Guidelines on the Issuance of Certificate of Product Registration for Equipment or Devices Used for Treating Sharps, Pathological and Infectious Waste

March 14, 2007

DOH ADMINISTRATIVE ORDER NO. 2007-0014

 

I. RATIONALE/BACKGROUND

The safety of the public against the adverse health and environmental effects of the improper treatment and disposal of health care waste in the Philippines has always been a concern of the society. In order to address this issue, the Department of Health included the regulation of such in Chapter XVIII "Refuse Disposal" of Code of Sanitation of the Philippines (P.D. 856) in April 1998.

In line with 7.10.1 of section 7 of the implementing rules and regulations of Chapter XVIII, "Other types of or methods of solid waste processing and disposal such as incineration technology, microwave technology, autoclave technology and others shall be subject to compliance with pertinent laws and the rules, regulations and standards set by appropriate government agencies".

Pursuant to Joint Department of Environment and Natural Resources-Department of Health (DENR-DOH) Administrative Order No. 02 series of 2005 dated August 24, 2005 entitled "Policies and Guidelines on effective and proper handling, collection, transport, treatment, storage, and disposal of health care wastes" Section V, item b.7, the Department of Health (DOH) shall require all health care waste treatment, storage, disposal (TSD) facility operators and health care waste generators with on-site waste treatment facilities to use DOH registered equipment or devices used for the treatment of health care wastes.

The Bureau of Health Devices and Technology (BHDT) of the DOH is hereby mandated to implement these guidelines for the issuance of Certificate of Product Registration for equipment and devices used to treat sharps, pathological and infectious waste in accordance with the existing rules and regulations of laws relevant to the management of sharps, pathological and infectious waste.

II. SCOPE

These guidelines shall apply to all manufacturers, importers, distributors and users of equipment and devices for treating sharps, pathological and infectious waste in the Philippines. DIcSHE

III. OBJECTIVE

This Administrative Order is developed to establish a guideline with respect to the registration, monitoring and evaluation of devices and equipment used in the treatment of sharps, pathological and infectious wastes with DOH-BHDT to ensure safety and efficiency of said equipment/devices.

IV. DEFINITION OF TERMS

For purposes of this order, the terms below are defined as follows:

1. APPLICANT — shall refer to health care waste TSD facility operator, waste generator with TSD facility, local or foreign individual/establishment that seeks to include its equipment or devices used in treating health care wastes in the BHDT list of registered devices;

2. AUTOCLAVE — shall refer to the treatment process using steam sterilization to render waste harmless;

3. BHDT — shall refer to the Bureau of Health Devices and Technology of the Department of Health;

4. CERTIFICATE OF PRODUCT REGISTRATION (CPR) — shall refer to a certification issued by the Secretary of Health through his duly authorized representative, the Director of BHDT, attesting to the safety and efficacy of the equipment/device;

5. CHD — shall refer to the Center for Health Development of the Department of Health.

6. CHD CERTIFICATION — shall refer to the certification issued by the CHD regional office attesting the validity of the CPR issued by the BHDT upon request of the client.

7. CHEMICAL DISINFECTION — shall refer to the treatment process where chemicals like aldehydes, chlorine compounds, phenolic compounds, etc. are added to waste in order to kill or inactivate pathogens present in health care waste;

8. DOH — shall refer to the Department of Health;

9. DEVICE — shall refer to a piece of equipment including its accessories and appurtenances, used in the treatment of health care wastes;

10. DISTRIBUTOR — shall refer to a person or establishment to where a device is delivered or sold for the purpose of selling to waste treater, TSD facility operators and health care waste generators;

11. HEALTH CARE WASTE GENERATORS — shall refer to health care facilities, institutions, business establishments and other similar health care services with activities or work processes that generate health care waste (Please see Annex A);

12. HRDRD — shall refer to the Health Related Device Regulation Division of the Bureau of Health Devices and Technology (BHDT) of the Department of Health;

