Medical Personal Protective Equipment (PPE) along with administrative, environmental and engineering controls play a crucial role in protecting health professionals. PPEs are used to minimize their risks of exposures to infectious diseases while caring for patients.
The COVID-19 pandemic coupled with supply chain disruptions resulted in the abrupt surge of demand for PPEs like face masks and other medical apparels. As businesses repurpose to producing and testing PPEs for healthcare workers, the need to know the fundamentals of testing, best practices and applications of products has emerged. A new supplier or manufacturer marketing PPE in the healthcare industry should be aware of relevant standards and regulations to make sure that their products are fit for purpose and safe for use.
Recognizing the demand for more information and support to the supply and manufacture of PPE, the Philippine Accreditation Bureau – Promotion and Documentation Division (PAB-PDD) conducted the webinar, “Accreditation: Ensuring the Quality of Medical Personal Protective Equipment (PPE)” on December 21, 2020. Forty-five participants from the government and private sectors, particularly those who are engaged in the supply, manufacture and use of PPEs joined this webinar.
The speakers provided knowledge on standards and regulatory changes in the current market conditions for PPEs, ventilators, and respirators in light of COVID-19. The DOH-FDA’s requirement that testing of the finished products (PPEs) be done by the appropriate accredited laboratory of PAB was also emphasized on the said webinar.
“Accreditation of Conformity Assessment Services,” as discussed by Ms. Amor F. Lahoz, Chief of PAB-PDD, highlighted the role of accreditation in ensuring the quality of PPEs through accredited testing, certification or inspection. Accreditation is an added quality assurance that warrants the compliance of CABs to standards, quality, safety and integrity.
Mr. Marthy Cantillo of Intertek Testing Services Philippines Inc. provided a lecture on “Ensuring the Quality of Medical Personal Protective Equipment through Testing.” Thorough and accurate testing capabilities deliver assurance that products can provide sustained protection even in the most stressful and hazardous conditions.
Dir. Maria Cecilia Credo Matienzo of Food and Drug Administration’s Center for Device Regulation, Radiation Health, and Research (FDA-CDRRHR) informed how their agency promotes quality and safety of PPE to the general public, on her presentation entitled, “Ensuring the Quality of Medical Protective Equipment”. She also provided information on how manufacturers and suppliers can comply with FDA-CDRRHR’s requirements by discussing the Application of License to Operate (LTO); Application of Certificate of Medical Device Notification (CMDN); and Application of Certificate of Medical Device Registration (CMDR). To further provide guidance, she also discussed the, “FDA Circular 2020-014 Interim Guidelines on the Manufacture of Personal Protective Equipment (PPE), Ventilators, and Respirators in Light of COVID-19 Situation”.
This webinar was arranged to help our stakeholders, consumers and businesses meet relevant regulations and comply with prescribed standards as well as appreciate the role of accreditation in complying with these requirements.
Personal protective equipment is equipment to minimize exposure to hazards that can cause serious workplace injuries and illnesses. These injuries and illnesses may result from contact with chemical, radiological, physical, electrical, mechanical, or other workplace hazards. PPE may include items such as gloves, safety glasses and shoes, earplugs or muffs, hard hats, respirators, or coveralls, vests and full body suits.
All personal protective equipment should be safely designed and constructed, and should be maintained in a clean and reliable fashion. It should fit comfortably, encouraging worker use. If the personal protective equipment does not fit properly, it can make the difference between being safely covered or dangerously exposed. When engineering, work practice, and administrative controls are not feasible or do not provide sufficient protection, employers must provide personal protective equipment to their workers and ensure its proper use.
If a PPE program should be implemented, this program should address the hazards present; the selection, maintenance, and use of PPE; the training of employees; and monitoring of the program to ensure its ongoing effectiveness.
For more information about PAB’s services and events, log on to www.dti.gov.ph/pab or email us at pab@dti.gov.ph.
Release Date: 28 December 2020