Medical Supplies, Equipment: & Lab Reagent Management
Medical Supplies, Equipment: & Lab Reagent Management
Medical Supplies, Equipment: & Lab Reagent Management
Equipment: capital equipment and durable items that last for several
years,
e.g. beds, examination tables, sterilizers, microscopes, weighing scales and
bedpans → will be addressed in
•
Surgical Dressings
Definition:
Surgical dressing is a term applied to a wide range
of materials used for dressing wounds or injured
or diseased tissues.
Functions:
Prevent desiccation (drying) & facilitate wound
healing
Prevent wound maceration by permitting
evaporation or absorption of exudation
Excessive moisture induce enzyme & damage repairing tissue
Exudation favors microbial growth – infection!
… Surgical Dressings
Functions (cont’d):
Reduce heat loss
Control microbial growth (by incorporating
antimicrobials)
Provide support
Reduce pain, increase patient comfort, and improve
functional use of wound site
Reduce odor
Improve the appearance of the wound site eg. scar
Reduce overall costs associated with wound
treatment
… Surgical Dressings
Selection of a Wound Dressing bases on:
The degree of exudation
Presence of likelihood of infection
Presence of necrotic tissue
Anatomical site
The state of wound repair
1. 1o dressings:
Plain Gauze, Impregnated Gauze, & Film Dressing
2. 2o dressings:
Surgical cotton (absorbent), Nonabsorbent Bleached
Cotton, Surgical gauze, bandages, Adhesive tapes
Another Classification:
Dressings may also be classified as:
1. Fibers e.g. cotton
2. Fabrics e.g. Absorbent Gauze
3. Bandages e.g. Elastic Bandages
4. Self adhesive plasters e.g. ZnO plasters
5. Compound dressings
Absorbent Cotton (BP)
Pure, white cellulose
Prepared from raw fiber by series of processes
Natural wax, oils & impurities removed from it
Absorbs water readily
Its absorbency may decrease by prolonged storage,
moisture, heat, dust
Use: absorb wound exudates, cleaning, swabbing,
medicating wounds, applying antiseptics
Absorbent Gauze
It is a soft cotton cloth of plain weave
specifications
Mesh No. determines absorbency capacity
Introduction
Classification of sutures
Suture size & indications by location
Surgical needle
Surgical sutures for National Procurement
Summary
Introduction
The technique of closing wounds by means of needle
and thread is several thousand years old
Physicians have used sutures for at least 4,000 years.
Archaeological records from ancient Egypt show that
Egyptians used linen and animal sinew to close
wounds.
The oldest known
reports of surgical
suture is in a mummy
from 1100 BC (ancient
Egypt)
… Introduction
A surgical suture: is a medical device used to hold body
tissues together after an injury or surgery.
It generally consists of a needle with an attached suturing material
(thread).
There are numerous types of surgical sutures that vary
by the size, nature and length of thread and shape and
length of the needle.
The choice of surgical sutures depends on the task it is
required for, the handling characteristics and the
surgeon’s preference
Classification of suture materials
The two main classes of suture materials are:
absorbable and non-absorbable.
1. Absorbable:
Those that are absorbed or digested by the body cells and
tissue fluids in which they are embedded during and
after the healing processes. Of two types
a) Natural origin
Surgical gut: Derived from the small intestine of healthy
sheep.
It is uniformly fine-grained and possesses great tensile
strength and elasticity.
Chromic suture material:
Undergone various intensities of tanning with the salt of
chromic acid to delay the tissue absorption time.
Typical examples of chromic suture and absorption times
are:
Type A plain, 10 days,
Type B mild chromic, 20days
Type C medium chromic, 30days
Type D medium chromic, 40days
Limitation: can be digested by enzymatic action → can
initiate tissue reaction
b) Synthetic
Absorbable synthetic sutures are made from polyglycolic
acid or other glycolide polymers.
Dexon® (Polyglycolic acid): Widespread absorbable
suture material of synthetic origin
Dexon® has low rate of reactivity and infection rate, and
has excellent knot security and tensile strength.
