Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources
From UPSC perspective, the following things are important:
Prelims level: Ayushman Bharat scheme
Mains level: The inequality between public and the private sector in healthcare and its impact on citizens especially poor
Faulty Designs risking patients lives
- A recent investigation on hip implants manufactured by well known firm required some patients to undergo revision surgeries because of allegedly faulty designs.
- The investigation has found the firm to be evasive in providing the information regarding the design of the implants and patient details.
- Such revision surgeries pose serious risks to patients.
- Hence registries are needed for all implantable devices to effectively study adverse effects associated with medical devices.
Proposed Registry for Implantable Medical Devices
- The Drug Technical Advisory Board (DTAB) will take up a proposal for setting up a national registry for all implantable high-risk devices to protect patients.
- The new registry being will be on the lines of the UK’s medicines and healthcare products regulatory agency (MHRA) and the Australian registry.
- As many as 4,700 patients in India had received ASR hip implants between June 2004 and August 2010.
- This will encourage healthcare professionals, patients and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues.
- These reports, along with data from other sources, can provide critical information that will help improve patient safety.
Expected benefits of the registry
- Setting up of registry will help issue warnings and alerts to the manufacturers and consumer in case of a device malfunction.
- The registry will also help in providing a trend analysis of performance and usage of various medical devices in India annually.
- Provisions will be introduced under the law to have legal backing for issuing alerts and warnings to a manufacturer.
Other Policy Measures
- The government is also contemplating changes under the Medical Device Rules, 2017.
- This will make it mandatory for companies to compensate patients in case of serious adverse events due to malfunctioning of a medical device.
- The patients have to live a restricted lifestyle with a compromised physical state, thus putting them at pain and agony throughout their life.
- This will also have a bearing on their dependents apart from loss of work and no amount of money can fill this void.
- There should be adequate compensation provided to each and every patient who had undergone revision surgery to mitigate some of the pain and sufferings.
Hip Replacement Surgery
- Hip replacement is a surgical procedure in which the hip joint is replaced by a prosthetic implant, that is, a hip prosthesis.
- Such joint replacement orthopaedic surgery is generally conducted to relieve arthritis pain or in some hip fractures.
- A total hip replacement consists of replacing both the acetabulum and the femoral head.
- The Articular Surface Replacement (ASR) Hip uses the metal bearing acetabular cup resurfaced with metal prosthesis that fits into acetabular cup.
- It is secured to the patient’s femur with a short stem inserted into the top of the femur bone.