The document discusses decontamination of medical devices in the NHS. It outlines the importance of effective decontamination to reduce healthcare associated infections and minimize risks of disease transmission. It also examines current guidelines and challenges related to decontamination processes. Regulatory bodies are working to improve standards and ensure uniformity in decontamination practices across the NHS.

1. Decontamination of Medical Devices
Investigate best practice and make recommendations for improvement to the Policies,
Procedures, of clinical sterilisation of instruments within the NHS…..Table of contents3. 1.0
Decontamination of medical devices3. 1.1 Introduction3. 1.2 Overview5. 1.3 Category of
risk7. 1.4 Reasons for Decontamination as an issue of public health7. 1.5 HAI (Hospital
Acquired Infections)8. 1.6 Theoretical risk of iatrogenic Transmissions9. 1.7 The
Decontamination process11. 1.8 regulatory bodies11. 1.9 MDA (Medical Devices
Agencies)11. 2.0 NHS Trust12. 2.1 Concerns12. 2.2 Decontamination Process
management12. 2.3 Central Decontamination units12. 2.4 Local Decontamination units13.
2.5 Safe use of medical devices13. 2.6 Conclusion14 References 1.0 Decontamination of
Medical Devices1.1 IntroductionPatient safety is the most fundamental aspect in the
management of healthcare associated infection. Therefore, to ensure patient’ s safety,
effective decontamination of surgical instruments becomes vital.Decontamination of
surgical instruments has to be carried out using processes and practices of the highest
quality. The processes and practices have to reflect the modern day standards too.This
paper is going to concern itself with assessing the current clinical practises and look into the
supposed and acceptable clinical risks when using sterile surgical sets.1.2 OverviewAn
initiative to address the problems associated with the substandard TSSU (Theatre Sterile
Surgical Service Units) by shifting to off-site sterile service super-centres that are run
commercially and are used to serve many hospitals was launched by the department of
Health (DOH). It was forecasted that by the year 2007, more than 100 NHS trusts would be
dependant on the proposed model. The NHS is tasked with the responsibilities of
reprocessing services has made steps to inquire on the issues that surround
decontamination processes. The NHS has sought advice from various organisation key
amongst them the Association of British Healthcare Industry and the Medical Royal
Colleges.The NHS has been prompted to look into this issue due to the fact that many
surgical groups relate the loss of influence and control (local) of the decontamination
process and have pushed for increased instrumentation to help cater for the increase of
turnaround times and to help combat the decontamination inabilities and re-stabilise on
site. What is aimed is achieving a high standard modern decontamination of implants and
instruments but at the same time minimising, eliminating and taking care not to create new
logistical risks and practical clinical care problems for the personnel in the operating
department and surgeons at surgery.As stated, patients have to be treated in environments
that are clean and safe and the standards of care have got to be consistent to each patient.

2. The standard of care should also be consistent very time a patient walks into a health
facility. By doing this, the person-to-person risk of infection is minimised. It has also been
seen that to be able to reduce the risk of person-to-person infection, then, effective
decontamination of medical services that are re-usable is fundamental. This effective
practices and process normally include acquiring healthcare transport and equipments,
good disposal and storage. Therefore, the Teaching Primary Care Trust must be
implemented by the management system. Of much importance too is the validation of
systems that are in place to pave way fro tracking and decontamination of surgical
instruments sets to make sure that the process and practice has been carried out efficiently
and effectively. This will help in identifying patients who have been exposed to potential
risks.It has also been agreed that as a standard practice, the staff should also protect
themselves when dealing with patients. After all, both parties – health practitioners and
patients- are prone to contamination. The protective clothing does not just serve to protect
the person – to- person infection; it also helps in protecting members of staff who are
involved in the decontamination process.When carrying out the decontamination process,
the cleaning, disinfection and sterilization process are employed to destroy microorganisms
that cause diseases. With the existence of different decontamination methods, the best
decontamination process should be used. As a general practice, the method chosen usually
depends on issues like the organisms that are involved in the process and the material (type
of) being disinfected1.3 Category of RiskEffective decontamination is arrived upon by if the
health staff are aware of the risk categories and that the same staff should show an
approach that is competent and show their awareness about the risk categories. The risk
categories include high risk category. Under this category, equipment that is in close contact
with skin breakages or mucous membranes or equipment that that has been introduced in
to a sterile area of the body. For this kind of risk, the instruments must be sterilised at the
source. Secondly we have the intermediate category which involves equipment contact with
skin, bodily fluids or mucous membranes or those instruments introduced into a sterile
area of the body. They are normally dealt with sterilisation or disinfection. Thirdly, there
exists the low risk level where the equipments get into contact with health skin, mucous
membranes, or a section of the environment that is not in close contact with the patient or
the immediate surroundings of the patient. This risk is always dealt with by general
cleaning. These risks are summarised in the table below:(NHS East Lancashire,
2010)Decontamination process is not a one sided affair. This is to mean that the health
practitioners cannot be left to decide wholly on how they are going to operate in as far as
decontamination processes are concerned. Just like other professions, regulation is vital to
ensure conformity and uniformity in the decontamination process. This need for conformity
and uniformity has been the reason of the recent concern of the DOH to reiterate on the
importance of adhering to the guidelines set for the decontamination of medical devices
(CHRISP, ).In assessing the effectiveness of the guidelines, there are various questions that a
person should have in mind:a). Have the guidelines been implemented effectively?b). Are
the current guidelines on the decontamination of medical or surgical instruments
adequate?c). What is needed to help in improving the effectiveness of the
decontamination process in the NHS?d). Are there any practical difficulties hindering the

