A Lecture by Ms. Victoria Villanueva, RN during the 23rd PHICS Convention at the Crowne Plaza Galleria Manila

1. 1
Victoria D. Villanueva, RN
Consultant, Chong Hua Hospital, Cebu City
Former Associate Director, St. Luke’s Medical Center, QC & GC
Past President, Phil. Hospital Infection Control Society
Past President, Phil. Hospital Infection Control Nurses Association
Board Member, Asia Pacific Society of Infection Control (ASEAN)

2. The ASEAN Guidelines For Disinfection
and Sterilization of Instruments in
Healthcare Facilities
THE ASEAN GUIDELINES
FOR DISINFECTION AND STERILIZATION OF INSTRUMENTS IN
HEALTH CARE FACILITIES

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Dr. Le Thi Anh Thu, Vietnam
Members:
Chairperson:
would like to acknowledge the contribution and expertise of the ASEAN
Chapter that developed this document:
Prof. Nordiah A Jalil, Malaysia1
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Ms Saitip Arnpothong, Thailand
Ms. Victoria Villanueva, Philippines
Mrs Costy Pandjaitan, Indonesia
Dr Ling Moi Lin, Singapore

4. 4
1. Infection Control Association of Singapore (ICAS)
2. Philippine Hospital Infection Control Society Inc. (PHICS)
3. Philippine Hospital Infection Control Nurses Association Inc. (PHICNA)
4. Association of Infection Prevention Control Nurse Indonesia
5. Ho Chi Minh City Infection Control Society (HICS)
Endorsed by:

5. written in 2012
contains 70 pages
has 81 recommendations
http://apsic.info/documents/The-ASEAN-
Guidelines-for-Disinfection-and-Sterilisation-of-
Instruments-in-Health-Care-Facilities.pdf
clustered or grouped into topics which have
similarities (by the undersigned) for easier
understanding
5

6. 9) Oversight
10) Audit
11) Recall
12) Cleaning
13) Disinfection
(Pasteurization)
14) Disinfection of
Endoscopes
15) Sterilization
16) Single-use Device
1) Policies and Procedures
2) Physical Environment
3) Education and Training
4) Separation of Clean from
Dirty
5) Product Selection
6) Compatibility
7) Safety (to the worker,
medical equipment, and
environment)
8) Preventive Maintenance
Program 6

7. On all aspects of reprocessing based
on current recognized standards and
are reviewed annually. (i.e., cleaning,
disinfection, sterilization) (8)
7

8. Ideally, reprocessing should be done in a
centralized area that complies with the physical
and human resource requirements. (1)
Reprocessing performed outside the centralized
area must be kept to a minimum. (15)
The decontamination work area shall be physically
separated from clean areas by walls or partitions.
(16)
8

9. Air quality must be monitored when using
products that produce toxic vapors and
mists when disinfection and sterilization is
performed. (17)
Ventilation shall be such to remove toxic
vapors generated by or emitted from
cleaning and disinfecting agents.(50)
9

10. Specific requirements for, frequency of
education and training; competency
assessment for all personnel involved in
reprocessing of medical equipment/devices (11)
All aspects of reprocessing shall be supervised
and shall be performed by knowledgeable,
trained personnel. (12)
10

11. Managers, supervisors and staff
involved in reprocessing have
completed a recognized
qualification/certification course in
reprocessing practices. (13)
11

12. Contaminated equipment/devices shall
not be transported through areas
designated for storage of clean or sterile
supplies, client/patient/resident care areas
or high-traffic areas.(28)
Sterile and soiled equipment/devices
shall not be transported together.(29)
12

13. Products used for any/all stages in
reprocessing (i.e., cleaning, disinfection,
sterilization) must be approved by the
committee responsible for product
selection, by an individual with
reprocessing expertise and by an
individual with infection prevention and
control expertise. (39)
13

14. The process and products used for
cleaning, disinfection and/or
sterilization of medical
equipment/devices must be
compatible with the
equipment/devices.(42)
14

15. Occupational Health and Safety for the
healthcare setting will review all protocols for
reprocessing medical equipment/devices to
eliminate or minimize the risk of exposure of
hcws.(19)
Appropriate personal protective equipment
(PPE) should be worn for all reprocessing
activities.(21)
15

