CLINICAL PROTOCOL - Halton and St Helens PCT

CLINICAL PROTOCOL
For use in:
Target Audience:
Purpose
Document Author:
Approved by:
Ratified by:
Policy Index No:
Sterile Instrument Pack Protocol
Version Number: 1.0
PCT-wide
All Trust Podiatry Staff
To set the standard for use and handling of
sterile reusable instrument packs used by the
Halton Podiatry Service
Julie Griffiths
Clinical Polices Guidelines Group or Equivalent
Policy Sub-Committee (PSC)
HStHCL223
Effective From: December 2009
Review Date: December 2012
Statutory and legal requirements
Implementation Lead
Implementation Process
Standards for Better Health/Code of Practice
for the Prevention and Control of Health Care
Associated Infections. Protocol based on
recommendations from the NHS Litigation
Authority
Head of Podiatry
Refer to attached dissemination plan
The Trust is committed to creating an environment that promotes equality and embraces
diversity, both within our workforce and in service delivery. This document should be
implemented with due regard to this commitment
This document seeks to uphold the duties and principles contained within the Human Rights
Act. All Staff within the PCT should be aware of its implications
This protocol is due for review by December 2012. After this date, this protocol and associated
process documents may become invalid. All users should ensure that they are consulting the
current version of this document.
Page 1 of 15

Key individuals involved in developing the document (Internal Staff Only)
Name(s)
Designation
Julie Griffiths
Andrew Lythgoe
Podiatry Manager
Podiatry Team Leader
Distributed to the following for approvals and comments
Committee(s)
Members of the Policy Sub Committee (PSC)
Members of the Clinical Policies Guidelines
Group (CPG)
All Members of Halton Podiatry Team
Page 2 of 15

Table of Contents
Rationale......................................................................................................................................4
Protocol Steps..............................................................................................................................5
References.................................................................................................................................10
Appendix 1 .................................................................................................................................11
Appendix 2 .................................................................................................................................12
Appendix 3 .................................................................................................................................13
Appendix 4 .................................................................................................................................14
Page 3 of 15

RATIONALE
The rationale of this protocol is to document the Podiatry department’s procedure for the
handling of podiatry instruments to ensure that all reasonable steps are taken to reduce the risk
of cross infection during podiatry treatment through contact with podiatry instruments.
This protocol should be read in conjunction with the Trust’s Policy Prevention and Management
of Occupational Health Exposure to BBV and Prevention of Sharps Injuries, on the Document
Portal, and Infection Prevention and Control Policy No.27 Aseptic Technique
The Podiatry Department uses both reusable and disposable instruments in order to carry out
podiatry treatments.
The Countess of Chester Hospital (COCH) decontaminates the department’s reusable
instruments to the standard HTM2010.
Decontaminated reusable instruments are supplied as sets of multiple instruments and single
instruments (Refer to Appendix 1) in sterile packaging.
Disposable instruments are supplied as individual instruments in sterile packaging.
The majority of podiatry treatments will be undertaken using a basic pack of reusable
instruments. However at times it will be clinically appropriate to supplement these packs from
the range of single wrapped reusable and disposable instruments.
For nail surgery and local anaesthetic procedures separate packs are available.
All podiatry treatments must be carried out using authorised podiatry instruments as supplied in
their sterile state.
No other instrumentation may be used than those authorised and supplied by the department.
It is each individual staff member’s responsibility to ensure that they fully follow this protocol.
All new podiatry staff as part of their induction will be given training on this protocol.
Page 4 of 15

PROTOCOL STEPS
Steps
1. Storage of instruments
Reusable instruments are transported to and from COCH in bespoke (Blue) transportation
boxes.
Fast transport will deliver processed clean instruments and remove dirty instruments from
each podiatry site, on a 48 hour turnaround.
Clean instruments must be stored separately from dirty instruments. Areas have been
designated for the segregated storage of clean and dirty instruments at each podiatry site
Clean disposable instruments, must be stored in the designated clean areas.
Podiatry staff whilst undertaking domiciliary visits should store clean and dirty instrument
sets separately. A carried bag inside a second carry bag is sufficient to keep dirty
instrument sets separate from the podiatrist’s / podiatry assistants visiting bag and clean
instrument sets.
2. Checking Supplies
The Black tie should be removed with a pair of scissors. Podiatry staff should then check
the boxes’ contents against the delivery note, which is inside each box of clean
instruments.
If there are any discrepancies between the delivery note and the box contents, these
should be noted on the delivery note, the note then photocopied prior to storing it in the
file. The photocopy of the delivery note should then be forwarded to the line manager for
monitoring.
Clean packs of instruments should be transferred to the treatment area as required.
3. Use of Instruments
Examining the Packaging
Reusable instruments
The podiatrist / podiatry assistant should ensure that they select the appropriate
instrumentation prior to commencing treatment. The packaging should be examined to
ensure that it is intact.
Any instruments sets with damaged packaging must not be used. The contents list should
be removed from the packaging and note made to describe the way in which the
packaging is damaged. The contents list should be signed and returned to the packaging.
The set should then be returned to the processing company as a dirty set
Page 5 of 15