3. provision of good services?NHS decontamination efficacy has little data to boost it. This is
unfortunate because the awareness the public has on the impact of hospital acquired
infection is on the rise.1.4Reasons for Decontamination as an issue of Public Health1.5 HAI
(Hospital Acquired Infection)At any given time, 9% of the in-patients of a hospital have a
HAI. The most prevalent are lower respiratory tract infections, surgical wounds and urinary
tract infections (National Audit Office, 2000). What is surprising is that 15% to 30% of the
HAI are preventable if the health practitioners are to put into practice the most effective and
realistic methods of controlling infection control (Harley et al, 1985). However, in most
cases, the quick spread of HAI as a result of decontamination methods that are ineffective
can go unnoticed. Therefore it becomes very important if effective decontamination is
employed to reduce the prevalence of HAI.1.6Theoretical risk of iatrogenic transmission of
vCJDThe normal contact with a person suffering from CJD or vCJD does not pose a risk of
infection according to epidemiological evidence. In healthcare situations evidence to
suggest that vCJD can spread to another person is nil. This is not to mean that vCJD cannot
be transmitted after all. In certain situations it has been found to be transmitted. For
instance:a). It can be transmitted from one person to the other through neurosurgery,
duramater and corneal transplantation and during human growth hormone injection. Some
studies have been done and one study has pointed out the fact that erratic CJD is associated
with surgical treatments (Collins et al 1998).b). A consensus has not been reached
regarding the agent that causes vCJD and BSE. There is a notion however amongst scientists
and researchers that prion (PrP) a form of a corrupted protein is a component of the agent
causing organism. The diseases that are associated with this protein are found in the spleen,
nostrils and lymph nodes of dead patients who were suffering from vCJD (Hill et al 1999).c).
Concentrated sodium hypochlorite solution has been found to be effective to neutralise the
PrP protein (Taylor, 2000). Initially it was found out that PrP was resistant to most of the
sterilisation techniques in order to inactivate infectivity in the tissue (Taylor, 1996). PrP can
be killed effectively by a kill temperature of 134 degrees for a period of 18 minutes in a
porous clay autoclave. The time can however be increased to an hour albeit it may not
guarantee effective sterilisation. Complete removal of infectivity therefore appears to be
hard to achieve, however it is hoped that with advancement of sterilisation techniques the
infectivity level will be reduced.Effective decontamination is thus vital in combating the
risks of TSEs with the intention of reducing their risks; this is according to the SEAC
(Spongiform Encephalopathy Advisory Committee) which is tasked with advising the UK
government on the transmissible spongiform encephalopathies (Taylor, 2000).The risks
posed have resulted to the increased attention towards ensuring that medical devices are
decontaminated effectively before they are re-used and when it warrantees the use of
single-use instruments is encouraged for most of the procedures.To keep the medical
fraternity at breast, SEAC/ACDP (Advisory Committee on Dangerous Pathogens) joint
committee is in place to advice the government and help in setting guidelines to help in
controlling measures that are related to vCJD and other TSEs. A guideline was published in
1998 and it has got a series of regulations which are always been changed and reviewed as
new findings are brought to light in so far as the agents of these unusual diseases are
concerned (BDA, 2009).1.7 The Decontamination processes and practiceAs has been