16. All staff working in reprocessing shall be
offered Hepatitis B immunization unless
they have documented immunity to
Hepatitis B. (22)
Prevent and manage injuries from sharp
objects.(23)
Immediate response to worker exposure
to blood and body fluids. (24) 16

17. Preventive maintenance program for
pasteurizing equipment must be
implemented and documented.(36)
17

18. Reprocessing medical
equipment/devices require review
by an individual with infection
prevention and control expertise. (9)
18

19. Audits of the cleaning process must be
done on a regular basis. (7)
The process of high-level disinfection
requires monitoring and auditing. If a
chemical product is used, the
concentration of the active ingredient(s)
must be verified and a logbook of daily
concentration test results is to be
maintained. (34)
19

20. Recall of improperly reprocessed
medical equipment/devices. (10)
The recall procedure should include
assessment of client/patient/resident risk
and a procedure for subsequent
notification of physicians,
clients/patients/residents, other facilities
and/or regulatory bodies if indicated. (73)
20

21. Health care settings shall have a
process for receiving and
disseminating medical device alerts
and recalls originating from
manufacturers or government
agencies. (74)
21

22. There must be a regular schedule for
environmental cleaning in the Sterile
Processing Department that includes
written procedures and clearly defined
responsibilities.(18)
Reusable medical equipment/devices
must be thoroughly cleaned before
disinfection or sterilization.(3)
22

23. If cleaning cannot be done immediately, the
medical equipment/device must be submerged
in tepid water and detergent or enzymatic
cleaner to prevent organic matter from drying
on it.(4)
The process for cleaning should include
written protocols for disassembly, sorting,
soaking, physical removal of organic material,
rinsing, drying, physical inspection, lubrication
and wrapping.(6) 23

24. Two major methods of disinfection:
Chemical
Pasteurization
Pasteurization is a process of hot water
disinfection (minimum 71°C for 30 minutes),
which is accomplished through the use of
automated pasteurizers or washer disinfectors.
Semi-critical medical equipment/devices suitable
for pasteurization include equipment for
respiratory therapy and anesthesia. 24

25. Disposable sheaths/condoms placed over the
endoscope reduce the numbers of microorganisms
on the scope but do not eliminate the need for
cleaning/disinfection/sterilization between uses. (47)
Endoscope cleaning shall commence immediately
following completion of the clinical procedure. (51)
Patency and integrity of the endoscope sheath
should be verified through leak testing, performed
after each use. (52)
25

26. Critical endoscopes shall be sterilized. (54)
Semi-critical endoscopes and accessories
(excluding biopsy forceps and brushes) must
receive at least high-level disinfection after
each use. (55)
If an automated endoscope reprocessor
(AER) is used, ensure that the endoscope and
endoscope components are compatible with
the AER. (57) 26

27. Semi-critical endoscopes shall be stored
hanging vertically in a well-ventilated area in a
manner that minimizes contamination or
damage. Endoscopes shall not be coiled,
allowed to touch the floor or bottom of the
cabinet while hanging, or stored in their cases.
(59)
27

28. Healthcare settings shall have policies in place
providing a permanent record of endoscope
use and reprocessing, as well as a system to
track endoscopes and patients/residents that
includes recording the endoscope number in
the patient/resident record. (62)
28

29. The preferred method for sterilization of heat-
resistant equipment/devices is steam. (pre-vacuum
sterilizers are preferred). The preferred
sterilization method for heat sensitive instruments
would be low temperature sterilization. (63)
All sterilizers must be tested for performance
using physical, chemical and biological monitors
and indicators. Chemical indicators do not replace
the need to use a biological indicator. (64)
29

30. Flash sterilization shall only be used in
emergency situations and must never be used
for implantable equipment/devices. (65)
Boiling, use of ultraviolet light, glass bead
sterilization, and use of microwave ovens are
NOT acceptable methods of sterilization. (66)
30

31. The health care setting must have written
policies regarding single-use medical
equipment/devices. (75)
Critical and semi-critical medical
equipment/devices that are SUDs must not be
re-used unless the reprocessing is done by a
licensed reprocessor. (76)
Needles must be single-use and must not be
reprocessed. (77)
31

32. Catheters, drains and other medical
equipment/devices with small lumens
(excluding endoscopy) be designated as
SUD and not be reprocessed and re-
used, even if designated as reusable by
the manufacturer. (78)
32

