Classification and design of a Manufacturing company for a

medical device
(Surgical Scalpel)
College of Biomedical Engineering and applied sciences

Submitted by:
Pranav Upadhyaya
B12
8th Semester

Submitted to:
Er. Saurav Sharma

Table of Contents
1.

Introduction.........................................................................................................................................2

2.

Surgical Scalpel: A medical device......................................................................................................3

3.

Classification of Surgical Scalpel........................................................................................................4

4.

Manufacturing process:.......................................................................................................................5
5.

Device Description..........................................................................................................................5
5.1

Manufacturer:..........................................................................................................................5

5.2

Device name:...........................................................................................................................5

5.3

Device detail............................................................................................................................6

5.4

General Instruction for Reprocessing of Reusable Surgical Scalpel............................................7

5.4.1

Warnings..............................................................................................................................7

5.4.2

LIMITATIONS ON REPROCESSING................................................................................7

5.4.3

INSTRUCTIONS FROM POINT OF USE..........................................................................7

5.4.4

PREPARATION FOR DECONTAMINATION...................................................................7

5.4.5

CLEANING: MANUAL......................................................................................................7

5.4.6

CLEANING INSPECTION.................................................................................................7

5.4.7

MAINTENANCE................................................................................................................8

5.4.8

PACKAGING......................................................................................................................8

5.4.9

STERILIZATION................................................................................................................8

5.4.10

STORAGE...........................................................................................................................8

6.

CE marking routes:..............................................................................................................................8

7.

Organizational design:.......................................................................................................................10

8.

Conclusion.........................................................................................................................................11

1. Introduction
The demand for precision surgical knives is enormous. Considering use in cataract surgery alone,
the requirements are staggering. Over 10 million cataract surgeries are performed each year
worldwide and the numbers are expected to increase dramatically as the world population over
60 years of age increases rapidly over the next 2-3 decades [1]. Perhaps more significantly, many
are suffering reduced quality of life in going without this important surgery due to its cost [2]. An
important part of this surgery is the availability of affordable precision surgical knives to perform
corneal incisions. It has been shown that smaller incisions with higher quality blades create
shorter heal times, less trauma and smaller chances of surgical complications.
An economically-viable alternative material for precision surgical knives should satisfy the
following four criteria: 1) it should have a high hardness so that the integrity of the blade edge is
maintained; 2) the grain size of the material should be such that the desired edge radius can be
obtained; 3) the manufacturing costs involved in making blades of various shapes, sizes and edge
radii have to be such that it provides a compelling cost benefit over the 3 use of diamond knives;
4) the material should be bio-compatible.
Surgical scalpel is most commonly used by surgeons. A surgical scalpel is a small and extremely
sharp bladed instrument used for surgery, anatomic dissection, and various medical purposes.
Scalpels may be single-use disposable or re-usable. Re-usable scalpels can have attached
resharpen- able blades or, more commonly, non-attached, replaceable blades. Disposable scalpels
usually have a plastic handle with an extensive blade and are used once, then the entire
instrument is discarded.
The purpose of the scalpel (either re-usable or disposable) is for carrying out the surgical
dissections by the surgeons. It is the most common device which is used for surgical procedures
and hence has a high demand in the medical industry. Scalpel blades are made up of stainless
steel, titanium, high carbon steel, ceramic, diamond etc. For example : for performing surgery
under MRI guidance, Stainless steel are unacceptable cause it may produce artifacts so use of
other material scalpels are preferred.

2. Surgical Scalpel: A medical device

An Instrument, apparatus, implement, machine, contrivance, in vitro reagent, or other similar
related article, including any component, part or accessory, which is intended for use in the
diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of
disease in man or intended to affect the structure or any function of the body of man or other
animals, and which does not achieve its primary intended purposes through chemical action
within or on the body of man or other animals and which is not dependent upon being
metabolized for the achievement of its primary intended purposes.
Surgical Scalpel is thus a medical device intended for assisting the surgeons for carrying out
anatomical dissections during surgery which does not achieve its intended action on the human
body by pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means.

