Republic of the Philippines 
House of Representatives 
Quezon City 
19th Congress 
Third Regular Session 
House Bill No. 11282
======================================================================= 
Introduced by HONORABLE PETER B. MIGUEL 
======================================================================= 
AN ACT MANDATING TO PROFESSIONALIZE AND ELEVATE THE STERILE 
PROCESSING AS A CRITICAL COMPONENT OF HEALTHCARE QUALITY AND PATIENT 
SAFETY AND DEVELOP THE INTERNATIONAL STANDARD, RESOURCES AND BEST 
PRACTICES IN STERILIZATION SCIENCES 
EXPLANATORY NOTE 
The State declares that it shall protect and promote the right to health of all Filipinos. Therefore, the 
State shall take appropriate steps to ensure that the exercise of this right will be beneficial and not 
detrimental to patients and public health.  
The right to health includes the right to be provided with safe medical care and procedures. It includes 
the expectation that when one seeks medical assistance, they will be able to go home treated and well. 
One seeks medical assistance to become better and not to contract diseases and infections while being 
treated. One in thirty-one (1 in 31) hospital patients has at least one healthcare-associated infection (HAI). 
In fact, Southeast Asia has been pinpointed by the World Health Organization as the region that has 
the highest frequency of people suffering from infectious complications acquired in healthcare facilities.  
HIAs are infections that are acquired by patients during their hospital stay, which may manifest during 
or even 
after 
their 
discharge. 
These 
infections 
are 
largely 
a 
direct 
result 
of 
poor 
sterilization, decontamination, and disposal of wastes. The decontamination of reusable devices plays a 
vital role in preventing the transmission of healthcare-associated infections. Of equal importance is the 
disposal of single-use devices which should not be reused. These processes are often 
unregulated and not standardized 
and 
remain 
as 
hazards 
to 
patients 
and 
practitioners 
alike. 
The 
processes 
of decontamination are complex, require specific infrastructure and 
equipment and involve several steps that need to be precise, from device collection, receipt by the 
unit, processing and storage, up to distribution throughout the facility. 
Emphasizing the need to address this problem, the recent pandemic brought about a concrete example 
of how fast viruses can spread when not properly contained. It was an unprecedented outbreak which 
paralyzed not only the medical but also the economic, social and political fields of our country. The virus 
began as a local outbreak which, through transmission, became a global pandemic.  
In the Philippines alone, at least 3 million were affected. Thus, there is a need for established standards 
which will prevent the transmission of microorganisms to personnel and patients; minimize damage to 
medical equipment due to foreign materials or inappropriate handling and to ensure that medical 
devices are disinfected and sterilized as required for reuse. In our country, infections acquired in 
healthcare settings are among the major causes for death and increased morbidity among 
hospitalized patients. This becomes both a burden for the patients and a threat to public health and 
safety.  
In conclusion, the standardization of sterile processing, decontamination and disinfection are vital 
to keeping infection prevention and control both inside the health care facility and outside of it. It 
ensures patient safety as well as the safety of our healthcare workers. 
Through this Act, healthcare associated infections will be monitored, prevented, and ultimately 
eliminated. With this purpose in mind, the immediate approval of this bill is strongly requested. 
PETER B. MIGUEL 
Representative, 2nd District South Cotabato 
January 14, 2025
5:09 pm