4. discussed, the purpose of decontamination is ensure that medical devices are made re-
usable. They should be made re-usable in a way that will put the safety the safety of the
client first and at the same time ensure that the staff handling the medical devices does not
present an infecting opportunity or hazard to the patients and to themselves. The process
of decontamination can be summarised in the diagram below:Effective decontamination
requires adherence to the above cycle. Each of the process shown should be followed to the
letter and the correct monitoring and suitable controls should be established to oversee
such. What should be realised and appreciated is that the swiftness of medical devices
through the above cycle has got a huge brunt on the efficiency of the decontamination
process. This is mostly influenced by the number of devices that do require processing.
Minimum standards are achieved depending on the availability of facilities, management of
the process, procedures and policies employed and the location (Janet, 2010).For the most
effective decontamination process and practise, there are some requirements that have to
be met. It should be ensured that medical devices that are meant for single use should not
be re-used. Secondly, the staff that deals with the decontamination procedures should be
well trained and their supervision should be immaculate. Thirdly a proper record should
always be kept and maintained. Fourthly, the appropriate facility for the decontamination
process should be made readily available. Apart from acquiring the facilities, the most
appropriate equipment should be used. Such equipment should be fit for the intended
purpose, it should be well maintained and well calibrated and it should also be well
monitored and well validated. The decontamination process for maximum effectiveness
must be automated. There should be systems which can enable tracing of medical devices
through the decontamination process and then link such devices to individual
patients.1.8Regulatory BodiesThe standards and guidance affecting decontamination of
medical services have been consolidated and supplied to all the NHS Trusts and its related
organisations (SEHD, 1999). There is no single agency that has been tasked however to
control the compliance to the expected standards decontamination guidelines. The several
regulatory bodies that exist include:1.9 MDA (Medical Devices Agency)It is a government
agency that has been charged with ensuring that medical devices adhere to the appropriate
standards of safety, performance and quality. Under the European Medical Devices
Directives, this body is the competent Authority of the UK.2.0 NHS TrustIt make sure that
the trusts have got Infection Control Committees and infection Control Teams which are
tasked with planning monitoring compliance and infection control policies as has been
specified by the Health Boards (Mersey Care NHS Trust, 2008).2.1 ConcernsIt is evident
from the above experts that there are issues that have to be rectified in the decontamination
of medical devices in order to reduce the instances of infection on patients. The
shortcomings of the decontamination process can be summarised as follows:2.2
Decontamination process managementThe decontamination process management is limited
in nature. Logical policies on surgical instruments procurement are almost absent.
Furthermore, infection control, safety and health, procurement of medical devices and
decontamination lack a link between them. In fact it is highly possible that most of the
managers of health institution are unaware of the dangers that the patients and the medical
staff are exposed to. This has resulted to rare use of quality reusable medical devices.2.3

5. Central Decontamination unitsThe decontamination process according to many researches
is being done in environments that is not best suited for the process. This inappropriate
environments has placed a lot of constrains on the decontamination process and separation
of dirty and clean processes.2.4 Local Decontamination unitsMany local decontamination
units in the most of the health facilities are located in very inappropriate facilities. Physical
separation between dirty and clean processes therefore, is hard to separate.2.5 Safe use of
medical devicesThe decontamination cycle turnaround times has been affected by
inadequacies of surgical instruments stock.2.6 ConclusionThere is widespread ignorance on
the decontamination process particularly amongst individuals not associated directly with
the process. The guidelines for cleaning and sterilisation or the decontamination process
are present. This is true particularly the technical aspect of the guidelines. However, these
guidelines do need amendments. Implementation of the guidelines in place is not effectively
done. This is because there is no single body appointed to oversee the decontamination of
medical devices. Therefore there is no proper control of the re-usable medical devices and
their reprocessing is inadequately done. The facilities too do not meet the recommended
standards and in fact, most of the facilities do need upgrades and some do need
replacement. Generally there are a lot of improvements that still needs to be done to make
the decontamination process effective.ReferenceCollins S et al. (1998). “ Surgical Treatment
and risk of sporadic Creutzfeldt Jakob disease; a case control study” Lancet; 353; 693-
97. Hill A.F et al. (1999) “ Investigation of variant Creutzfeldt Jakob disease and other
human prion diseases with tonsil biopsy samples” Lancet; 353; 183-89. Haley R.W, White
J.W, Culver D.H, Meade Morgan W, Emori T.G, Munn V.P, Hooton T.M. (1985). National Audit
Office. (2000). “ The Management and Control of Hospital Acquired Infection in Acute NHS
SEHD. (1999). “ NHS in Scotland Infection Control: Decontamination of Medical Devices”
(enclosing CDRom “ NHS in Scotland: Decontamination Guidance” ) NHS MEL79.Scottish
Executive Health Department Working Group. (2001). Decontamination of Surgical
Instruments and other Medical Devices.Trusts in England – A Report by the Controller and
Auditor General” House of Commons “ The efficacy of infection surveillance and central
programs in preventing nosocomial infections in US hospitals” (SENIC). American Journal
of Epidemiology 121: 182-205.Taylor D.M. (2000). “ Inactivation of Transmissible
degenerative encephalopathy agents: A review” Vet J 159; 10-7.Taylor D.M.
(1996). “ Exposure to, and inactivation of the unconventional agents that cause
transmissible spongiform encephalopathies” In Backer H F, Ridley R M, Eds. “ Methods in
molecular medicine: priondiseases” Totawa N J: Humana Press 105-18.Additional
materialsBDA. (2009). Decontamination Guidelines (England)CHRISP. (2011). Disinfection
and Sterilization Infection Control Guidelines: Section 1 Overview.Janet, D. (2010).
Decontamination of Re-usable instrumentsMersey Care NHS Trust. (2008). Policy and
Procedure for the Management and Decontamination of Medical Devices.NHS Trust. (2011)
Sterilisation of Re-usable Medical Devices (Dental Service) PolicyNHS Estates. (2003). A
guide to the Decontamination of Re-Usable Surgical Instruments.NHS Trust. (2008).
Cleaning and Disinfection PolicyNHS East Lancashire, (2010) Decontamination of Reusable
instruments.Staff News. (2006). Best in EuropePress order button now……………………