3. Classification of Surgical Scalpel

For manufacturing a medical device it must be classified. In order to define the class of the
medical device various criteria are to be looked upon for regulating the device for its correct
class and its CE marking procedures. The device classification can be done by the classification
rules of a medical device in European Council Directive 93/42/EEC on medical device, Annex
IX, subsection 1.
The first thing that is to be looked upon is the duration of contact of the device whether it is short
term of long term. The device which is intended for manufacture i.e. surgical scalpel falls under
transient use normally intended for continuous use for less than 60 minutes. The second thing
which comes under the invasive device falls in surgical invasive device as it penetrates inside the
body through the surface or body. As the device which is intended for manufacture is a reusable
type surgical scalpel handle and blade , it is intended for surgical use by cutting without
connection to any active medical device and which can be reused after appropriate procedures
have been carried out, it falls in reusable surgical instrument.
According to European Council Directive 93/42/EEC on medical device Rule number 6,
subsection 2, Annex IX, all surgically invasive devices intended for transient use are in class IIa
unless they are reusable surgical instruments , in which case they are in class I.
The flowchart showing the classification of the medical device is shown as follows;
Rule 6
Surgically Invasive
Transient Use

IIa

Specifically to
control/correct defect
of the heart or central
circulatory system
through direct contact.

For use in
direct contact
with central
nervous
system.
III

Reusabl
e
surgical
instrum
I

Supply
energy/ionizati
on radiation.
IIb

Biological effectmainly or wholly

absorbed.
IIb

III

Fig: Flowchart showing Rule 6 for the classification of medical device

Intended to
administer
medicine in a
potentially
hazardous
IIb

As a manufacturer company, it has been confirmed that the reusable surgical scalpel blade falls
in class I medical device. Since it is a surgically invasive device which is used for anatomical
dissection in surgery intended for transient use.

4. Manufacturing process:
The materials used mainly in surgical scalpel are primarily stainless steel, high carbon steel or
ceramic, diamond etc. Also the materials use in scalpel handles is primarily made of stainless
steel. To manufacture the scalpel blades and the handle from scratch, strips of stainless steel is
passed through a press which cuts the blunt pieces of blades and its punched out the unfinished
blades. Blades will vary with size and contour but they all have the centre slot for attaching the
handle. The unfinished blades or blanks are flexible and bend easily so to make them fixed and
hard, they are passed through a furnace which alters the molecular structure of the metal
hardening it. After heating the blanks, they have the flexibility a scalpel blade requires. The
blanks are stacked on a peg. Then the blanks are threaded on a metal ring and are passed for
surface polishing which will restore the shining of the metal which was dulled by heat treatment.
The blanks are then transferred from ring to a metal rod suing gauze to measure the right number
and then mounted on a grinding machine in which each one of the blade is picked up by a
magnet in a holder that runs it through the wheel coated by diamond particles. This powerful
abrasive shapes and sharpens a cutting angle transforming the blank into the blade. The blades
are then demagnetized and washed in an ultrasonic cleaning tank the blades are inspected and
scrutinized discarding the imperfect blades and are packed with anticorrosion chemical and
labeled with blade model number and tracking code and quality checked lastly and is boxed for
market. It is critical for the blades to be sterile so it is passed to a cobalt radiation chamber for 6
hours which obliterates any lingering contaminants. The Blade handle are made similarly with
stainless steel mould poured into a chamber which gives the handle the desired shape and
processed according to its design and sterilized and packed.

5. Device Description
5.1 Manufacturer: Care Instruments limited
5.2 Device name: Care Surgical Scalpel
Intended to be used in carrying out surgical procedures.
Intended for various type of cutting and dissection of the body in accordance with the
body part and procedure to be followed.
Intended to fit various types of surgical blades and be reused.

5.3 Device detail:

Scalpel blades provide with an accurate and steady dissection procedures and includes various
design and ranges i.e. blades number 10, 10A, 11, 11k, 12, 15 and 15S which fits on all number 3
fitment handles and blades number 18, 19, 20, 21, 22, 22A, 23, 24, 25 and 36 fits on all number 4
fitment handles. The Care scalpel blades comes in 100 quantity and are made up of stainless
steel and carbon steel with satin finish or mirror finish upon request packed in Care TM branded
sterile pouches. The Care scalpel handle correctly fits to standard surgical blades. The distal
ends are tapered and beveled for use in blunt dissection. Each handle is contoured for firm grip,
strength, manipulation and comfort. They are sold one handle each per package.
The Care reusable scalpel handle is manufactured from the finest German surgical instrument
grade stainless steel. The Care reusable scalpel handle is supplied in a sterile condition and
must be cleaned and sterilized prior to reuse in accordance with the processing instructions
described in this document and in compliance with local, state and national health & safety
regulations. This will ensure that the Care scalpel handle is processed safely and continues to
meet its performance specification. The Care reusable scalpel handle is latex free. It is marked
with a unique serial number for identification and traceability.
Each blade is individually packed in aluminium foil. Carbon Steel blades are VPI paper
protected. Blades sizes are clearly identified on the reverse side of the foil peel-pack and by a
colour coded sticker on unit boxes and are supplied sterile in unit dispenser boxes of 100. All
sterile products are sterilized by Gamma radiation and all products carry the CE mark as per the
European Medical Device Directive 93/42/EEC.
5.3.1

