INSIGHT REPORT
Vol 5  No. 1
January
2002

INSIGHT REPORT

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Insight Report No.1  Vol.  5

Closing Gaps in Our Post-market Safety Net
for Medical Devices:
It’s Everybody’s Business!

Early last year Larry Kessler, Sc.D., Director, Office of Surveillance and Biometrics CDRH at an FDLI meeting gave a talk concerning Post-market surveillance of medical devices.

There are several Questions of Interest in the Post-market Period that the FDA has concern over:

• 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

The FDA’s has several methods of learning about problems once a device has been marketed:

What can 'go wrong' and how we find out

However, the FDA feels that there are  “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 is not a good mechanism for certain product classes, e.g., IVDs 
• New technology and the learning curve, e.g., AAA Stent Grafts

The FDA believes the 'The Fundamental Problem' is that:, for many devices, the lack of systematic data in the post-market period hampers reasonable, science-based decision-making

The Agency is looking for ways of  'Fixing the Holes in the Net'  by the use of the following available mechanisms :

• Medical Product Surveillance Network (MedSuN)
• Global Harmonization Task Force: SG2
• Post-market 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.

Post-market Study Authorities:
Post-market Surveillance (Section 522) and Post-approval (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 Post-market Problems

• CDRH will: identify, prioritize, and communicate about Post-market 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 post-approval or Post-market 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/Post-market balance - expedite time to market w/ reliable Post-market data

The FDA’s “Vision for the Future” includes:

• Focus on total product lifecycle (feedback to pre-market)
• 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 Post-market problems: focus on risk mitigation
• Begin to issue Post-market surveillance orders under 522
• Expand access to different data sources, e.g., registries, for both pre-market (least burdensome) and Post-market control

What does this mean for the future of the medical device industry?

As the industry matures the FDA’s concerns relating to post market surveillance and follow up is more intent. With the ability to control the approval process and QSR requirements, the FDA needs to be able to respond in a more rapid time frame to problems that occur once the device is being marketed.

The FDA will expect the industry to maintain a comprehensive complaint handling procedure along with the MDR requirements as well as where it is appropriate an device tracking procedure that is effective in being able to learn where various devices can be located.

The FDA’s expectations on the industry will only increase and the industry must be ready to address these issues.

The next Insight Report –

Next Insight Report - A Warning Letter Review

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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