Project 1

• whether any particular me equipment or me system is required to be provided with alarm systems;
• the particular circumstances which initiate an alarm condition;
• the allocation of priorities to a particular alarm condition; or
• the means of generating alarm signals.

• "the general standard" designates IEC 60601-1 alone;
• "this collateral standard" designates IEC 60601-1-8 alone;
• "this standard" designates the combination of the general standard and this collateral standard.

Other IEC Standards

• IEC 60417, Graphical symbols for use on equipment
• IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-6:, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability
• IEC 60651:1979, Sound level meters
  Amendment 1 (1993)
  Amendment 2 (2000)
• ISO 3744:1994 Acoustics — Determination of sound power levels of noise sources using sound pressure — Engineering method in an essentially free field over a reflecting plane
• ISO 7000: 1989 Graphical symbols for use on equipment — Index and synopsis

• alarm limits;
• the characteristics of any alarm signal inactivation states; and
• the values of variables or parameters that determine the function of the alarm system

• Budget available
• Level of ICU needed
• Location
• Number of Beds needed
• Designs
• Human Resource Development
• Engineering and designing constraints
• What type of Case mix the ICU team is likely to deal with and therefore help in
  prioritise equipment type
• In Case of existing facility being upgraded or relocated, then the review of past
  mistakes
• Patient safety and prevention of infection programme
• Transition in case of relocation during reconstruction of the existing ICU

Designing ICU/Level/No of ICUs/No of Beds and Individual Bed

Following ICU Levels are proposed

Level I

• It is recommended for small district hospital, small private Nursing homes, Rural centres
• Ideally 6 to 8 Beds
• Provides resuscitation and short-term Cardio respiratory support including Defibrillation.
• ABG Desirable.
• It should be able to Ventilate a patient for at least 24 to 48 hrs and Non invasive
• Monitoring like - SPO2, H R and rhythm (ECG), NIBP, Temperature etc
• Able to have arrangements for safe transport of the patients to secondary or tertiary centres
• The staff should be encouraged to do short training courses like FCCS or BASIC ICU Course.
• In charge should be preferably a trained doctor in ICU technology and knowledge Blood Bank support
• Should have basic clinical Lab (CBC, BS, Electrolyte, LFT and RFT) and Imaging back up (X-ray and USG), ECG
• Some Microbiology may be desirable
• At least one book on Critical Care Medicine as ready reckoner

Level II (Recommendations of Level I Plus)

• Recommended for larger General Hospitals
• Bed strength 6 to 12
• Director be a trained/qualified Intensivist
• Multisystem life support
• Invasive and Non invasive Ventilation
• Invasive Monitoring
• Long term ventilation ability
• TC Pacing
• Access to ABG, Electrolytes and other routine diagnostic support 24 hrs
• Strong Microbiology support with facility for Fungal Identification desirable
• Nurses and duty doctors trained in Critical Care
• CT must & MRI is desirable
• Protocols and policies for ICUs are observed
• Research will be highly recommended
• Should be supported ideally by Cardiology and other super specialities of Medicine
  and Surgery
• HDU facility will be desirable
• Should fulfil all requirements for IDCC Course
• Resident doctors must be exposed to FCCS course/BASIC course/Ventilation workshops and other updates
• Blood banking either own or outsourced

Level III (All recommendations of Level II Plus)

• Recommended for tertiary level hospitals
• Bed strength 10 to 16 with one or multiple ICUS as per requirement of the institution
• Headed by Intensivist
• Preferably Closed ICU
• Protocols and policies are observed
• Have all recent methods of monitoring, invasive and non invasive including continuous cardiac output, SCvO2 monitoring etc.
• Long term acute care of highest standards
• Intra and inter-hospital transport facilities available
• Multisystem care and referral available round 24 hrs
• Should become lead centres for IDCC and Fellowship courses
• Bedside x-ray, USG, 2D-Echo available
• Own or outsourced CT Scan and MRI facilities should be there
• Bedside Broncoscopy
• Bedside dialysis and other forms of RRT available
• Adequately supported by Blood banks and Blood component therapy
• Optimum patient/Nurse ratio is maintained with 1/1 pt/Nurse ratio in ventilated patients.
• Protocols observed about prevention of infection
• Provision for research and participation in National and International research programmes
• Patient area should not be less than 100 sq ft per patient (>125 sq ft will be ideal). In addition there is optimum additional space for storage, nursing station and relatives
• The unit is assisted by an Ethical Committee which formulates policies about DNAR, Organ donation, EOLS etc
• Doctors, Nurses and other support staff be continuously updated in newer technologies and knowledge in critical Care

Human Resource for ICU

Human resource development is one of the most important task and component of the whole programme. Dedicated, highly motivated, ready to work in stress situations for long periods of time are the type of personal needed. They includes Intensivist, Resident doctors, Nurses, Respiratory Therapists, Nutritionist, Physiotherapist, Technicians, Computer programmer, Biomedical Engineer, and Clinical Pharmacist, Other support staff. Like cleaning staff, guards.