Composition:

Blades are made of carbon and stainless steel has the composition given in the tables below:
Carbon Steel Ref. BS 2982: 1992
Range % (m/m)
Carbon
0.60 0.70 %
Silicon
0.50% maximum
Manganese
1.00 % max.
Chromium
12.00 13.50 %
Sulphur
0.025 % maximum
Phosphorous
0.03 % maximum
Nickel
0.50 maximum

Stainless steel Ref. 5194: 1991

Range % (m/m)
Carbon
1.20 1.30 %
Silicon
0.10 0.35 %
Manganese
0.20 0.45%
Chromium
0.10 0.40%
Sulphur
0.025 maximum
Phosphorous
0.035 maximum

Fig: Table showing the compositions of materials for manufacture

5.4 General Instruction for Reprocessing of Reusable Surgical

Scalpel
The following instructions are for all reusable surgical instruments supplied by Care Instruments
Limited, unless stated otherwise with the packaging of the product. These instructions are
intended for use only by person with the required specialist knowledge and training.
5.4.1

Warnings

Follow instructions and warnings as issued by the manufacturers of any decontaminants,

disinfectants and cleaning agents. Wherever possible avoid use of mineral acids and harsh,
abrasive agents.
No part of the process shall exceed 140C.
Some sensitive materials (e.g. Aluminium) are damaged by high alkaline solutions
(pH>10).

5.4.2 LIMITATIONS ON REPROCESSING

Repeated processing has minimal effect on these instruments.

End of life is normally determined by wear and damage in use.

Any specific limitations on the number of reprocessing cycles shall be made available
with the instrument.
5.4.3

Wherever possible, do not allow blood, debris or bodily fluids to dry on instruments. For
best results and to prolong the life of the medical device reprocess immediately after use. If
they cannot be reprocessed immediately, use an enzymatic foam spray cleaner to help
prevent soil from drying.
5.4.4

INSTRUCTIONS FROM POINT OF USE

PREPARATION FOR DECONTAMINATION

Reprocess all instruments as soon as it is reasonably practical following use. Disassemble

only where intended, without the use of tools unless specifically provided by the
manufacturer. Where instructions for disassembly are required, these are available with the
device.

5.4.5 CLEANING:MANUAL
Manual cleaning is not advised if an automatic washer-disinfector is available. If the equipment
is not available, use the following process:
Use a double sink system (wash/rinse) dedicated for instrument cleaning (not used for
hand washing). Ensure that the water temperature does not exceed 35C.

In the first sink, keeping the instrument submerged, with an autoclavable brush, apply CE
marked cleaning solution to all surfaces until all soil has been removed. In the second sink,
rinse instruments thoroughly with soft, high purity water which is controlled for bacterial
endotoxins, so that the water reaches all parts of the instrument, then carefully hand dry or
use a drying cabinet.
5.4.6

CLEANING INSPECTION

After cleaning, visually inspect all surfaces, cannulations, ratchets, joints, holes and
lumens for complete removal of soil and fluids. If ANY soil or fluid is still visible, return the
instrument for repeat decontamination.
5.4.7

Apply surgical grade lubricant to hinges, joints and moving parts as per the lubricant
manufacturers instructions.
5.4.8

PACKAGING

All instruments to be packed following local protocol in accordance with ISO 11607-1 or
AAMI/CSR technique.
5.4.9

MAINTENANCE

STERILIZATION

Either CE marked or validated vacuum autoclave operating at 134-137C bar for a

minimum holding time of 3 minutes always following the instructions of the machine
manufacturer.
When sterilizing multiple instruments in one autoclave cycle, ensure that the steriliser
manufacturers stated maximum load is not exceeded.
5.4.10 STORAGE

Ensure instruments are dry before storage, and stored in dry, clean conditions at an
ambient room temperature.

6. CE marking routes:
For CE marking of the medical device i.e. reusable surgical scalpel, it should be classified first
which has been already done. After that conformity assessment route is chosen according to the
flowchart given below and since it is a manufacturer of sterile product (Is), it is mandatorily
applied to a notified body for certification of the aspects of manufacture related to sterility after
its technical documentations has been compiled. After the manufacturing has been satisfied and
the product meets all the relevant essential requirements, it is registered with the Competent
Authority (CA) and the affix of the CE marking on the product is given by Annex VII with
Annex IV, V or VI and is placed on the market. For the manufacture of this product and its CE
marking route, Annex VII is followed which prepares the technical documentations to support
declaration of conformity. Since our interest of manufacturing medical device falls under sterile
device, options of Annex IV, V or VI are there.

