Manufacturing of Surgical Scalpel project

Classification and design of a Manufacturing company for fo r a medical device (Surgical Scalpel) College of Biomedical Engineering and applied sciences

Submitted by: Pranav Upadhyaya Upadhyay a B!" #th Semester

Submitted to: Er Saurav Sharma

$able 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............................................................................................................................

5.4

!eneral Instruction for "eprocessing of "eusa#le Surgical Scalpel............................................$

5.4.1

%arnings..............................................................................................................................$

5.4.2

&IMI'A'I()S () "*+"(C*SSI)!................................................................................$

5.4.3

I)S'",C'I()S -"(M +(I)' (- ,S*..........................................................................$

5.4.4

+"*+A"A'I() -(" D*C()'AMI)A'I()...................................................................$

5.4.5

C&*A)I)!: MA),A&......................................................................................................$

5.4.

C&*A)I)! I)S+*C'I().................................................................................................$

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5.4.

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S'*"I&IA'I()................................................................................................................

5.4.1

S'("A!*........................................................................................................................... 

.

C* maring routes:.............................................................................................................................. 

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(rganiational design:....................................................................................................................... 1

.

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

! %ntroduction 'e demand for precision surgical nives is en ormous. Considering use in cataract surger6 alone7 te re8uirements are staggering. (ver 1 million cataract surgeries are performed eac 6ear  9orld9ide and te num#ers are epected to increase dramaticall6 as te 9orld population over   6ears of age increases rapidl6 over te net 2;3 decades <1=. +eraps more significantl67 man6 are suffering reduced 8ualit6 of life in going 9itout tis important surger6 due to its cost <2=. An important part of tis surger6 is te availa#ilit6 of afforda#le precision surgical nives to perform corneal incisions. It as #een so9n tat smaller incisions 9it iger 8ualit6 #lades create sorter eal times7 less trauma and smaller cances of surgical complications. An economicall6;via#le alternative material for precision surgical nives sould satisf6 te follo9ing four criteria: 1> it sould ave a ig ardness so tat te integrit6 of te #lade edge is maintained? 2> te grain sie of te material sould #e suc tat te desired edge radius can #e o#tained? 3> te manufacturing costs involved in maing #lades of various sapes7 sies and edge radii ave to #e suc tat it provides a compelling cost #enefit over te 3 use of diamond nives? 4> te material sould #e #io;compati#le. Surgical scalpel is most commonl6 used #6 surgeons. A surgical scalpel is a small and etremel6 sarp #laded instrument used for surger67 anatomic dissection7 and various medical purposes. Scalpels ma6 #e single;use disposa#le or re;usa#le. "e;usa#le scalpels can ave attaced resarpen; a#le #lades or7 more commonl67 non;attaced7 replacea#le #lades. Disposa#le scalpels usuall6 ave a plastic andle 9it an etensive #lade and are used once7 ten te entire instrument is discarded. 'e purpose of te scalpel @eiter re;usa#le or disposa#le> is for carr6ing out te surgical dissections #6 te surgeons. It is te most common device 9ic is used for surgical procedures and ence as a ig demand in te medical industr6. Scalpel #lades are made up of stainless steel7 titanium7 ig car#on steel7 ceramic7 diamond etc. -or eample : for performing surger6 under M"I guidance7 Stainless steel are unaccepta#le cause it ma6 produce artifacts so use of  oter material scalpels are preferred.

" Surgical Scalpel: & medical device An Instrument7 apparatus7 implement7 macine7 contrivance7 in vitro reagent7 or oter similar  related article7 including an6 component7 part or accessor67 9ic is intended for use in te diagnosis of disease or oter conditions7 or in te cure7 mitigation7 treatment or prevention of  disease in man or intended to affect te structure or an6 function of te #od6 of man or oter  animals7 and 9ic does not acieve its primar6 intended purposes troug cemical action 9itin or on te #od6 of man or oter animals and 9ic is not dependent upon #eing meta#olied for te acievement of its primar6 intended purposes. Surgical Scalpel is tus a medical device intended for assisting te surgeons for carr6ing out anatomical dissections during surger6 9ic does not acieve its intended action on te uman  #od6 #6 parmacological7 immunological or meta#olic means7 #ut 9ic ma6 #e assisted in its function #6 suc means.