13. HYDROCLAVE — shall refer to a treatment process similar to the autoclave where steam, heat and pressure are used; ECSHAD

14. IMPORTER — shall refer to any person or establishment that receives devices used in the treatment of health care wastes from a foreign manufacturer for the purpose of offering them for sale and/or distribution in the Philippines;

15. INFECTIOUS WASTE — shall refer to type of waste suspected to contain pathogens (bacteria, viruses, parasites or fungi) in sufficient concentration or quantity to cause disease in susceptible hosts;

16. ITDI-DOST — shall refer to the Industrial Technology Development Institute of the Department of Science and Technology;

17. MANUFACTURER — shall refer to any maker or assembler of equipment or devices used in treating health care wastes provided that if such a device is manufactured or assembled for another person/establishment who/which attaches his/its own brand name to the product, such shall be deemed the manufacturer;

18. MATERIAL SAFETY DATA SHEET (MSDS) — shall refer to a form containing general information on the properties, safety and potential hazards of a particular chemical;

19. MICROWAVE — shall refer to a technology that typically incorporates some type of size reduction device. Shredding of wastes is being done before disinfection or after disinfection. In this process, waste is exposed to microwaves that raise the temperature to 100°C (237.6°F) for at least 30 minutes. Microorganisms are destroyed by moist heat that irreversibly coagulates and denatures enzymes and structural proteins;

20. NRL-EAMC — shall refer to the National Reference Laboratory for Environmental and Occupational Health, Toxicology and Micronutrient Assay-East Avenue Medical Center in East Avenue, Quezon City;

21. PATHOLOGICAL WASTE — consists of tissues, organs, body parts, human fetus and animal carcasses, blood and body fluids. This category should be considered as a subcategory of infectious waste, even though it may also include healthy parts;

22. PYROLYSIS — shall refer to the thermal decomposition of substance and materials in the absence of supplied molecular oxygen in the destruction chamber in which the said material is converted into gaseous, liquid or solid form;

23. SHARPS — shall include needles, syringes, scalpels, saws, blades, broken glass, infusion sets, knives, nails and any other items that can cause a cut or puncture wounds;

24. TREATMENT, STORAGE AND DISPOSAL (TSD) FACILITIES — shall refer to facilities where hazardous wastes are stored, treated, recycled, reprocessed and/or disposed of, as prescribed under DENR AO No. 2004-36, Chapter 6-2 (Categories of TSD Facilities) (as defined in section IV "Definition of Terms" in the Joint DENR-DOH Administrative Order No. 02 Series of 2005);

25. HEALTHCARE WASTES — shall include all wastes generated as a result of the following:

a. Diagnosis, treatment, management and immunization of humans or animals; TAacCE

b. Research pertaining to the above activities;

c. Producing or testing of biological products; and

d. Waste originating from minor or scattered sources (i.e. dental clinics, alternative medicine clinics, etc.).

V. POLICIES AND GUIDELINES

A. General Guidelines

1. All local manufacturers, importers and distributors, including generators of healthcare wastes that sell and/or use equipment and devices in treating sharps, pathological and infectious wastes shall apply for a Certificate of Product Registration to the Department of Health through the Bureau of Health Devices and Technology if their product falls under any of the following conditions:

a. Equipment and devices that are already installed and in operation prior to the publication of this guideline;

b. New devices and/or equipment (refer to Article X: Transitory Provisions) that shall be used to treat sharps, pathological and infectious waste either for commercial or exclusive use by an institution and/or business entity in the Philippines;

c. Devices or equipment using new technology to treat sharps, pathological and infectious wastes into commercial distribution for the first time in the Philippines;

d. Equipment/device that has undergone significant change in design that could affect safety and efficiency.

The registration shall be applied on a per device per model basis.

2. The following shall be exempted from registration requirements:

a. Manufacturers/distributors and suppliers of equipment and devices used to treat sharps, pathological and infectious waste that are not being marketed or commercially distributed and being used in the Philippines.

b. Autoclaves and sterilizers in hospital laboratories, dermatology and dental clinics that are used only to sterilize surgical instruments, needles, hand pieces and the like.

