Decontamination of Medical Devices Homework Help

Investigate best practice and make recommendations for improvement to the Policies, Procedures, of clinical sterilisation of instruments within the NHS…..

Table of contents
3. 1.0 Decontamination of medical devices

3. 1.1 Introduction

3. 1.2 Overview

5. 1.3 Category of risk

7. 1.4 Reasons for Decontamination as an issue of public health

7. 1.5 HAI (Hospital Acquired Infections)

8. 1.6 Theoretical risk of iatrogenic Transmissions

9. 1.7 The Decontamination process

11. 1.8 regulatory bodies

11. 1.9 MDA (Medical Devices Agencies)

11. 2.0 NHS Trust

12. 2.1 Concerns

12. 2.2 Decontamination Process management

12. 2.3 Central Decontamination units

12. 2.4 Local Decontamination units

13. 2.5 Safe use of medical devices

13. 2.6 Conclusion

14 References

1.0 Decontamination of Medical Devices

1.1 Introduction
Patient 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 Overview
An 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. 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 disinfected

1.3 Category of Risk
Effective 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 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 Health
1.5 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 vCJD
The 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 practice
As has been 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 Bodies
The 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 Trust
It 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 Concerns
It 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 management
The 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 Central Decontamination units
The 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 units
Many 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 devices
The decontamination cycle turnaround times has been affected by inadequacies of surgical instruments stock.

2.6 Conclusion
There 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.

Reference

Collins 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 materials

BDA. (2009). Decontamination Guidelines (England)

CHRISP. (2011). Disinfection and Sterilization Infection Control Guidelines: Section 1 Overview.

Janet, D.  (2010). Decontamination of Re-usable instruments

Mersey 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) Policy

NHS Estates. (2003). A guide to the Decontamination of Re-Usable Surgical Instruments.

NHS Trust. (2008). Cleaning and Disinfection Policy

NHS East Lancashire, (2010) Decontamination of Reusable instruments.

Staff News. (2006). Best in Europe

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