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Since setting up of the first CSSD in India at Jaslok Hospital in July, 1973 by Nalini
Gaithonde, much has changed. Today, nurses, who lacked expertise in sterilisation
procedures, leading to manual errors, no longer carry out sterilisation.
The scope of CSSD has enlarged from that of a department, which was similar to an
autoclave sterilisation unit to encompass hospital infection control and stands for a
dedicated workflow of sterile supplies and goods. Ideally, CSSD is an independent
department with facilities to receive, clean, pack, disinfect, sterilise, store and
distribute instruments (both multi-use and single-use device), as per well-delineated
protocols and standardised procedures. The workload in a CSSD varies from hospital
to hospital.
But in this age of cost cutting and space constraints, why have a separate
department for sterilisation? Says Ganesh Devadiga, Head, CSSD, Dr L H
Hiranandani Hospital, Mumbai, “By having separate CSSD, we can decrease the cost
of sterilisers through centralisation of equipment in one department. Besides, this
would also ensure that a dedicated staff can effectively monitor the sterilisation
process as per the Standard Operative Procedures (SOPs).”
Says Vishwanath Kokitkar, CSSD and Laundry In- Charge, S L Raheja Hospital,
“CSSD requires technical competency, which implies that the department controls all
the activities of asset management pertaining to selective procurement of general
and specialised surgical instruments and other inventory. CSSD in Indian hospitals
imply quality service with scarce resources.” An alarming rate of Hospital Acquired
Infections (HAI) in Indian hospitals has highlighted the importance of CSSD. If the
CSSD is not in place, there is a definite surge in HAI. Explains Gopinathan T,
Manager, CSSD, Amrita Institute of Medical Sciences (AIMS), Kochi, “The rise in
incidence of nosocomial infection with corresponding increase in mortality, length of
stay and cost can be brought down by establishing a good CSSD set-up.”
Informs Rekha Batura, Asst Medical Superindentent, Tata Memorial Hospital (TMH),
Mumbai, “CSSD was generally looked upon as an essential part of an OT as the use
of sterile supplies in a hospital is maximum to the OT. However, all that has
changed. CSSD is considered today, integral to the function of Out Patient
Department (OPDs), wards and other departments.”
The most important factor in running a smooth CSSD is good workflow. According to
Ruth Edwards, CSSD In-Charge, Christian Medical College (CMC), Vellore, “To
maintain good workflow, sterilisation process implies proper functioning and co-
ordination between four zones: dirty area, which is also called as washing area,
assembly area or packing area, sterile area and finally the sterile goods storing
area.” Manned with a staff of around 80 personnel, the CSSD at the 2700-bed CMC
consistently upgrades itself to deal with huge patient flow. Hospitals, mainly
government ones, which are built without a CSSD, end up in poor planning and
design, when the department is incorporated as an afterthought.
Reality Check
Though new technology has arrived, CSSD is yet to take off in India. In Mumbai, only
30 per cent of big hospitals (with 100 or more beds) have CSSD. The infrastructure
for CSSD is poor in other districts of Maharashtra. However, analysts say that 85 per
cent of most of the upcoming hospitals have a well-equipped CSSD.
Says R G Sawant, Head, CSSD, TMH, “One of the major impediments for CSSDs not
taking off with Indian hospitals is that there is no uniform accreditation system in
place. The gulf between the concept and implementation of CSSD can also be
attributed to paucity of funds and lack of expertise in this area.”
Besides, hospital management does not accord importance to CSSD as they consider
it as a non-profitable venture. Setting up a CSSD costs Rs three lakh to five lakh for
a small hospital and around one crore for a big hospital.
Latest trend
Today, the upcoming advanced sterilisers are all computer controlled with a backup
that leaves no margin for error. Achieving cent per cent sterilisation is the biggest
challenge. “Theoretically, one can achieve 100 per cent sterilisation, but practically
achievement of true sterilisation is a factor that follows the law of chance. Hence,
achieving 99.99 per cent log kill of bacterial spores is considered good enough to
pronounce the material as sterile. There is a specific protocol called the spaulding
classification, which is followed for sterilising or disinfecting critical and semi-critical
items,” informs Sawant.