3. The National Reference Laboratory-East Avenue Medical Center (NRL-EAMC) and the designated laboratories of the DOH shall conduct the performance evaluation tests for wastes samples collected after the treatments that used equipment or devices with reference to regulated reduction levels for different technologies. For the guideline limits for microbiological testing, please see Annex B (NRL-EAMC Guidelines on Microbiological Efficacy Testing).

The results of the performance evaluation shall be valid for three (3) years subject to monitoring by the BHDT. Tests other than microbiological test may be required subject to compliance with the applicable standards such as but not limited to air quality sampling, leachate toxicity characteristics test. IacHAE

4. The following are the approved technologies or processes that may be used in the treatment of sharps, pathological and infectious wastes:

a. Autoclave

b. Hydroclave

c. Pyrolysis

d. Microwave

e. Chemical disinfections

Technologies or processes not listed above that have been given a technology approval by the DOST-ITDI are likewise required to secure a Certificate of Product Registration upon review by the BHDT.

5. The Certificate of Product Registration (CPR) to be issued by the BHDT Director shall be valid for one (1) year from the date of issuance and subject to annual renewal unless sooner suspended or revoked in accordance with the rules of the Department of Health.

6. The following shall be grounds for disapproval or revocation of CPR:

a. Material misrepresentation or concealment of significant data or information about the product sought for certification;

b. Submission of falsified documents by the applicant;

c. Failure of device;

d. Failure to meet the required standards; and

e. Non-reporting of the failure of the device during operation.

B. Specific Guidelines

1. All fees are payable to the Bureau of Health Devices and Technology (BHDT) in accordance with the following schedule. Fees for initial applications shall be based on the total cost of the equipment.

a. The registration fee for initial applications of TSD Facilities, manufacturers/distributors of equipment/device used for the treatment of sharps, infectious and pathological wastes are the following:

Registration Fee	Capitalization (Total Cost of Equipment)
PhP5,000.00	Below PhP1,000,000
PhP8,000.00	PhP1,000,000-PhP5,000,000
PhP10,000.00	Above PhP5,000,000

b. The registration fee for the renewal of the CPR for manufacturers, distributors and TSD facility operators shall be Php3,000.00 per equipment per device. HcACTE

c. The registration fee for initial and renewal applications of healthcare waste generators shall be PhP3,000.00 and PhP2,000.00 per equipment/device respectively.

2. The registration fee is exclusive of the performance evaluation fee.

3. Fees and charges are subject to change, as may be deemed necessary.

4. Filing of renewal for CPR shall be made within two months before the expiration date. A penalty of fifty (50%) percent of the registration fee shall be paid by the applicant for late filing of CPR renewal.

VI. PROCEDURAL GUIDELINES

A. Documentary Requirements

1. Initial CPR Applications of Manufacturers and Distributors

a. Properly filled up application form;

b. Copy of SEC Articles of Incorporation or DTI Certificate of Business Registration (original copy should be presented for verification);

c. Technology Approval from DOST-ITDI for new technologies (original copy should be presented for verification);

d. Certificate of Technical Evaluation from NRL-EAMC or any designated laboratory;

e. Technical Report that includes the following data:

i. Company Profile including the office address and manufacturing plant;

ii. Characteristics and Sources of generated waste;

iii. Detailed description of treatment equipment to be tested including manufacturer's instructions and technical specifications;

iv. Operating procedures and conditions including as applicable treatment time, pressure, temperature, chemical concentration, doses, feed rates and waste load composition;

v. Storage, handling and volume capacity;

vi. Applicable emission controls for suspected emissions;

vii. Potential hazards/toxicities of waste residues;

viii. Energy efficiency;

ix. Occupational safety and health assurance.

