HLTINF002: Process Reusable Medical Devices and Equipment Report

This report addresses the reprocessing of reusable medical devices and equipment, focusing on the procedures for sterilization and the importance of maintaining a sterile environment to prevent infections. It begins by explaining the Spaulding classification system, which categorizes medical instruments based on their risk of infection, and outlines the required levels of disinfection or sterilization. The report then details the steps involved in reprocessing instruments in a dental healthcare setting, from receiving and cleaning to packaging, sterilization, and storage, emphasizing the need for physical separation of areas to prevent contamination. It also highlights the significance of proper training for personnel and maintaining sterilization records. Furthermore, the report covers the maintenance and monitoring of sterilizers, including leak rate tests and calibration, to ensure quality assurance. Finally, it offers recommendations for improving current practices, such as centralized reprocessing, adherence to manufacturer instructions, and the adoption of written policies for single-use devices.

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HLTINF002 Process Reusable Medical Devices and Equipment
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1. Identification and clarification of the key issues. Discuss and provide some
suggestions as to what has caused these
If any instrument or piece of equipment is to be reused it requires reprocessing such as
disinfection, sterilization, and or cleaning. The level of reprocessing the instruments that are
reusable depends on the specific situation. There is an approach developed by Spaulding 30
years ago for patient care items and equipment. This approach is taken for sterilization and
disinfection is still retained and refines it successfully1. It is used by all professionals of infection
control and also others whenever disinfection or sterilization method is planned (Rutala and
Weber 2008). On the basis of items and the instruments for patient care, the system is divided
into critical, semi critical, and non-critical. This categorization is as per the level of risk of
infection involved while using the items.
Critical: These items if contaminated with any microbes will deliberate a high risk of infection.
Therefore, these are to be sterile whenever they are in use. For instance, objects which enter the
vascular system or sterile tissue are included since any microbial contamination might transmit
the disease.
Semi-critical: Items that come in contact with mucous membranes or non-intact skin is included
under this. It should be of single use or it has to be sterile after every use. If that is not possible,
then the level of disinfection should be at a high level2.
Noncritical: Items that are not in contact with the mucous membrane but that come in contact
with intact skin, is included under this. For most of the noncritical items, proper cleaning is
enough after every individual use. However, either medium or low-level disinfection will be
appropriate in certain situations.
2. Key facts and information that is relevant and demonstrates your ability to provide
solutions
In the settings of dental healthcare, cleaning, sterilizing, and disinfecting of all instruments has to
be taken place. It should occur in a selected central processing area so that it is made sure of
safety and quality is controlled easily. The processing area of the instrument has to be divided
physically into the following sections:
1 Gold, Kathryn M., and Victoria M. Hitchins. "Cleaning assessment of disinfectant cleaning wipes on an external surface of a medical device
contaminated with artificial blood or Streptococcus pneumoniae." American journal of infection control 41, no. 10 (2013): 901-907.
2 Smith, Bret W., David N. Plescia, Michael J. Stokes, Sora Rhee, Timothy G. Dietz, Kevin D. Felder, Jeffrey L. Aldridge, and Emmanuel V.
Tanghal. "Medical device packaging with window for insertion of reusable component." U.S. Patent 9,089,338, issued July 28, 2015

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i. Receiving it, then cleaning, and later decontamination
ii. Should go for preparation and then packaging
iii. Sterilization and
iv. Storage
This categorization is designed in such a way so that all the items contaminated will go to that
specific area for cleaning. By this contamination of the other clean areas are prevented where
other processes like packaging, sterilization, and storage are done. In the cleaning area,
contaminated instruments and devices that are to be reused are received, organized and cleaned
will be kept3.
For inspection, assembling, and then packaging of the instruments are taken place in the
packaging area which is the final process of preparation. Steam sterilizers are to be loaded with
utmost care. The items are to be packed properly and place it in the sterilizer. It works under the
principle of steam under pressure. Then unload of materials is to be done after the pressure of the
instrument comes down to normal temperature.
The sterilizers and the related supplies are maintained at the sterilization and the storage areas
along with the incubators for analysing the spore tests. This area will also contain bounded
storage space for storing the sterile and disposable items if physical separation of these areas is
not possible than it has to be labelled properly4. By this, each area will be maintained sterile from
contaminated areas.
The personnel whoever is processing the instruments is to be trained properly in their work
practices. This will prevent contamination of the cleaned and sterile areas. Sterilization records
should be maintained for verifying that processing system is appropriate in that place. It should
be in accordance with the state and federal legislation5.
3. Templates and resources that could assist managers in the future when managing
their teams
3 Siebrecht, Wayne A., David J. Wesley, David B. Mogill, and Daniel S. Goldberger. "Handpiece for ultrasonic medical devices including seal
for mechanical isolation of ultrasonic driver assembly." U.S. Patent 8,795,183, issued August 5, 2014
4 Scully, Christopher G., Shawn Forrest, Loriano Galeotti, Suzanne B. Schwartz, and David G. Strauss. "Advancing regulatory science to bring
novel medical devices for use in emergency care to market: the role of the Food and Drug Administration." Annals of emergency medicine 65, no.
4 (2015): 400-403
5 Scott, David, Hayley Kane, and Annette Rankin. "‘Time to clean’: A systematic review and observational study on the time required to clean
items of reusable communal patient care equipment." Journal of Infection Prevention (2017): 1757177417714046