A drawback of Dexon® is its high friction that binds and
snags when wet.
Polyglatin [Vicryl®]- synthetic absorbable sutures
2. Non Absorbable
Not absorbed by the body cells or fluids.
a) Natural origin
Surgical silk: Suture made of raw silk spun by silkworm
• Problem of acute inflammatory reaction that may lead to
encapsulation by fibrous connective tissue
b) Synthetic
Nylon (ethilon): monofilament nylon is the most commonly used
in surface closures.
Table: Types of Sutures
Absorbable Non-Absorbable
Natural Synthetic Natural Synthetic
Mono- Multi- Mono- Multi-filament Mono- Multi- Mono- Multi-
i. Size (Gauge): refers to the outside diameter of the cannula (needle shaft):
The gauge is given in number and the larger the number, the smaller the diameter.
The usual range of gauges in common use range from 13 (largest diameter) to 27
gauge (smallest diameter).
Subcutaneous injection usually requires a 24-gauge or 25-gauge needle.
Intramuscular injection requires a needle with gauge between 19 and 22.
Needles between 18 gauges and 20 gauges are commonly used for compounding
parenteral.
For injection administration, gauge usually not greater than 16 G (1.65 mm)
ii. Needle length:
Length of needle shaft (starting from the hub & shaft junction point)
Usually ranges from 0.25 to 6 inches
Water Flow
Color Length Internal diameter Outer diameter
Size Rate
(mm) (I.D), mm (O.D), mm
(ml / min)
2.1
14G Orange 45 1.7 305
Gray 1.7
16G 45 1.3 200
White 1.5
17G 45 1.1 142
1.3
18G Green 45 0.9 95
1.1
20G pink 32 0.8 65
0.9
22G blue 25 0.6 36
0.7
24G yellow 19 0.5 23
Figure. Cannula of different sizes
Description:
Intravenous cannula (IV) Set Sterile Polythene with introducer and injection
Valve external diameter 1.3mm Length 45mm 18G.
Tubes and Drains
• They are wide ranges of materials made of clear
plastics, latex, synthetic polymers or medical grade
polyvinyl chloride (PVC).
• Tubes can be inserted into a body cavity, duct or
vessel to allow drainage, injection of fluids or access
by surgical instruments.
• Drains are common features of the post-operative
management of surgical patients.
• Drains may be superficial, that is placed in the wound
or deep intra-peritoneal are used to prevent the
formation of a or to remove an accumulation of fluids
(hematoma ) that may become infected.
• Tubes and Drains are designed for a variety of purposes.
These include
Endotracheal tube,
Tracheostomy tube
Nasogastric tube,
Oxygen nasal prong,
Rectal tube,
Foley catheter,
Condom catheter,
Blood bag,
Colostomy bag,
Urine bag,
Suction tube and
Chest tube,
Also called as Breathing Tube
inserted into a patient’s trachea in order to ensure that
the airway is not closed off and that air is able to reach
the lungs
connects the respirator to the patient
Used in general anesthesia, intensive care unit (ICU)
and emergency medicine for airway management and
mechanical ventilation
Types: oral or nasal, cuffed or uncuffed, performed,
reinforced tubes, double-lumen tubes and tracheotomy
tubes.
Figure. Endotracheal tube
Description:
Endothracheal tube, sterile CH 3 cuffed
V. Nasogastric tube (NG tube)
devices.
Therefore, according to the above definitions medical
equipments are subset of medical devices which in turn are
type of health technology in the larger context of health care
technology as described in figure below.
Limitation Patients with metal implants can get CT Patients with Cardiac Pacemakers, tattoos
and metal implants are contraindicated due
for scan. A person who is very large (e.g. to possible injury to patient or image
Scanning over 450 lb) may not fit into the opening distortion (artifact). Patient over 350 lb
may be over table's weight limit. Any
patients of a conventional CT scanner or may be ferromagnetic object may cause
over the weight limit for the moving trauma/burn
table.
