ENGINEERING GOVERNANCE


manufacturers, have historically managed their activities in alignment with HTM guidance. It is acknowledged that many of the points highlighted in this paper are difficult to follow for such commercial suppliers, and revised HTMs have not considered the specific implications in some of these areas. It is advised that those in the commercial sector endeavour to work within the HTM principles, using specialist expertise, such as that of AE(D)s, to support and improve practice, and identify any applicable limitations in the governance.


Conclusions Where do these concerns leave us, and what can we do – as AEs and as other professionals associated with healthcare engineering – to minimise risks? As AEs we must promote regular training and review organisational plans as part of routine assessments/annual reports. The AE must work with the AP to ensure


that documentation is correct within the organisation, to include a review of CP competency assessments, equipment registers, maintenance logbooks, permit to work protocols, and validation reports etc. We must also promote concise


communication across the system, so that all involved have an understanding of who is responsible for which action, and escalation of any concerns found, and a determination of any action plan needed in accordance with safe systems of work. Such discussions must include relevant


roles named within HTM 01-01 Part A. As providers of services, we must


invest in education and courses for our CPs. They are an asset, and if trained appropriately, can reduce costs and enhance patient safety. There needs to be routine CPD training to cover specific topics such as steam principles, calibration, chemical disinfectants, and our problem area – rinse water quality. As an industry which includes medical device sectors, along with commercial entities such as pharmaceutical production units, we have much to think about, and we need to evolve training to meet ever- changing needs. HTM guidance, specific to decontamination requirements for training, should align with other guidance within healthcare, such as HTM 02-01: Medical gas pipeline systems. Are current industry/commercial


standards different to those in healthcare, and – in compliance with health and safety accountability – should such standards be consistent? Also, as a Technical Platform (Decontamination), should we work to embrace consistent protocols and governance guidance? The CP(D) and AP(D) certification


process must ensure that individuals understand the principles behind the development, validation, and control of the decontamination/sterilisation process.


Here, engineers were unable to remove covers.


They must also have an awareness of the operational management and implementation of relevant regulatory guidance and standards. There is a need to specify a refresher training timescale for CP(D)s and AP(D)s. This would provide the industry with a governance structure that ensures that the relevant personnel are suitably trained and conversant with changes to HTM guidance.


Competent Persons (Decontamination) To be deemed a CP(D), the engineer must demonstrate that they have a minimum 12-months’ experience working on relevant decontamination equipment; this must include the theoretical background of sterilisers (porous load, laboratory, pharmaceutical, benchtops, VHP etc), washer-disinfectors (thermal, chemical), and controlled environment storage equipment etc. CP(D)s should:


n Have completed a relevant apprenticeship, or equivalent training, in mechanical, electrical, or electronic disciplines. This must include core experience with electrical safety, steam, and water systems.


n Understand microbiological, chemistry, and infection control principles, appropriate to the systems they are


working on. Such an understanding should be supported by attendance at relevant training, such as seminars or webinars applicable to the duties they are expected to complete. This may include items such as aseptic water sampling techniques, and awareness of the importance of water quality, and/or chemical purity of steam etc.


n Have completed a minimum NVQ level 3, City & Guilds, or BTEC qualification, or equivalent, in mechanical, electrical, or electronic disciplines.


n Have completed and passed accredited training courses covering validation of relevant decontamination/ sterilisation equipment. This can include sterilisers (porous load, laboratory, pharmaceutical, benchtops, VHP etc), washer-disinfectors (thermal, chemical), and controlled environment storage equipment etc. This training is considered relevant only if undertaken within 10 years of assessment.


n Have completed training courses provided by manufacturers of decontamination equipment. This training is considered relevant only if undertaken within 10 years of assessment. Such training must include general maintenance and/or fault finding of equipment installed.


February 2024 Health Estate Journal 41


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