Medical devices to get better maintenance in view of patient safety

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New Delhi: Poorly maintained medical devices in hospitals that can become a potential risk for patients will soon have superlative overhauling services and special engineers for their maintenance.

The ministry of health and family welfare, under its draft patients’ safety implementation framework, says all healthcare facilities should have biomedical engineers for maintenance of medical equipment from installation stage onwards.

According to the proposal, there should be updated standard operating procedures (SOPs) for utility, breakdown, monitoring of medical devices, and restricting access of single-use devices for reuse. Also, a clear policy on discarding of equipment and SOPs of calibration for electronically operated medical devices has been proposed.

“We have proposed that biomedical engineers should be a full-time employee as most of the deaths in coronary care units (CCU) occur due to machine failure which could be averted if the machines could be checked immediately,” said Jagdish Prasad, director general, health services (DGHS), union health ministry.

Safer medical devices as per good manufacturing practices (GMP) and World Health Organization (WHO) standards for infection control and patient safety do exist in India. But their management and functioning is crucial to saving lives of patients. Healthcare experts say that unsafe usage of medical devices can also impact patient safety to a larger extent. Medical devices are well covered under the Clinical Trials Services Unit (CTSU). While a draft bill is in the public domain, a separate legislation is in the offing.

“Drug controller general of India (DGCI) has a few national medical device regulatory and monitoring programmes, but to a very limited extent. Though much has not been done on medical device safety in India, a health technology assessment division exists in National Health Systems Resource Centre (NHSRC) and was recently designated as a WHO collaborating centre,” said Prasad.

There have been reports of defunct and poorly functional medical devices in government hospitals.

Last month, union health minister J.P. Nadda said that the centre had spent Rs113 crore in 2016-17 on maintenance of 4,560 medical devices which were not functional in various public hospitals.

The health minister said that there were a total of 756,000 pieces of equipment in 29,115 government medical institutions. However, 4,560 medical devices are not working.

“The maintenance was not being done for many medical equipment. We had started an initiative under which Rs113 crore has been spent and all non-functional medical devices in the country’s government hospitals have become functional,” Nadda had said.

The draft patients’ safety implementation framework has also proposed a mandatory hospital infection control committee in hospital accreditation programmes. “The key stakeholders involved in the committee could be the head of facility such as administrator or manager, representative of a nursing staff, key clinicians, lab specialist or microbiologist, biomedical engineer with clear roles and responsibilities,” said Prasad.

“For instance, a biomedical engineer is responsible for building construction and maintenance, which is also a key element in infection prevention and control,” he said.

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