33. Victoria D. Villanueva, RN
Consultant, Chong Hua Hospital, Cebu City
Former Associate Director, St. Luke’s Medical Center, QC & GC
Past President, Phil. Hospital Infection Control Society
Past President, Phil. Hospital Infection Control Nurses Association
Board Member, Asia Pacific Society of Infection Control (ASEAN)
, 2016

34. published in 2016
contains 120 pages
http://www.who.int/infection-
prevention/publications/decontaminat
ion/en/
34

36. Cleaning
Disinfection
Sterilization

39. It is not recommended that
housekeeping staff be involved in
cleaning medical devices unless they
have been trained and certified and
moved into the SSD staffing structure.

40. Educational requirements and qualifications:
Entry level operator: high school leaving certificate
Two-year trained operator: completion of the basic
SSD curriculum
Five-year trained operator or supervisor: completion
of the intermediate SDD curriculum
More than 8 years of training or manager level:
completion of the advanced SDD curriculum

41. Medical devices processed outside the
SSD cannot be controlled and are
considered unsafe unless these processes
are under the supervision of highly-
trained staff of a similar calibre to those
in the SSD.
41

42. The of the SSD is to provide
safe, reprocessed, reusable, invasive
medical devices for clinical procedures,
carried out on wards, critical care areas,
ambulatory surgery, nutrition, dialysis and
endoscopy.
The of the SSD is to
receive, clean, decontaminate, package,
sterilize and distribute medical devices.

43. All spaces used for the reprocessing
of medical instruments must be
equipped with hand hygiene facilities
at the entrance and exit points.

45. Preparing devices at the point of use does not
replace the cleaning process - it is the beginning of
the cleaning process.

46. Cleaning is the first and most essential step before
any process of disinfection or sterilization can be
carried out.
One can clean without sterilizing, but one cannot
sterilize without cleaning!
Enzymatic cleaners are NOT disinfectants; they only
remove protein from surfaces.

47. Brushes should be thermally disinfected and
dried at the end of the day. If this is not
possible, they should be cleaned and left dry.
Brushes must be replaced when damaged.
Chemical disinfection prior to cleaning is
unnecessary, ineffective and of little value in
the presence of organic matter.

49. Sterilization wrap made from cellulose fibres and
non-wovens made from a combination of cellulosic
and synthetic fibres may be used. Both types are
suitable for porous-load steam sterilization and
most gas processes because they are permeable to
air, steam and other gases.
Rigid reusable sterilization containers should be
suitable for the method of sterilization used and
compatible with the cleaning method and cleaning
agent

50. Transparent pouches should be placed paper to
plastic for sterilization. Single instruments only
should be packed in pouches

51. Metal (sterilization) drum trays with holes that can
be opened and closed manually. These do not
guarantee sterility of its contents
Newspapers, brown paper bags and other products
that do not allow air removal or penetration of
steam must not be used
Recycled material packaging because these have lost
their integrity and the bacterial barrier and do not
allow adequate air removal or steam penetration

52. The total weight of instrument sets and
their packaging should not exceed 10 kg
and the total weight of wrapped basin sets
should not exceed 3 kg.

69. The preferred method for
sterilization of heat-resistant critical
devices is steam/moist heat
sterilization (pre-vacuum sterilization
is preferred).

70. Physical (notebook, displays and printout)
Chemical (internal and external indicators)
Biological

71. Also known as Flash Sterilization.
This sterilization method should be avoided as
the material is sterilized without packaging and
the cycle eliminates drying. As a result, the
possibility of recontamination of the material
increases.

85. Any person who reprocesses or reuses a device
intended by the manufacturer for single use bears
full responsibility for its safety and effectiveness and
becomes the manufacturer.

86. A reusable device, such as a surgical instrument, is
designed to be used many times on different
patients, and the manufacturer provides detailed
instructions on how it can be safely reprocessed
between each patient.
A single-use device is designed by a manufacturer to
be used on a single patient only and then discarded.
Emphasis is on a “single patient” and a device may
be used multiple times on the same patient,
depending on its design and manufacturers’
instructions.

87. Don’t do it, but if you do it,
very good reprocessing systems
must be in place

88. Thank you!