f. Copy of Operation Manual of the device/equipment including the Pollution Control Installations, and additional components; ISAaTH

g. Layout/Plans;

i. Location of installation;

ii. Design/Drawing or picture of the device/equipment applied for;

h. Supplementary requirements for equipment/devices used for:

i. Thermal Process (Pyrolysis, Plasma Pyrolysis etc.)

a) Results of Leachate Toxicity Characteristics Tests.

b) Operation/Maintenance Logbook (for healthcare waste generators and TSD Facility only)

ii. Chemical Disinfections

a) Material Safety Data Sheet (MSDS) of the chemicals to be used for disinfections.

b) Results of Microbiological Tests.

c) The chemical to be used should be registered with the DENR-EMB or must be compliant with the WHO guidelines for hazardous wastes.

d) Operations Logbook.

iii. Wet and Dry Thermal Treatment (Autoclave, Microwave, Hydroclave)

a) Results of Microbiological Tests.

b) Operations/Maintenance Logbook.

For healthcare waste generators (e.g. hospitals, clinics) and TSD Facilities, the Environmental Compliance Certificate (ECC) issued by the Environmental Management Bureau-Department of Environment and Natural Resources (EMB-DENR) and the License to Operate issued by the Department of Health shall be submitted together with the above documentary requirements.

2. Renewal applications for CPR of Manufacturers, Distributors, TSD Facility Operators and Healthcare waste generators.

a. Properly filled up application form.

b. Photocopy of issued CPR.

c. Results of valid Microbiological Tests/Leachate Characteristic Toxicity Tests.

d. Location of Installation.

B. Specific Procedures

1. The applicant shall submit all the documentary requirements to the Health Related Device Regulation Division (HRDRD) Secretariat. All information must be submitted in English. When the material is not originally in English, an authenticated translation shall be submitted. BHDT may request the original material at any time. DHIETc

2. The Secretariat shall receive the documents submitted by the applicant and indicate the time and date the documentary requirements were received and issue the Order of Payment for the application.

3. The applicant pays the required fees at the Cashier Section of the DOH, and then submits a photocopy of the receipts upon presentation of the original copy to the Secretariat for further processing of the application. The Secretariat forwards the application to the HRDRD Chief who then assigns an HRDRD technical staff to evaluate the documents.

4. The BHDT-HRDRD technical staff shall evaluate the documents forwarded by the Chief for review of all the requirements. If all the requirements are complete, an ocular inspection shall be undertaken and a report submitted to the HRDRD Chief.

5. The HRDRD Chief shall recommend approval/disapproval of the application based on the following:

a. Completeness of the documents and results of Microbiological Tests of the equipment and/or device.

b. Compliance of the devices/equipment used in health care waste treatment with the provisions of the Philippine Clean Air Act (RA 8749), Toxic and Hazardous Waste Act (RA 6969), Ecological Solid Waste Management Act (RA 9003), The Clean Water Act of 2004 (RA 9275), Sanitation Code of the Philippines (P.D. 856) and other applicable laws.

6. Applicants whose documents have deficiencies shall be notified and be given (30) thirty calendar days abeyance period to correct the deficiencies otherwise the application shall be discarded.

VII. ROLES AND FUNCTIONS OF THE CENTERS FOR HEALTH DEVELOPMENT

A. The Centers for Health Development nationwide shall assist the BHDT in the implementation of this Administrative Order in the following:

1. Disseminate information to the stakeholders regarding the implementation of this Administrative Order (A.O.);

2. Distribute application forms and set of requirements to the clients in remote areas applying for a CPR with the BHDT;

3. Issue the CHD Certification indicating the validity of the issued CPR by BHDT to the clients in remote areas upon request;

4. Coordinate with the BHDT and the local government units in their area of jurisdiction on the implementation of the A.O.;

B. The CHD may receive applications for CPR in remote areas provided that such shall be forwarded to the BHDT office in Manila for evaluation and issuance of CPR.

