Cleaning and Sterilization of Used Cardiac Implantable Electronic Devices With Process Validation

Abstract

CIEDs can be cleaned and sterilized according to a standardized protocol achieving a 12-log reduction of inoculated product, resulting in sterility assurance level of 10.

Reuse of cardiac implantable electronic devices in developing countries perspectives: A literature review

“…CIEDs could then be explanted, primarily cleaned and shipped, following local medical waste regulations, to a the reprocessing organization 10 . Collected devices could then be standardly analyzed, reconditioned, cleaned and sterilized using a validated protocol and transferred to specific hospitals in developing countries for reimplantation 40 …”

Worldwide pacemaker and defibrillator reuse: Systematic review and meta‐analysis of contemporary trials

“…This viewpoint is not surprising as the cost for a new pacemaker pulse generator (approximately $2,500–$8,000 US dollars) or a new defibrillator generator (approximately $10,000–$18,000 US dollars) by itself represents a prohibitive obstacle for most people in low‐ and middle‐income nations. By contrast, the reported estimated cost of collecting, interrogating, reprocessing, and distributing such devices is $75–$100 US dollars per device, albeit this is contingent upon volunteer assistance at a variety of levels . As a consequence, governmental authorities, hospital administrators, physicians, and their patients in several underserved nations have proven receptive to assisting clinical studies examining the safety and efficacy of reusing devices, most of which were donated by those in high‐income nations in Europe and the USA where current laws prevent their reuse in humans.…”

Reuse of catheters and devices labelled for single use: evidence, recommendations and oversight

“…The yield of acceptable devices harvested during device upgrades was higher at about 50% 34. There is evidence that sterilisation of pacemakers and ICDs can be achieved 35. A set of essential algorithms should also be tested to assure proper function.…”