' Classification of Surgical Scalpel -or manufacturing a medical device it must #e classified. In order to define te class of te medical device various criteria are to #e looed upon for regulating te device for its correct class and its C* maring procedures. 'e device classification can #e done #6 te classification rules of a medical device in *uropean Council Directive 0342**C on medical device7 Anne IB7 su#section 1. 'e first ting tat is to #e looed upon is te duration of contact of te device 9eter it is sort term of long term. 'e device 9ic is intended for manufacture i.e. surgical scalpel falls under  transient use normall6 intended for continuous use for less tan  minutes. 'e second ting 9ic comes under te invasive device falls in surgical invasive device as it penetrates inside te  #od6 troug te surface or #od6. As te device 9ic is intended for manufacture is a reusa#le t6pe surgical scalpel andle and #lade 7 it is intended for surgical use #6 cutting 9itout connection to an6 active medical device and 9ic can #e reused after appropriate procedures ave #een carried out7 it falls in reusa#le surgical instrument. According to *uropean Council Directive 0342**C on medical device "ule num#er 7 su#section 27 Anne IB7 all surgicall6 invasive devices intended for transient use are in class IIa unless te6 are reusa#le surgical instruments 7 in 9ic case te6 a re in class I. 'e flo9cart so9ing te classification of te medical device is so9n as follo9s? "ule  Surgicall6 Invasive   'ransient ,se

IIa

Specificall6 to controlcorrect defect of te eart or central circulator6 s6stem troug direct contact.

For use in direct contact with central nervous

Reusabl e surgical  I

Supply energy/ionizati on radiation. IIb

Biological efectmainly or wholly absorbed.

Intended to administer medicine in a potentially

IIb

III III

ig: lochart shoing *ule + for the classification of medical device

IIb

As a manufacturer compan67 it as #een confirmed tat te reusa#le surgical scalpel #lade falls in class I medical device. Since it is a surgicall6 invasive device 9ic is used for anatomical dissection in surger6 intended for transient use.

, Manufacturing process: 'e materials used mainl6 in surgical scalpel are primaril6 stainless steel7 ig car#on steel or  ceramic7 diamond etc. Also te materials use in scalpel andles is primaril6 made of stainless steel. 'o manufacture te scalpel #lades and te andle from scratc7 strips of stainless steel is  passed troug a press 9ic cuts te #lunt pieces of #lades and its punced out te unfinised  #lades. Elades 9ill var6 9it sie and contour #ut te6 all ave te centre slot for attacing te andle. 'e unfinised #lades or #lans are flei#le and #end easil6 so to mae tem fied and ard7 te6 are passed troug a furnace 9ic alters te molecular structure of te metal ardening it. After eating te #lans7 te6 ave te flei#ilit6 a scalpel #lade re8uires. 'e  #lans are staced on a peg. 'en te #lans are treaded on a metal ring and are passed for  surface polising 9ic 9ill restore te sining of te metal 9ic 9as dulled #6 eat treatment. 'e #lans are ten transferred from ring to a metal rod suing gaue to measure te rigt num#er  and ten mounted on a grinding macine in 9ic eac one of te #lade is piced up #6 a magnet in a older tat runs it troug te 9eel coated #6 diamond particles. 'is po9erful a#rasive sapes and sarpens a cutting angle transforming te #lan into te #lade. 'e #lades are ten demagnetied and 9ased in an ultrasonic cleaning tan te #lades are inspected and scrutinied discarding te imperfect #lades and are paced 9it anticorrosion cemical and la#eled 9it #lade model num#er and tracing code and 8ualit6 ceced lastl6 and is #oed for  maret. It is critical for te #lades to #e sterile so it is passed to a co#alt radiation cam#er for  ours 9ic o#literates an6 lingering contaminants. 'e Elade andle are made similarl6 9it stainless steel mould poured into a cam#er 9ic gives te andle te desired sape and  processed according to its design and sterilied and paced.