Mammography unit
Other common names:
Mammo units; X-ray system, diagnostic, mammographic,
stationary, digital
Intended use : Mammographic radiographic units
use x-rays to produce images of the breast—a
mammogram—that provide information about beast
morphology, normal anatomy, and gross pathology.
Mammography is used primarily to detect and
diagnose breast cancer and to evaluate palpable
masses and no palpable breast lesions.
Principles of operation
Low energy X-rays are produced by the x-ray tube (an evacuated
tube with an anode and a cathode) when a stream of electrons,
accelerated to high velocities by a high-voltage supply from the
generator, collides with the tube’s target anode. The cathode contains
a wire filament that, when heated, provides the electron source. The target anode is struck by the impinging
electrons. X-rays exit the tube through a port window of beryllium. Additional filters are placed in the path o
the x-ray beam to modify the x-ray spectrum.
User(s): Neurologists, neurosurgeons, or other physicians, EEG technicians, sleep lab technicians
Electrosurgical Unit
Other common names:
Bovies; Coagulators, Electrosurgical; Diathermy Units, Surgical;
Electrocautery Units; Electrosurgical Generators;
Endometrial Ablation Systems; ESUs; Hyfrecators; Malis
Coagulators; Stimulators, Muscle; Surgical Diathermy Units;
Surgical Units; Wapplers; Apparatus, electrosurgical; Surgical
diathermy generator
Intended use
Devices intended for surgical cutting and for controlling bleeding by causing coagulation
(homeostasis) at the surgical site. Electro surgery is commonly used in dermatological,
gynecological, cardiac, plastic, ocular, spine, ENT, maxillofacial, orthopedic, urological,
neuro- and general surgical procedures as well as certain dental procedures.
Principles of operation
In monopolar electrosurgery, tissue is cut and coagulated by completion of an electrical circuit that
includes a highfrequency oscillator and amplifi ers within the ESU, the patient, the connecting cables,
and the electrodes. In most applications, electric current from the ESU is conducted through the surgical
site with an active cable and electrode. The electrosurgical current exits the patient through a dispersive
electrode (usually placed on the patient at a site remote from the surgical site) and its associated cable
connected to the neutral side of the generator.
User(s): Surgeon
Technical specification of Electrosurgical Unit (Monopolar-bipolar)
• Outputs of cut, coagulate and blend Maximum output 300 W for monopolar cut
Activation :
• Double pedal switch which may be used for the monopolar and bipolar functions .
• Hand-switch handle
• Bipolar electrode with pedal switch or with automatic Start/Stop system ( for
• coagulation only)
Control
• The Unit shall stop automatically in case of internal error which shall be identified on
• Display and with audible alarm
• Memorization : User shall be able to use at least 4 working programs
Safety :
• Neutral plate safety circuit shall control connections and contacts of Neutral Plate with Tissues:
• Defective Contact shall be notified with visual Alarm and immediate reducing of power
• Output circuit : floating - protected against defibrillator interferences . Shall have HF
• leakages less than 150mA through each electrode
• Power Supply : 220VAC, 50Hz
• Cooling: convection without fan
• HF electrosurgical unit shall be used to execute monopolar and bipolar surgery in many fields of
application where high precision and reliability are essential
Forceps shall be provided with a standard European connection
Straight Forceps - 18 cm. (7")
Curved Forceps - 18 cm. (7")
Curved Forceps - 20 cm. (7 3/4")
Bayonet Forceps - 18 cm. (7")
Bayonet Forceps - 20 cm. (7 3/4")
Straight Forceps - 20 cm. (7 3/4")
Cable, Bipolar
Adaptor, Bipolar Cable
User Manual
Standards : EC Marked, US FDA; ISO certification
Aspirator
Other common names:
Suction unit, suction pump, evacuator, vacuum pump
Intended use:
Most surgical procedures require suctioning to remove
blood, gas, tissue, or other foreign materials and irrigating fl
uids that accumulate in the operative field and obstruct the
surgeon’s view. Portable or mobile aspirators can be used if
there is no central vacuum system or if suctioning is
required in areas that do not have vacuum inlets.
