Republic of the Philippines Department of Health Food and Drug Administration INITIAL MEETING AND CONSULTATION MEDICAL OXYGEN-GENERATING MACHINE Food and Drug Administration Bureau of Health Facilities and Services Bureau of Product Standards 1 2 Republic of the Philippines Department of Health Food and Drug Administration Outline A.FDA Standards B.BPS Standards C.Presentation of Reports D.Presentation of Findings E.Comments and Discussion F.Agreement 3 Republic of the Philippines Department of Health Food and Drug Administration FDA STANDARDS 4 FDA (RA 9711) • Collection of samples of health products (food, drug, device, cosmetics) [FROO] • analyze and inspect health products [Centers] • Recommend standards of identity, purity, safety, efficacy, and quality [Centers] • Issue certificates of compliance as the basis for the issuance of authorization (establishments) [FROO and Centers] 5 BHFS (RA 4226 and other regulations) • Approval of construction and licensure of hospitals (PTC, LTO, CTO, and COA) • Inspection of hospitals for their compliance with regulatory standards • Set standards for regulation of health facilities 6 Drugs (R.A. 9502) • recognized in the USP-NF, HPUS, PP, PNDF, BP, EP, JP, IP, any national compendium or any supplement to any of them; • intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals; • Medical oxygen included 7 FDA Requirement for Medical Grade Oxygen - Product • Registration • Philippine Standard Quality Certification Mark issued by Bureau of Product Standards (BPS) • Memo:PSD02-12 8 9 FDA Requirement for Medical Grade Oxygen - Manufacturer • Licensing • Compliance with cGMP requirements, including PIC/S: PE 009-10, Annex 6 • AO 2012-0008 10 11 Republic of the Philippines Department of Health Food and Drug Administration BPS STANDARDS 12 • PNS 103:1987, PNS 103:2003 • Philippine Standard Quality Certification Mark issued by Bureau of Product Standards (BPS) = 99% purity consistent with Philippine National Standards (PNS 103:1987) and USP requirement 13 14 Republic of the Philippines Department of Health Food and Drug Administration PRESENTATION OF REPORTS 15 • 6 letters received by this Office from Stakeholders Medical oxygen Concentrators • Not regulated by FDA/BHFS – no license as manufacturer, no registration • Quality: 90-95% purity • Safety issues regarding 93% 16 Listed hospitals with such machine 1. Veterans Regional Hospital (R II) 2. Ospital ng Palawan (R IV-B) 3. Culion Sanitarium (R IV-B) 4. Bicol Sanitarium (R V) 5. Southern Philippines Medical Center (Davao Medical Center) (R XI) 6. East Avenue Medical Center (NCR) 17 Republic of the Philippines Department of Health Food and Drug Administration PRESENTATION OF FINDINGS 18 Veterans Regional Hospital • • • • • Existing since 2010 From Hundredfolds Industries Corp. 24 hours/day 70 tanks/day No longer procuring from licensed manufacturers 19 Culion Sanitarium • Existing since February 2014 • From Hundredfolds Industries Corp. 20 Bicol Sanitarium • No medical oxygen generating machine • Procures from Magarao Air Products 21 Southern Philippines Medical Center • Existing • From Hundredfolds Industries Corp. • 40-45 cubic meter/hr – not meeting the need of their patients which is 70 cubic meter/hr • Still procuring from licensed manufacturers 22 East Avenue Medical Center 23 Republic of the Philippines Department of Health Food and Drug Administration COMMENTS AND DISCUSSION 24 Republic of the Philippines Department of Health Food and Drug Administration AGREEMENT 25