Urology Facilities And Devices Dermatology Facilities And Devices Otorhinolaryngology And Audiology Facilities And Devices Ophthalmology And Optometry Facilities And Devices

xv CONTENTS FOREWORD . i PREFACE . iii ACKNOWLEDGEMENTS . iv PARTICIPANTS OF THE NATIONAL MEDICAL DEVICE SURVEY . v AbOUT THE NATIONAL MEDICAL DEVICE SURVEY . vii NMDS GOVERNANCE bOARD . viii MEMbERS OF NMDS EXPERT PANELS . ix NMDS PROjECT STAFF . xiii CONTENTS . xv AbbREVIATIONS . xvi METHODS . xvii Chapter 1: Imaging And Diagnostic Facilities And Devices . 1 Chapter 2: Nuclear Medicine Facilities And Devices . 5 Chapter 3: Oncology Facilities And Devices . 9 Chapter 4: Anaesthesiology And Intensive Care Facilities And Devices . 11 Chapter 5: General Surgery Facilities And Devices . 15 Chapter 6: Orthopaedic And Traumatology Facilities And Devices . 21 Chapter 7: Physiotherapy And Occupational Therapy Facilities And Devices . 23 Chapter 8: Obstetrics Gynaecology Facilities And Devices . 27 Chapter 9: Neurology Facilities And Devices . 31 Chapter 10: Psychiatry Facilities And Devices . 35 Chapter 11: Cardiology And Cardiothoracic Surgery Facilities And Devices . 39 Chapter 12: Respiratory Facilities And Devices . 43 Chapter 13: Gastroenterology Facilities And Devices . 47 Chapter 14: Nephrology Facilities And Devices . 53 Chapter 15: Urology Facilities And Devices . 57 Chapter 16: Dermatology Facilities And Devices . 63 Chapter 17: Otorhinolaryngology And Audiology Facilities And Devices . 69 Chapter 18: Ophthalmology And Optometry Facilities And Devices . 73 Chapter 19: Gaps In Medical Technology In Malaysia . 79 xvi AbbREVIATIONS AbbI Advanced Breast Biopsy Instrumentation APC Argon Plasma Coagulation bAER Brainstem Auditory Evoked Response bER Beyond Economic Repair biPAP Bilevel Positive Airway Pressure Cathlab Cardiac Catheterization Laboratory CCU Coronary Care Unit COPD Chronic Obstructive Pulmonary Disease CPAP Continuous Positive Airway Pressure CPM Continuous Passive Motion CRC Clinical Research Centre CRRT Continuous Renal Replacement Therapy CT Computed Tomography CTG Cardiotocography CUSA Cavitron Ultrasonic Surgical Aspirator DbE Double Balloon Enteroscope DG Director General of Health, Ministry of Health, Malaysia ECG Electrocardiography ECMO Extra-Corporeal Membrane Oxygenator ECT Electroconvulsive Therapy EEG Electroencephalography EMG Electromyography EOG Electrooculography EP Evoked Potential ESWL Extracorporeal Shockwave Lithotripter EUS Endoscopic Ultrasound FESS Functional Endoscopic Sinus Surgery Gb Governance Board HAL Haemorrhoid Artery Ligation HD Haemodialysis HDU Haemodialysis Unit HFOV High Frequency Oscillatory Ventilator HKL Kuala Lumpur Hospital HDR High Dose-Rate IAbP Intra-Aortic Balloon Pump ICU Intensive Care Unit IMRT Intensity Modulated Radiotherapy IVUS Intra Vascular Ultrasound KKM Kementerian Kesihatan Malaysia LINAC Linear Accelerator LDR Low Dose-Rate LVAD Left Ventricular Assist Device MDb Medical Device Bureau MMHD Malaysian Medical Health Directory MOH Ministry of Health MRI Magnetic Resonance Imaging NC Not Classiied cannot be classiied between public and private sectors NCV Nerve Conduction Velocity NCS Nerve Conduction Study ND No Data Nd:YAG Neodymium-Doped Yttrium Aluminium Garnet NMDS National Medical Device Survey OAE Otoacoustic Emission ORL Otorhinolaryngology PCA Patient Controlled Analgesia PD Peritoneal Dialysis PET Positron Emission Tomography PICU Paediatric Intensive Care Unit PSG Polysomnography PUVA Psoralen combined with exposure to ultraviolet light A UVA SDP Source Data Providers SSEP SomatoSensory Evoked Potential SWD Short Wave Diathermy TCD Transcranial Doppler TEE Trans-Oesophageal Echocardiography TENS Transcutaneous Electrical Nerve Stimulation UVA Ultraviolet light A UVb Ultraviolet light B VACS Vacuum Assisted Closure System VEP Visual Evoked Potential VT Video-Telemetry WHO World Health Organization xvii METHODS Introduction The NMDS is designed, broadly speaking, to estimate the quantity and pattern of use of medical devices in Malaysia, as well as to estimate our expenditure on devices. This is an ambitious project, which requires multiple surveys targeting the various levels of the medical device supply chain and utilization in healthcare facilities in the country in order to capture all the required data to meet its purpose. For this irst effort, we had therefore realistically targeted data sources that are absolutely critical and accessible. Hence, the statistics on the availability of medical device in this report are estimated based on data from only a limited number of surveys. In particular, the scope of the survey was limited to: • Hospitals only, though for certain therapy areas Nephrology, Cardiology, we