Principles of operation
Various pump configurations include rotary-vane, diaphragm, and piston. Each mechanism
alternately increases and decreases the vacuum and/or chamber volume, creating suction.
Air is drawn from the external tubing into the chamber, drawing aspirate into a collection
canister. Most surgical aspirators have an over flow-protection assembly that prevents fluid
from overflowing into the pump and valves.
User(s): Surgeons, assisting surgeons, nurses, respiratory therapists, other medical
staff
Technical specification of Aspirator/ suction pump
Suction Unit for Major Surgery Procedures . Mains-powered , mobile on 4 antistatic
Castors, ABS Casing and 2 graduated Canisters of 2,000ml each made of
Polycarbonate autoclavable at 121°C and disposable suction bags
Shall require no maintenance nor lubrication
Oil-free pump, maximum suction of at least 500 mm Hg
Free flow rate at least 25 l/min
Main Switch with Pilot Lamp . Fuses
Pedal Action
Shall be equipped with a protective thermal cut-out relay.
Shall be equipped with motor-protection cap that totally prevents aspirated liquids or
secretions from reaching and damaging the vacuum pump
Suction command with continuous adjustment , Vacuometer
2X2,000ml Canisters with airproof screwing-cap with independent Overflow devices
. Fast Connectors and silicone Tubing
Power Supply : 220VAC.50Hz.
Ventilation Fan for overheating
Sound level: Shall be not more than 55 dBA
Accessories
Silicone Tubing , sterilizable
Transparent Cannula Holder, Sterilizable
Anti-Bacterial Filters ( 4 )
Set of 4 canulaes with Holder : Yankhauer , Soft Universal Yankhauer
Diameter : 8.0/6.0mm with anti-sticking Lumen and High Suction Lumen
Universal Soft Canulaes diameter : 6.0/4.0mm
Frazier Canulaes (Fergusson) diameter :1,5/2.0/3.0/4.0mm
Jackson Canulaes
Standards
CE; EC Marked; US FDA; ISO certification
Electrocardiograph, ECG
Other common names:
Computer-assisted electrocardiographs; interpretive
ECG machines; interpretive electrocardiographs;
automated electrocardiographs; EKG machines;
Electrocardiograph multichannel;
Intended use
Electrocardiographs detect the electrical signals associated with cardiac activity
and produce an ECG, a graphic record of the voltage versus time. They are used
to diagnose and assist in treating some types of heart disease and arrhythmias,
determine a patient’s response to drug therapy, and reveal trends or changes in
heart function. Multichannel electrocardiographs record signals from two or
more leads simultaneously and are frequently used in place of single-channel
units. Some electrocardiographs can perform automatic measurement and
interpretation of the ECG as a selectable or optional feature.
Intended use
Colonoscopes are used for the removal of foreign
bodies, excision of tumors or colorectal polyps
(polypectomy), and control of hemorrhage. Routine
colonoscopy is important in diagnosing intestinal
cancer, the second leading cause of cancer deaths in
the United States. These endoscopic procedures
reduce the need for invasive surgical diagnostic and
therapeutic procedures.
Principles of operation
Video colonoscopy insertion tubes contains a fiberoptic
light bundle, which transmits light from the light source
to the tip of the endoscope. Each fiberoptic bundle
consists of thousands of individual glass fibers coated
with glass causing internal reflections that allow light
transmission through the fiber even when it is flexed.
The light is used to illuminate the field of view in the
patient’s colon. Video images are detected by the CCD
and are then transmitted to the video processor and then
display monitors or recording devices.
User(s): Gastroenterologist
Technical specification of Colonoscopy (With halogen light source)
Optical System :
Field of view: at least 120°
Depth of field: 5 –÷100 mm.
Distal end : Outer diameter: not more than 13mm.
Bending Section
Range of tip bending: not less than Up 180°, Down 180°, Right 160°, Left 160°
Insertion tube : Outer diameter: not more than 13.3mm
Working length: not less than 1680mm.
Instrument channel; Inner diameter: not less than 3.2mm.
