Authors' objectives: To ensure the refurbished medical device is effective, safe and conforms to acceptable standards for the benefits of the public, before implementing it in Ministry of Health facilities.

Authors' results and conclusions: A total of 384 records were identified through several databases and other sources. Thirteen studies included in this review. Seven cohort studies on effectiveness of cardiac implantable electronic devices (CIEDs) that include pacemaker, defibrillator, implantable cardioverter defibrillators (ICD), cardiac rhythm management device (CRM) and cardiac resynchronisation device (CRD) found that there was no significant difference between refurbished CIEDs and new devices for outcome battery depletion for average three years’ follow-up [Odds Ratio (OR): 2.30, 95% CI: 0.84, 6.33; p=0.74, I2=0%], infection rate [OR: 0.81, 95% CI: 0.49, 1.36; p=0.66, I2=0%] and device malfunction or dysfunction [OR: 1.21, 95% CI: 0.53, 2.78;p=0.86, I2=0%]. The evidence also suggested that no death related to device implantation was reported and no significant difference for all-cause mortality in both groups [Risk Ratio (RR): 0.89, 95% CI: 0.61, 1.31; p=0.25, I2=24%]. In terms of organisational issues, companies that undertaking refurbishment activities should comply with the requirements stipulated in the guidelines by WHO and FDA on good refurbishment practice of medical device. Also, they should be complied with the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012 and 2019 and Circular Letter 1/2016 Refurbishment of Medical Device (Revision 2).11, Malaysia. Implantable pacemaker pulse generator has been classified under class III. Based on Malaysian’s societal legal and ethical perspective, it may raise issues on acceptability of the patient, relatives and society as from their perception, it was not appropriate to take device or anything from dead body. In some religions, it is considered taboo. Six cost analysis studies were retrieved. Based on several cost analysis studies from the physician and company perspective, the costs of reused devices or equipment are generally preferred than the new devices or equipment. Cost analysis studies shared that refurbished medical device may save up to 28% when compared to using a new device. However, the cost parameters included varied among the reused devices or equipment and the analysis has not been taken into account the re-implantation and complications cost that might be occurred as well as the cheaper price is due to the shortened battery life of the CIED.

Authors' recommendations: Based on the review, although refurbished Cardiac Implantable Electronic Device (CIED) appeared to function well with acceptable battery life and no adverse events reported, however, in terms of societal, ethical and legal issues, it may not be recommended to be used. In terms of cost, the analysis has not been taken into account the re-implantation and complications cost that might be occurred.

Authors' methods: The following electronic databases were searched through the Ovid interface: Ovid MEDLINE® In-process and other Non-indexed citations and Ovid MEDLINE® 1946 to present, EBM Reviews - Cochrane Central Register of Controlled Trials – March 2020, EBM Reviews - Cochrane Database of Systematic Reviews - 2005 to March 2020, EBM Reviews - Health Technology Assessment – 4th Quarter 2016 and EBM Reviews – NHS Economic Evaluation Database 1st Quarter 2016. PubMed and Google Scholar were used to search for additional web-based materials and information. The references of retrieved articles were scrutinised for additional articles. No limits were applied. The last search was conducted on 25th May 2020.

Authors' identified further research: Research on other medical devices which are high-complexity, high-cost equipment such as medical imaging equipment (X-rays, MRI machines), patient monitors and anaesthesia machines

Project Status: Completed

Year Published: 2020

URL for published report: http://www.moh.gov.my/index.php/database_stores/store_view_page/30/360

Requestor: Decision making committee

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Malaysia

Organisation Name: Malaysian Health Technology Assessment

Contact Address: Malaysian Health Technology Assessment Section, Ministry of Health Malaysia, Federal Government Administrative Centre, Level 4, Block E1, Parcel E, 62590 Putrajaya Malaysia Tel: +603 8883 1229

Contact Name: htamalaysia@moh.gov.my

Contact Email: htamalaysia@moh.gov.my

Copyright: Malaysian Health Technology Assessment Section (MaHTAS)