Republic of the Philippines 
House of Representatives 
Quezon City 
19th Congress 
Third Regular Session 
House Bill No. 11282 
======================================================================= 
Introduced by HONORABLE PETER B. MIGUEL 
======================================================================= 
AN ACT MANDATING TO PROFESSIONALIZE AND ELEVATE THE STERILE 
PROCESSING AS A CRITICAL COMPONENT OF HEALTHCARE QUALITY AND PATIENT 
SAFETY AND DEVELOP THE INTERNATIONAL STANDARD, RESOURCES AND BEST 
PRACTICES IN STERILIZATION SCIENCES 
Be it enacted by the Senate and House of Representatives of the Philippines in Congress 
assembled: 
SECTION 1. Short Title. – This Act shall be known as the “Sterile Permit Act of the Philippines.” 
SECTION 2. Declaration of Policy. – The State shall promote, foster, nurture, and protect the 
right to health of the people by issuing policies and standards intended for use by healthcare 
members and for use by health care facilities to help ensure that reusable medical instruments 
are sterilized and decontaminated for patient use, work spaces have been properly disinfected 
and single use devices have been disposed of properly.  
SECTION 3. Definition of Terms. - As used in this Act, the following terms shall mean: 
1. Central Services: service which provides cleaning, storing, and dispensing of supplies
and equipment required for all aspects of patient care.
2. Central Sterile Services Department: area in the hospital where medical devices, both
sterile and non-sterile, are cleaned, packed, disinfected/sterilized, stored and then issued
for patient care.
3. Sterilization: Sterilization describes a process that destroys or eliminates all forms of
microbial life and is carried out in health-care facilities by physical or chemical methods.
4. Cleaning: The removal of visible soil (e.g., organic and inorganic material) from objects
and surfaces and normally is accomplished manually or mechanically using water with
detergents or enzymatic products.
5. Decontamination: Process of cleaning and disinfecting soiled medical devices to render
then safe for handling and to the extent necessary for subsequent processing.
6. Disinfection: Process that kills pathogenic and other microorganisms by physical or
chemical means. Disinfection destroys most recognized pathogenic microorganisms but
not necessarily all microbial forms, such as bacterial spores. Disinfection processes do
not ensure the margin of safety associated with sterilization processes.
7. Health care products: Medical devices, including in vitro diagnostic medical devices, or
medicinal products, including biopharmaceuticals.
8. Health care facility: Specialized facility where professionals deliver services utilizing
medical devices. It means hospitals, nursing homes, extended-care facilities, free-
standing surgical centers, clinics, and medical and dental offices.


9. Contaminated: Presence of potentially infectious, pathogenic organisms (e.g., found in 
blood or other potentially infectious material) in or on an object. 
 
10. Decasing/breakout area or space: Unpacking area or space where products are removed 
from their external shipping containers before being taken into the preparation and 
packaging area or the sterile storage area. 
 
11. Decontamination room: Room designated for collection, retention, and cleaning of soiled 
and/or contaminated items. 
 
12. Labeling: Any legend, work, or mark attached to, included in, belonging to, or 
accompanying any medical device or product. 
 
13. Loaned items: Medical devices used in health care facilities that are not owned by the 
facility 
 
14. Medical device: Instrument, apparatus, material, or other article, whether used alone or 
in combination, including the software necessary for its proper application, intended by 
the manufacturer to be used for human beings for the purpose of: 
• diagnosis, prevention, monitoring, treatment, or alleviation of disease; 
• diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or 
handicap; 
• investigation, replacement, or modification of the anatomy or of a physiological 
process; or 
• control of conception; and 
• which does not achieve its primary intended action in or on the human body by 
pharmacological, immunological, or metabolic means, but which may be assisted 
in its function by such means. 
15. Medical washer: Device that is intended for general medical purposes to clean and dry 
surgical instruments, anesthesia equipment, hollowware (e.g., basins, medicine cups), 
and other medical devices. 
 
16. Occupational exposure: Contact, through inhalation, ingestion, skin contact, or 
absorption, with a potentially hazardous material during the course of employment. 
 
17. Office-based health care facility: Health care facility designed for short-term treatment of 
ambulatory patients (e.g., freestanding surgical centers, clinics, and medical and dental 
offices). 
 
18. Personal protective equipment (PPE): Specialized clothing or equipment worn for 
protection against hazardous materials, blood-borne pathogens, or other potentially 
infectious materials. 
 
19. Prions: Transmissible pathogenic agents that cause a variety of neurodegenerative 
diseases of humans and animals, including scrapie in sheep and goats, bovine 
spongiform encephalopathy (BSE) in cattle, and Creutzfeldt-Jakob disease (CJD) in 
humans. They are unlike any other infectious pathogens, including viruses, because they 
are composed of an abnormal conformational isoform of a normal cellular protein, the 
prion protein (PrP). Prion diseases are disorders of protein configuration involving 
template-assisted replication and resulting in abnormal protein accumulation in the brain, 
which causes neuronal dysfunction, degeneration, and death. Prions are extremely 
resistant to inactivation by heat and disinfecting agents.  
 


20. Process failure: Condition in which one or more monitored parameters of cleaning, 
sterilization, or packaging is outside the defined specification for that parameter. 
 
21. Pyrogen: Fever-producing substance. Debris from killed microorganisms can be 
pyrogenic. Limiting the bioburden before sterilization minimizes this debris. 
 
22. Qualified: As the term is used with respect to personnel, prepared by training and 
experience to perform a specified task. 
 
23. Restricted area: Area where access and traffic are limited to authorized personnel and 
where special attire is required. 
 
24. Reusable medical device: Device intended for repeated use on different patients, with 
appropriate decontamination and other processing between uses. Examples include 
surgical instruments, endoscopes, basins, and electromedical equipment. 
 