Light Source
Halogen technology shall provide a high light intensity of at least 150W .
Variable light intensity
Fast and easy bulb change during operation : In case of a bulb failure immediate
switch to the second bulb with the reverser shall be possible
Adjustment of brightness and power with buttons and switches on the front panel.
Shall be connectable with conventional telescopes, fiberscope,
Shall be adaptable to all endoscopic procedures
Optionally , an automatic built-in swivel mechanism will bring the spare halogen
bulb into working position.
Technical Data : Halogen , 150 watts , Halogen, 2 pieces
Manual switch , 2 x 150 W ,24 V, Power Supply : 220 VAC 50Hz .
Standards
CE; EC Marked, US FDA; ISO certification
For more detailed technical specifications one can refer to the
references depicted at the end of this paper including the
Ethiopian List of Medical Instruments with minimum
specification which is drafted by EFMHACA.
Considerations for equipment providers
One major problem concerning medical equipment in developing countries is
the huge / large variety of models from different manufacturers. This greatly
complicates the use and maintenance of equipment. Different models entail
different operating procedures that can limit the number of users. Unfamiliar
users carry high risks of making mistakes. In-service training is often not well
established in developing countries.
Different models also require special spare parts and service skills that are
again difficult to acquire. Lack of recurrent operating and maintenance budget
pose another problem. Sometimes one can see donated equipment lying unused
after the initial excitement of high expectations. If not carefully considered,
donated equipment can bring more problems than it benefit the patient.
Potential donors may consider the following points:
Medical equipment platform …???
Medical Instruments Procurement
Demand /request from MOH, RHB or HFs
Specification
Tendering
Hand over/receive
Storage
Distribution
Installation
Training
After sales service
During procurement Medical Equipment
Sophisticated or complex equipment is concerned, the
‘turnkey’ approach is always adopted (where the supply
of equipment includes installation, commissioning,
initial training for operators, warranty, building
modification, safety, service and maintenance for five
years after warranty)
NB: an expert committee at national level formulates
generic specifications for each item and circulates them
among healthcare institutions in the country. These
specifications are upgraded annually.
Product selection is an important stage in the procurement
process. Products must be selected based on a thorough
needs analysis and adjudication system, taking into account
the level of the health facility and the skills available.
More sophisticated equipment is generally needed at
higher levels, as the range of diagnostic and treatment
services offered broadens,
Tip Generally speaking, the greater the technical nature and
complexity of an item, the greater the involvement should be of
technical staff in the buying decision.
Economies of Scale
Procurement of small quantities increases both the initial
and the life-cycle costs of equipment because you cannot
benefit from the savings that bulk-buying offers.
By combining procurement for several facilities at the
same time, and gaining the resulting standardization, you
can obtain significant advantages.
These include better prices for bulk orders of equipment,
consumables, and spare parts, shared training costs, and
improved after sales commitment from the supplier.
Guideline for Describing Medical Devices
Example
CT Scan - Whole body, 128slice, with Anesthesia + Defibrillator + ECG +
Patient Monitor + Injector
SN Guideline Example Remark
Please refer
Resuscitator (Preferred Term )
Medical Devices should always be Ambubag (Commonly used Brand Name) Annex I for
1 Bed – ICU, Adult, Manual ,4section definition of
written in their preferred term Analyzer - Laboratory, Hematology, Automated, 24 preferred term
parameter, 5 differential
Please refer
Table - Ophthalmic, Operating , Electro Annex II for
2
Preferred term should always begin with hydraulic list of
commonly
a parent name Analyzer - Laboratory, Hematology, used parent
Automated, 24 parameter, 5 differential names
3
Preferred term of should have a data Anesthesia Unit
Bed – ICU, Adult, Manual ,4section
structure having the following Set – Cervical, Dilation and Evacuation
sequence : Table - Ophthalmic, Operating ,
Electrohydraulic
Parent - Class/Category , Type, Analyzer - Laboratory, Hematology,
Automated, 24 parameter, 5 differential
Application/ Purpose, Operation, CT Scan - Whole body, 64slice, with
Capacity/Size/Dimension/Color, Anesthesia + Defibrillator + ECG + Patient
Monitor + Injector
Combination
Bowl - Lotion, 500ml, with Stand
properly/ Select describe appropriate reagents , supplies and equipment for the
laboratory tests. i.e.