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An integral part of sterilization is the maintenance and monitoring of the sterilizer regularly so
that the equipment is maintained properly. Sterilizers are the equipment’s which are subjected to
breakdowns and faults. Most of these machines are delicate, so they can only be maintained by
cautious monitoring. The essential prerequisites required for the operation of the sterilizer are
maintenance and monitoring. The general maintenance procedure is to be followed by the
technician who is operating the sterilizing equipment.
The procedure has to be carried out daily and or weekly so that it is well-maintained. Though this
general maintenance might sound simple it is an essential part. This would be the routine
checking and proper cleaning is to be carried out.
For determining the rate of air leaking into the chamber the leak rate test has to be performed.
This is to be done for pre-vacuum sterilizers and is performed weekly. For checking the
efficiency of the sterilization process the monitoring cycles are designed. The prescriptive
standard is AS/NZ standard 4187 for regular monitoring. It has to be performed and recorded for
all the sterilizers that are used within the SSD6.
The testing method that is used and the importance of ensuring quality assurance of sterilisation
equipment is calibration. This testing is carried out only on orders given by the sterility assurance
committee of Australian Standards. This is performed every quarterly, half yearly, and annually.
Based on the calibration history this testing is done, which will be forming an integral part of
quality assurance. This calibration is documented.
4. Recommendations, both short term and long term, to improve the current situation
 It is always recommended strongly that whenever it is possible reprocessing has to be
performed. Also, it has to be taken place in the centralized area only to prevent
contamination. This area should comply the physical and the human resource
requirements for the reprocessing method7.
 The chemical disinfectant that is used as the disinfectant for the medical devices and or
equipment’ should follow the manufacturer’s instructions. Its instructions should be
compatible with both manufacturer and cleaning products that are used for reprocessing.
6 Parker, Brent. "Reusable pulse oximeter probe and disposable bandage apparatii." U.S. Patent 8,706,179, issued April 22, 2014
7 Krucoff, Mitchell W., Art Sedrakyan, and Sharon-Lise T. Normand. "Bridging unmet medical device ecosystem needs with strategically
coordinated registries networks." Jama 314, no. 16 (2015): 1691-1692

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 On regarding the one time use of the medical equipment’s the health care settings should
have the written policies
 The medical devices or equipment’s of critical and semi-critical if at all labelled as one
time use; then it should not be reprocessed. Also, it should not be reused till the time
reprocessing is not done by a licensed reprocessor8.
 It is advisable that the workplace manager is required to take appropriate measures. These
measures should be taken with respect to workplace policy and procedures for fixing the
problems.
Bibliography
Gold, Kathryn M., and Victoria M. Hitchins. "Cleaning assessment of disinfectant cleaning
wipes on an external surface of a medical device contaminated with artificial blood or
Streptococcus pneumoniae." American journal of infection control 41, no. 10 (2013): 901-907.
Houser, Kevin L., Foster B. Stulen, William D. Dannaher, Bret W. Smith, David N. Plescia,
Michael J. Stokes, Sora Rhee et al. "Medical device with feature for sterile acceptance of non-
sterile reusable component." U.S. Patent 9,072,523, issued July 7, 2015.
Krucoff, Mitchell W., Art Sedrakyan, and Sharon-Lise T. Normand. "Bridging unmet medical
device ecosystem needs with strategically coordinated registries networks." Jama 314, no. 16
(2015): 1691-1692.
Parker, Brent. "Reusable pulse oximeter probe and disposable bandage apparatii." U.S. Patent
8,706,179, issued April 22, 2014.
Scott, David, Hayley Kane, and Annette Rankin. "‘Time to clean’: A systematic review and
observational study on the time required to clean items of reusable communal patient care
equipment." Journal of Infection Prevention (2017): 1757177417714046.
Scully, Christopher G., Shawn Forrest, Loriano Galeotti, Suzanne B. Schwartz, and David G.
Strauss. "Advancing regulatory science to bring novel medical devices for use in emergency care
to market: the role of the Food and Drug Administration." Annals of emergency medicine 65, no.
4 (2015): 400-403.
Siebrecht, Wayne A., David J. Wesley, David B. Mogill, and Daniel S. Goldberger. "Handpiece
for ultrasonic medical devices including seal for mechanical isolation of ultrasonic driver
assembly." U.S. Patent 8,795,183, issued August 5, 2014.
8 Houser, Kevin L., Foster B. Stulen, William D. Dannaher, Bret W. Smith, David N. Plescia, Michael J. Stokes, Sora Rhee et al. "Medical device
with feature for sterile acceptance of non-sterile reusable component." U.S. Patent 9,072,523, issued July 7, 2015

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Smith, Bret W., David N. Plescia, Michael J. Stokes, Sora Rhee, Timothy G. Dietz, Kevin D.
Felder, Jeffrey L. Aldridge, and Emmanuel V. Tanghal. "Medical device packaging with window
for insertion of reusable component." U.S. Patent 9,089,338, issued July 28, 2015.