SURGICAL INSTRUMENT

PURCHASE AND CARE

GUIDE
Guidance for purchasing and caring for surgical instruments
from ABHI’s Surgical Instruments Special Interest Section
Group
CONTENT THE PURPOSE OF THIS
S GUIDE
The Purpose Of This 2 This booklet is designed to help healthcare providers achieve
Guide
Understanding Quality the best whole life value for money in their purchasing decisions.
Buying The Right Instrument 3
Is A Collective Responsibility Surgical instruments are a critical The Association of British Healthcare
component of surgical procedures. Industries (ABHI) is the UK’s industry
Know Your Standards 4 It is important that purchasers are well association for the medical technology
Know Your Materials 5 informed, to ensure patient safety as sector. The companies we represent
well as best value. produce around 85% of the industry’s
Manufacturing Processes 6 total UK output.
This Guide is an educational and training
Common Features And 7 tool. It helps improve awareness and We promote the rapid adoption of medical
Terminology For understanding of how surgical instruments technologies in the UK and key global
Quality are made, the standards which apply to markets to maximise patient outcomes,
Instruments them and the quality of the instruments. and support ethical procurement.
8-9
Identifying Common By enabling effective procurement,
Instrument Features we hope to help healthcare providers achieve
Maintaining High Quality the best return on their investment, while
A Guide To Reprocessing 10-11 putting patients at the heart of decision-
Re-Usable Surgical making.
Instruments
Care And Maintenance 12-13
Tips
Ethical Supply 14 Quality is always top and non-negotiable
Lord Carter Health and Care Show, July 2016

2 ABHI
UNDERSTANDING QUALITY
BUYING THE RIGHT INSTRUMENT IS A COLLECTIVE
RESPONSIBILITY
Purchasing Surgical
CLEANING DISINFECTION
Instruments needs
to be a co-ordinated (New Prion
process with input Deactivation
Technology)
from the
appropriate health TRANSPORT
professionals before INSPECTION
(& Protein Testing)
and after purchase:

At all stages:
Location
Facilities
Equipment
USE Management
Policies
PACKAGING
/Procedures

The surgeon, theatre

staff, sterilisation and
decontamination teams
are all essential to
surgical instrument STORAGE
purchasing decisions. STERILIZATION
Their feedback is critical
in making the right Health Technical Memorandum 01-01: Management

decision. TRANSPORT and decontamination of surgical instruments (medical

devices) used in acute care (or as appropriate)

Surgical Instrument Purchase and Care Guide 3

UNDERSTANDING
QUALITY KNOW YOUR
STANDARDS
Surgical instruments are governed by a number of standards including, but not limited to:

Medical Devices Directive ISO 7153-1:2001

93/42/EEC BS 51994-1:1991 BS 5194-4:1985 ISO 13485

FFMDD – this Directive FFThe Standard for the FFFor the specifications FFRequirements for a quality
includes the essential composition of the of scissors, shears, management system,
requirements such as CE different materials and and other cutting where an organisation
marks to be followed by steel grades used. instruments. needs to demonstrate
manufacturers. its ability to provide
medical devices.

FF FF FF
BS 5194-4:1989 BS 5194-3:1995 CE Marking

FFFor the specifications FFFor the specifications of FFOn every device, look for a CE mark, the name of
of instruments with dissecting forceps. the manufacturer and a traceability code. Be aware
pivot points. that a CE mark is a sign of compliance with MDD
however and should not be taken as an automatic
sign of quality.

4 ABHI
UNDERSTANDING
QUALITY KNOW YOUR
MATERIALS
Most surgical instruments start life as
forgings or “blanks”. They are governed by Martensitic Grade B-420 S29 Martensitic Grade C or D-420 S45
two International Standards for material
specification: DIN 17442 and FFUsed for non-cutting instruments, FFUsed for cutting instruments,
DIN EN 10088-3 8/95. e.g. artery forceps e.g. scissors & gouges
Surgical instruments are mainly made from Hardness 40-48 HRC Hardness 50-58 HRC
two types of stainless steel: martensitic and Carbon content 0.16-0.25% Carbon content 0.35-0.45%
austenitic. Some are made from titanium. Chromium 12-14% Chromium 12-14%
The boxes on the right illustrate the types content content
of instrument materials.

