Keeping electronic records secure

However, the accuracy of the data held on them, and a level of security that prevents tampering with records, or other unauthorised changes to them to ‘cover’ poor practice, are both essential, so that, should an individual be injured or killed on hospital grounds, and a law suit follow, the estates team can be confident that it has accurate data to prove it has fulfilled its duty of care. Here David Easton MSc CEng FIHEEM MIET, director of Zener Engineering Services, and chair of IHEEM’s Medical Devices Advisory Group, discusses the issues around maintenance databases, and the security and integrity of maintenance data.

In the pharmaceutical and medical device manufacturing industries, the use of computer maintenance management systems, or CMMS for short, and the validation of other such computer systems, have been commonplace for a number of years. The FDA and MHRA are ‘very hot’ on such topics, and have cited many companies for failing in this area. The NHS adopts similar computer systems for maintenance management, yet, in my personal experience, the standards of validation, integrity, and security standards of electronic maintenance data and records in some quarters of the NHS lag behind those enforced by regulatory authorities, and adopted by industry as standard. With the adoption of advancing technology, the creation, modification, maintenance, and transmission, of electronic asset maintenance records relating to the NHS estate has become more prevalent, replacing paper-based systems. The use of sophisticated software or elementary spreadsheets is now commonplace in the NHS, saving time, and driving efficiencies.

A lack of understanding?