CLASS I MEDICAL DEVICES: CE MARKING ROUTES

Class I
Device

Annex VII: Prepare

Technical
documentation to
support declaration of

Yes
Class Is

Yes
Class Im
Follow Annex IV, V
or VI

Notified body
involvement required
to access conformity
with the metrological
requirements.

If a notified body has

been involved in the
assessment,
its
registration
number
must
appear
alongside
the
CE

Is the device
sterile?

Follow Annex IV, V

or VI

Does the device

have a measuring
function?
Compile
declaration of
conformity

Notified body
involvement required to
access aspects of
manufacture concerned
with securing and
maintaining sterile

Register with the

Competent Authority
(CA)

Affix CE mark
Retain declaration of
conformity & supporting
evidence for CA inspection

Market
device

Fig: CE routing of Class I medical Device

The route for CE marking includes following Annex VII and preparing technical documentation
for supporting the declaration of conformity.
It also includes if the device is sterile which in this case is true so it must follow Annex IV, V or
VI. Since Annex V gives the production quality assurance except the design so Annex V is ideal
for the company which notifies the involvement required to access the aspects of manufacture
concerned with securing and maintaining sterile conditions and its registration number alongside

the CE mark since its involvement with a notified body. The CE mark is then affixed which
retains the declaration of conformity and supporting evidence for CA inspection and finally
brought to the market.

7. Organizational design:
In order to regulate the manufacturing process of the medical device efficiently an organizational
design is mandatory. The main objective of manufacturing reusable surgical scalpel is to increase
the sales of this domestically manufactured device within Nepal, as this device has higher needs
in hospitals and clinics for assisting the medical personnel i.e. doctors and surgeons. In order to
achieve these goals effectively and efficiently, an organization should establish itself with well
managed departments directed towards objectives like manufacturing, research and development,
marketing, financing and so on. In the context of Nepal, the organization structure should be
decentralized in such a way that it appropriately mitigates the demand of the surgical scalpel in
different region of the country. The feasibility study of the devices showed that the consumption
is high in Kathmandu valley in comparison to the five development regions excluding
Kathmandu valley.
Looking at these facts, the best organizational design that helps the organization to meet its
goals, satisfy the product quality and marketing is geographical based approach.
The organizational structure is as follows:

Board of directors

CEO

Far-Western
Region

Mid-Western
Region

Western Region

Legal advisor

Central
Region(excluding

Eastern
Region

valley)

Kathmandu
valley

Manufacturing

Manufacturin
g

Manufacturin
g

Manufacturin
g

Manufacturin
g

Manufacturin
g

Marketing

Marketing

Marketing

Marketing

Marketing

Marketing

Account &finance

Account &finance

Account &finance

Account &finance

Account &finance

Account &finance

Research &
development

Research &
development

Research &
development

Research &
development

Research &
development

Research &
development

Fig: Chart showing the Organizational structure

Overseas sales & forces

Export
Department

The organization includes board of directors who will take care of the major decision regarding
the organizations plans and policies and modify it accordingly. The Chief Executive Officer i.e.
CEO will control and monitor the on-going activity of the organization and act accordingly and
seek guidance from the board of directors also a legal advisor will in the panel for suggesting and
guiding the manufacturing company. The organization will have its branch on Far Western
Region, Mid-Western Region, Western Region, Central Region, Eastern Region and on
Kathmandu Valley. Since the number of patient flow in the Kathmandu valley is large as there is
large number of hospitals and is the most centralized place, it should be considered separately.
There will be interlinked communication channel between the branch and the headquarter to
solve the problems encountered during the life of an organization, and an advisory board to
provide constant positive suggestions for the upliftment of the organization. If the feedback from
the market becomes good enough with the addition demand from outside the country the
organizational structure will be modified by adding the export department.

8. Conclusion
In order to manufacture and bring the Surgical Scalpel in the market, several standard rules and
protocols were followed. The work began with the study of need of the surgical scalpel in Nepal,
progressed with the classification of devices, collection of method and material for the
manufacture of the device followed by the CE marking route and establishment of an
organization to distribute and continue the manufacture of the device. Till date 20,000 surgical
scalpels have been placed in the market and the feedback is positive and some hospitals from
India, Bangladesh and Bhutan are interested with the scalpels we have manufactured. If they
demand our product, the organizational structure will be modified with addition of export
department and the device will also be continuously modified in order to meet different
challenges with the devices and the export will be extended to many countries overseas and
abroad.