Clients with valid CPR may opt to get a Certified True Copy (CTC) of the document from the BHDT record's office in lieu of the CHD Certification. TAECSD

VIII. TRANSITORY PROVISIONS

Upon effectivity of this Order, healthcare waste generators/TSD facility with equipment/devices that are already installed and in operation shall be given six (6) months from the date of publication of this Order in leading newspaper to comply with the provisions of this guideline. A certificate of pending application shall be given upon request of the company.

Likewise, manufacturers and distributors of new equipment or devices used in the treatment of sharps, pathogenic and infectious wastes that have been marketed or commercially distributed in the Philippines prior to the publication of this guideline shall be given a grace period of six (6) months upon publication of this guideline to comply with the above requirements.

IX. SEPARABILITY CLAUSE

In the event that any rule, section, paragraph, sentence, clause or words of these rules and regulations is declared invalid for any reason, the other provisions thereof shall not be affected thereby.

X. REPEALING CLAUSE

All administrative orders, rules and regulations and administrative issuances or parts thereof inconsistent with the provisions of this guideline are hereby repealed or amended accordingly.

XI. EFFECTIVITY

This order shall take effect fifteen (15) days after its publication in the Official Gazette or in a newspaper of general circulation.

 

(SGD.) FRANCISCO T. DUQUE III, M.D. M.Sc.Secretary of Health

ANNEX A

Healthcare Waste Generators

1. Birthing Homes

2. Clinics

a. Alternative medicine

b. Ambulatory

c. Dental

d. Dialysis

e. Health care centers and dispensers

f. Medical

g. Surgical

h. Tattooing and piercing establishments

i. Veterinary

3. Drug Manufacturers

4. Hospitals (Primary Care, Secondary Care and Tertiary Care)

5. Infirmaries

6. Institutions

a. Dental Schools

b. Drug rehabilitation center

c. Medical Schools

d. Med-tech intern training centers

e. Nursing Homes

f. Schools of Radiologic Technology

g. Training centers for embalmers

7. Laboratories and Research Centers

a. Animal research and testing

b. Biotechnology laboratories

c. Blood banks and blood collection services

d. Dental prosthetic laboratories

e. Drug testing laboratories

f. HIV testing laboratories

g. Medical and biomedical laboratories

h. Medical research centers

i. Nuclear medicine laboratories

j. Water testing laboratories

8. Mortuary and Autopsy Centers

ANNEX B

January 23, 2007

PROCEDURAL GUIDELINES RELATED TO PERFORMANCE EVALUATION OF EQUIPMENT/DEVICES USED IN TREATMENT OF HEALTH CARE WASTES AND MONITORING OF MICROBIAL TEST OF TREATED WASTES

I. RATIONALE

The purpose of treating health care waste is to change its biological and chemical character, in order to reduce its potential to cause harm to the health workers, the public and the community. There are a number of ways in treating health care waste in order to render them harmless, some of which necessitates the use of treatment devices/equipment. As such, it is critical that criteria be established to determine the efficiency of microbial destruction thru the use of this medical equipment/device and that guidelines for the performance evaluation be formulated to quantitatively define the level of microbial destruction. The safety, efficiency and quality of these equipment/devices are major public health concerns.

To guarantee the quality of the treatment of health care wastes, there is a need for strict regulation in compliance with the standards set by the Department of Health and Department of Environment and Natural Resources.

The Bureau of Health Devices and Technology (BHDT) has been designated to be the agency within DOH to issue Certificate of Product Registration for equipment/devices used in technology treatment of health care waste.

The National Reference Laboratory for Environmental and Occupational Health Toxicology and Micronutrient Assay-East Avenue Medical Center, being the reference and referral laboratory for Environmental Health as well as its designated laboratories shall assist BHDT as its technical arm to issue Certificate of Technical Evaluation. As part of its mandate, the NRL-EAMC and its designated laboratories are tasked to evaluate performance of products relative to environmental health for registration purposes to ensure that all products manufactured, sold and used in the Philippines are safe, of consistent quality and effective.