Describe basic hematological laboratory tests and their equipment’s, reagents &
supplies
Identify basic immunological tests and their equipment’s, reagents& supplies
Recognize basic chemistry tests and their equipment’s, reagents& supplies
Identify basic urinalysis tests and their commodities required
List common parasitological laboratory methods and their commodities
Describe common microbiological laboratory methods and their commodities
Understand the unique nature of Lab commodities and handle laboratory
equipment, reagents and supplies properly.
Conduct inventory of equipment, reagents and supplies regularly.
Basic Laboratory tests and reagents
6.1. Hematological tests
6.2. Serological/Immunological tests
6.3. Clinical chemistry tests
6.4. Urinalysis tests
6.5. Parasitological tests
6.6. Microbiological tests
6.1 Hematological tests and commodities
Hematology is the study of blood, the blood-forming organs,
and blood diseases. Hematological information assesses the
body’s ability to carry oxygen, provide immunological
surveillance, and prevent hemorrhage.
Typical hematological tests include complete blood counts,
which measure the number of red blood cells/hemoglobin,
white blood cells, and platelets. Other tests include examination
of blood film for differential WBC count and red cell
morphology. Romanosky stains (gimsa and write stain) are used
for staining of blood film.
6.1.1 Complete blood count (CBC)
CBC includes – Total white blood cells count (WBC) or Total
Leukocyte Count (TLC), Differential WBC Count (DLC), Red
Blood Cells (RBC) count, Platelets count, Hemoglobin,
Hematocrit, and a Peripheral blood smear examination.
6.1.1.1 Total white blood cell (WBC) count or TLC: it is mostly
helpful in diagnosis of infectious diseases. TLC estimates the
total number of white cells in cubic millimeters of blood.
Equipment, Reagent and Supplies required
Microscope
Counting chamber provided with cover slip
WBC (Thoma) Pipette, Hand Tally counter
Diluting fluid ( 2% Glacial acetic acid or 1N hydrochloric acid)
Lancet or Syringe with needle , Ethylene Diamine Tetra Acetic Acid ( EDTA)
as anticoagulant- if venous blood is used
Tourniquet- if venous blood is to be used
70% Alcohol and cotton
6.1.1.2 Differential WBC count: in addition to Total WBC Count,
differential WBC count aids in diagnosis of different infectious diseases.
Equipment, Reagent and Supplies required
Microscope
Staining jar Staining jar
Manual differential counter/Cell calculator
Giemsa or Wright stain solution
Slides, Immersion oil , Lancet , Syringe with needle
Slide drying rack , EDTA as anticoagulant Staining jar
Tourniquet WBC differential
counter
70% Alcohol and cotton
Pencil for marking or labeling Drying rack
Blood lancet
Microscope slides
6.1.1.3. Red Blood Cells (RBC) count: A red blood cell
(RBC) count is typically ordered as part of a complete blood
count (CBC) and may be used as part of a health checkup to
screen for a variety of conditions. This test may also be used to
help diagnose and/or monitor any number of diseases that affect
the production or lifespan of the red blood cells.
Equipment, Reagent and Supplies required
Diluting fluid: The diluting fluids for RBC count should be
isotonic to prevent hemolysis.
Microscope, Counting chamber provided with cover slip
RBC (Thoma) Pipette , Hand Tally counter
Diluting fluids: Formal Citrate or Hayem's fluid
Syringe with needle or Lancet, EDTA, Tourniquet
6.2. Immunological/Serological Tests
Immunology is the study of immunity and all of the
phenomena connected with the defense mechanism of the
body.
Immunological tests can be used in the diagnosis of bacterial,
viral, fungal and parasitic infectious agents.