FFMartensitic is magnetic and

contains up to 1% carbon Austenitic Grade 304 S15 Titanium
which allows the
instrument to be heat- FFUsed for instruments which do FFUsed for Ophthalmic &
treated not require hardening, e.g. Microsurgery instruments
FFAustenitic is the most dental
common type of stainless tweezers and holloware Ti-6Al-4V ELI or grade 23 titanium
steel and is highly Hardness 40-48 HRC
versatile Carbon content 0.07-0.15%
Chromium 16-19%
ISO 7153-1 has a full list of the suitable content Nickel 8-11%
grades of stainless steel available. content

Surgical Instrument Purchase and Care Guide 5

MANUFACTURI PROCESSE
NG S
1 2 3 4 5

INSPECTION,
MARKING
AND
MACHININ HARDENIN TRACEABILI
FITTING FINISHING
G G TY
the market, instruments
AND AND
ASSEMBLY POLISHING Before being placed on
Metal cutters mill the Before instruments for their functional
forgings to create a The various parts of are machined, they The hardening process and
should be inspected
box joint, serrations, an instrument are held are annealed to soften creates a black oxide A CE mark,
teeth, with screws and them, prolonging layer which must be the
cosmetic qualities.
or racks. This is a rivets. Using a series the life of the cutters removed. This is done and a traceability code
critical stage in ensuring of grindstones and and helping form the by either rumbling the manufacturer’s name,
the functionality of a lathes, the instrument instrument correctly. instruments or
device and making sure is fashioned to the Then they’re polishing and glazing on every device.
manufacturer’s name
that it will perform as correct size, weight re-hardened, often them to a fine finish.
the surgeon expects. and dimensions of using a vacuum Although the
not a requirement of the
the intended pattern. hardening process.
marked on a device is

Medical Devices
Directive, we feel that this
is the
best way to ensure that the
product guarantee can be
maintained and enforced.
6 ABHI
COMMON FEATURES ANDTERMINOLOGY FOR
QUALITY INSTRUMENTS

There are a huge variety of features SERRATION

which S
appear on reusable surgical instruments.
Here are a few common features and
what to look for in a quality item:
FFTeeth and prongs should be sharp
and mesh exactly when jaws close BOX JOINT
FFSerrations on both jaws should be
identically shaped and mesh exactly JAWS
FFWhen pressure is released, the teeth,
prongs, and serrations should part RATCHETS
freely without catching
FFNo slippage in Needleholder jaws
FFShould mate accurately when engaged
FFShould be symmetrical to achieve a positive lock that will
FFRectangular section should give not become disengaged in use
maximum strength to the joint FFRatchet steps should not impair
FFShould avoid unnecessary gaps strength of the shanks
FFUse of countersink prevents rivet FFRatchet thickness should be the same
from moving as the shank
FFJoint should move smoothly, FFAngles should be uniform
not too tight, not too loose FFLeading surfaces should be flat for
FFIt should be possible to open and a smooth and gradual ride
close the joint easily with 2 fingers

FINGER SHANK
BOWS

Surgical Instrument Purchase and Care Guide 7

IDENTIFYING COMMON INSTRUMENT FEATURE
& WHERE THEY MAY BE SEEN S

Box Joint Screw Joint Ratchet

Found on: Found on: FFMayo Found on:
FFSpencer Wells artery forceps scissors FFMetzenbaum F FNorfolk and Norwich retractors
FFHalstead Mosquisto artery forceps scissors FFMcIndoe
F FTravers retractors
FFCrile artery forceps scissors F FWest and Weitlander
FFStevens scissors retractors

Teeth Rack Scissor Blades

Found on: Found on: Found on:
F FLittlewoods tissue forceps F FMayo-Hegar FFMayo scissors
F FAllis tissue tissue forceps needle holder FFMetzenbaum scissors
F FLanes tissue forceps F FSpencer Wells F FDressing scissors scissors
artery forceps

8 ABHI
Lumen Finish Tungsten Carbide Tips
Found on: FFBright polished or satin Found on:
FF American, Adson, Magill finished steel
F FNeedle holders for durability
& Zoellner suction tubes

Serrations Atraumatic Teeth Bows

Found on:
Found on: Found on:
FFArtery forceps F FDebakey clamps and forceps F FScissors,
F FDerra & Cooley vascular clamps needle holders
& artery forceps

