Reduce Risk with Proactive Medical Device Hazard Analysis

 Medical devices are any devices involved in healthcare, from disposable latex gloves to MRI machines. All these must be sterile, safe, and functional during their operation, and must remain safe throughout their lifecycle. Hazards that medical devices face in their lifetime include:

• Contamination
• Component failure
• Shipping damage
• Tampering or counterfeiting
• Electromagnetic interference
• Improper disposal
• Reuse of single-use devices
• Varying medical device regulations, both in the UK and across global regions

Incidents arising from any of these can hinder operations and cause health and safety incidents, legal ramifications, fines, and reputational damages. This guide will help you consider safety concerns in each lifecycle phase of medical equipment.

To mitigate risks through each phase of the medical device’s lifecycle, you must consider them during the device’s design work. This starts with a risk analysis.

The basic phases of a risk analysis are:

1. Brainstorm and identify the hazards users could encounter as they interact with the device in different ways through its lifecycle. It’s important to assess each device’s normal and fault conditions: the hazards present when being used normally, and what could happen if the device breaks or is used improperly
2. Rank each incident a hazard could produce by severity and likelihood. A colour-coded risk matrix can help with visualising this
3. Determine what measures are necessary to reduce each incident’s severity and likelihood to acceptable levels. This can involve changing the design to omit the hazard, mandating procedures to avoid it, or wearing personal protective equipment (PPE) to mitigate it
4. Document all this to prove your due diligence in safety

More specifically, in the design process, think about the health and safety implications of your design’s materials (and packaging materials): their toxicity, flammability, and reactivity. Picture how the device will be manufactured, packaged, stored, shipped, used, maintained, and disposed of. People using it need to be kept safe every step of the way, as does the environment and the public.

A major factor that medical device design needs to consider is electromagnetic interference (EMI): electromagnetic fields that disturb signals in electronic devices, preventing them from operating properly. EMI can come from Bluetooth or cellular signals, lightning, faulty power lines, inefficient electronics in the device itself, and nearby alternating current devices like generators or lighting. Medical devices that must consider this include pacemakers, ventilators, MRIs, ECGs, and electrosurgical equipment. If EMI degrades their performance, this risks incorrect instrument readings, misdiagnoses, failed life support, and surgical mistakes.

To avoid EMI, design the medical device to withstand it using:

• EMI shielding: Films, tapes, sprays, metal shields, and gaskets that prevent EMI from entering your device. EMI-shielded cables are particularly important for transmitting patient data cleanly
• Grounding: Design ground paths to minimise resistance and separate different grounding circuits, like analogue and digital ones
• EMI filtering: Dedicated EMI filtering devices exist for things like cable connectors. It’s also important to design your device’s circuits to prevent EMI-causing voltage buildup using components like voltage regulators, voltage supervisors, and voltage controllers.

As with all design work, testing and prototyping are key tools for verifying and validating that your medical device will hold up to all the use cases of its lifecycle. EMI testing is especially important: Test for power integrity (whether voltage and current transmissions fully arrive) and signal integrity (electrical signal quality).

Finally, document all this design work as required in your quality assurance programme or industry regulations to show you’ve thoroughly planned this device around health and safety.

Read on for design factors to consider for all the other lifecycle phases.

Risks in medical device manufacturing are like those in other industries:

• Pinches and entanglement from moving equipment
• Shock from electrical equipment
• Leaking fluid causing slips or pressure injury
• Toxic fumes and inhaled particulates
• Ergonomic injury from repetitive strain

As part of your medical device hazard analysis, assess the materials and manufacturing machines for producing the device. Consider what hazards each machine produces and controls to protect workers from them:

• Engineering controls: Guards and emergency stop devices that physically prevent contact with hazards
• Administrative controls: Written procedures mandating training, proper posture, safe operation, and areas not to enter
• PPE: This last line of defence assures protection for workers’ eyes, hands, feet, ears, head, and lungs

Also analyse the scrap and shavings manufacturing will produce, both from a cost savings standpoint and to prevent workers from breathing hazardous particulates.

Additionally, practise quality control to ensure you’re shipping medical devices that will perform properly and keep patients safe. This can take the form of regular measurements and tests of output products to verify they’re meeting specifications and withstanding their expected operating conditions.

After the medical device’s manufacture, it still must arrive functional at the clinic, laboratory, or hospital. Supply chain networks these days are global and complex, as are their hazards:

• Physical damage
• Compromised sterility
• Fluid, ultraviolet (UV), and temperature exposure
• Worker injury from mishandling, such as drops or cuts
• Tampering and counterfeiting
• Shipments going missing
• Language challenges as part of operating in multiple countries
• Violating medical device regulations, leading to recalls, fines, and loss of certification

In your medical device hazard analysis, look at the following distribution and storage factors:

• Temperature and ventilation conditions
• Degree of exposure to sunlight
• Expected exposure to water, heavy dirt, or chemicals
• How the device will be packaged, and how that packaging could be damaged
• How it will be tracked through its entire journey
• All the regions and markets of the journey
• Chances for human error, including misreading handling instructions

Measures for mitigating these include:

• Temperature and humidity controls
• UV-resistant packaging
• Packaging that alerts people to device fragility or required orientation—though consider regional languages
• Designing the device and its packaging for easy handling
• Packaging that prevents tampering, or at least reveals evidence of it
• Certificates of authenticity and telltale design features to deter and spot counterfeiting
• Security measures and training governing who can authorise the device’s transportation
• Tracking through IIoT devices like RFID tags and GPS
• Thorough documentation and regular inventory validation
• Monitoring suppliers’ performance to ensure they meet quality benchmarks and medical device regulations

All this can ensure your medical device arrives functional and sterile, though ensure you also have procedures for verifying that before it enters service.

