Frequently Asked Questions about Healthcare Engineering Systems in Day Procedure Centres and Clinics

The specified healthcare engineering systems of day procedure centres are electrical installation for critical care areas (e.g. operating room and recovery area), specialized ventilation system of operating room, and medical gas pipeline system.  The requirements for the systems have formed part of the regulatory standard in the Code of Practice for Day Procedure Centres.   As a transitional arrangement, such requirements will take effect from 1 January 2028.   On the other hand, if there are healthcare engineering systems installed in the clinic, the design, installation, operation and maintenance of the systems comply with the relevant requirements in the Code of Practice for Day Procedure Centres.

The day procedure centres / clinics must ensure that the healthcare engineering systems comply with the relevant requirements, complete all application and approval procedures, and obtain an approval notification from the Department of Health before the end of the transition period.

In accordance with the Code of Practice for Day Procedure Centres, the requirements of the design and installation of the healthcare engineering systems as specified apply to new installations, existing installations, and additions and alterations to existing installations in the facility.  Therefore, the healthcare engineering systems in both new and existing day procedure centres must comply with the relevant requirements.

Prospective applicants and licensees of existing facilities may refer to Question Q1 and the information in "Implementation of Regulatory Requirements of Healthcare Engineering Systems for Day Procedure Centres" for details.

In accordance with the Code of Practice for Clinics, where healthcare engineering systems are installed in the facility, the design, installation, operation, and maintenance of the systems comply with the relevant requirements in the Code of Practice for Day Procedure Centres.  Since the relevant requirements in the Code of Practice for Day Procedure Centres apply to new installations, existing installations, and additions and alterations to existing installations in the facility, both new and existing clinics must ensure the healthcare engineering systems comply with the relevant requirements.

Prospective applicants of clinic licences may refer to Question Q1 and the information in "Implementation of Regulatory Requirements of Healthcare Engineering Systems for Clinics" for details.

In accordance with the Guidance Notes for Application for Variation of Service / Particulars of Day Procedure Centres, additions and/or alterations to the specified healthcare engineering systems within the facility, namely electrical installation for critical care areas, specialized ventilation system of operating room and medical gas pipeline system, are considered a variation of service.  The licensee must apply to the Director of Health for the above variations.

In accordance with the Guidance Notes for Application for Variation of Service / Particulars of Day Procedure Centres, an application fee is not required for applications involving additions and/or alterations to the healthcare engineering systems only and received by the Department of Health before 1 January 2028.

If a day procedure centre / clinic needs to be equipped with operating room, critical care area other than the operating room (e.g., recovery area), or medical gas pipeline system, it is required to install healthcare engineering systems that comply with the relevant requirements.  Please refer to Questions Q7 to Q9 for details.

In accordance with the Code of Practice for Day Procedure Centres and the Code of Practice for Clinics, "Specialized Ventilation System" means the ventilation system of an operating room in a facility.  The design, installation, operation and maintenance of this system must comply with the requirements of the relevant codes of practice.  While the ventilation system for areas outside the operating room is not considered a specified healthcare engineering system, the day procedure centres and clinics must ensure adequate and appropriate ventilation systems are in place, and the systems are in compliance with relevant ordinances and regulations of the Laws of Hong Kong.  (See question Q15).

In accordance with the Code of Practice for Day Procedure Centres and the Code of Practice for Clinics, "Critical Care Area" means any area in a facility where failure of electrical power supply is likely to kindise the immediate safety or even cause major injury or death of patients or caregivers, examples are operating room and recovery area.  The design, installation, operation, and maintenance of electrical installations for critical care areas must comply with the requirements of the relevant codes of practice.  While the electrical installations for areas outside the critical care area are not considered a specified healthcare engineering system, the day procedure centres and clinics must ensure the systems are in compliance with relevant ordinances and regulations of the Laws of Hong Kong.  (See question Q15).

In accordance with the Code of Practice for Day Procedure Centres and the Code of Practice for Clinics, "Medical Gas Pipeline System" means a system comprising sources of supply, a pipeline distribution system, terminal units (to which the user connects and disconnects medical equipment), and a warning and alarm system.  It applies to medical gases, medical vacuum and anaesthetic gas scavenging disposal systems.  Therefore, all the medical gas pipeline systems installed in the facility are considered healthcare engineering systems.  The design, installation, operation and maintenance of this system must comply with the requirements of the relevant codes of practice.  The day procedure centres and clinics must also ensure the system is in compliance with relevant ordinances and regulations of the Laws of Hong Kong.  (See question Q15).