The latest trends in the West are to use single use devices (SUDs) and automated
equipment in CSSD. A single use device is a medical device to be used only on one
patient for a single procedure. The high cost of SUDs and CSSD automation is,
however, a constraint in developing countries like India, informs Dr Umesh Gupta ,
Co-ordinator, Division of Innovations in Clinical Excellence, Indraprastha Apollo
Hospitals, New Delhi.
Indian hospitals are generally known to clean, disinfect or sterilising SUDs. “This
practice should be adopted only very judiciously to reduce disposable medical waste
and costs, without compromising on patient safety,” remarks Dr Batura.
Another trend, very new in Indian hospitals is that the hospitals don’t outsource
sterilisation of equipment to third party processors. US-FDA ensures that the
hospitals, companies and third party processors, reprocessing of SUDs should meet
the same standards used by the original manufacturer.
Some Indian hospitals even prefer using indigenous sterilisers for cost cutting. Says
Vishwanath Kokitkar, CSSD and Laundry In-Charge, S L Raheja Hospital, Mumbai,
“Maintenance cost is the most important factor governing the success of the CSSD.
Therefore, Raheja Hospital has installed indigenous equipment. This will lead to
optimisation on quality and cost-effectivity, with the cost of a CSSD running in
crores.”
The trend for small size Indian hospitals is to use an indigenous autoclave, which
may be difficult to monitor or validate. The automated steriliser on the other hand is
equipped with quality control checks, gives an automated and digital output in the
form of print-outs and graphs. There is a constant effort to bring out safer sterilisers
and make them more reliable. Experts say that sterilisation involves a lot of
variables, hence the effort should be to minimise the chances of an instrument not
getting sterile, which can be a hazard to the patient.
Suggestions
Though the government has laid down guidelines to protect sweepers and waste
collectors, there is sheer absence of guidelines or a regulatory body to check if
instruments used are properly sterilised. A ray of hope is perhaps the Government’s
initiative in laying down guidelines for hospital hygiene.
While hospitals are waking up to the importance of CSSD and the need for
guidelines, some experts suggest that CSSD should also be installed at primary
health centres. While that may take some time, what hospitals can start with is by
taking the initiative to train their staff in using latest technologies and using available
international guidelines in CSSD.
1. Risk Asssement
It is the responsibility of the principal investigator or laboratory director to
conduct a risk assessment to determine the proper work practices and
containment requirements for work with biohazardous material. The risk
assessment process should identify features of microorganisms as well as
host and environmental factors that influence the potential for workers to
have a biohazard exposure. This responsibility cannot be shifted to
inexperienced or untrained personnel.
Pathogenicity:
The more severe the potentially acquired disease, the higher the risk.
Salmonella, a Risk Group 2 agent, can cause diarrhea, septicemia if
ingested. Treatment is available. Viruses such as Ebola, Marburg, and Lassa
fever cause diseases with high mortality rates. There are no vaccines or
treatment available. These agents belong to Risk Group 4.
Route of transmission:
Agents that can be transmitted by the aerosol route have been known to
cause the most laboratory-acquired infections. The greater the aerosol
potential, the higher the risk of infection. Work with Mycobacterium
tuberculosis is performed at Biosafety Level 3 because disease is acquired
via the aerosol route.
Agent stability:
The greater the potential for an agent to survive in the environment, the
higher the risk. Consider factors such as desiccation, exposure to sunlight or
ultraviolet light, or exposure to chemical disinfections when looking at the
stability of an agent.
Infectious dose:
Concentration:
Consider whether the organisms are in solid tissue, viscous blood, sputum,
etc., the volume of the material and the laboratory work planned
(amplification of the material, sonication, centrifugation, etc.). In most
instances, the risk increases as the concentration of microorganisms
increases.
