Gaps in Your Postmarket Safety Net for Medical Devices

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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, long term concerns, rare and ususual events, unknown problems, and common and know problems as pieces of a puzzle.

Report Card for CDRH: The Sum Total of PM

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 concerns (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 Surveillance 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

Construction worker bolting metal frame together

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.

Nurse administrating an IV on a patient lying in a hospital bed.

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

(Updated 4/23/01)

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