- .evice .escription

5.1 Manufacturer: CareF Instruments limited

-" .evice name: Care Surgical Scalpel Intended to #e used in carr6ing out surgical procedures. • Intended for various t6pe of cutting and dissection of te #od6 in accordance 9it te • •

 #od6 part and procedure to #e follo9ed. Intended to fit various t6pes of surgical #lades and #e reused.

-' .evice detail:

Scalpel #lades provide 9it an accurate and stead6 dissection procedures and includes various design and ranges i.e. #lades num#er 17 1A7 117 117 127 15 and 15S 9ic fits on all num#er 3 fitment andles and #lades num#er 17 107 27 217 227 22A7 237 247 25 and 3 fits on all num#er 4 fitment andles. 'e CareF scalpel #lades comes in 1 8uantit6 and are made up of stainless steel and car#on steel 9it satin finis or mirror finis upon re8uest paced in Care 'M   #randed sterile pouces. 'e CareF scalpel andle correctl6 fits to standard surgical #lades. 'e distal ends are tapered and #eveled for use in #lunt dissection. *ac andle is contoured for firm grip7 strengt7 manipulation and comfort. 'e6 are sold one andle eac per pacage. 'e CareF reusa#le scalpel andle is manufactured from te finest !erman surgical instrument grade stainless steel. 'e CareF reusa#le scalpel andle is supplied in a sterile condition and must #e cleaned and sterilied prior to reuse in accordance 9it te processing instructions descri#ed in tis document and in compliance 9it local7 state and national ealt G safet6 regulations. 'is 9ill ensure tat te CareF scalpel andle is processed safel6 and continues to meet its performance specification. 'e CareF reusa#le scalpel andle is late free. It is mared 9it a uni8ue serial num#er for identification and tracea#ilit6. *ac #lade is individuall6 paced in aluminium foil. Car#on Steel #lades are H+I paper   protected. Elades sies are clearl6 identified on te reverse side of te foil peel;pac and #6 a colour coded sticer on unit #oes and are supplied sterile in unit dispenser #oes of 1. All sterile products are sterilied #6 !amma radiation and all products carr6 te C* mar as per te *uropean Medical Device Directive 0342**C. 5.3.1

Composition:

Elades are made of car#on and stainless steel as te composition given in te ta#les # elo9: Car#on Steel "ef. ES 202: 1002 "ange  @mm> Car#on .  .$  Silicon .5 maimum Manganese 1.  ma. Cromium 12.  13.5  Sulpur .25  maimum +osporous .3  maimum  )icel .5 maimum

Stainless steel "ef. 5104: 1001 "ange  @mm> Car#on 1.2  1.3  Silicon .1  .35  Manganese .2  .45 Cromium .1  .4 Sulpur .25 maimum +osporous .35 maimum

ig: $able shoing the compositions of materials for manufacture

-, General Instruction for Reprocessing of Reusable Surgical

Scalpel 'e follo9ing instructions are for all reusa#le surgical instruments supplied #6 Care Instruments &imited7 unless stated oter9ise 9it te pacaging of te product. 'ese instructions are intended for use onl6 #6 person 9it te re8uired specialist no9ledge and training. -,! •

• •

• • •

-ollo9 instructions and 9arnings as issued #6 te manufacturers of an6 decontaminants7 disinfectants and cleaning agents. %erever possi#le avoid use of mineral acids and ars7 a#rasive agents.  )o part of te process sall eceed 14JC. Some sensitive materials @e.g. Aluminium> are damaged #6 ig alaline solutions @pKL1>. -," 0%M%$&$%12S 12 *EP*1CESS%23 "epeated processing as minimal effect on tese instruments. *nd of life is normall6 determined #6 9ear and damage in use. An6 specific limitations on te num#er of reprocessing c6cles sall #e made availa#le 9it te instrument. -,'

•

%2S$*UC$%12S *1M P1%2$ 1 USE

%erever possi#le7 do not allo9 #lood7 de#ris or #odil6 fluids to dr6 on instruments. -or   #est results and to prolong te life of te medical device reprocess immediatel6 after use. If  te6 cannot #e reprocessed immediatel67 use an en6matic foam spra6 cleaner to elp  prevent soil from dr6ing. -,,

•

/arnings

P*EP&*&$%12 1* .EC12$&M%2&$%12

"eprocess all instruments as soon as it is reasona#l6 practical follo9ing use. Disassem#le onl6 9ere intended7 9itout te use of tools unless specificall6 provided #6 te manufacturer. %ere instructions for disassem#l6 are re8uired7 tese are availa#le 9it te device.

