Design Article
Developing medical sensors compliant with global requirements
James McKenna, Honeywell
3/6/2013 10:56 AM EST
Supplier quality assurance is critical
Not only do sensor manufacturers have to meet a variety of materials regulations, and global electrical requirements, including UL in the United States, cUL or CSA in Canada, ENEC in Europe and CQC in China, they also need to have quality assurance systems in place to ensure chain of custody and quality control.
Suppliers should meet Six-Sigma quality standards in their manufacturing processes to ensure high quality products. This is critical for any medical device manufacturer since their products can impact a patient's safety.
Reliability of supply also is important to designers. sensor manufacturers should have a global presence to support design and production requirements. As an example, European designers often will develop a product that requires several modules or subassemblies that are typically outsourced to electronics manufacturing service (EMS) companies in different parts of the world. The modules or subassemblies are then shipped back to the manufacturer in Europe for final assembly.
Emerging technical trends
Medical device engineers also require suppliers to provide product support for emerging technical trends. A few examples include digital interface options and single-use sensors. sensor manufacturers are offering digital interfaces, particularly I2C outputs, for a few reasons. A digital I2C output allows designers to eliminate signal conditioning circuitry from the printed circuit board (PCB), which saves board real estate and costs related to the signal conditioning. It also reduces the amount of copper traces and wires for a further cost savings. The fewer components on the PCB allow for miniaturization.
The on-board signal conditioning provides the sensor's compensation, calibration and amplification. This delivers higher accuracy and reliability, which contributes to patient comfort and quality of care. It also lowers the overall cost of ownership for the medical hospital or clinic. This can benefit a wide range of applications from dialysis machines and infusion pumps to incubators and respiratory equipment.
There is also a growing trend for single-use sensors in applications such as infusion pumps to eliminate the need to clean areas that come into direct contact with medicated or patient fluids. However, medical practitioners should take into account the reliability of single-use sensors as the performance of the sensor can be a determining factor in how well the equipment performs for the patient.
Cross contamination is a big concern in systems intended for single-use, when the sensor is not changed with every patient when it's supposed to be. This is especially true for devices used with patients with illnesses such as HIV/AIDS, the bird flu and Legionnaire's disease that are transmitted by bodily fluids. While medical device manufacturers recommend using one sensor per patient when using single-use sensors, there is the risk of multiple use at clinics in areas that also face budgetary issues combined yet with fewer regulatory controls.
About the author
James McKenna is Product Director in EMEA for the Pressure and Thermal product portfolio of Honeywell Sensing and Control, a manufacturer of sensors and switches within the ACS Strategic Business Group. More information about Honeywell and its technologies can be found at http://sensing.honeywell.com/.
Courtesy of EETimes Europe
Related posts
Not only do sensor manufacturers have to meet a variety of materials regulations, and global electrical requirements, including UL in the United States, cUL or CSA in Canada, ENEC in Europe and CQC in China, they also need to have quality assurance systems in place to ensure chain of custody and quality control.
Suppliers should meet Six-Sigma quality standards in their manufacturing processes to ensure high quality products. This is critical for any medical device manufacturer since their products can impact a patient's safety.
Figure 3: The Honeywell's 20PC series of liquid media compatible pressure sensors offer many options for pressure range, package style, and digital/analog outputs
Reliability of supply also is important to designers. sensor manufacturers should have a global presence to support design and production requirements. As an example, European designers often will develop a product that requires several modules or subassemblies that are typically outsourced to electronics manufacturing service (EMS) companies in different parts of the world. The modules or subassemblies are then shipped back to the manufacturer in Europe for final assembly.
Emerging technical trends
Medical device engineers also require suppliers to provide product support for emerging technical trends. A few examples include digital interface options and single-use sensors. sensor manufacturers are offering digital interfaces, particularly I2C outputs, for a few reasons. A digital I2C output allows designers to eliminate signal conditioning circuitry from the printed circuit board (PCB), which saves board real estate and costs related to the signal conditioning. It also reduces the amount of copper traces and wires for a further cost savings. The fewer components on the PCB allow for miniaturization.
The on-board signal conditioning provides the sensor's compensation, calibration and amplification. This delivers higher accuracy and reliability, which contributes to patient comfort and quality of care. It also lowers the overall cost of ownership for the medical hospital or clinic. This can benefit a wide range of applications from dialysis machines and infusion pumps to incubators and respiratory equipment.
There is also a growing trend for single-use sensors in applications such as infusion pumps to eliminate the need to clean areas that come into direct contact with medicated or patient fluids. However, medical practitioners should take into account the reliability of single-use sensors as the performance of the sensor can be a determining factor in how well the equipment performs for the patient.
Cross contamination is a big concern in systems intended for single-use, when the sensor is not changed with every patient when it's supposed to be. This is especially true for devices used with patients with illnesses such as HIV/AIDS, the bird flu and Legionnaire's disease that are transmitted by bodily fluids. While medical device manufacturers recommend using one sensor per patient when using single-use sensors, there is the risk of multiple use at clinics in areas that also face budgetary issues combined yet with fewer regulatory controls.
About the author
James McKenna is Product Director in EMEA for the Pressure and Thermal product portfolio of Honeywell Sensing and Control, a manufacturer of sensors and switches within the ACS Strategic Business Group. More information about Honeywell and its technologies can be found at http://sensing.honeywell.com/.
Courtesy of EETimes Europe
Related posts
. Endoscopy, X-rays drive image sensor demand
. Medical monitoring gets personal, goes mobile
. Sensor fusion and MEMS for 10-DoF solutions
. Improving medical imaging with direct radiography
. Smart devices are key for medical gear makers
. Top 10 medical ‘how-to’ articles of 2012
. Wearable sensor devices leverage MEMS motion tracking innovations
|
|
|
|
|
Navigate to related information
WKetel
3/12/2013 9:10 PM EDT
All of those regulations are why my product won't be sold to EU residents. They can lease them, but if they choose to get rid of them they must be returned. Of course, my products are well worth repairing and being re-sold here, or leased to some other EU party. Now I am waiting for the leasing to become ilegal as well. Then they will need to purchase the much more expensive products from others.
Sign in to Reply