Team Leader

It is important to have a good team led by an Intensivist (who spends >50% of his time in ICU). He should be a full timer particularly for tertiary centres. He should be qualified and trained and able to lead the team. Experience is absolutely essential to lead the ICU team .

Resident Doctors

• Post graduates from Anaesthesia, Medicine or Respiratory Medicine or other allied branches even surgical specialties. Other residents may be graduates depending upon total Bed strength of ICU.
• Though need of resident doctors per number of patient has not been prescribed in literature, however, it is understood and recommended that one doctor cannot take care of more than five patients who are critically sick on ventilator and/or undergoing invasive monitoring with MOFS.
• Therefore, it is suggested that one PG resident with one graduate resident may be good for an ICU of 10 to 14 beds with 1/3 of the pts may be falling into above category. Total no of residents should include who will relieve those going on leave or have to take sudden offs.

Nursing staff

• Nursing – 1/1 nursing for Ventilated or MOFS patients is desirable but in no circumstance the ratio should be < 2 /3 (Two nurses for 3 such patients).
• This will affect the outcome immensely.
• 1/2 to 1/3 nurse patient ratio is acceptable for less seriously sick patients who do not
  require above modalities.

Other staff

• Respiratory Therapist looks after the patients being ventilated respiratory physiotherapy, this takes away lot of load off the duty doctor and the nurses.
• Physiotherapist help in mobilisation, and Technicians who can perform simple procedures like taking samples and sending them to proper place in proper manner makes the task easy and less stressful.
• Computer person can prepare reports, enter data and bring out print outs as and when needed. He can also maintain library, Internet and protocols practiced in ICU.
• Biomedical engineer within the campus makes the job of ICU less frustrating when snags creep in within sensitive ICU equipment. He can be correct them fast.
• Nutritionist is also a very important professional who can contribute to outcome of patient. They have to be trained in desired practices and should be more inclined towards enteral feeding than TPN.
• Cleaning, class IV and Guards are also important to ICU particularly when they understand needs of ICU and its patients. They have a huge role to play in prevention of Nosocomial infection, keeping ICU clean and protect from overcrowding.

How many ICUS and Beds are needed

• Brain storming sessions should be held as to decide how many ICU beds are needed and how many ICUs should be made which may include Advanced ICU, HDU, PICU and Speciality related ICU like Neurointensive care, Cardiac Intensive Care and Trauma.
• The number of Intensive Care beds will depend on the data available from the hospital and current/future requirements of the hospital.
• Some ICUs particularly in Private set ups in our country may be main speciality in the hospital and they should be very careful in deciding about the number of beds and budgetary provisions and viability issues are very important in such cases.
• Numbers of ICU Beds recommended in a hospital are usually 1 to 4 per 100 hospital beds
• ICUs having <6 beds are not cost effective and also they may not provide enough clinical experience and exposure to skilled HR of the ICU. At the same ICU with bed strength of >24 are difficult to manage and major problems may be encountered in management and outcome.
• Recommendations suggest that efficiency may be compromised once total number of beds crosses 12 in ICU.
• The Canadian Department of National Health and Welfare has developed a formula for calculating the number of ICU beds required based on the average census in the existing unit and the desired probability of having an ICU bed immediately available for a new admission.
• Therefore, it is recommended that total bed strength in ICU should be between 8 to 12 and not <6 or not >14 in any case.

Location/entry/exit points of ICU in Hospital

• Safe, easy, fast transport of a critically sick patient should be priority in planning its location, therefore, ICU should be located in close proximity of ER, Operating rooms, trauma ward.
• Corridors, lifts & ramps should be spacious enough to provide easy movement of bed/trolley of a critically sick patient.
• Close/easy proximity is also desirable to diagnostic facilities, blood bank, pharmacy, etc.
• No thoroughfare can be provided through ICU.
• There should be single entry/exit point to ICU, which should be manned.
• However, it is required to have emergency exit points in case of emergencies and disasters.

