How to Improve and Promote Safety in The Medical Device Industry

‘Medical Device’ is a terminology used for a wide variety of ‘devices’ associated with the treatment or therapy of a condition. It could be

• An appliance
• An apparatus
• An instrument
• A machine
• An implant
• A material
• In vitro usable reagents
• Software used in medical devices and so on.

Each medical device has a defined purpose and is considered safe and effective when it delivers the objectives for which it was designed. Conversely, its non-performance will have serious implications for the health of the patient or the handler.

To prevent such an occurrence, regulations such as Medical Device Regulations (MDR), and In Vitro Device Regulations (IVDR) lay down standards and rules. Compliance with these will not only keep the device manufacturers from getting into trouble with the bodies but also improve product quality, workplace safety, and patient safety. Further, regulatory bodies such as Occupational Safety and Health Administration (OSHA) ensure workplace safety to protect workers during the manufacturing process.

Use a Risk-based Approach to Assess Patient Safety When Using the Medical Device

Needless to say, patient safety is a crucial aspect of medical device usage. Whatever the nature of the device, it is intrusive and any defect can endanger the patient’s life or cause severe damage – reversible or irreversible. Therefore, medical device compliance is critical to demonstrate that the device is behaving as expected and is safe for patients to use.

ISO 13485 is a standard governing medical device quality and the foundational principle for all regulations. Noncompliance can lead to penalties and recalls, damaging your brand reputation and overall business prospects.

Therefore, it is important to adhere to standards right from the time of design to post-market surveillance to ensure that the device design meets the specifications, and adheres to correct manufacturing processes to deliver finished products that conform to the original specifications. Factors such as design control, end-to-end project management, documentation, training, change management, and risk management become an essential part of the device manufacturing process.

A unified view of patient safety-related data, creating a feedback loop for continuous improvement of the device, audits, and inspections also add to eliminating problems with the device and mitigating risks. This improves the overall quality of the device and enhances patient safety.

This is further ensured with periodic resting for establishing a traceability matrix to improve compliance and device safety. Integrated risk management capabilities with pharmacovigilance and adverse events reporting management will ensure there is no time wasted in identifying and correcting patient safety issues to enhance the safety of the device.

These should be supported by sourcing only the best quality materials for the manufacturing of the devices. This makes assessing the toxicity of the various materials used to manufacture the device and assessing the quality and capabilities of the suppliers also becomes important.

Automating these processes will help manage the complexities involved in safety compliance and improve the quality and safety of medical devices.

Improving Health and Safety in the Manufacturing Environment of Medical Devices

Worker safety is an equally important aspect of the medical device manufacturing process. In some cases, materials used in the manufacturing process can possibly be toxic, adding to the already present threats in a manufacturing environment. Risks of trips, falls, electrical accidents, hazards of working near machinery, and dangers of performing hot work and cold work are omnipresent dangers common to all manufacturing environments.

A proactive approach to worker safety through the identification of risks and implementing mitigative measures will minimize accidents and improve worker health and safety. This will also improve worker trust, loyalty, and engagement in the processes, creating a culture of safety, and enhancing compliance.

Some of the ways to ensure worker safety include:

Periodic and Well-Planned Audits and Inspections: Periodic audits and inspections help to identify hazards and risks, take timely action, and proactively address safety issues.

Ensure Availability and Usage of PPE: Ensure that there is enough PPE of the appropriate nature – full body, for the eyes, ears, hands, etc., and that they are used as required to minimize harm to workers when exposed to potential risks.

Manage Hazardous Chemicals: Ensure all hazardous chemicals are labeled appropriately, stored as specified, and handled only by authorized team members in the prescribed manner.

Housekeeping: An important aspect of workplace safety is to ensure clean surfaces to avoid trips and falls caused by loose stings, wires, etc., or wet floors that can cause one to slip. It also is important to prevent fires from spreading in case of an accident.

Permit to Work: Highly dangerous tasks must be identified and only authorized personnel allowed to perform the task with proper permits to minimize risks. The work area must be prepared to improve safety and controls put in place to proactively respond in case of an emergency.

Safety Observations and Incident Reporting and Management: As cliched as it may be, prevention is better than cure! Safety observations help to monitor workplaces and worker behavior to identify anything unsafe and correct it before it can become an event. In case of an event happening, the workers must be empowered to report and manage the incident. Preventive measures must be put in place to prevent a recurrence.

Risk Management: A centralized repository of risks, their intensity and frequency, and putting appropriate controls in place will help to predict incidents and address them proactively.

Training and Documentation: Worker training and documentation of processes complete the loop on safety as they equip employees to imbibe safe behavior and improve workplace safety. Documentation is important for compliance and is also a rich source of data that can empower managers and leaders with data needed for continuous improvement.

Predictive Maintenance: Machinery itself can be a source of danger to workers if not maintained well. Periodic, predictive maintenance helps to reduce disruptions to production, improve product quality, and increase worker safety.

ComplianceQuest provides end-to-end solutions for workplace safety and patient safety, improved product quality, and enhanced compliance. Being modular and well-integrated, you can choose the features best suited for your need for building a formidable, yet cost-effective, safe work environment that protects employees, customers, the environment, and your business as well.

To know more about CQ can drive safety, and compliance for your medical device company, request a demo here: https://www.compliancequest.com/lp/ehs/