Surgical Instrument Purchase and Care Guide 9

MAINTAINING HIGH QUALITY
A GUIDE TO REPROCESSING RE-USABLE SURGICA INSTRUMENT
L S
To prepare for Automated Cleaning
decontamination, reprocess Use CE marked or validated
all instruments as soon as washer-disinfector machines and
practicable following use. low-foaming, non-ionising
Disassemble only where cleaning agents and detergents.
intended, without the use Follow the manufacturers’
of tools, unless specifically instructions for use, warnings,
made available with the concentrations, and recommended
instrument and provided by cycles.
the manufacturer. FFLoad instruments carefully, with box
FFjoints and hinges open, and so that
Place heavy instruments with care in
any fenestrations can drain.
the bottom of containers. Do not
FROM POINT OF PREPARATIO CLEANIN overload wash baskets.
USE N G FFPlace instruments with concave
surfaces facing down to prevent
pooling of water.
Wherever possible, do not FFUse appropriate attachments to flush
allow blood, debris or in side reamers, and devices with
bodily fluids to dry on lumens or cannula.
instruments. To prolong their FFEnsure that soft, high purity water which is
life, reprocess immediately controlled for bacterial endotoxins is
after use. If that’s not used in the final rinse stage.
possible, use an enzymatic
Note Automated Cleaning may not be suitable for
foam all lumens and cannula, in which case clean
spray to help prevent manually with a water jet gun, if available, and an
soil from drying. appropriate brush and /or stilette that reaches the
depth of the feature.
After manually cleaning, pass all devices through
an automatic cleaning cycle to achieve disinfection.

10 ABHI
 IMPORTANT NOTE: This is not comprehensive. For a full, validated reprocessing guide,
speak to your instrument supplier and follow current MHRA guidelines for reprocessing
instruments.

Ensure that instruments are dry before sterilisation.

Always follow the instructions of the machine
manufacturer. Use a CE marked or validated vacuum
autoclave operating at 134-137oc
2.25 bar for 3 minutes minimum holding time.

When sterilising multiple instruments in one cycle,

always make sure that the stated maximum load is
not exceeded.

INSPECTIO PACKAGING & STORAG

N STERILISATION E

After cleaning, visually inspect all All instruments to be

packed following local
FFSurfaces FFRatchets
protocol in accordance
FFCannulations FFHoles with BS standards.
FFJoints
Lumens for complete removal of soil
and fluids. If any soil or fluid is still
visible, return the instrument for
repeat decontamination.

Surgical Instrument Purchase and Care Guide 11

MAINTAINING HIGH QUALITY
CARE & MAINTENANCE TIPS
For full guidance see www.a-k-i.org ‘Red
Brochure’
BROKEN/CRACKED BOX JOINTS DISCOLOURATION
Tension stress Water spots Yellow brown to dark
Cause Heating and Light coloured, often with brown spots
cooling in sharply defined edges
sterilisation Cause Final rinse or Cause Debris has dried
on the device
process sterilisation water
Solution Close instrument supply contains or hasn’t been
before cleaning
to first notc h only high concentratio n
during sterilisation of minerals removed due to
poorly performing detergents
Solution Use demineralised water in Solution Remove by thoroughly scrubbing
Forced stress final rinse, and pure steam with a good detergent, otherwise
Cause Overloading in sterilisation corrosive pitting will occur
instruments
Solution Ensure corr Oxidisation spots O
device and ect
attachment Light coloured, without Other causes of discolouration
harply defined edges
being used is s
NB: Also sut
C
ause Final rinse or FFInsufficient rinsing off
ures and needle holders sterilisation water
supply contains detergents and disinfectants
General stress
FFChlorides
Cause Build up of blood high concentratio n FFWater droplets slowly
of heavy metal ions and/or silicates
and debris in
box joint Solution Use demineralised water in final condensing on instruments
rinse, and pure steam during sterilisation
Solution Ensure
instruments are
in sterilisation FFInferior detergent
cleaned in open position during washing
and disinfection

