Press Statement DG of Health 25th October 2017 – Reprocessing and Reuse of Single-Use Medical Device

The Ministry of Health (MOH) would like to refer to the online media report published by Free Malaysia Today titled “Govt Hospitals recycling single-used devices to save money” and “Safe to reuse disposable devices, says health ministry”. The MOH view seriously this allegation which was perhaps made with the intention to sensationalise the matter, whereby the report quoted an unnamed source, suggesting that MOH hospitals are compromising on patient safety. The MOH would like to strongly refute that and emphasise that MOH has always upheld and prioritised on patient safety and standard of care in healthcare provision.

Firstly, the MOH would like to inform that all of the consumables and single-use medical devices utilised for patient with Blood Borne Diseases are disposed after single used. The MOH has published specific guideline in relation to this (Policies and Procedures on Infection Control) and health professionals are expected to adhere to this guideline in their clinical practice. Similarly, majority of consumables and single-use medical devices are also disposed after single use for other patients.

However, there are some single-use medical devices that are used more than once, whereby it has to undergo reprocessing via thorough cleansing and sterilisation processes before it can be reused for few times. This has been long practiced in Malaysia and it has no correlation with health financing or budget issue. In fact, this reprocessing practice is a norm even in private health facilities in Malaysia and in developed countries such as United States, European Nations and OECD countries. US FDA for instance, had listed 229 single-use devices known to be reprocessed or considered for reprocessing. The Medical Device Authority (MDA) has conducted a preliminary survey to look into this practice in Malaysian public and private hospitals. Interestingly, the finding revealed that 37 percent out of 40 private hospitals surveyed reuse and reprocessed the single-use devices, similar to the practice in MOH hospitals. The important factors which can never be compromised in this practice are infection control and the patient safety.

The patient safety culture is now stronger than ever in MOH and it has always been a priority for MOH to prevent harm to patients. The trending of Healthcare Associated Infection (HCAI) has improved tremendously over the years. For instance, the total HCAI prevalence in MOH health facilities was 1.65 percent in October 2016, as compared to 3.3 percent in March 2009 and 4 percent HCAI reported in a study conducted in 2009 by Centers for Disease Control and Prevention (CDC), United States. Similarly, the Healthcare Associated Blood Stream Infection in MOH health facilities is at all time low in 2016 which is only 0.22 percent, as compared to 9.9 percent quoted in the same study by CDC in 2009. These improvements were made possible due to proactive and comprehensive infection control measures and patient safety program at MOH health facilities.

The MOH also made a huge step forward when the Medical Device Act [Act 737] came into effect in 2012, whereby the medical devices are now better regulated in Malaysia. The Medical Device Authority (MDA) is in the process of drafting a holistic guideline and policy on reprocessing of medical device, by drawing expert opinions and best practices as practiced in United States, Canada, Australia and EU Nations for reprocessing of single-use medical device. This is an iterative process led by MDA and will take into consideration all kind of factors, with the main focus on patient safety.

The MOH would like to reiterate its full commitment towards delivering high quality healthcare services, delivered at reasonable cost and accessible to all. Patient safety will remain at the core of all MOH services and will not be compromised. The MOH urged for more responsible reporting by Free Malaysia Today in line with the journalism ethics and professional reporting.

DATUK DR. NOOR HISHAM ABDULLAH

DIRECTOR GENERAL HEALTH MALAYSIA

 

25th October 2017

 

 

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