-,- C0E&2%23:M&2U&0 Manual cleaning is not advised if an automatic 9aser;disinfector is availa#le. If te e8uipment is not availa#le7 use te follo9ing process:; ,se a dou#le sin s6stem @9asrinse> dedicated for instrument cleaning @not used for  • and 9asing>. *nsure tat te 9ater temperature does not eceed 35JC. In te first sin7 eeping te instrument su#merged7 9it an autoclava#le #rus7 appl6 C* • mared cleaning solution to all surfaces until all soil as #een removed. In te second sin7 rinse instruments torougl6 9it soft7 ig purit6 9ater 9ic is controlled for #acterial endotoins7 so tat te 9ater reaces all parts of te instrument7 ten carefull6 and dr6 or  use a dr6ing ca#inet. -,+

C0E&2%23 %2SPEC$%12

•

After cleaning7 visuall6 inspect all surfaces7 cannulations7 ratcets7 oints7 oles and lumens for complete removal of soil and fluids. If A)N soil or fluid is still visi#le7 return te instrument for repeat decontamination. -,4

•

Appl6 surgical grade lu#ricant to inges7 oints and moving parts as per te lu#ricant manufacturers instructions. -,#

•

•

P&C5&3%23

All instruments to #e paced follo9ing local protocol in accordance 9it IS( 11$;1 or  AAMICS" tecni8ue. -,6

•

M&%2$E2&2CE

S$E*%0%7&$%12

*iter C* mared or validated vacuum autoclave operating at 134;13$JC #ar for a minimum olding time of 3 minutes  al9a6s follo9ing te instructions of te macine manufacturer. %en steriliing multiple instruments in one autoclave c6cle7 ensure tat te steriliser  manufacturers stated maimum load is not eceeded. -,!8 S$1*&3E

•

*nsure instruments are dr6 #efore storage7 and stored in dr67 clean conditions at an am#ient room temperature.

+ CE mar9ing routes: -or C* maring of te medical device i.e. reusa#le surgical scalpel7 it sould #e classified first 9ic as #een alread6 done. After tat conformit6 assessment route is cosen according to te flo9cart given #elo9 and since it is a manufacturer of sterile product @Is>7 it is mandatoril6 applied to a notified #od6 for certification of te aspects of manufacture related to sterilit6 after  its tecnical documentations as #een compiled. After te manufacturing as #een satisfied and te product meets all te relevant essential re8uirements7 it is registered 9it te Competent Autorit6 @CA> and te affi of te C* maring on te product is given #6 Anne HII 9it Anne IH7 H or HI and is placed on te maret. -or te manufacture of tis product and its C* maring route7 Anne HII is follo9ed 9ic prepares te tecnical documentations to support declaration of conformit6. Since our interest of manufacturing medical device falls under sterile device7 options of Anne IH7 H or HI are tere.

C0&SS % ME.%C&0 .E%CES: CE M&*5%23 *1U$ES

Class I

nne! "II# $repare  %echnical documentation to

Nes Class Is Is the device

Follow nne! I"( "

Nes Class Im Follow nne! I"( "

*oti+ed body involvement re,uired to access con&ormity with the metrological

I& a noti+ed body has been involved in the assessment( its registration number must appear

'oes the device have a measuring

ompile declaration o& 

*oti+ed body involvement re,uired to access aspects o&  manu&acture concerned with securing and

Register with the ompetent uthority

!  mar0 Retain declaration o&  con&ormity 1 supporting evidence &or  inspection

2ar0et

ig: CE routing of Class % medical .evice

'e route for C* maring includes follo9ing Anne HII and preparing tecnical documentation for supporting te declaration of conformit6. It also includes if te device is sterile 9ic in tis case is true so it must follo9 Anne IH7 H or  HI. Since Anne H gives te production 8ualit6 assurance ecept te design so Anne H is ideal for te compan6 9ic notifies te involvement re8uired to access te aspects of manufacture concerned 9it securing and maintaining sterile conditions and its registration num#er alongside

te C* mar since its involvement 9it a notified #od6. 'e C* mar is ten affied 9ic retains te declaration of conformit6 and supporting evidence for CA inspection and finall6  #rougt to te maret.

