Means of Patient Protection in Medical Devices
Medical professionals vow to “do no harm,” and that promise should extend to the medical devices they are using. While some discomfort or pain is inevitable when using certain medical equipment, when it comes to medical electrical devices, there should not be an unnecessary risk of electric shock. This is where means of protection (MOP) comes into play, and specifically means of patient protection (MOPP). We’ll talk about what MOPP is, the types most pertinent to patients, and how manufacturers can design with MOPP standards in mind.
What is MOPP?
Means of Patient Protection (MOPP) are measures that manufacturers can take to reduce the risk of electrical shock from a medical device to a patient. MOPP is a subcategory of means of protection (MOP) which apply to all medical devices.
Because patients may be in a more vulnerable position than operators – they may be restrained, in a weakened state, or otherwise prone to additional hazards – the MOPP standards are stricter than those for operators (MOOP). If a device meets MOPP standards, it will protect patients and non-patients, such as operators.
Why is MOPP important?
The most important reason for MOPP comes down to patient safety. Patients should be able to experience as little risk and harm as possible when entrusting medical professionals with their care. In turn, medical device manufacturers should ensure MOPP are in place to reduce the risk of electrical shock and meet compliance standards as outlined by EN 60601-1 for medical electrical equipment.
Types of MOPP
Many means of protection (MOP) that help safeguard operators are also important for patients. These include isolation, grounding, PPE, warning labels, overcurrent protection, and residual current devices (RCDs). However, two measures that are especially key for patients are basic insulation and double insulation.
Medical electrical equipment, at the minimum, requires basic insulation to be compliant. Basic insulation should cover all live parts of the equipment. For patients, this means any part of the device that comes into contact with their body should be protected properly.
Double insulation is just what it sounds like, two layers of insulation instead of just one. A second material or method of insulation is used, such as rubber or plastic, to provide additional protection against electric shock.
Basic and double insulation also correspond with the two means of protection (MOP) levels that devices can meet – 1xMOP and 2xMOP. A device that meets 2xMOPP standards means it abides by stricter standards than 1xMOPP or any MOOP requirements.
How to implement MOPP with equipment design
Medical electrical devices need to meet EN 60601-1 standards to be on the market. Depending on the type of device, different levels of MOPP or MOOP may need to be achieved. These levels are generally satisfied by adding insulation, meeting standards for air clearance and creepage distance, and including protective earth ground connections.
Medical device manufacturers should use guidance from EN 60601-1 to determine MOPP or MOOP requirements for their equipment, which later will be evaluated by an independent laboratory that can certify the appropriate MOP level.
Any PC-based medical device used with patients should meet 2xMOPP requirements. The easiest way to achieve this is by including components in the device that are also 2xMOPP compliant. RAM Technologies power supplies are rated to 2xMOPP. This cuts out a potential next step – some power supplies that are rated to 1xMOPP can be changed to 2xMOPP by adding an isolation transformer, but this can be both bulky and an added expense.
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