12 ABHI
 CORROSIO
N The Red Brochure
Pitting corrosion Contaminated steam
Cause 1 Excessive chloride corrosion The Instrument Reprocessing
concentrations Rusty steam in
Solution Use demineralised
Cause
Working Group was set up in
sterilisation pro
cess 1976. They have produced a
water Solution Regular validation
and maintenan ce Surgical Instrument guidance
Cause 2 Prolonged exposure
to saline solutions (blood, debris decontaminatio of document for the past 40
or contaminated disinfectant or n years. This provides exhaustive
detergent) where bacterial activity Surface corrosion equi
pme
guidance on all aspects of
creates acidic residue Cause Damage to surgical instrument care and
Solution Clean instruments as soon as passivation layer possiblent
after use Solution Avoid use of strong best practice. www.a-k-i.org
acid, alkaline or
Abrasion corrosion caustic solutions
Treatment
titan aluminum carbonitride
yellow zirconium nitride

components.
(TiAlCN) la yers as
(ZrN) and titanium
well as originally
nitride (TiN ) coa
goldish-
ted products/

NB: Aluminium is particularly susceptible

recommendation
As a result of r epai r,
s recoat.

Cause Build up of debris Preventive measures

Risk assessment
Use only neutral

70 °C when using
or mild-alkaline
cleane r. Do not exceed
alkaline cleaners.
a t emperature
of

stops devices ment

Reduced wearing

Instruroc
properties and in
creased reflection.
Note: Because of the
extremely strong
cleaning ef fect of such
cleaning programs special
the friction su rfaces
of metal instruments
oiled following each must
step of cleanin g. Otherwise be
there is a high

essing
"metal pitting" or friction

Spreading corrosion
risk of
corrosion.

Rep
from opening and Reprocessing of of surface change
Type
12.7 Metal/Corrosion
– Pitting

Instruments causing
Value
operating smoothly, Cause Instruments to Retain

destruction sterilised with of passivation

Scissors with pitting
Example of pitting
Ex amp le of pitting

layer at joints already rusty Example of pitting

pitting Example of
Example of pitting

and crevices devices - rust is of

Solution Ensure instruments are cleaned in transferred through open

- seen under a scanning
P Pitting on tweezers.
i tron microscope - magnified
t
t harmful substances Cause: Over-aging of color
i times containing chloride -co d ing b an d allow s
n to inf iltr ate.
g
e
l
e
c

the detergent
200

position & lubricate regularly

etain Value , 10th anniversary
edition 2016, ww
w.a -k-i.org
69

Reprocessing of Instrumen
ts to R

solutions 10
Solution Separate rusty devices from
Working Group
sing
Instrument Reproces

“healthy” ones

Surgical Instrument Purchase and Care Guide 13

ETHICAL
SUPPLY
ABHI Code of Business Practice
Ethical Manufacturing & the NHS Supply At ABHI, we place ethical compliance at the
Chain’s Labour Standards Assurance heart of the medical technology industry.
Healthcare professionals and patients must feel
System (LSAS) they can be confident in our ethical standards
ABHI has its own code of business practice and we support at all times, so they can work with us to
the ethical sourcing of products. The Surgical Instruments SIS improve the innovations we develop.
Group worked with NHS Supply Chain as part of the
2012 (and pending 2017) Surgical Instruments Framework We have been working hard for several years
Agreement to launch its Labour Standards Assurance System. to help member and other companies reach the
highest standards – both as organisations and as
LSAS is a matrix of ethical requirements designed by NHS individuals at all levels.
Supply Chain and the Department of Health, through which It is a condition of ABHI membership that a
suppliers are audited and assessed by a third party notified company adheres to the ethical standards in the
body. The responsibility is with the supplier to ensure there is
ABHI Code of Business Practice. The Code
continual progress and regular risk assessment and review, to
stipulates minimum standards for members’
mitigate potential ethical and labour risks in the supply chain.
business practices in the UK, Europe and
elsewhere.
This has been embedded since 2012 and many of our
members have improved to obtain level 2 and 3 on FFMore information can be found at
the framework. www.abhicodeofpractice.org.uk

ABHI is commited to promoting good ethical practice amongst

members, we see this as integral and essential for improving
labour standards in both single use and reusable surgery
instrument manufacturing.

14 ABHI
This document has been produced
by members of the ABHI Surgical
ARAB HEALTH
Instruments Special Interest Section.
 ABHI Member details

Association of British Healthcare Industries

107 Gray’s Inn Rd, London WC1X 8TZ
Tel: +44 (0)20 7960 4360 Fax: +44 (0)20 7960 4361
[email protected] www.abhi.org.uk
@UK_ABHI

Version 1