Clinical investigations of medical devices – new Standard

A new Standard for Clinical investigation of medical devices for human subjects – General requirements BS EN ISO 14155-1:2009 defines the procedures for the conduct and performance of clinical investigations of medical devices, where their clinical performance and safety is being assessed in people. The Standard is intended to protect people and to ensure the scientific conduct of the clinical investigation.

BS EN ISO 14155-1:2009 specifies:

• requirements for the organisation, conduct, monitoring, data collection, and documentation of the clinical investigation
• requirements that establish the performance of the device under conditions intended to mimic normal clinical use, thereby revealing adverse events in normal use and allowing the assessment of acceptable risks.

Health care products sterilisation – new Standard

A new ISO Standard includes guidance for the selection, use, and interpretation of results from the application of biological indicators when used in the development, validation, and routine monitoring of sterilisation processes. ISO 14161:2009 Sterilization of health care products – Biological indicators – Guidance for the selection, use and interpretation of results applies to biological indicators for which Standards exist (for example, in the ISO 11138 series).

The information provided in ISO 14161:2009 can have useful application for processes and biological indicators not currently addressed by existing Standards, for example, new and developing sterilisation processes.

Targeted nanoparticles 'could treat heart disease'

Scientists in the USA have created new 'nanoburrs', which they claim could be used to target and treat damaged areas of the heart.

The group from Massachusetts Institute of Technology (MIT) and Harvard University found that the targeted nanoparticles could be directed to affected vascular tissue, where they cling and deliver drugs aimed at clearing arteries slowly.

STANDARD IN DEVELOPMENT

Pharmacy services Standard

Committee: P8120
Project Manager: Carolyn Gay
Estimated Publication Date: Late March 2010
Comments: The Pharmacy services Standard is progressing well. A balanced expert committee from across the sector is working to ensure the Standard demonstrates that consumers are clear about their rights, and providers are clear about their responsibilities for good and safe outcomes. The committee met at the end of October to review the comments received from the public comment phase of the project. The draft is being updated to reflect the committee's decisions and will be ready for postal ballot in March.