Tuesday, November 15, 2011

Guidance on the use of AGILE practices in the development of medical device software - AAMI Technical Information Report - Working Committee Draft

I had the opportunity to see an advanced copy of the document from the Association for the Advancement of Medical Instrumentation .
Agile TIR SW Committee Draft 1.0 10/7/2011 working draft
AAMI Technical Information Report AAMI/TIR XX:201X
Guidance on the use of AGILE practices in the development of medical device software
Abstract: Over the past several years, agile software development has become an accepted method for developing software products. There have been questions from both manufacturers and regulators as to whether (or which) agile practices are appropriate for developing medical device software. Enough medical device manufacturers have implemented agile practices in their software development that answers to these questions can be documented. Having clear guidance of what practices have been found to be appropriate will be very useful for all developers of medical device software. This TIR will provide recommendations for complying with international standards and United States Food and Drug Administration (FDA) guidance documents when using practices to develop medical device software.
The paper describes how AGILE can bring value to medical device software, when adapted to the unique needs of medical devices.

Watch for the public version of this document, review it, and comment on it.

Sunday, November 13, 2011

Surviving an FDA Audit: Heuristics for Exploratory Testing

I am presenting at:
In FDA regulated industries, audits are high-stakes, fact-finding exercises required to verify compliance to regulations and an organization’s internal procedures. Although exploratory testing has emerged as a powerful test approach within regulated industries, an audit is the impact point where exploratory testing and regulatory worlds collide. Griffin Jones describes a heuristic model—Congruence, Honesty, Competence, Appropriate Process Model, Willingness, Control, and Evidence—his team used to survive an audit. You can use this model to prepare for an audit or to baseline your current practices for an improvement program. Griffin highlights the common misconceptions and traps to avoid with exploratory testing in your regulated industry. Avoid mutual misunderstandings that can trigger episodes of incongruous behavior and an unsuccessful audit. Learn how to maintain your composure during a stressful audit and leave with valuable heuristics to help you organize and present your exploratory testing results with confidence.

Software glitch causes prescription error across R.I.


Software glitch causes prescription error across R.I. 

The software issue led to some discharged patients, who should have received a prescription for timed-release form of their medication, possibly receiving a prescription or instructions for the regular form. Timed-release medications are generally taken once a day, whereas the regular formulation provides the same effective dose of the medication, but the medication is taken multiple times over the course of a day.

The issue does not affect emergency room patients or outpatients.

Lifespan contacted 2,000 patients affected by this issue to ensure they receive the correct form of their medications. Many of the patients were already taking the correct medication, according to the provider.

Many patients? Many patients are not overdosing?

Doesn't that mean that some patients are/were overdosing?