Origin:
Medical surveillance:
2. Risk Groups
Infectious agents may be classified into risk groups based on their relative
hazard. The table below, which was excerpted from the NIH Recombinant
DNA Guidelines, presents the "Basis for the Classification of
Biohazardous Agents by Risk Group."
Risk
Agents that are not associated with disease in healthy adult
Group 1
humans
(RG1)
Risk Agents that are associated with human disease which is rarely
Group 2 serious and for which preventive or therapeutic interventions are
(RG2) often available
Risk Agents that are associated with serious or lethal human disease
Group 3 for which preventive or therapeutic interventions may be available
(RG3) (high individual risk but low community risk)
Risk Agents that are likely to cause serious or lethal human disease for
Group 4 which preventive or therapeutic interventions are not usually
(RG4) available (high individual risk and high community risk)
1. Generation of rDNA
All protocols involving the generation of rDNA for human gene transfer
must be approved locally by the IBC and the Institutional Review Board
(IRB) prior to submission to outside agencies and the initiation of
experimentation. For more details about IBC approval of human gene
transfer protocols, call 215-898-4453. For information about IRB
submissions, call 215-898-2614.
Recombinant vaccine trials must be reviewed and approved by the IBC and
the Institutional Review Board (IRB) before research participants can be
enrolled. For more details about IBC approval of human recombinant
vaccine protocols, call 215-898-4453.
4. Transgenic Animals
Laboratory personnel (faculty and staff) who work in HIV or HBV research
laboratories must fulfill additional OSHA requirements as follows:
o a. The employee must attend EHRS Introductory Laboratory
and Biological Safety Training at Penn and annual update training
thereafter.
o b. The employee must have prior experience in the handling of
human pathogens or tissue cultures before working with HIV or
HBV.
o c. In the laboratory, the employee must demonstrate
proficiency in standard microbiological practices and techniques and
in the practices and operations specific to the laboratory to the
satisfaction of the principal investigator/laboratory supervisor before
being allowed to work with HIV or HBV.
o d. An employee with no prior experience in handling human
pathogens must be trained in the laboratory prior to handling
infectious materials. Initial work activities shall not include handling
of infectious agents. A progression of work activities will be assigned
as techniques are learned and proficiency is developed. Participation
in work activities involving infectious agents will be allowed only
after proficiency has been demonstrated to the satisfaction of the
principal investigator/laboratory supervisor.
o e. The employee must view the video "Working Safely with
HIV in the Laboratory". A copy of the video is available for loan from
EHRS (email or phone EHRS at 215-898-4453).
2. Use of Animals
Primate cell lines derived from lymphoid or tumor tissue, all cell lines
exposed to or transformed by a primate oncogenic virus, all clinical
material (e.g., samples of human tissues and fluids obtained after surgical
resection or autopsy), all primate tissue, all cell lines new to the laboratory
(until proven to be free of all adventitious agents) and all virus and
mycoplasma-containing primate cell lines are classified as Risk Group 2 and
should be handled at Biosafety Level 2.
Healthcare Environment
Laboratory
F. Clinical Laboratories
Clinical laboratories, especially those in health care facilities, receive clinical
specimens with requests for a variety of diagnostic and clinical support services.
Typically, the infectious nature of clinical material is unknown, and specimens are
often submitted with a broad request for microbiological examination for multiple
agents (e.g., sputa submitted for "routine," acid-fast, and fungal cultures). It is
the responsibility of the laboratory director to establish standard procedures in the
laboratory that realistically address the issue of the infective hazard of clinical
specimens.
G. Select Agents
The federal government, through the Department of Health and Human Services
and the Department of Agriculture, regulates certain biological agents and toxins
that are considered a threat to the public health, animal or plant health and
animal or plant products. Investigators must contact EHRS to register with the
University's Select Agent Program and the appropriate federal agency prior to
possession, use or transfer of any Select Agent.
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