Serology is the study of blood serum and its constituents,
particularly their contribution to the protection of the body
against disease. Serological tests are basically used antigen
and antibody reaction.
Some of the tests are very simple emerging low-cost, low-tech
systems are being introduced into this dynamic field such as
Weil-Felix and Widal tests.
Others like enumeration of CD4 cells require sophisticated
instrumentation, expensive labile reagents, and a high degree of
training.
Some of the immunological/serological tests have cold chain
reagents. These areas require very careful analysis of the
appropriateness of any technology proposed
6.2.1 ABO Grouping
Blood typing is used to determine an individual's blood group and
what type of blood or blood components the person can safely
receive. It is important to ensure that there is compatibility
between a person who requires a transfusion of blood or blood
components and the ABO and Rh type of the unit of blood that will
be transfused
A potentially fatal transfusion reaction can occur if a unit of
blood containing an ABO antigen to which a person has an
antibody is transfused to that person. For example, people with
blood group O have both anti-A and anti-B antibodies in their
blood.
If a unit of blood that is group “A”, “B”, or “AB” is transfused to
this person, the antibodies in the person's blood will react with
the red cells, destroying them and causing potentially serious
complications.
If an Rh-negative individual is transfused with Rh-positive blood,
it is likely that the person will produce antibodies against Rh-
positive blood. Although this does not cause problems for the
person during the current transfusion, a future transfusion with
Rh-positive blood could result in a serious transfusion reaction.
Equipment, Reagent and Supplies required
Ring Slide
ABO Grouping antisera: Anti-A, Anti-B and Anti-D
antiserum
Mixing sticks (applicator stick) , Lancet
6.2.6 Diagnosis of pregnancy
STAT-PAK
Figure Rapid HIV Test Kits used in Ethiopia Uni-Gold
Characteristics of HIV Rapid Testing Kits used in Ethiopia.
Materials required:
•Disposable
KHBglove, Safety box STAT-PAK Uni-Gold
Contains: Contains: Contains:
Test cassette (50 tests per •Sample delivery loop •Test cassette( 20 tests per pack)
pack ) •20 Test cassette (20 tests per •Separate buffer solution
pack) •Separate pipette or micro-titer
Buffer solution • Buffer solution tube
Use this test as a: Use this test as a: Use this test as a: Tie-
Screening test Confirmatory test breaker test
StorageTemp:2-30 oC Storage Temp: 8-30 oC Storage Temp: 2-27 oC0
Shelf life:12 months Shelf life:12-18 months Shelf life: 15 months
ELISA to detect HIV antibodies
Enzyme Linked Immuno Sorbent assay is used for detection of antibodies to
Human Immunodeficiency Virus (HIV) type 1 and/or type 2 (HIV 1/ HIV 2)
virus in human serum or plasma.
HIV antibody ELISA is used to screen blood donors and for clinical diagnosis
of HIV infection. In developing countries ELISA is limited in few laboratories as
it requires sophisticated equipment’s and extensive training to perform the test.
Equipment, Reagents and Supplies Required:
Antigen coated plate ( 96wells), Sample diluents , Enzyme Conjugate , Conjugate
diluents , Positive control , Negative control , Wash solution , Multichannel Pipettes
Chromogen-substrate , 37oC water bath or incubator, 5% sodium hypochlorite solution.
Disposable pipette tips, Absorbent paper, Stop solution (1 vial, 12 ml
Cardboard sealer, ELISA reader with 450 and 630nm, ELISA washer
UNIQUE CHARACTERISTICS AND CLASSIFICATION
OF LA BOTORY PRODUCTS
a)Large numbers of products are needed.
Depending on the level, laboratory services need between 350 and 3,000
different types of products. Each test performed in a laboratory requires
several types of products. For example, a simple malaria test can require
five products— three chemicals and two consumables. More complex tests
often require more products, including equipment. The lowest-level
laboratory may offer as many as 20 or more tests, whereas higher-level
laboratories may offer 50 or more. Although one test may require many
products, a single product may also be used for more than one type of test.
