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Assurance cases for Infusion Pumps

ASCE is now being used by customers in the US for the development of Assurance Cases for infusion pumps.

  • News: Adelard ran a successful course on 28th-29th September 2010 (Washington DC). This course will be repeated both in the USA and Europe, both as public courses and delivered in-house. For further details, see our events page

U.S Food and Drug Administration guidance on Assurance Cases for Infusion Pumps

As part of a general initiative to improve patient safety with infusion pumps, FDA recently issued Guidance document to industry: "Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions.", DRAFT GUIDANCE (April 23, 2010) as part of set of materials about regulating Medical devices. (510k approval is the mandatory FDA approval for medical devices).

In it, the concept of a "safety case" is recommended as a mechanism to suppliers to communicate information about their device and how risks have been identified and mitigated, e.g in Clause 6:

"In making this demonstration of substantial equivalence for your infusion pump, FDA recommends that you submit your information through a framework known as an assurance case or assurance case report."

The language of safety cases is the familiar device of Claims, Arguments and Evidence. It is stated that claims are decomposed into other claims, ultimately supported by evidence. Arguments are seen as how the evidence is linked to the claims.

A standard set of well-known classes of risk (operating hazards, Electrical, Software, Use etc) is provided to help applicants cover areas that they are required to be shown to be mitigated. However suppliers are still expected to do their own hazard identification.

The table of contents is as follows:

  • 1. INTRODUCTION
  • 2. BACKGROUND
  • 3. SCOPE
  • 4. DEVICE DESCRIPTION
  • 5. RISKS TO HEALTH
  • 6. ASSURANCE CASE REPORT
  • 7. CLINICAL EVALUATION
  • 8. RISK MANAGEMENT
  • 9. 510(K) PRE-CLEARANCE INSPECTION FOR INFUSION PUMP
  • 10. LABELING
  • 11. POSTMARKET SURVEILLANCE OF INFUSION PUMPS

FDA workshop

There has been an FDA industry workshop to discuss some aspects of this new guidance.

In the slides and transcripts ASCE is mentioned in the talk by Richard Chapman

Further information

For further information about how ASCE can be used to support Assurance Cases for Infusion Pumps, contact the ASCE team to discuss your needs.

Adelard is running a series of courses on Assurance Cases for Medical Devices, both in house and public courses.