ICU Bed Designing and Space Issues

• Space per bed has been recommended from 125 to 150 sq ft area per bed in the patient care area or the room of the patient. Some recommendation has placed it even higher up to 250 sq ft per bed. In addition there should be 100 to 150% extra space to accommodate nursing station, storage, patient movement area, equipment area, doctors and nurses rooms and toilet.
• However in Indian circumstances after reviewing and feed back from various ICUs in our country it may be satisfactory to suggest an area of 100 to 125 sq ft be provided in patient care area for comfortable working with a critically sick patient where all the paraphernalia including monitoring systems, Ventilators & other machines like bedside X-ray will have to be placed around the patient. Bedside procedures like Central lines, Intubation, Tracheostomy, ICD insertion and RRT are common.
• It may be prudent to make one or two bigger rooms or area which may be utilised for patients who may undergo big bedside procedures like ECMO, RRT etc and has large number Gadgets attached to them.
  10 % (one to two) rooms may be designated isolation rooms where immunocompromised patients may be kept, these rooms may have 20% extra space than other rooms.
• The planners may think about, if they are thinking of introducing newer technologies in their ICU like ECMO, Nitric Oxide and Xenon clearance etc. Do they need Lamellar flow for specific patient population in their ICUs. This will be highly specific for High end up ICUs and is not recommended in routine Provisions may be kept open for such options in future.

10% of beds ( 1 or 2 ) rooms may be used exclusively as isolation cases like for burns, serious contagious infected patients. Each group should decide if they want to provide the patient access to music (audio), telephone etc. However an alarm bell which has both indicators by sound and light must be provided to each patient and he be taught about it, how to use it when needed.

Recommendations for Indian ICUs

• Bed space- minimum 100 sq ft (Desirable) >125.
• Additional space for the ICU (Storage/Nursing stn/doctors/circulation etc) 100 % extra of the bed space (Keep the future requirement in mind)
• Oxygen outlets 2
• Vacuum outlets 2
• Compressed air outlets 1
• Electric outlets 12 of which 4 may be near the floor 2 on each side of the patient.
• Electric outlets/Inlets should be common5/15 amp pins. Should have pins to accommodate all standard International Electric Pins/Sockets. Adapters should be discouraged since they tend to become loose.

Central Nursing Station

• This is the nerve centre of ICU, despite lots of development, the old standard of a central station is still holds good and endorsed by most guidelines and regulations regardless of today's practice needs.
• All/near-all monitors and patients must be observable from there, either directly or through the central monitoring system. Most ICUs use the central station, serving six to twelve beds arranged in an L or U fashion.
• Patients in rooms may be difficult to observe and therefore may be placed on remote television monitoring, These monitors may satisfy regulatory requirements but do not really provide adequate patient safety if the clarity of the picture is poor.
• Some ICUs have unit pods of about four or five beds, each served by a separate workstation, Nurses assigned to patients in the pod form a team, A monitor technician is required, The unit Nursing clerk and the supervising nurse will usually work together to oversee the efficient interaction among the staff and with support services.
• Careful consideration of what level or type of activity will occur in the central station will insure adequate space planning, New equipment purchased over the next decade will probably increase the amount of desk and shelf space required.
• At times of high use the number of people in the central station can increase several fold. Having enough space and chairs to meet needs during such times should be provided for.
• The space should accommodate computer terminals and printers. A large number of communication cables may be required per bedside to connect computers and faxes to other departments, as well as to other institutions and offices.
• Adequate space for charting on the platform is absolutely important.
• Patients must be easily visible from the charting area whether the nurse is sitting or standing, taller chairs are often necessary.
• In case of space constraint, Collapsible desktops or shelves that can flip up off the wall can be planned.
• Space allotted for storage of the previous charts of patients currently in the unit should also be provided.
• It is also important that a storage space is provided for equipment, linen, instruments, drugs, medicines, disposables, stationary and other articles to be stored at the Nursing tation must be provided. All these cupboards should be labelled.
• The latest generation of monitoring systems allows access to patient data from any bedside; This means that the doctor who is busy caring for one patient can monitor others without leaving that bedside.
• Consoles can be programmed to automatically display critical events from one bedside at several sites without personnel calling for it. There is need for more effective alarming system with less noise, which can send signals to CNS as well as remote pager carried by the caregiver.
• Ideally in Indian ICUs, there are over bed tables with each bed. These tables may be so deigned of stainless steel to have a broad top to accommodate charts and cupboards enough in number and size to store medicines, disposables investigations and records of the patient.
• The Central Nursing Station has in charge nursing, duty doctors/s, clerk/computer guy, machines, store attached and monitors and spare machines/spares, linen and other ancillaries.

List Of Equipments (8 Bedded ICU)

Patient monitor central monitoring system (Pictures attached by name: Display mode, Review patients data list, ECG review mode, Alarm event review mode of waveform and tabular trend with High Med Low levels, Review full, specific patient data)

• Wired : up to 64 monitors / Wireless : up to 16 monitors
• Support dual monitors: up to 32 monitor displays in 1 monitor
• 2,4, 8, 16, 32 channels with Pageview mode
• Server functions in different location
• Dual monitoring mode
• Broker server function ( Nurse station & Doctor’s station )
• Up to 10 days of file storage per patient for Admin/Discharged patient information
• Alarm events, waveforms: graphic & tabular trend, ECG review
• Alarm ON/OFF
• NIBP Start / Stop triggering menu with STAT ON/OFF
• Patient Admin/ Discharge
• Remote setting from CMS to patient monitor

Displays for Result

To choose the right TFT LCD display for a medical application, engineers and decision-makers need to have a comprehensive understanding of how TFT LCD display specifications affect final products.