25. Spaulding Classification: The selection of a disinfectant must be based, in part, upon the 
intended use of the device and the degree of disinfection required for that device. The 
Spaulding Classification System divides patient care items into three categories, each 
based on the degree of risk of infection when the items are used in patient care. the 
Center for Disease Control and Prevention (CDC) and the Association for the 
Advancement of Medical Instrumentation (AAMI) use the Spaulding Classification System 
in their guidelines and standards. The three Spaulding categories are: 
 
a. Critical items - Instruments or objects introduced directly into the bloodstream or 
into other sterile areas of the body; examples include surgical instruments, cardiac 
catheters and implants, these items must be sterilized before use (disinfection is 
inadequate). 
 
b. Semi-critical items - Although these items come in contact with intact mucous 
membranes, they do not ordinarily penetrate body surfaces. Examples include 
non-invasive flexible fiberoptic endoscopes, endotracheal tubes and anesthesia 
breathing circuits. Semi- critical items should be subjected to a high- level 
disinfection process that can be expected to destroy all microbial organisms, but 
not necessarily microbial spores. 
 
c. Non-critical items -These items usually come into direct contact with the patient’s 
unbroken skin. Examples include crutches and countertops. These items require 
thorough Cleaning, and in some cases, low- level disinfection to intermediate-level 
disinfection. 
 
26. Sterile: Free from viable microorganisms. 
 
27. Sterile processing department/area: Area within a health care facility that processes and 
controls medical supplies, devices, and equipment, sterile and not sterile, for some or all 
patient care areas of the facility. 
 
28. Sterile storage room: Room designed to store clean and sterile items and protect them 
from contamination. 
 
29. Sterilization cycle: Defined sequence of operational steps designed to achieve 
sterilization and carried out in a sealed chamber. 
 
30. Transmission-based precautions: Precautions designed for patients documented or 
suspected to be infected with highly transmissible or epidemiologically important 
pathogens for which additional precautions beyond standard precautions are used to 
interrupt transmission in health care facilities. There are three types of transmission-
based precautions: airborne precautions, droplet precautions, and contact precautions. 


 
31. Work practice controls: Safe work practices that reduce the risk of exposure to blood-
borne pathogens and other potentially hazardous materials. 
Section 3. Sterile Permits. — No hospital, government or private, health care facility, office-
based health care facility or any establishment providing medical or diagnostic services shall be 
allowed to operate unless plans have been approved and a sterile permit is issued by the 
licensing agency as defined in this Act. 
Section 4. Licensing Agency. – For purposes of setting standards in sterile processing, the 
Health Facilities and Services Regulatory Bureau and the Regulation Licensing and 
Enforcement Division within the regional offices, in addition to its present duties shall act as the 
licensing agency. The Secretary of Health shall reorganize this Bureau to include a staff of 
hospital infection prevention and control practitioners, hospital administrators, sanitary 
engineers, at least two (2) prominent citizens from the private sector who have distinguished 
themselves in their profession or fields of central services and sterile management and such 
personnel as may be necessary to carry out the purposes of this Act without necessarily 
increasing the present personnel strength of this Bureau. 
Section 5. Powers and duties of the licensing agency. - the Licensing/Accreditation of Health 
Facilities and Services under the Health Facilities and Services Regulatory Bureau, shall have 
the following powers and duties: 
a. To conduct an ocular survey of all existing health care facilities and hospitals in the 
Philippines, government or private, with a view to determine their fitness to operate 
considering their respective Central Sterile Services Department. 
b. To prescribe guidelines for processing of medical devices according to the Spaulding 
classification for the intended level of use. 
c. To provide for the standardization of decontamination, disinfection and sterilization 
processes in line with validated required standards as prescribed by the Department of 
Health and best practices  
d. To ensure that healthcare facilities are providing medical devices that are safe to use 
on patients 
e. To approve plans for healthcare facilities and hospitals, government or private, and to 
issue sterile permits to hospitals in accordance with the provisions of this Act. 
d. To keep a permanent register of licensed health care facilities or those issued licenses 
to operate indicating the name of the facility, address or location, type of facility, name of 
the director or administrator, ownership, number of authorized beds and bassinets and 
such other pertinent data as may be necessary. 
e. To grant licenses for the operation and maintenance of hospitals or revoke the same 
in accordance with the provisions of this Act. 
f. To make periodic inspection of all hospitals so as to check compliance with rules and 
regulations legally promulgated or with the provisions of this Act and to make 
recommendations to directors or administrators of hospitals for the correction of defects 
found during such inspections. 
g. To publish yearly a list of all approved hospitals indicating the name, location, type, 
authorized beds, and name of the director or administrator. 
h. To make a yearly report of infection rates due to HAIs within the licensed hospitals and 
the steps taken by such hospitals to control such. 
h. To submit yearly reports to the Secretary of Health, the Speaker of the House of 
Representatives, the President of the Senate and the chairmen and members of the 
Committees on Health of both Houses of Congress, such reports to include a list of 
approved health care facilities indicating the name of the facility, location, bed capacity 


