Guidance on reuse of cardio-vascular catheters and devices in India: A consensus document

Abstract

Reuse of medical device is accepted worldwide. Benefits of reuse include not only cost saving but a favorable impact on environment. However, certain requirements should be met for reuse to be safe and effective. The devices, which can be reused, should be clearly defined, a meticulous process for dis-infection and sterilization followed and its functionality ascertained before use. Further, an appropriate consent should be obtained where necessary and the cost saving entailed should be directly passed on to the patient.

Single-use medical devices: economic issues

“…Authors in the USA21 indicate that the number of times a catheter is reused varies considerably, with one-half of the devices being reprocessed 5 times or less. In India, authors9 have estimated a desired range of reuses of between 2 and 5 times. We should note that the actual cost of reprocessing for any device—that is, the resources that go into the reconditioning process itself —will not change if the wholesale or ex-factory price for a specific device is lowered, so there is probably some wholesale price for a new device below which the cost of reprocessing will not be worth it.…”

Cadaveric Donation and Post-mortem Reuse of Pacemakers and Defibrillators in Nepal: Medical, Legal and Ethical Challenges

“…Devices should only be considered for reuse if the previous clinical record has been reliable, without any documented malfunction, and it has an adequate remaining life often arbitrarily set at more than 4-5 years or cutoff of more than 70% battery life 4 , 8 . Reuse should be avoided when the device has been recovered from a patient who has died suddenly (since in such cases device malfunction cannot be ruled out with certainty) 4 . Adequate sterilization of the device with removal of all protein material is necessary before reuse.…”

“…A sterilization technique used in a study of 100 reused and 100 new pacemaker pulse generators in Sweden included cleaning the device with a brush, soap and water, soaking in phenoxypropanol and benzalconiumchloride solution, and wiping with 70% ethanol, packaging and sterilizing with ethylene oxide. Kapoor et al 4 have described a sterilization protocol suitable for Indian subcontinent. It may be advisable for the professional societies to lay down norms and standardized sterilization protocols based on the locally available resources.…”

“…This disparity can be explained in part by the cost of device and socio-economic situation of the developing world. The cost of a bradycardia pacemaker in its basic form in India varies from INR 60,000/-to 1.5 lakhs; the implantable cardioverter defibrillators (ICD) cost from INR 2 lakhs to 5 lakhs, the bi-ventricular pacemakers from INR 2.5 to 7 lakhs (COMBO devices) in India 4 (equivalent cost in US dollars are $ 600 to 1500 US $ 2000 to $ 5000 to $ 2500 to 7000). This cost can be prohibitive to many given Nepal's GDP per capita of USD 732.00 30 , and more importantly because there is no uniform policy of insurance and re-imbursement.…”

“…In this context reuse of CRMDs from deceased donors may serve as a feasible and cost effective option. The reuse of devices has been in practice for many years 3,4,5 . Several charity organizations in the west like My Heart Your Heart, Pace4Life are involved in harvesting CRMDs from deceased donors through funeral homes, hospitals, clinics, physicians, and distributing them to LMIC for reuse.…”