In the old days, medical device with a display was usually bulky and had many dials & buttons. A machine with buttons and knots makes for a good breeding space for harmful pathogens, as it is harder to clean than modern one with flat touch screen interface. Using TFT LCD touch screen on medical device not only makes disinfecting easy, but also save a lot of front panel spaces for displaying vital medical information.

Medical device can be put through extreme temperature, vibration and shock, moisture and variable ambient lighting. Thus, it demands highly reliable TFT LCD screen, and possibly the use of clear protective cover that safeguards the display from the rigors of day-to-day use.

While normal LCD display's performance is not sufficient, medical TFT suppliers like Topway can add enhancements such as optical bonded front panel with anti-reflection coating, transflective display that combines both reflective and transmissive properties.

Medical TFT LCDs are typically used in three kinds of applications: standard (e.g. bedside monitor), life-support (e.g. glucose meter) and life-critical (e.g. ventilator). These applications have drastically different requirements on functionality, reliability and MTBF (mean time between failure). Two well-known standard organizations' acceptance test rules are generally accepted by the industry, European DIN and American Association of Physicists in Medicine. The two organizations have well defined standard on resolution, noise, viewing angle, glare, color uniformity, distortion, reflection, luminance response and luminance uniformity.

Qualification process for these standards is very tedious and expensive. Device manufacturers are not willing to modify an approved system and are demanding long-term availability for LCD display. Topway guarantees the TFT LCD module's longevity. A lot of the color LCD models' life span even last over ten years.

Medical Devices using TFT LCD

• Ventilators
• Humidifiers
• Infusion Pump
• ECG monitor

Examples of alarming medical devices

Source: Seibig 2010 and alarm data

Medical Device Data Systems (MDDS)

These are hardware or software products intended to transfer, store, convert formats, and display medical device data. A MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS may or may not be intended for active patient monitoring.

Per section 520(o)(1)(D) of the Federal Food, Drug, and Cosmetic Act:

• Software functions that are solely intended to transfer, store, convert formats, and display medical device data or medical imaging data, are not devices and are not subject to FDA regulatory requirements applicable to devices. The FDA describes these software functions as "Non-Device-MDDS."
• Hardware functions that are solely intended to transfer, store, convert formats, and display medical device data or results are "Device-MDDS."

Examples of Non-Device-MDDS include software functions that:

• Store patient data, such as blood pressure readings, for review at a later time;
• Convert digital data generated by a pulse oximeter into a format that can be printed; and
• Display a previously stored electrocardiogram for a particular patient.

The DICOM standard, which is the dominant protocol for medical imaging communications, provides a new concept for communication service design. It accepts E-mail service and adopts web-enabled services through the standardization of WADO service. DICOM is a message standard (i.e., a specification for interchange of information between computer systems). DICOM is a comprehensive specification of information content, structure, encoding, and communications protocols for electronic interchange of diagnostic and therapeutic images and image-related information.

Medical image sharing is the electronic exchange of medical images between hospitals, physicians and patients. Rather than using traditional media, such as a CD or DVD, pendrive or hard drives and either shipping it out or having patients carry it with them, technology now allows for the sharing of these images using the cloud. DICOM uses TCP (transmission control protocol) as its underlying network transport layer, and despite its widespread and generally successful use around the world for most Internet use, TCP does have some significant limitations. CEN ISO/IEEE 11073 enables the communication between medical devices and external information systems. This standard provides plug-and-play interoperability between devices, and facilitates the efficient exchange of data acquired at the point of care in all care environments.

Medical image processing encompasses the use and exploration of 3D image datasets of the human body, obtained most commonly from a Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scanner to diagnose pathologies or guide medical interventions such as surgical planning, or for research purposes.

DICOM^® is implemented in almost every radiology, cardiology imaging, and radiotherapy device (X-ray, CT, MRI, ultrasound, etc.), and increasingly in devices in other medical domains such as ophthalmology and dentistry. HIS is the core informational system for patient management across the health-care system and radiology information system (RIS) is considered the core system for the electronic management of imaging departments. RIS is used by radiologists to edit and report the radiology diagnosis. PACS provide storage and convenient access to medical images such as ultrasounds, MRIs, CTs, and x-rays. DICOM is both a protocol for transmitting images and a file format for storing them.

DICOM is most commonly used for storing and transmitting medical images enabling the integration of medical imaging devices such as scanners, servers, workstations, printers, network hardware, and picture archiving and communication systems (PACS) from multiple manufacturers.