were able to supplement the data from more specialized surveys conducted by the National Renal Registry NRR and National Cardiovascular Disease Database NCVD • Asset device only. Data on disposable devices will have to await future survey. Survey Population, Sampling And Response Coverage Rate The survey conducted by NMDS and supplemented by those by NRR and NCVD, its survey population, its sampling unit and sample size, and the survey response or coverage rates are summarized in the table below. Site Classiication Survey population MaximumResponse Rate Minimum Response Rate 1. Public sector 137 71 43 2 Private sector 79 55 37 Note: 1. Public sector consists of 132 MOH, 3 University and 2 Armed Forces hospitals. 2. Response rates vary between specialties. The survey conducted by NMDS and supplemental surveys by NRR and NCVD were entirely by primary data collection. For MOH data, available database on device asset was also used to cross- check the data. Data Management The collected data, whether in databases, on paper or electronic data collection form, is compiled into a single database, appropriately processed and coded prior to statistical analysis. The database server is running on a Windows 2000 Server. The server environment is Intel Xeon 2.4 Mhz, with a total of 2GB RAM memory and 67.8GP Raid5 Hard disk. The NMDS database was created in Ms SQL Server 2000. The application has 3 modules: Contact Management, Data Entry and Data Processing. xviii The data processing steps for this initial version of NMDS data are presented as follows, in 2 phases: Phase 1 SurveyDatabase Development and Data Collection 1. On the basis of the NMDS project’s Terms of Reference ToR, some initial discussions were held within CRC, supplemented with research on literature to develop the irst drafts of NMDS survey forms. 2. Various existing databases were obtained and studied to extract learnings for application on the NMDS. Where relevant, these learnings were used to enhanceedit the structure and content of survey forms. 3. On the basis of the said information in 1 2, the irst draft of the survey forms were produced and presented for challenge of adequacy in the required data ields variables for each specialty. 4. Draft survey forms were shared with internal and external referees and the feedback was collated for the inalization of the survey forms. In most cases, the project team had to consult with the experts in various disciplines to get a better understanding of the variables of signiicance. 5. The survey forms were then inalized for approval, with the inal versions being made up of 28 medical specialties and 5 supportive specialties. The variables required were divided into 3 sections: Section 1: Establishment Details. Section 2: Diagnostic and Therapeutic Facility. Section 3: Associated Equipment of Interest. 6. Approval of the NMDS survey was granted by the Chairperson of the NMDS, allowing the team to proceed with actualizing the survey activities. 7. The approved survey forms were shared with the IT department for them to use as the basis for creating the NMDS Database. The intention was for the Database to be ready for populating by the time the completed survey forms had been returned by the SDPs. 8. Upon approval, survey forms were sent out to the Directors of relevant identiied SDPs to seek voluntary participation into the survey. SDPs were identiied from the Malaysian Medical Health Directory MMHD and counter-checked by staff making the calls. 9. The project team was dependent on the SDP sites to ensure the survey forms were appropriately distributed within their institutions. The project team then followed up with each individual specialty. The follow up was dependent on the availability of the specialty at the site with the MMHD used as reference. Where there are uncertainties, the NMDS project team contacts the SDP directly to ascertain the availability of specialties. A “service provider” of a particular specialty was deined as any participating site that provides specialists services respective to the discipline and includes sites that only provide visiting specialist services. It does not require a resident specialist to be available at the site. 10. SDPs are meant to respond within a set deadline. Feedback is received either by fax or post prior to Data processing. The NMDS project team also takes the initiative to pursue timely feedback from the respondents. xix Data Processing of Survey Data 1. Survey data was entered into the NMDS Database that had been created by the IT department based on the inalized survey forms refer to Phase 1: 7 above. Drop down options similar to that in the survey form of each specialty was part of the database design to minimize data entry errors. Prior to data entry, personnel were fully briefed on how to use the database and enter the data via a training event which included a demonstration. Personnel were supervised whilst doing the irst few entries to make sure suficient competency had been developed to minimize if not eliminate errors. A standard document on steps and precautions on Data entry was mailed to each personnel. Those who were unable to decipher the feedback were advised to enquire from senior staff. Each entry is recorded for quality assurance purposes. 