Wide variety of surveillance approaches acceptable: think least burdensome but answer the key surveillance question

## Attacking Postmarket Problems

- CDRH will: identify, prioritize, and communicate about postmarket device problems; even those not being addressed
- Focus on device type, not manufacturer-specific problems
- The focus is risk-reduction
- Registries may provide surveillance data
- Partnerships needed: FDA not always in lead

## Registries and Possible Carrots from FDA’s Perspective

- New product information
- Source of data for postapproval or postmarket surveillance studies
- Broader analysis of adverse events
- Regulatory requirements such as device tracking
- As potential sources for historical comparator data: from FDA’s least burdensome guidance
- Pre/postmarket balance - expedite time to market w/ _**reliable**_ postmarket data

## Vision for the Future

**Focus on total product lifecycle (feedback to premarket)**
**Developing a new system of reporting for a selected sample**
**of well-trained and motivated hospitals; electronically based**
**Develop a prioritized and public list of device **
**postmarket problems: focus on risk mitigation**
**Begin to issue postmarket surveillance orders under 522**
**Expand access to different data sources, e.g., registries, for **
**both premarket (least burdensome) and postmarket control**