Disposable instruments
The podiatrist / podiatry assistant should ensure that they select the appropriate
instrumentation prior to commencing treatment. The packaging should be examined to
ensure that it is intact.
Any instruments with damaged packaging must not be used.
The instrument should be disposed of in the instrument sharps bin.
The packaging should be disposed of in the domestic waste.
Prior to treatment
The instruments / sets should be placed in the treatment field.
The podiatrist / podiatry assistant will then open the sterile packaging.
Hands then must be washed, prior to treating the patient, before the contents of the pack
are removed.
The podiatrist / podiatry assistant will then visually check the packs contents against the
content list to establish if the all instrumentation is as stated.
If any instruments are missing the podiatrist / podiatry assistant will make a clinical
decision as to whether there are sufficient instruments to undertake the treatment
required.
If it is decided that the pack contents are insufficient, the contents list should be removed
from the packaging and note made as to which instruments are missing. The contents list
should be signed and returned to the packaging.
The set should then be returned to COCH as a dirty set
The podiatrist / podiatry assistant will then repeat the procedure with a new set.
Following treatment
After washing their hands the podiatrist/ podiatry assistant should apply one of the
barcode stickers from the reusable instrument set after completing the patient’s notes and
before signing the record. If more that one set of reusable instruments or single wrapped
reusable instruments have been used then a sticker from each individual pack must be
applied. The second barcode should be stuck to the day sheet next to the patient
undergoing the treatment
Page 6 of 15

Disposable instruments do not have tracking barcodes as they are disposed of after use.
The podiatrist / podiatry technician, should then tick the content list on the pre op
box to confirm that all instruments were present, and sign to say that all the
instruments are being returned and that all scalpel blades have been removed on
the separate section.
Lubrication of nipper hinges using dental aerosol lubrication is at the discretion of
practitioner.
The instruments and tray must be placed in the supplied return bag. Podiatry staff should
not undertake any pre cleaning of instruments.
The content list should then be placed in the return bag.
The return bag should be securely folded over and placed in a transit box. Note this
transit box must only be used for dirty instruments.
Once the transit box is full to the acceptable level (no more than 25 sets), the box should
be closed and secured with another black tag, the box should then be transferred to the
dirty instrument storage area.
The sterile field and outside bag should be placed in the domestic waste.
4. Quality Issues
Reusable instruments
Quality issues fall into 2 categories.
1. Problems with the quality of the instrument – e.g. it is broken; nail nippers stiff,
broken springs, cutting edge may become worn, shaft of bur bent. These may be
identified on opening a pack. However in many cases it is not until the instrument
is used the problem is identified. The podiatrist / podiatry assistant should
document on the contents list a description of the problem and any action required
to remedy, e.g. replacement. Lubrication of nipper hinges using dental aerosol
lubrication is at the discretion of practitioner.
The podiatrist / podiatry assistant will make a clinical decision to determine if the
remaining instruments are sufficient to continue treatment. If not then a new pack
should be opened.
2. Quality issues with the decontamination process e.g. dirty, foreign body present,
adhesive from podiatry products present. No part of the instrument pack must be
used under any circumstances. The pack should be isolated and not returned to
Page 7 of 15

processing company until this has been reported to and return authorised by the
line manager. The manager will complete the incident reporting.
Disposable instruments
If the quality of the instrument as supplied is a cause for concern the product log number
should be recorded. If the instrument has not been used then it should be kept for
inspection by the line manager, if the instrument has been used then the instrument must
be disposed of and the product log number and a description of the fault should be
reported to the line manager.
5. Scalpel Blades
Podiatry scalpel handles are supplied as reusable instruments in the basic sets.
There is one scalpel in each basic set.
If multiple blades are required for one treatment, that have not come into contact with
body fluids (blood, pus), then the podiatrist should change the blade using a single use
surgical blade remover this should then be immediately disposed of in the sharps bin.
The podiatrist can then continue to use the scalpel with the new blade.
For treatments in clinic, once the treatment is complete then the blade should be removed
using a sharps bin with an integral blade remover (as this is the most cost effective
method).
For treatments in patient’s own homes, hospitals etc all blades must be removed using a
single use surgical blade remover this should then be immediately disposed of in the
sharps bin.
If the scalpel blade has been in contact body fluids e.g. blood, pus or used for wound
debridement. The blade must be immediately removed using a sharps bin with an integral
blade remover if in clinic or with a single use surgical blade remover if this type of sharps
bin is not available.
The podiatrist must not continue to use this handle; it should be isolated with its set of
instruments and returned as dirty instruments.
If a scalpel is required to continue treatment a new instrument set must be used.
It is the podiatrist’s responsibility to check scalpel handles prior to returning
instrument sets to the processing company to ensure that no blades are left on the
handles. When initialling the contents list prior to the sets return the podiatrist is
verifying that all blades are removed. This process will be monitored via returns
from COCH; repeated breaches, following incident reports will be dealt with under
the Trust’s Disciplinary Procedure.
Page 8 of 15