Once your medical device enters medical service, what hazards come up in its actual use? Simply, the device must properly perform its role in patient care, do no harm to patients or personnel, and hold up to the rigours and cleanliness standards of the medical field.

In the medical device hazard analysis, consider the following for its operations:

• Will the device be deployed in a hospital, clinic, operating room, laboratory, office, or even inside someone’s body?
• Who will be using the device, and what training do they need?
• Is the device single-use or multiple-use? Single-use devices must be disposed of promptly, while multiple-use devices must follow strict cleaning protocols
• Does the device present risks from sharp edges, shocks, electromagnetic fields, or fluid leaks?
• Does cleaning the device require hazardous chemicals that need risk assessments?
• How complicated is the cleaning process?

What are the three levels of decontamination of reusable medical devices?

• General cleaning: A visibly clean state. It removes microbes but doesn’t always kill them
• Disinfection: Kills most microbes but doesn’t kill spores. This involves intense heat, chemicals, and UV light
• Sterilisation: Kills spores. It requires specific, stronger chemicals or an autoclave (for applying intense pressure)

The decontamination levels a given medical device requires depend on its operational risk level:

• Low risk: Contact with only intact skin. General cleaning is often sufficient
• Medium risk: Contact with, but no penetration of, intact mucous membranes. Either disinfection or sterilisation is required, depending on the scenario
• High risk: Penetrates the mucous membranes of the patient’s body. These devices need all three levels of decontamination before re-entering service

It’s important to ensure all multiple-use medical devices are properly classified according to their risk level and decontamination procedures, and that staff are adequately trained on this.

Medical devices operating long-term need regular maintenance to ensure they stay functional and safe for their designed lifetime. Maintenance can be either reactive (fixing something when it breaks) or proactive (preventative or predictive maintenance to fix issues before they cause incidents). Proactive maintenance mitigates these hazards:

• Reduced reliability: Downtime, delayed patient care, reduced revenue
• Risks to patients and personnel: Devices performing poorly or completely failing pose serious health and safety risks. Medical devices hooked up to patients for long periods of time especially must run reliably
• Higher maintenance costs later: As with all maintenance, neglecting spending the time and money for it only results in more downtime and money for fixes later
• Failing compliance: Some medical device regulations mandate regular documented maintenance

Examples of medical equipment that needs regular maintenance:

• Refrigerators (their temperature controls in particular) for storing medicine and vaccines
• Defibrillators
• Weigh scales
• Blood pressure instruments
• Spirometers
• Anaesthesia machines
• Therapeutic machines for electrotherapy, cold therapy, SCD, CPM, etc.

This is only a small sample of the many types of medical equipment that needs regular maintenance, though. Familiarise yourself with the maintenance needs of any medical devices you introduce.

To plan for this service in the lifecycle, start by designing for disassembly:

• Consider fragility of key components, especially instrumentation
• Ensure disassembly doesn’t compromise EMI protection
• Make interiors cleanable
• Minimise the number of tools needed for disassembly; especially minimise proprietary, non-standard tools
• Make disassembly intuitive and minimise the need for instructions—though make those intuitive as well, and unambiguous. Prioritise symbols and images to mitigate language challenges

Next, incorporate these measures in your maintenance programme:

• Plan medical operations around this maintenance, ensuring availability of redundant devices or scheduling maintenance outside of business hours (if applicable)
• Maintain cleaning standards since contaminants must be kept out of the device interior. Performing maintenance in cleanrooms may be needed, which requires specific PPE and practices
• Establish performance benchmarks, and calibrate and test the devices after service to ensure they meet these standards

Track your assets and their maintenance needs using a computerised maintenance management system (CMMS), which you can expand to manage spare parts supply.

This final stage in a medical device’s lifecycle carries significant hazards:

• Environmental damage: Hazardous materials can spread through the ground, water, and atmosphere if not disposed of properly
• Spreading disease: Single-use high-risk items, such as needles, can spread disease if released into the public
• Reusing single-use devices: Along with spreading disease, reusing these devices risks them rupturing from fatigue (thus breaching sterile barriers) and mistakenly spreading chemicals
• Failing compliance: Just like regulations for ensuring medical devices keep patients and personnel safe, there are regulations, such as WEEE, for ensuring their disposal keeps the environment and public safe

Most hospital waste comes from single-use devices: items used once on a single patient and then discarded. This is often unavoidable to ensure their sterility. Examples include needles, tongue depressors, and staff PPE like gloves, masks, and some gowns. It’s important to identify single-use devices as such by providing the crossed-out ‘2’ on their packaging and to provide information on safely disposing of them, if possible.

Some single-use items require incineration, particularly infectious waste (items that came into contact with blood or bodily fluids) and sharps waste like used needles. This requires dedicated receptacles and procedures for separately collecting these items and directing them to incineration. Incineration prevents the spread of disease and contaminating soil and water.

Disposal also factors into the design of electronic medical devices:

• Consider which components have regulations for proper disposal and design methods for disassembling and removing those parts easily and safely. Keep in mind all the regions your device will operate in.
• Minimise the permanent bonding of different materials together, which can prevent recycling.
• Minimise components, different materials used, and fastener types and sizes.
• Make materials identifiable, with marks indicating a plastic’s type and recyclability.
• Avoid hazardous coatings.
• Connect your customers with proper channels for materials disposal in their region.

All these guidelines will allow medical devices to achieve their primary goal of helping people. For reliable, high-quality first aid equipment, explore RS’ solutions today.