(HLTINF002)- Process Reusable Medical Devices and Equipment

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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