apsic and who sterilization and instrument reprocessing guidelines

1

Victoria D. Villanueva, RNConsultant, 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)

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, Malaysia 1

2

3

4

5

Ms Saitip Arnpothong, Thailand

Ms. Victoria Villanueva, Philippines

Mrs Costy Pandjaitan, Indonesia

Dr Ling Moi Lin, Singapore

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:

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

understanding5

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

On all aspects of reprocessing based

on current recognized standards and

are reviewed annually. (i.e., cleaning,

disinfection, sterilization) (8)

7

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

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

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

Managers, supervisors and staff

involved in reprocessing have

completed a recognized

qualification/certification course in

reprocessing practices. (13)

11

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

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

The process and products used for

cleaning, disinfection and/or

sterilization of medical

equipment/devices must be

compatible with the

equipment/devices.(42)

14

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

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

Preventive maintenance program for

pasteurizing equipment must be

implemented and documented.(36)

17

Reprocessing medical

equipment/devices require review

by an individual with infection

prevention and control expertise. (9)

18

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

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

Health care settings shall have a

process for receiving and

disseminating medical device alerts

and recalls originating from

manufacturers or government

agencies. (74)

21

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

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

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

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

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

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

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

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

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

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

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

Victoria D. Villanueva, RNConsultant, 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

published in 2016

contains 120 pages

http://www.who.int/infection-

prevention/publications/decontaminat

ion/en/

34

Cleaning

Disinfection

Sterilization

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.

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

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

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.

All spaces used for the reprocessing

of medical instruments must be

equipped with hand hygiene facilities

at the entrance and exit points.

Preparing devices at the point of use does not

replace the cleaning process - it is the beginning of

the cleaning process.

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.

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.

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

Transparent pouches should be placed paper to

plastic for sterilization. Single instruments only

should be packed in pouches

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

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.

The preferred method for

sterilization of heat-resistant critical

devices is steam/moist heat

sterilization (pre-vacuum sterilization

is preferred).

Physical (notebook, displays and printout)

Chemical (internal and external indicators)

Biological

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.

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.

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.

Don’t do it, but if you do it,

very good reprocessing systems

must be in place

Thank you!