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Published 06 Aug 2024

Gametes storage alarm and notification system

Guy's and St Thomas' NHS Foundation Trust · London

Key facts

Engagement closes
26 Aug 2024
Buyer type
Health

Description

ACU undertakes fertility procedures that fall under the scrutiny of the Human Fertilisation and Embryology Authority (HFEA).

The storage of gametes (sperm and oocytes) for reproductive purposes involves strict regulations and guidelines to ensure their safety, viability, and integrity. Here are key requirements for storage alarm systems: 1. **Temperature Monitoring**: - Continuous monitoring of storage temperatures. - Alarms for temperature deviations from the set range, typically -196°C for liquid nitrogen tanks used in cryopreservation.

2. **Alarm Systems**: - Audible and visual alarms for immediate alerting of personnel. - Remote alarm systems to notify responsible staff via phone, email, or other communication methods to contact staff outside normal working hours in case of an alarm event. There should also be - Backup power supply for alarm systems to ensure functionality during power outages.

3. **Data Logging**: - Continuous data logging of temperature and alarm events. - Regular review and maintenance of logs to ensure compliance and traceability.

4. **Redundancy and Fail-Safe Measures**: - Redundant sensors and alarm systems to prevent single points of failure. - Fail-safe mechanisms that activate in case of system malfunction.

5. **Regular Maintenance and Calibration**: - Routine checks and calibration of temperature sensors and alarm systems. - Scheduled maintenance to ensure all components are functioning correctly.

6. **Compliance with Regulatory Standards**: - Adherence to local and international standards such as those from the Human Fertilisation and Embryology Authority (HFEA), the American Society for Reproductive Medicine (ASRM), and the College of American Pathologists (CAP).

7. **Personnel Training**: - Regular training for staff on alarm response protocols. - Clear documentation and procedural guidelines for handling alarm events.

8. **Physical Security**: - Controlled access to storage areas to prevent unauthorized entry and tampering. - Security systems integrated with alarm monitoring. These measures collectively ensure the protection and viability of stored gametes, minimizing the risk of damage or loss due to temperature fluctuations or system failures. We are seeking knowledge of the market before commencing a formal procurement process.

Categories (CPV)

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