The day procedure centres and clinics should refer to the "Checklist of Documents of Healthcare Engineering Systems of Day Procedure Centre or Clinic to be available on site for inspection" (Form PHF 216) to properly prepare and maintain the relevant documents.

The requirements of healthcare engineering systems in day procedure centre will take effect from 1 January 2028.  On the other hand, where healthcare engineering systems are installed in the clinic, the systems comply with the relevant requirements in the Code of Practice for Day Procedure Centres.

If particular day procedure centres or clinics are currently not able to fully comply with the requirements due to the venue or building infrastructure limitations, the relevant day procedure centres or clinics should approach the engineering service provider / building owner / building facility management company early and make appropriate arrangements to ensure that all relevant requirements of the healthcare engineering systems are adhered to before the end of the transition period.

The work process involved in engineering and construction for day procedure centre / clinic, from planning to execution, often entails the engagement of service providers (e.g. consultant / contractor / registered professional engineer (RPE) / relevant professional with healthcare engineering experience) to carry out design, installation, testing & commissioning and certification for healthcare engineering systems and offer professional opinion and service as necessary to ensure that the systems are in compliance with the requirements of relevant ordinances, codes of practice and internationally acceptable standards.  Prospective applicants and licensees of existing facilities should engage the engineering service providers early to ensure that all relevant requirements pertaining to the healthcare engineering systems are adhered to.  Details can be referred to the information in "Service Providers" for reference.

The certificate of compliance with healthcare engineering requirements is certified by a registered professional engineer to ensure that the healthcare engineering systems have been designed and installed in compliance with the relevant Code of Practice.  In general, regular maintenance of the healthcare engineering systems (including replacement of equipment within the systems) does not require re-certification, as long as additions or alterations to the systems are not involved.  However, the licensee must submit an application for variation of service and engage a registered professional engineer in the relevant discipline to certify the healthcare engineering systems if additions or alterations work is conducted.  Details about the required disciplines of registered professional engineers can be found in the "Registered Professional Engineers".

There is no such requirement in the Code of Practice for Day Procedure Centres and the Code of Practice for Clinics.

The licensee of the facility is wholly responsible for the operation of the facility, particularly ensuring the facility’s compliance with the condition of the licence, the Code of Practice and any direction that may be given by the Director of Health.  The Chief Medical Executive (CME) shall ensure that the construction and use of the facility are in compliance with relevant ordinances and regulations of the Laws of Hong Kong, which may involve various government departments, including but not limited to the Fire Services Department, the Electrical and Mechanical Services Department, the Buildings Department, and the Labour Department.  Prospective applicants and licensees of existing facilities may refer to the following websites for relevant information on the other engineering requirements.

• Fire Services Department –
  https://www.hkfsd.gov.hk/eng/fire_protection/notices/
• Electrical and Mechanical Services Department –
  https://www.emsd.gov.hk/en/electricity_safety/publications/guidance_notes_guidelines/notes_for_registered_electrical_contractors/
• Buildings Department –
  https://www.bd.gov.hk/en/building-works/minor-works/minor-works-items/index_mwcs_items_c27c.html
• Labour Department –
  https://www.labour.gov.hk/eng/public/content2_10.htm

The above information is by no means exhaustive and is for reference only.  Prospective applicants and licensees of existing facilities should engage the engineering service providers (e.g. consultant / contractor / registered professional engineer (RPE) / relevant professional with healthcare engineering experience) to obtain professional opinion and service as necessary, or consider approaching relevant government departments for details.

Where DAVS are installed in day procedure centres, licensees may refer to Annex III of the Code of Practice for Day Procedure Centres (i.e.  Guidelines for Dental Compressed Air and Vacuum Systems) for general guidance.  The feasibility of implementing the regulatory requirements of the DAVS would be reviewed as appropriate.  Licensees are encouraged to observe the requirements in preparation for its implementation.  On the other hand, where DAVS are installed in the clinic, the design, installation, operation and maintenance of the systems may refer to the relevant requirements in the Code of Practice for Day Procedure Centres for general guidance.