II. PURPOSE

These guidelines are promulgated to protect the health of the people by ensuring that all health care waste treatment equipment/device shall be validated through performance evaluation prior to commercial marketing.

III. LEGAL MANDATE

Pursuant to Joint DENR-DOH Administrative Order No. 02, s. 2005; on subject regarding "Policies and Guidelines on effective and proper handling, collection, transport, treatment, storage and disposal of health care waste", all Treatment, Storage and Disposal (TSD) facility operators and health care waste generators shall, with on-site waste treatment facilities, use DOH-BHDT registered equipment or devices in the treatment of health care waste.

Department Order No. 393-E s. 2000, created the National Reference Laboratory at East Avenue Medical Center and designated it to be the reference laboratory for Environmental and Occupational Health, Toxicology and Micronutrient Assay. One of its mandates is to conduct technical validation and performance evaluation of reagents, medical equipment and devices. The joint DENR-DOH Administrative Order No. 02, s. 2005 also designated NRL-EAMC as the agency within DOH to issue Certificate of Technical Evaluation.

IV. SCOPE

The guidelines shall cover all equipment and devices used in treatment of health care waste for commercial marketing.

V. DEFINITION OF TERMS

The following are the operational definition of terms used particularly for this guideline:

1. Applicant — refers to an establishment or a natural or juridical person that seeks to evaluate the equipment or device used in treatment of health care waste.

2. Device — for the purpose of this guideline, this shall refer to any of the health care waste treatment equipment/device/system such as steam disinfector, autoclave or microwave.

3. Health care waste sample — refers to untreated waste product generated from health care facilities of infectious nature.

4. Level III inactivation — refers to inactivation of vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites and mycobacteria at a 6 log 10 reduction or greater; and inactivation of B. stearothermophillus spores and B. subtilis spores at a 4 log 10 reduction or greater.

5. Level IV inactivation — refers to inactivation of vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites and mycobacteria and B, stearothermophilus spores at 6 log 10 reduction or greater.

6. Manufacturer's Performance Claim — refers to the technical specifications and capability of the device as claimed by the manufacturer.

7. Performance Evaluation — refers to the process by which the device is subjected to a series of tests to validate the ability of a device to perform as intended and in accordance with associated labeling and in conformance with applicable technical specifications and relevant product standards.

8. Recovery media — refers to culture stock solution containing reagents that ensures optimum growth and revival of organism.

9. Sample Device — refers to the device/equipment/water system submitted for performance evaluation.

10. Steam autoclave — refers to a system of equipment/device that combines moisture, heat and pressure to inactivate microorganisms.

11. Test organism indicators — refers to microbiologic organism with properties of resistance to thermal, mechanical and chemical inactivation and thus can serve as a gauge of effectiveness of waste treatment system. The recommended test organism indicators are the spores of Bacillus subtilis var. niger (BSN) and B. stearothermophilus (BTS).

12. Treated health care waste — refers to health care waste collected and subjected to waste treatment technology.

VI. REQUIREMENTS

1. Letter of endorsement from BHDT

2. Manufacturer Data Submission

To support claims with respect to the particular health care treatment equipment and devices, the applicant/manufacturer is required to submit the following data to NRL or to its designated laboratories.

2.1 List of raw materials used as components of the equipment/device

2.2 Manufacturer's performance claim

2.3 Test Procedures and Manuals written in English

2.4 Certificate of Analysis/Report of Analysis from the manufacturer, * to present original copy

2.5 Performance comparison studies of pre-treated to post treatment of health care waste, * to present original copy

3. Submission of Equipment/Device

3.1 The applicant shall submit the equipment/device to NRL or its designated laboratories for performance evaluation purposes.

3.2 The applicant shall install the device at NRL or its designated laboratories.

3.3 If device is installed in a particular area and cannot be brought to NRL-EAMC or its designated laboratories, staff shall be allowed to go to the area where it is installed and shall carry out the performance evaluation procedure for health care waste sample treatment. Treated health care waste sample shall be analyzed only at NRL or its designated laboratories.