2. Visual review and manual assessment of entries are performed to capture erroneous, inconsistent or inaccurate entries in the survey forms. These typically occur when information is entered under the “Others” or “Shared Equipment” section. Follow-up with the SDP is performed where required. Where data was provided using brand names, online searches or follow-up with the SDP was conducted to guide any required editing of the survey form data. 3. The populated Database then underwent Edit Checks, with the database entries being meticulously crosschecked against the original survey forms. 4. It was then decided to exclude further data processing of a subset of devices reported by the SDPs due to limitations in resources. The criteria for selection of devices to be reported per specialty were outlined by priority for treatment and quality of survey data available. Selection was done by the NMDS project team with support from the Chairperson. Only data on functioning medical devices were processed and reported. Functioning medical devices were deined as medical equipment that were used in daily procedures at the participating site and excludes: • equipment deemed as in Beyond Economic Repair as well as • equipment which, although were still in working condition, were non-operational not used at the site. 5. Data is then exported to Datamed Bio-Statistics for further data processing. This included a speciic focus on estimation of missing data from poorly populated survey forms or non-responsiveness. Datamed personnel were tasked with grouping and collating the NMDS data into forms and reports that would allow further study by the project team. These forms and reports were used by the team to assess the quality of the NMDS data internally as well as with assistance from the expert panel. xx Statistical Methods In this report, the quantity of the availability of a device is expressed as in absolute count as well as in number per million inhabitants. The latter statistics are calculated as follows: Where T is an estimate of the total quantity of the device available in the country in the year under consideration P is the mid-year population of Malaysia or the relevant geographic region where the survey was conducted T the total is estimated from the sample of relevant health care facilities as follows: The total is estimated by T = Σ W i T i Where; T i is the value of the quantity of device available in the i th facility in the year W i is the sampling weight of the i th facility W i = Bb b i Ь Where B is total number of beds in the population, b is number of beds of the responding hospitals sample, b i is number of beds in the i th facility, and Ь the mean number of beds in the population. The sampling weight for each sampling unit or unit of analysis therefore has the following components: 1. Probability of selection. The basic weight is obtained by multiplying the reciprocals of the probability of selection at each step of sampling design.

2. Adjustment for non-response.

The response rate was less than 100 for hospital surveys; an adjustment to the sampling weight is required. The non-response adjustment weight is a ratio with the number of units in the population as the numerator and the number of responding sampling units as the denominator. The adjustment reduces the bias in an estimate to the extent that non-responding units have same characteristics as responding units. Where this is unlikely, some adjustments took into account differences in some relevant characteristics between responding and non-responding units that may inluence drug utilization, such as bed strength, staff strength, scope of services for hospitals etc. Finally, adjustments are also made to the statistical estimates to approximate known values from existing device asset database and from key informants, where these are available. T Number of devicemillion population = P T Number of devicemillion population = P 1

CHAPTER 1 IMAGING AND DIAGNOSTIC FACILITIES AND DEVICES