and name of the director or administrator and make recommendations on hospital needs 
or requirements for hospital central sterile services.  
Section 6. Filing of Application for Sterile Permit.— Application for a sterile permit shall be 
submitted to the Office of the Director, Bureau of Medical Services in a form prescribed by the 
latter and accompanied by a decontamination plan proposed to be implemented. The application 
shall state the name of the healthcare facility, ownership, location and type of facility. 
Section 7. Minimum Standards for Issuance of Sterile Permit.— In order that a sterile permit 
can be issued the hospital plan shall provide a specified plan for cleaning, disinfection and 
sterilization for its medical devices and workspaces. There must also be a decontamination 
room/area, disinfection room/area, a medical washer, a decasing/breakout area or space, a 
sterile processing department/area and sterile storage room/area. There must also be a showing 
of proper labeling in the required areas as well as procedures for dealing with loaned items.  
There must also be specified plans containing personnel qualifications, PPE requirements, work 
practice controls, transmission-based precautions, and dealing with process failures, 
occupational exposures, prion and pyrogen outbreaks.  
Section 8. Inspection.— A sterile permit shall be issued by the licensing agency only after a 
representative of the licensing agency has conducted an ocular inspection and certified that the 
applicant has satisfactorily complied with requisites prescribed in this Act. The sterile permit shall 
be renewed every year upon payment of the prescribed fees. 
Section 9. Revocation of License.— The licensing agency may suspend or revoke a license 
already issued for any of the following grounds: (a) repeated violation by the licensee of any 
provision of this Act or of any other existing law; (b) repeated violation of rules and regulations 
prescribed in the implementation of this Act; or (c) repeated failure to make necessary 
corrections or adjustments required by the licensing agency in the improvement of facilities and 
services. 
Section 10. Hearing.— Any person, association, corporation, or any other private entity who 
has been refused a sterile permit or whose permit has been suspended or revoked shall be 
entitled to an administrative hearing to be conducted by the Secretary of Health and his two 
undersecretaries to determine the justifiability of such denial, suspension or revocation of the 
permit: Provided, That such party may resort to the courts, as in other cases provided by law. 
Section 11. Separate Permits Required.— Separate permits shall be required for health care 
facilities or branches thereof maintained in separate premises, even though they are operated 
under the same management: Provided, However, That separate permits shall not be required 
for separate buildings in the same compound: Provided, further, That permits of buildings within 
the same compound shall also be secured from the licensing agency to determine compliance 
with standards and requirements herein authorized. 
Section 12. License not transferable.— The permit shall not be transferable. The licensing 
agency shall be notified of any change in ownership, change of name of the health care facility, 
and transfer of location and in the latter case, an application for a new permit should be 
submitted. 
Section 13. Rules and Regulations.— The Health Facilities and Services Regulatory Bureau 
acting as a licensing agency and subject to the approval of the Secretary of Health, shall 
promulgate rules and regulations to implement the provisions of this Act. 
Section 14. Fees.— Each applicant for a sterile permit shall pay the amount of five hundred 
pesos as permit fee. A registration fee of five hundred pesos and an annual license fee of one 
thousand pesos shall likewise be collected for each hospital and for each approved 
license: Provided, That a government hospital shall be exempt from the payment of such fees. 
The amount herein collected shall be officially receipted by the licensing agency and shall 
constitute as a revolving fund for the use of the licensing agency. 
Section 15. Penalties.— Any person, partnership, association, or corporation who establishes, 
operates, conducts, manages or maintains a hospital or health care facility within the meaning 


of this Act without first obtaining a permit as provided for in this Act or violates any provision 
hereof shall be guilty of a misdemeanor, and upon conviction thereof shall be liable to a fine of 
not more than five hundred pesos for the first offense and not more than one thousand pesos 
for each subsequent offense, and each day that the hospital shall operate after the first 
conviction shall be considered a subsequent offense. 
Section 16. Effectivity.— This Act shall take effect upon its approval. 
Approved,