1 Introduction

A comprehensive and sustainable Pharmacovigilance Programme of India (PvPI) has been initiated by the ministry of Health & Family Welfare (MoHFW), government of India in 2010 to focus the safety of all post marketed Pharmaceuticals in the country through a systematic and scientific approach.^1–3 The scope of PvPI has been further expanded, in order to focus the safety of medical devices as well; therefore, a Materiovigilance Programme of India (MvPI) launched in 2015. The Materiovigilance or Materials Vigilance is the system of detection and assessment of medical device related adverse events or device malfunctions to assure patient’s safety.^3,4 Both PvPI and MvPI receives funding from the MoHFW for their effective implementation and expansion. The PvPI and MvPI equipped with necessary tools/techniques for capturing of adverse events related to drugs and medical devices respectively and communicating the risk to the concerned stakeholders.

The effective implementation of MvPI including recognizing medical devices adverse events monitoring centres at the region to capture the adverse events associated with various kinds of medical devices is progressing at par with international practice.^4-6 The adverse events associated with Orthopaedics implants (OI) is one amongst the medical devices also emerge in the literature; the recent studies have reported various safety related issues of them.^7,8 A retrospective case study which analyzed over 1900 adverse events associated with various medical devices concluded that OIs one amongst them poses larger proportion of adverse events.⁹ As per the Medical Devices Rules (MDR) 2017, released by the Government of India has envisages the regulation on medical devices including OI and also there is a statutory requirement for the manufacturer/importer to report the adverse event(s) if any with the use of medical devices. The process of OI’s suspected adverse events reporting at MvPI is voluntary for the healthcare professionals; whereas its mandatory for respective manufacturers/importers.

The MDR classifies the medical devices based on their level of risk associated - such as Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (high risk). The OIs are classified as Class B, C and D (low moderate to high-risk) (Table 1); all such implants are regulated in India. The MDR 2017 envisages the concerned OI’s marketing authorization holders to report the adverse events to National Regulatory Authority i.e. Central Drugs Standard Control Organization and MvPI. However, reporting of adverse events is voluntary for the healthcare provides. Therefore, it’s an appropriate time for the stakeholders to be vigilant on all such OI’s about their safety and anticipated adverse event’s reporting practice to MvPI. The intention of this article is to make aware of the stakeholders in particular with the process and methods available for adverse events reporting for OI at MvPI.

2 Methods

The MvPI enables the stakeholders such as orthopaedicians, marketing authorization holders, pharmacists, nurses, biomedical/clinical engineers, lab technicians, patients and others to report adverse events. The reporting of adverse events of OI can be done either through a though customized e-reporting form (https://www.ipc.gov.in/images/MEDICAL_DEVICE_ADVERSE_EVENT_REPORTING_FORM_editable.pdf) or helpline (1800 ​180 3024). The reports can be submitted to Medical Devices Adverse Events Monitoring Centres (MDMCs); These are multispecialty/superspeciality hospitals, teaching hospitals (both public and private sector) etc have been identified/recognized under MvPI. The responsibility of such MDMCs is to compile the adverse event report (including the causality assessment of report at possible extent) and forward them to NCC-MvPI for further processing. The NCC-MvPI is responsible for clinical evaluation (with the support of subject experts) and then to arrive a conclusion.

In order to ascertain a valid adverse event report, the minimum essential information such as identifiable reporter and patient, name of the device, name of the event, date of the event, device category and product exposure are expected to be provided. The stakeholders are encouraged to report both known and un known events, seriousness and non-seriousness events. The process derived at MvPI to manage the adverse events with OIs is given in Fig. 1.

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Fig. 1 Process of Orthopedic implant’s associated adverse events management at Materiovigilance Programme of India (MvPI).

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3 Discussion

The current trend in MvPI reveals that, the adverse events reporting (associated to OI) from orthopedicians and other stakeholders has been negligible in quantity. Though it has been over 07 years since the MvPI introduced in the country with the target of safety monitoring of medical devices, its pertinent to state that safety data available at MvPI currently, was only trace number of adverse events associated with OI have been reported i.e., 2.4% as compared to overall adverse events reported with other medical devices. The adverse events with the use of OIs (such as femur plate, femoral nail, orthopedic nail, orthopedic plate, knee implant, hip implant, spinal rod and screw, tibia plate and nail, bone cement etc) reported to MvPI as device broken, surgical site infection, swelling and pain. There were some commonest and rare reported suspected adverse events with the of OIs available in the literature such as revision of surgery, dislocation, component loosening, infection, cyst formation, procedural error, metalosis etc. Besides these, OI’s mal function also reported as adverse event.^10–16 As adequate studies were conducted across India and global as well to understand the knowledge, attitude and practice of healthcare providers about the medical device’s vigilance/adverse events reporting, found lack of awareness, and knowledge gap is the main reason for under reporting.^17–20 These studies were also reported that healthcare providers knew a very little about medical devices' post-market monitoring, but their attitudes towards its benefits were positive. Majority of these studies have recommended that for enhancing reporting through regulations, professional training and publicity, sharing of information etc. In India, several of the recommended areas have been addressed as capacity building and strengthening of the reporting system. The MDR is the regulatory reforms for medical devices. In order to ensure the sustainability of the professional’s engagement in adverse events reporting at MvPI, a regular feedback, personal communication, inviting them in scientific meetings/trainings etc have already been initiated. Periodic training for the professionals (Skill development programme) is conducted by MvPI through physical or virtual platform. As information sharing is one of the recommendations of the above studies, MvPI communicates the device safety related information to the stakeholders via e-newsletter (also available in www.ipc.gov.in)

Pharmacovigilance for drugs which was emerged in 1960s, still under reporting is global challenge; therefore, we have to go a long way in getting the adverse events reports of medical devices including OIs; continuous engagement of the stakeholders is the only solution to improve reporting. Medical devices vigilance in USA, candida, Australia, UK, Croatia and many other countries online database is well established for public and marketing authorization holders for reporting of adverse events with the use of medical devices. Hence, developing similar electronic platform or notification form (instead of filling five pages form) and mobile app will enhance the orthopaedicians reporting. This article also urges for the collaborative approach among the healthcare providers, MvPI, regulatory authorities, patients and others to minimize the risk associated with OI.

Funding/sponsorship

None.

Informed consent

Not applicable.

Institutional ethical committee approval

Not applicable.

Authors contribution

V. Kalaiselvan: Conceptualization, validation, Reviewing and editing, Shubhang Arora: Writing- Original draft preparation; Rajeev Singh Raghuvanshi: Supervision.