Organ & Tissue Transplant- Policies, Technologies, etc.

Medical registry to track implantable medical devices


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

  1. A recent investigation on hip implants manufactured by well known firm required some patients to undergo revision surgeries because of allegedly faulty designs.
  2. The investigation has found the firm to be evasive in providing the information regarding the design of the implants and patient details.
  3. Such revision surgeries pose serious risks to patients.
  4. Hence registries are needed for all implantable devices to effectively study adverse effects associated with medical devices.

Proposed Registry for Implantable Medical Devices

  1. 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.
  2. The new registry being will be on the lines of the UK’s medicines and healthcare products regulatory agency (MHRA) and the Australian registry.
  3. As many as 4,700 patients in India had received ASR hip implants between June 2004 and August 2010.
  4. 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.
  5. These reports, along with data from other sources, can provide critical information that will help improve patient safety.

Expected benefits of the registry

  1. Setting up of registry will help issue warnings and alerts to the manufacturers and consumer in case of a device malfunction.
  2. The registry will also help in providing a trend analysis of performance and usage of various medical devices in India annually.
  3. Provisions will be introduced under the law to have legal backing for issuing alerts and warnings to a manufacturer.

Other Policy Measures

  1. The government is also contemplating changes under the Medical Device Rules, 2017.
  2. This will make it mandatory for companies to compensate patients in case of serious adverse events due to malfunctioning of a medical device.

Way Forward

  1. The patients have to live a restricted lifestyle with a compromised physical state, thus putting them at pain and agony throughout their life.
  2. This will also have a bearing on their dependents apart from loss of work and no amount of money can fill this void.
  3. 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

  1. Hip replacement is a surgical procedure in which the hip joint is replaced by a prosthetic implant, that is, a hip prosthesis.
  2. Such joint replacement orthopaedic surgery is generally conducted to relieve arthritis pain or in some hip fractures.
  3. A total hip replacement consists of replacing both the acetabulum and the femoral head.
  4. The Articular Surface Replacement (ASR) Hip uses the metal bearing acetabular cup resurfaced with metal prosthesis that fits into acetabular cup.
  5. It is secured to the patient’s femur with a short stem inserted into the top of the femur bone.
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