4 1rgani;ational design: In order to regulate te manufacturing process of te medical device efficientl6 an organiational design is mandator6. 'e main o#ective of manufacturing reusa#le surgical scalpel is to increase te sales of tis domesticall6 manufactured device 9itin )epal7 as tis device as iger needs in ospitals and clinics for assisting te medical personnel i.e. doctors and surgeons. In order to acieve tese goals effectivel6 and efficientl67 an organiation sould esta#lis itself 9it 9ell managed departments directed to9ards o#ectives lie manufacturing7 researc and development7 mareting7 financing and so on. In te contet of )epal7 te organiation structure sould #e decentralied in suc a 9a6 tat it appropriatel6 mitigates te demand of te surgical scalpel in different region of te countr6. 'e feasi#ilit6 stud6 of te devices so9ed tat te consumption is ig in /atmandu valle6 in comparison to te five development regions ecluding /atmandu valle6. &ooing at tese facts7 te #est organiational design tat elps te organiation to meet its goals7 satisf6 te product 8ualit6 and mareting is geograpical #ased approac. 'e organiational structure is as follo9s:

Eoard of directors

C*(

-ar;%estern "egion

Mid;%estern "egion

%estern "egion

&egal advisor 

Central "egion@ecluding

*astern "egion

valle6>

/atmandu valle6

Manufacturing

2anu&acturin

2anu&acturin

2anu&acturin

2anu&acturin

2anu&acturin

Mareting

Mareting

Mareting

Mareting

Mareting

Mareting

Account Gfinance

Account Gfinance

Account Gfinance

Account Gfinance

Account Gfinance

Account Gfinance

"esearc G development

"esearc G development

"esearc G development

"esearc G development

"esearc G development

"esearc G development

ig: Chart shoing the 1rgani;ational structure (verseas sales G forces

!port

'e organiation includes #oard of directors 9o 9ill tae care of te maor decision regarding te organiations plans and policies and modif6 it accordingl6. 'e Cief *ecutive (fficer i.e. C*( 9ill control and monitor te on;going activit6 of te organiation and act accordingl6 and see guidance from te #oard of directors also a legal advisor 9ill in te panel for suggesting and guiding te manufacturing compan6. 'e organiation 9ill ave its #ranc on -ar %estern "egion7 Mid;%estern "egion7 %estern "egion7 Central "egion7 *astern "egion and on /atmandu Halle6. Since te num#er of patient flo9 in te /atmandu valle6 is large as tere is large num#er of ospitals and is te most centralied place7 it sould #e considered separatel6. 'ere 9ill #e interlined communication cannel #et9een te #ranc and te ead8uarter to solve te pro#lems encountered during te life of an organiation7 and an advisor6 #oard to  provide constant positive suggestions for te upliftment of te organiation. If te feed#ac from te maret #ecomes good enoug 9it te addition demand from outside te countr6 te organiational structure 9ill #e modified #6 adding te eport department.

# Conclusion In order to manufacture and #ring te Surgical Scalpel in te maret7 several standard rules and  protocols 9ere follo9ed. 'e 9or #egan 9it te stud6 of need of te surgical scalpel in )epal7  progressed 9it te classification of devices7 collection of metod and material for te manufacture of te device follo9ed #6 te C* maring route and esta#lisment of an organiation to distri#ute and continue te manufacture of te device. 'ill date 27 surgical scalpels ave #een placed in te maret and te feed#ac is positive and some ospitals from India7 Eanglades and Eutan are interested 9it te scalpels 9e ave manufactured. If te6 demand our product7 te organiational structure 9ill #e modified 9it addition of eport department and te device 9ill also #e continuousl6 modified in order to meet different callenges 9it te devices and te eport 9ill #e etended to man6 countries overseas and a#road.