This complicates the management of laboratory products.
b) Laboratory products come in a variety of
preparations
Laboratory products, particularly reagents, come in a variety of
preparations such as kits, powders, and solutions. The physical presentation
of a product has implications on its storage, distribution and quantification
Many reagents come as dry powders that are measured and reconstituted with distilled
water. Dry powders are measured using a balance or scale and the liquid used for
reconstitution is measured using a graduated beaker. The solution is held and stored in
a reagent bottle. Dry powders generally have a longer shelf-life than liquid reagents
and hence the shelf-life is significantly shorter for the reconstituted reagent.
c) Dry laboratory chemicals and consumable liquids are often
packed in bulk
Some laboratory products, particularly less expensive, often-used consumables such as
disinfectants, isopropyl alcohol, and distilled water, are procured and distributed in
bulk. Some dry powder reagents are also distributed in bulk. Products distributed in
bulk generally are ordered less frequently and require more storage space. In some
cases, higher-level facilities may redistribute in smaller quantities products that they
receive in bulk. Those facilities need to be sure that they have sufficient materials
available for repackaging.
D) Laboratory products have short shelf-life
Most laboratory reagents have a shelf life of approximately 24 months.
However, certain reagents have much shorter shelf lives, ranging to less than
7 months; others have longer shelf lives of up to 36 months. In general, dry
powder reagents, when stored properly, have a longer shelf life than liquid
reagents, and reconstituted reagents have a shorter shelf life than original
liquid reagents.
The length of the shelf-life is an important consideration when developing
the supply pipeline for laboratory products; a short shelf life requires a
shorter pipeline.
Table : An example of laboratory reagents storage information and shelf-life
Storage
Reagents Shelf Life Packaging
Temperature
Blood typing sera 24 months 2°–8°C 5 ml bottle (6
bottles in a
package)
Bacteriological 36 months 21°–30°C 500 g bottle
media
Chemistry reagent 12 months 2°–8°C or 21°– 100 tests per kit
kits 24°C
CD4 antibody ≤12 months 2°–8°C 50 tests per kit
reagent
Stains, dry powder 60 months 21°–30°C 25 g bottle
E) Some laboratory products have special storage
requirements.
Since a wide variety of products are required for laboratory
services, a wide variety of storage requirements exists for
their maintenance. Most laboratory products can be stored
following general storage procedures for health products.
However, there are laboratory products that require special
storage requirements. These include
•Flammables and corrosives, which should be stored
separately from other products
•Reagents that require cool or cold storage
•Products that deteriorate rapidly when exposed to light or
moisture
Classification of Laboratory Products
For the purpose of supply chain management, including designing and managing
laboratory logistics systems, there are various ways to classify laboratory products.
A) Based on their nature
Laboratory products can be classified into three categories: reagents, consumables, and
durables.
Reagents: are chemicals and biological agents that are used in laboratory testing for
detecting or measuring an analyte (the substance being measured or determined).
Reagents vary widely in cost, stability, storage conditions requirements, availability, and
the hazards associated with each one of them. Reagents can be further subcategorized
into liquid and solid.
Consumables: are items that are used once while performing a test and are not reused.
Consumables that are used across all testing services are classified as general laboratory
consumables.
Durables: are items that can be reused for multiple tests. They include items such as
glass wares that can be washed, sterilized, and reused. Durables are sub-classified as
equipment’s and instruments.
Generally, reagents and consumables are products that are routinely reordered. Whereas
durables are ordered on need base and do not require the same level of logistics
management
B) Based on their consumption
Based on their consumption, laboratory products are classified as:
•slow-moving
•Fast-moving.
Slow-moving products are those that will take several months to be
consumed whereas fast-moving items are highly consumed.
C) Based on their Shelf-Life
Laboratory products can also be classified based on their shelf-life.
The shelf life laboratory supplies vary significantly. For example,
products like biological products (controls) have very short shelf life
whereas reagents in the form of powders have relatively longer shelf-
life.
D) Based on their availability
Laboratory products can be classified as full- and Non-full-supply
based on their availability.
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