VII. REVIEW and PERFORMANCE EVALUATION

1. Data Review

Upon receipt of the data submitted from the manufacturer, NRL or its designated laboratories shall:

1.1 Review the data submission for completeness and compliance with the manufacturers specifications.

1.2 The applicant shall be given an opportunity to correct any deficiencies and shall be allowed to submit the data a second time within two weeks in case of non compliance with the above requirements.

2. Submission of Sample Device

Upon submission of sample equipment/device the NRL or its designated laboratories shall:

2.1 Inspect equipment/device submitted

2.2 Observe protocols for handling and operation including specifications for cycle of time, temperature and pressure achieved by the equipment/device, size and composition of waste load

3. Performance Evaluation

3.1 The NRL or its designated laboratories shall conduct analysis for health care waste samples collected after the treatment using the equipment/device

3.2 The NRL or its designated laboratories shall use mixture of health care waste samples comprising not less than 50% of the expected volume capacity of the equipment/device. These health care waste samples shall be composed of infectious waste made up cultures and stocks of infectious agents from laboratory work and waste from infected patients like soiled dressings, linen, gown, etc.

3.3 The parameters to be analyzed shall be based on the manufacturer's claims of sterilization or decontamination.

3.4 The NRL or its designated laboratories shall conduct organism recovery tests using appropriate recovery culture media in triplicates.

3.5 Growth of test indicator organisms shall be evaluated thru serial dilution in appropriate medium and quantitation performed thru enumeration of colony forming units (CFU)/ml.

3.6 Three triplicate analysis cycle using double test indicator organism shall be performed.

4. Supplies/Equipment

4.1 Untreated health care waste sample (raw waste)

4.2 Test indicator organism for level IV and level III inactivation:

4.2.1 Bacillus stearothermophilus ATCC 12980-10₆

4.2.2 Bacillus subtilis var. niger ATCC 9372-10₄

4.3 Recovery, differential media, inoculating media and reagents:

4.3.1 Trypticase soy agar

4.3.2 Nutrient agar

4.3.3 FDA Bacteriostasis Agar (FDA)

4.3.4 Beef Extract Glucose Agar (BEGA)

4.3.5 Tyrosine Agar (TYR)

4.3.6 Soybean-casein digest broth

4.4 Colony counter

4.5 Appropriate glassware, e.g. petri dish, test tubes, flask

4.6 Microbiologic incubator

4.7 Commercially prepared spore strips

4.8 Paper disks or strips and brown paper envelopes

4.9 Polypropelyne plastic tubes

5. Equipment/device operation and procedure:

5.1 Use exact protocols established by the manufacturer/package insert/operating manual

6. Health care waste sample:

The health care waste sample shall be prepared as follows:

6.1 Determine the composition and type of the waste load as specified in the manufacturer's manual. The waste sample shall be suitable for each specific medical waste treatment technology. Unsuitable waste samples, like body parts and animal carcasses, radioactive material and hazardous chemicals shall not be used.

6.2 Determine the size of the waste load as specified in the manufacturer's manual. The size of the sample waste to be loaded shall not be less than 50% of the expected volume capacity.

6.3 The waste sample shall oriented and loaded as to density and weight with the heaviest placed at the bottom.

7. Selection and preparation of test organism indicator:

7.1 Bacillus stearothermophilus ATCC 12980 with concentration of 10₆ and Bacillus subtilis var. niger ATCC 9372 at concentration of 10₄ are the organism of choice for the verification of Level IV and III of microbial inactivation respectively. Quantification of spore concentration shall be done using serial dilution and platings of spore suspension prior to strip or disc inoculation.

7.2 The organism shall be impregnated and placed in sterile paper strips or disks and enclosed and sealed in sterile paper envelops.