6. Instruments Contaminated with Body Fluid
Reusable instruments e.g. nail nippers, which are contaminated with body fluid during
treatments must be immediately isolated from the set being used. If the type of
instrument, which was contaminated, is not required to complete the treatment then the
remaining instruments in the set may continue to be used.
If the type of instrument, which was contaminated, is required then a new set of
instruments must be used.
Disposable instruments e.g. nail files, which are contaminated with body fluid during
treatments must be immediately disposed of in clinical waste.
7. Disposable Nail Files
Disposable nail files are routinely used for treatments. If following treatment the file is in
good order and has not been in contact with any body fluid or mycotic infection, this can
be offered to the individual patient, to support their self-care.
Nail files which have not been contaminated with body fluids and which are not given to
individual patients following treatment should be disposed of in domestic waste.
Nail files which have been contaminated with body fluids should be disposed of in clinical
waste.
8. Packs Returned from (COCH) with Scalpel Blades in Place.
(COCH) are not responsible for removing any scalpel blades returned on handles. They
may return the pack in a separate transit box, which is clearly identifiable as a hazard.
It is the responsibility of the podiatry department to remove such blades. Only podiatrist
should remove these blades.
The pack should be placed on a flat surface. A pair of scissors should be used to cut the
bag at the top to expose the contents. Once the scalpel handle is fully visible, the
podiatrist may then pick it up and remove the blade with using a sharps bin with an
integral blade remover.
The set of instruments must then be returned as a dirty set.
Page 9 of 15

REFERENCES
Reference
DH, Code of Practice for the Prevention
and Control of Healthcare associated
Infection (2008)
National Institute for Clinical Excellence
(2003) Clinical Guideline-Infection Control
Relevance (whole document
or section, please state)
Whole
Whole
Evidence
Grade
Code of
Practice
Nice Guideline
Page 10 of 15

APPENDIX 1
Nail Surgery Pack:-
Scalpel handle No 3
Dressing scissors
Dental syringe
Dental syringe (black plastic)
Lock elevator
Elevator small
Beaver blade handle
Tube gauze applicator small
Tube gauze applicator large
Blacks file
Mosquito forceps fine
Mosquito forceps med
Mosquito forceps wide
Thwaites nippers
Tourniquet blue / green / orange
Dressing Pack:-
Scalpel handle No 3
Dressing scissors
Mosquito forceps fine
Routine Treatment Pack:-
Scalpel handle No 3
Dressing scissors
Blacks file
Diamond file
Nail nippers
Single Instrument Pack:-
Scalpel handle No 3
In growing toe nail nippers
Extra fine blacks file
Beaver blade handle
Diamond burr
Tube gauze applicator small
Tube gauze applicator large
Page 11 of 15

APPENDIX 2
EQUALITY IMPACT ASSESSMENT TOOL
To be completed with the corporate document when submitted to the appropriate committee for
consideration, approval and ratification.
1. Does the corporate document affect one group
less or more favourably than another on the basis
of:
Race no
Ethnic origins (including gypsies and travellers) no
Nationality no
Gender no
Culture no
Religion or belief no
Sexual orientation including lesbian, gay and
bisexual people
Age no
Disability - learning disabilities, physical disability,
sensory impairment and mental health problems
2. Is there any evidence that some groups are
affected differently?
3. If you have identified potential discrimination, are
there any exceptions valid, legal and/or
justifiable?
4. Is the impact of the policy/guidance likely to be
negative?
5. If so can the impact be avoided? n/a
6. What alternatives are there to achieving the
policy/guidance without the impact?
7. Can we reduce the impact by taking different
action?
no
no
no
n/a
no
n/a
n/a
Comments
If you have identified a potential discriminatory impact of this corporate document, please refer it
to [insert name of appropriate person], together with any suggestions as to the action required
to avoid/reduce this impact.
For advice in respect of answering the above questions, please contact [insert name of
appropriate person and contact details].
Page 12 of 15

