CBAHI Medical Equipment

Standards
By
Dr Ibrahim Andijani
Dr. Ibrahim Andijani
BSc, MSc, MIPEM, SCFHS
Consultant Biomedical Engineer,
Princess Sultan Medical Military City (PSMMC)
Certified Facility Management & Safety Hospital Surveyor.
Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) previously
Chairman of Scientific Committee of Medical Equipment,
Saudi Commission for Health Specialties (SCFHS)
Chairman of Medical Engineering Chapter
Saudi Council of Engineers (SCE)
Member of professional Accreditation Committee
Saudi Council of Engineers (SCE)

In-charge of Scientific Events and Board Member.

Saudi Scientific Society for Biomedical Engineering (SSSBE).
Recall liaison officer and medical equipment accident investigator,
Saudi Food & Durg Authority (SFDA).

Twitter: @DrAndijani Mobile: 0505422659

Email: iandijani@yahoo.com
 How safe is healthcare?

Dangerous Risky Safe

(>1/1000) (<1/100K)
100,000
Healthcare
Deaths / year

Driving Regular air

10,000 transport
1000
Mountain Chemical European
100 climbing industry railways

10 Charter
Bungee Nuclear
jumping flights power
1
Contacts / 1 death

(Chang, JCI)
Medical equipment Standards
FMS.25 The hospital has a biomedical
equipment plan to ensure that the medical
equipment are regularly monitored,
maintained, and ready for use.
• FMS.25.1 The hospital has adequate number
of qualified biomedical staff.
 Medical equipment Standards
FMS.25 The hospital has a biomedical
equipment plan to ensure that the medical
equipment are regularly monitored,
maintained, and ready for use.
• FMS.25.2 There is a written biomedical
equipment plan that covers the following:
• FMS.25.2.1 A comprehensive inventory of medical
equipment with their corresponding locations.
• FMS.25.2.2 Preventive maintenance program that
conforms with the manufacturer’s instructions.
Medical equipment Standards
FMS.25 The hospital has a biomedical
equipment plan to ensure that the medical
equipment are regularly monitored,
maintained, and ready for use.
• FMS.25.2.3 The program specifies, for each
equipment, the frequency of checks, methods of
checks, acceptance criteria, and actions to be
taken in the event of unsatisfactory results.
Medical equipment Standards
FMS.25 The hospital has a biomedical
equipment plan to ensure that the medical
equipment are regularly monitored,
maintained, and ready for use.
• FMS.25.2.4 The program includes the process for
investigation and follow-up of equipment failure
that addresses reporting of failure, immediate
remedial actions, assessment of the failure effect
on reported results and services (needs
alignment), and requalification of the equipment.
Medical equipment Standards
FMS.25 The hospital has a biomedical
equipment plan to ensure that the medical
equipment are regularly monitored,
maintained, and ready for use.
• FMS.25.2.5 Electrical safety testing for patient
related equipment.
• FMS.25.2.6 History record for the maintenance
schedule, failure incidence, and repairs done.
 Medical equipment Standards
FMS.25 The hospital has a biomedical
equipment plan to ensure that the medical
equipment are regularly monitored,
maintained, and ready for use.
• FMS.25.3 Technical service manuals for all
equipment are available at the biomedical
workshops.
• FMS.25.4 Operator manuals are available at all
departments using the equipment.
Medical equipment Standards
FMS.25 The hospital has a biomedical
equipment plan to ensure that the medical
equipment are regularly monitored,
maintained, and ready for use.
• FMS.25.5 The hospital ensures that all
maintenance works are conducted by
qualified and trained staff.
Medical equipment Standards
FMS.25 The hospital has a biomedical
equipment plan to ensure that the medical
equipment are regularly monitored,
maintained, and ready for use.
• FMS.25.6 Equipment maintenance and repairs
are documented to help in the decision
making for replacement.
Medical equipment Standards
FMS.25 The hospital has a biomedical
equipment plan to ensure that the medical
equipment are regularly monitored,
maintained, and ready for use.
• FMS.25.7 Investigation procedures conform to
manufacturer’s instructions.
• FMS.25.8 There is an equipment recall system
that is implemented.
Medical equipment Standards
FMS.25 The hospital has a biomedical
equipment plan to ensure that the medical
equipment are regularly monitored,
maintained, and ready for use.
• FMS.25.9 Each department has a back-up or
alternative for each critical equipment to
cover for prolonged downtime.
• FMS.25.10 Preventative Maintenance data are
used for upgrading/replacing of equipment.
Medical equipment Standards
FMS.26 The hospital has policies and
procedures that support the medical
equipment management program.
• FMS.26.1 There is a policy to perform
inspection on all new equipment for
conformity before commissioning including
those brought for "demos".
 Medical equipment Standards
FMS.26 The hospital has policies and
procedures that support the medical
equipment management program.
• FMS.26.2 There is a written policy for tagging
medical equipment as follows:
• FMS.26.2.1 Preventive maintenance with
testing date and due date.
• FMS.26.2.2 Inventory number.
• FMS.26.2.3 Removal from service.
• FMS.26.2.4 Electrical safety check.
 Medical equipment Standards
FMS.26 The hospital has policies and
procedures that support the medical
equipment management program.
• FMS.26.3 There is a policy for removal of
equipment from service.
• FMS.26.4 There is a policy to address agent or
contractor repairs.
 Medical equipment Standards
FMS.26 The hospital has policies and
procedures that support the medical
equipment management program.
• FMS.26.5 There is a policy to eliminate the use
of extension cords.
• FMS.26.6 There is a policy to restrict the use
of cellular phones in the intensive care units,
operating room, and cardiology units, as
needed.
 Medical equipment Standards
FMS.27 Hospital staff are trained on safe
operation of medical equipment.
• FMS.27.1 Hospital staff are trained to operate
safely all medical equipment.
• FMS.27.2 The training includes physicians,
nurses, and paramedics.
 Medical equipment Standards
FMS.27 Hospital staff are trained on safe
operation of medical equipment.
• FMS.27.3 The training considers the following:
• FMS.27.3.1 New equipment.
• FMS.27.3.2 Staff transferred from a department to
another.
• FMS.27.3.3 New staff hired.
• FMS.27.3.4 Recurrent misuse of equipment.
 Dr Ibrahim Andijani,
iandijani@yahoo.com
Mobile: +966505422659
Twitter: @DrAndijani