8. Procedure for test pack preparation and loading

8.1 Dried test spores enclosed in small paper envelopes shall be placed in thermally resistant and steam permeable containers (polypropylene screwcapped container) with lid tightened. A single hole not to exceed 1.0 mm diameter is made in the side of the tube.

8.2 Two packaged test indicator organism shall be placed in the center of the waste load, with an attached string for easy retrieval and containing autoclave indicator tape.

8.3 The test preparation and loading shall be done in triplicate test cycle.

9. Procedure for performance evaluation:

9.1 The equipment/device is operated under normal conditions specified in the manufacturer's package insert/operating manual.

9.2 Duplicate health care waste test samples shall be run and treated in triplicate test run cycles.

9.3 Organism recovery testing shall be done by inoculating aseptically into 5.0 ml soybean-casein digest broth or equivalent media and incubated for at least 72 hours and observed for characteristic visible colony growth. Perform turbidity testing and subculture in differential media for confirmation. Quantify colony number using colony counter and reported in CFU/ml if growth is observed.

n8. Analysis of Results

8.1 Results must be within 95%-100% of the manufacturer's claim.

8.2 To establish level IV, complete inactivation of a minimum of 10₆BTS spores must be consistently killed in triplicate analysis cycle.

8.3 To establish Level III, microbial inactivation, 10₄ of BSN spores must be completely killed in triplicate analysis cycle.

9. Reporting of Results

9.1 Results of performance evaluation shall be released only to Bureau of Health Devices and Technology

9.2 Result of performance evaluation conducted by NRL or its designated laboratories is valid for one year but subject to monitoring

10. Failure to Comply with the Performance Evaluation

10.1 The NRL or its designated laboratories shall inform BHDT for non-compliance of the device or system.

10.2 BHDT shall issue a notice for re-evaluation to applicant whose device failed the performance evaluation as stipulated in items 8.1, 8.2 and 8.3.

10.2 Upon receipt of the notice, the applicant shall be given an opportunity to submit another device of the same type within ten (10) working days.

10.3 A payment equivalent to 70% of the original fee shall be charged for re-evaluation.

10.4 Failure to comply with the requirements within the prescribed period, the results and findings shall be forwarded to BHDT for appropriate action.

10.5 The NRL or its designated laboratories shall conduct re-evaluation of the device of a particular brand thrice. In the event that the third performance evaluation failed, the results shall be forwarded to BHDT for appropriate action.

VIII. PERFORMANCE EVALUATION FEE

1. The fee shall be based on the approved validation testing fee of NRL-EAMC for:

1.1 Health care waste sample preparation

1.2 Sample collection

1.3 Test pack preparation and loading

1.4 Bacteriologic analysis of total six samples

1.5 Safety protocol and requirements of handling hazardous and infectious material.

2. Other incidental expenses (including airfare and accommodation) incurred during sample collection and treatment not conducted at NRL or at its designated laboratories-EAMC shall be borne by the applicant.

3. If there's a complain to the safety, quality and effectiveness of the device within the validity period, BHDT shall inform NRL or its designated laboratories to conduct special test, the testing fee shall be borne by the applicant.

XI. NRL Designated DOH Regional Laboratories

NRL-EAMC shall designate DOH Regional Laboratories (DOH-RL) to assist in the conduct of the evaluation of equipment/devices used in treatment of health care wastes installed in the hospitals/laboratories in their respective regions for a more effective and efficient annual monitoring process.

1. The Designated DOH RL shall undergo training conducted by NRL.

2. The DOH-RL shall conduct performance evaluation submitted only by the users in their respective regions.

3. The DOH-RL shall follow the guidelines on performance evaluation set by NRL-EAMC.

Prepared by:

(SGD.) SOCORRO C. YANEZ, M.D.

Approved by:

(SGD.) ROLAND L. CORTEZ, M.D., MHA, CESECenter

n   Note from the Publisher: Copied verbatim from the official copy. Duplication of paragraphs 8 and 9.