Special Interest Groups - Medical Devices

Safety Surveillance of Medical Devices Group

ISoP SIG on Safety Surveillance of Medical Devices: finding solutions and moving forward

Background

Medical devices, which run the gamut from simple tongue depressors and thermometers to cardiac defibrillators and pacemakers, as well as a wide range of implantable and prosthetic devices, are regulated differently from pharmaceuticals, with less stringent requirements for initial clearance and safety follow-up. Medical device product recalls and adverse events have increased steadily over the past decade.
Some of the large number of recalls (high profile) of medical devices include, DePuy ASR metal-on-metal hip implants, Saint Jude Riata implantable defibrillator, Poly Implants Prosthese breast implants, STERIS System 1/1E, Surgical Mesh, Baxter COLLEAGUE infusion pumps etc. To address these challenges, safety-surveillance is of paramount importance to ensure patient safety. This further, has pointed to a need for more active monitoring of product performance from the standpoints of both safety and efficacy.

The SIG on Safety Surveillance of Medical Devices will be officially launched during the 18th ISoP Annual Meeting in Geneva (11-14 November 2018) where a session on Medical Devices will be held.

Goal of the SIG

We have created a ‘special interest group’ to provide a forum for members to share experiences and suggest best practices and policy in the field of medical device performance monitoring and safety surveillance.

Objectives

1. To develop a more proactive approach towards the safety surveillance of medical devices
2. To initiate awareness on recall systems for the medical device products
3. Create and maintain a forum for communication and collaboration between ISoP members and collaborators to address issues and challenges pertaining to safety of medical devices
4. To advance in the field of medical devices through expanded use of safety surveillance in medical devices
5. The SIG members communicate, meet, develop training materials, develop position papers and publications, support students, and organize programming ideas.

Methods for Adopting Safety Surveillance of Medical Devices

➢ Rigorous premarket testing
➢ Mandatory participation in a device registry to track and trace adverse events
➢ Active Surveillance by use of:
• Electronic health record systems
• National database of medical devices (Unique Device Identification(UDI) system) under distribution for any recall if safety issues are found
• Establish a common platform for complaint reporting and handling platform
➢ Practical recommendations to industry on processes and establishing training programmes to manufacturers and researchers on safety and efficacy of medical devices
➢ Communication with health professionals, Ideal hospital processes for managing hazards and recalls and working with all the stakeholders on reducing unregulated and unqualified medical devices in market
➢ Education, training and access to reliable information
➢ Train hospitals, distributors, and other supply chain partners on how to act when any issues of safety have been noticed and how to alert the end-user
➢ Make patient/end-users part of vigilance by giving accurate data on adverse events (AE’s) to regulatory groups or research groups. Work closely with end users on safety issues of Biomedical implants viz breast implants, facial implants, dental implants etc

Information Sharing and Networking

The SIG will engage in collaborative information sharing for medical device safety, the information sharing may include medical device risk assessments, host vulnerabilities, threat intelligence and reports on adverse events. Through regular events such as seminars, conferences workshops, social media venues and other forms of communication, the SIG will emphasize on enhanced understanding of medical device safety problems, identifying medical device-associated risks etc.

Advisory Role of the SIG

There are numerous issues relating to medical device manufacturing and those of us who are SMEs in this area believe much change is needed. A key role of this SIG will be to identify and collate these issues, develop an “issues agenda” and determine the necessary action to be taken. This is done through raising awareness of these issues by writing editorials, articles related, for international journals, professional organisations. The SIG will be committed to work as a repository to develop guidelines, recommendations and other solutions.

Membership of the ISoP SIG
Any member of ISoP with interest in medical device technology and safety is welcome to join the SIG. We are expecting and hoping the group will attract members from different countries and continents. We are expecting a good representation from countries who are strong in medical technology.

Mode of Communication
Meeting once every two months using web-based tool (Skype)

SIG Leaders:
Dr. Jitendar Sharma
Executive Director, Kalam Institute of Health Technology
MD&CEO, Andhra Pradesh MedTech Zone

SIG Coordinators:
Mr. P. Srinivasa Reddy
Senior Manager – Technical
Andhra Pradesh MedTech Zone

Mr. M. Santhosh Kumar
Senior Manager – Technical
Andhra Pradesh MedTech Zone

If you would like to join the Medical Devices group please contact Mr Santhosh Kumar at santhosh.kumar@amtz.in