APPENDIX 3
DISSEMINATION AND TRAINING PLAN
To be completed with the corporate document when submitted to the appropriate committee for
consideration, approval and ratification.
The status column must be given a Red, Amber or Green rating with evidence to demonstrate
an action has been completed.
DISSEMINATION PLAN
Title of document: Policy on development
of corporate documents
Date finalised: December 2009
Dissemination Lead: (Print name and
contact details) Linda Spooner
Previous document already being used?
No
Proposed action to retrieve out-of-date
copies of the document:
To be disseminated to:
Trust Times
Team Brief
Training sessions (Give Details Below)
Other (Give Details Below) √
IMPLEMENTATION PLAN
N/A
Disseminated
by whom?
Team
Leaders
Timescale
(Date)
Status
R A G
G
Paper
or
Electronic
Comments
Training Timescale Owner Status
R A G
Training Event Staff monthly Briefing Feb 2010 Julie
Griffiths
Training Plan Lead Julie Griffiths
Compliance Monitoring Timescale Owner Status
R A G
Methodology to be used for monitoring/audit (please include PCT
Audit Proposal Form)
Responsibilities for conducting monitoring/audit
Frequency of monitoring/audit (e.g. annually, 6 monthly etc)
Process for reviewing/reporting results
G
Denotes: Action not yet taken or deadline for action not met. Action plan to address this must be provided.
Denotes: Action partially implemented.
Denotes: Action complete.
Page 13 of 15

APPENDIX 4
CHECKLIST FOR THE REVIEW AND APPROVAL OF ALL CORPORATE
DOCUMENTS
Name of Document: Policy on the Development of Corporate Policies
Name of Author: Nikki Hotchin
To be completed by the author, signed and attached to all corporate documents which guide practice when
submitted to the Policy Sub-Committee for consideration and approval.
Please consider the checklist when developing any corporate document. All items under section 1 must be
answered “YES” before submitting to the approving committee and ratification by the Policy Sub-Committee.
Checklist
Yes/No/
Unsure
(Author to
complete)
Yes/No/
Unsure
(Committee
Use Only)
Committee Use
Only
1. Minimum Requirements
Does it have the completed approved checklist
attached?
Yes
Does the title properly describe the document? Is it
clear the document is a policy, procedure, clinical
guideline, SOP or protocol?
Yes
Is a completed dissemination and implementation
plan attached, including the necessary
training/support detailing who will be responsible for
co-ordinating the plan?
Yes
Does the document include a completed Equality
and Diversity Plan?
Yes
Is there a plan to review or audit compliance with
the document?
2. Rationale
Are reasons for the development of the document
stated?
Yes
3. Development Process
Are the purpose, aims, objectives and outcomes of
the document clear?
Yes
Is the target audience clear?
Yes
Are individuals/stakeholder/users with relevant
expertise involved or consulted in the development
of the document, identified and listed on the
contribution list?
Yes
Has the document been developed using the
corporate template including style and format?
Yes
Are the appropriate definitions and glossary of terms
listed? (If applicable)
Yes
4. Content
Is it clear that the policy neither duplicates nor
Yes
Page 14 of 15

Checklist
conflicts with other corporate documents?
Yes/No/
Unsure
(Author to
complete)
Yes/No/
Unsure
(Committee
Use Only)
Committee Use
Only
Does the document contain an approved Care
Pathway?
N/A
Has an Equality Impact Assessment been carried
out?
Yes
Has a Human Rights Impact Assessment been
carried out?
No
5. References and Evidence Base
Is the type of evidence required to support the
document identified explicitly i.e. referencing and
grading evidence including local corporate
documents.
Yes
Are key references cited?
Yes
6. Approval
Does the document identify which
committee/group/work stream will approve it?
Yes
Have the joint Human Resources/staff side
committee (or equivalent) approved the document?
Where applicable
N/A
7. NHS Constitution
Has due regard been paid to the NHS Constitution
which outlines what Staff, Patients and the Public
can expect from the NHS, along with what the NHS
expects of them – rights, pledges, duties and
expectations?
Yes
Individual Approval
If you are happy to approve this document, please sign and date it and attach it to the policy document in
preparation for committee approval.
Name
Signature
Committee Approval
If the Policy Sub-Committee is happy to approve this document, please sign and date it and forward copies to
the person with responsibility for disseminating and implementing the document and the person who is
responsible for uploading to the PCT’s library of corporate documents.
Name
Signature
Date
Date
Acknowledgement: Cambridgeshire and Peterborough Mental Health Partnership NHS Trust
Page 15 of 15