Edited by : Dr. Subramani al Venugopal 1 With contributions from : Dr. Che Zubaidah Che Daud 2 , Dr. Harikrishna al Sivaganabalan 3 , Dr. Hjh. Salwah Hashim 4 , Dr. Nik Fatimah Salwati 5 , Dr. Zaharah Musa 6 1 Hospital Tuanku Ja’afar, 2 Hospital Kuala Lumpur, 3 Hospital Tengku Ampuan Rahimah, 4 Hospital Pulau Pinang, 5 Hospital Sultanah Bahiyah, 6 Hospital Selayang REPORT The National Medical Devices Survey NMDS, a service initiated and supported by the Ministry of Health, and coordinated by the CRC, gives complete information on the availability of devices and services in all states in Malaysia. This information is crucial for future planning and inancing of equipment and manpower. The current survey can be considered a good starting point, but some minor changes will be made for future data collection, in order to better relect the Imaging and Diagnostic facilities, equipment and services that are available. Accurate compilation of data in this NMDS survey will greatly facilitate the planners to buy the right thing for the right place at the right time. With capital expenditure for Imaging and Diagnostic being very high, coupled with rapid advances in technology, it is imperative that we have accurate records of the devices available, so that they can be optimally utilized, with minimal or no duplication of services, for a given population. Almost all larger hospitals both public and private in the country are now fairly well equipped with general radiography, luoroscopy, ultrasound, mammography, computed tomography CT and magnetic resonance scanners. Angiography services are available in most tertiary centers. Basic and vascular interventional radiology is fast developing into a necessity. Smaller or primary hospitals and health facilities are also fairly well equipped with radiological services commensurate with the clinical services provided. However, the rapid explosion of technology has thrown so many new machines and techniques, which need careful evaluation, before being adopted in Malaysia. This report is done with the data provided by the contributors from all states. Some of the states cannot obtain accurate data from all hospitals, especially in the private hospitals. 2 Table 1: Available Therapeutic and Diagnostic Facilities in Imaging and Diagnostic Medicine Population Radiology Centre No in million No pmp Malaysia 26.64 108 100 4 Sector Public - 66 61 Private - 42 39 State Johor 3.17 9 8 3 Kedah Perlis 2.11 7 6 3 Kelantan 1.53 7 6 5 Melaka 0.73 5 5 7 Negeri Sembilan 0.96 2 2 2 Pahang 1.45 7 6 5 Perak 2.28 11 10 5 Terengganu 1.04 3 3 3 Pulau Pinang 1.49 11 10 7 Sabah 3 13 12 4 Sarawak 2.36 12 11 5 Selangor W.P. Kuala Lumpur 6.43 21 19 3 Table 2: Available Medical Devices in Imaging and Diagnostic Medicine Population Computed Tomography CT Scanner Magnetic Resonance Imaging MRI Unit Angiographic Unit Mobile C-Arm Unit No in million No pmp No pmp No pmp No pmp Malaysia 26.64 100 100 4 63 100 2 42 100 2 250 100 9 Sector Public - 51 51 31 49 17 40 152 61 Private - 49 49 32 51 25 60 98 39 State Johor 3.17 7 7 2 5 8 2 3 7 1 16 6 5 Kedah Perlis 2.11 7 7 3 6 9 3 3 7 1 18 8 9 Kelantan 1.53 3 3 2 2 3 1 2 5 1 11 4 7 Melaka 0.73 5 5 7 4 6 5 3 7 4 9 4 12 Negeri Sembilan 0.96 3 3 3 2 3 2 2 5 2 8 3 8 Pahang 1.45 4 4 3 2 3 1 1 2 1 11 4 8 Perak 2.28 6 6 3 4 6 2 2 5 1 22 9 10 Terengganu 1.04 1 1 1 1 2 1 8 3 8 Pulau Pinang 1.49 14 14 9 8 13 5 7 16 5 28 12 19 Sabah 3 7 7 2 3 5 1 2 5 1 11 4 4 Sarawak 2.36 11 11 5 5 8 2 3 7 1 21 8 9 Selangor W.P Kuala Lumpur 6.43 32 32 5 21 33 3 14 33 2 87 35 14 3 Population Total Mammography Conventional Mammography Digital Mammography Mammography with Stereotactic biopsy System No in million No pmp No pmp No pmp No pmp Malaysia 26.64 95 100 4 37 100 1 9 100 37 100 1 Sector Public - 48 51 10 27 2 22 27 73 Private - 47 49 27 73 7 78 10 27 State Johor 3.17 9 9 3 3 8 1 5 13 2 Kedah Perlis 2.11 7 7 3 1 3 1 11 4 11 2 Kelantan 1.53 2 2 1 1 3 1 1 3 1 Melaka 0.73 4 4 5 4 11 5 Negeri Sembilan 0.96 4 4 4 2 5 2 1 3 1 Pahang 1.45 4 4 3 2 5 1 1 3 1 Perak 2.28 8 8 4 3 8 1 4 11 2 Terengganu 1.04 1 1 1 1 3 1 Pulau Pinang 1.49 12 13 8 5 14 3 1 11 1 5 13 3 Sabah 3 6 6 2 2 5 1 1 11 3 8 1 Sarawak 2.36 8 8 3 5 14 2 1 11 2 5 1 Selangor W.P Kuala Lumpur 6.43 30 32 5 9 24 1 5 56 1 10 27 2 Population Ultrasound with Doppler No in million No pmp Malaysia 26.64 387 100 15 Sector Public - 203 52 Private - 184 48 State Johor 3.17 31 8 10 Kedah Perlis 2.11 31 8 15 Kelantan 1.53 21 5 14 Melaka 0.73 12 3 16 Negeri Sembilan 0.96 11 3 11 Pahang 1.45 13 4 9 Perak 2.28 25 6 11 Terengganu 1.04 6 2 6 Pulau Pinang 1.49 37 10 25 Sabah 3 31 8 10 Sarawak 2.36 29 7 12 Selangor W.P Kuala Lumpur 6.43 140 36 22 Note: 1. Counts for “Ultrasound with Doppler” units mentioned above exclude Echocardiocardiography units, which are mentioned under Chapter 11: Cardiology and Cardiothoracic Surgery Facilities and Devices.