ABB helps James Paget University Hospital meet annual MHRA audit
Norfolk’s James Paget University Hospital has passed its recent Medicines and Healthcare Products Regulatory Agency (MHRA) audit, after calling in ABB’s Measurement Products Service team to complete the cold chain fridge mapping of its blood product storage equipment.
The MHRA places stringent requirements on the way that cold storage facilities are monitored and maintained in UK hospitals and medical establishments. All equipment used to store blood must comply with appropriate standards and all UK hospitals can be subject to an MHRA audit, to ensure they comply.
James Paget University Hospital asked ABB to calibrate and validate their transfusion facilities, including refrigeration and freezer units for blood, drugs and reagents, and ancillary equipment used in the storage process, such as incubators, heaters and centrifuges.
Michael Dawe, Laboratory Transfusion Manager at James Paget University Hospital says:
“Prior to an MHRA inspection we needed a competent fridge mapping supplier to calibrate our storage equipment. Initially we only employed ABB as a one-off but we look forward to working with them again as they have shown themselves to be professional, quick to respond and considerate to the needs of this laboratory.”
All of ABB’s test equipment is traceable to national standards via UKAS accredited laboratories to ensure accurate and reliable temperature measurement. It also offers the latest data recording equipment to digitally record mapping data. Using these devices allows ABB to readily output data into a detailed report.
To meet MHRA requirements ABB provided the hospital with a full post survey report, detailing probe location and calibration certificates for all the test equipment. Dawe continues:
“The MHRA inspector failed to pick any holes in the excellent report. When the inspector enquired about the testing of fridge alarms we asked ABB’s service team for advice. They pulled out all the stops to help and put our needs above their own priorities.”
Part of ABB’s mapping toolkit includes the ScreenMaster SM500F and SM3000 videographic data recorders. These devices can collect a wealth of mapping data, which can quickly be compiled into a detailed post survey report. Compliant with FDA’s CFR21 Part 11 requirements for secure electronic data storage, ScreenMaster recorders feature a host of protective measures to eliminate the risk of unauthorised data tampering both during recording and the post-recording data gathering stage.
Standard security features include the ability to configure and allocate multiple users with individual password and access rights. There is also the option of an internal security switch protected by a tamper-proof seal preventing unauthorised personnel from altering the recorder configuration.
ABB can also hold mapping and calibration data on its fully supported server, with a unique customer web based portal called ‘ServicePort’. Customers are given secure website access to their own portal containing calibration certificates and mapping reports, providing an ideal safeguard against the risk of lost paperwork.
Joe Fudge, ABB Measurement Products Service Manager:
“ABB has over 125 years of experience in temperature measurement that enables us to offer a superior service in the calibration and thermal mapping of temperature chain equipment. This is a great example of how we can help hospitals and healthcare facilities ensure their cold storage operation and maintenance procedures remain compliant with MHRA guidelines.”
ABB (www.abb.com) is a leader in power and automation technologies that enable utility and industry customers to improve their performance while lowering environmental impact. The ABB Group of companies operates in around 100 countries and employs about 117,000 people.
Arlene Hutchinson
ABB Limited
Tel: 01224 592 123
Fax: 01224 592 690
E-mail : arlene.hutchinson@gb.abb.com
Web: www.abb.com
ABB Measurement & Analytics
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