Would you please comment on the medical device industry as we move into 2013?

Stanley Goodrich
Public Relations Manager, SYSPRO

The need for medical device manufacturers to have product recall plans in place was reaffirmed by the release of the latest figures on medical device unit recalls. According to the quarterly ExpertRECALL Index released August 22, 2012, over 123 million medical device units were recalled in the second quarter of 2012, reaching an eight-quarter high.

The Associated Press article reporting on this record number of recalls contains the following statement by Mike Rozembajgier, vice president of recalls at Stericycle ExpertRECALL, “The growing importance of this product category means that companies need to have a comprehensive recall plan in place that can be deployed within the blink of an eye and can effectively protect their customers…”

The recall plans should encompass lot traceability and serial tracking functionality and afford extensive visibility up or down the supply chain, as well as providing specific component to parent tracking, thereby providing the means to expedite recalls, should the need arise.

Rob Kim
Strategic Marketing Director, Honeywell Sensing and Control

Developers of medical equipment like chemistry analyzers, blood analyzers, ventilators, wound therapy, endoscopes, and flow cytometry are moving to the design in of liquid compatible pressure sensors that can handle a wide range of wet/wet situations on both sides of the sensor.

Designing in a wet/wet liquid media sensor can reduce the design complexity and costs often associated with protecting the sensor from liquids. In the past, designers would use a bulkier, medical isolated pressure transducer. Now they can use a smaller, board mounted pressure sensor, which saves space and cost. This means designers are able to develop smaller and more compact medical instrumentation with less empty space in the packaging. Even in systems where liquid compatibility should not be an issue, with about a 10% increase in the sensor cost versus dry/dry pressure sensors, liquid compatible pressure sensors can provide an additional layer of protection from the “what ifs” in case something goes wrong.

Gary Burnett
President and CEO, Burton Industries

The trend we are seeing at Burton Industries is greater collaboration between customers and contract manufacturers. There was a time when regional contractors in our size class weren’t expected to have the same tools or level of involvement in the product development cycle as our larger counterparts. That is no longer the case. It is as much a trend driven by our company as it has been requested by our customers. We see early involvement in the design phase as being a way to eliminate problems in sourcing or manufacturing before they start. It is particularly important in the medical realm because there is less ability to make design changes once a product has gone through its approval process. The areas we focus on include analyzing obsolescence risk, minimizing the number of sole-sourced components, and making design for manufacturing/testability recommendations.

We expect this trend of closer collaboration to continue. BOM scrubbing software tools make it easy to extend contractor engineering resources even in small engineering teams. And, the cost of failure to address manufacturability or sourcing issues in the design phase continues to increase. From our perspective, it is important to lead rather than follow. For that reason, we’ve also created a supplier alliance with custom component manufacturers who provide similar services for their commodities.

Dave Beckstoffer
Project Manager, Portescap

Medical analyzers are continually challenged by design changes, requiring the engineering team to make adjustments throughout the machine. One area affected by this is the motion control, ranging from driving pipettes to X-Y motion. Since these design changes can come suddenly, suppliers need to provide rapid engineering response to accommodate design changes and new features. Ideas are exchanged between engineers, tested in theory for the performance of the machine, and then confirmed. In addition, once the new motor has been selected, prototyping becomes the key driver to test out the design. Rapid prototyping via web-based ordering systems has become more common, enabling the engineer to go from design concept to testing in a short period of time. Additional options are provided in these web-based systems to allow further flexibility to the design concept changes.

Donald L. Sweeney
President and Senior EMC Engineer, D.L.S. Electronic Systems Inc.

Recently, a draft changing 60601-1-2 was circulated proposing some dramatic additions to medical immunity requirements. Over the years, medical equipment has had a primary concern that it functions properly in all the environments. This can mean life or death to a patient or even a worker.

At the 2002 IEEE EMC Symposium, examples were reported of wireless problems, such as cell phones causing an infusion pump to over infuse epinephrine, a defibrillator affected by a pager, a ventilator affected by a cell phone, etc. I once personally measured the field from a car cell phone at 50 Volts/meter so you can see how that could affect a medical device.

Many years ago, the only standard available was known as MDS-201-0004 1979. This standard preceded most civilian EMC test standards and was used by our testing laboratory to simulate failure that occurred in the field by customers’ products. Using this standard, we could recreate what was happening in the field. Once we had recreated it, we could then develop a solution.

I have always found the standard interesting as it not only contained the testing requirements but also the data recorded in the field for various environments. As an engineer, it not only told me what I had to do but why I needed to do the test and at what level. (This MDS standard is available at our website.)

When the European Community developed common EMC requirements for products starting with the proposals in 1989, we began to see standards written to cover many of the phenomena we had been seeing from the field. The earliest requirements for medical equipment were:

  • IEC 801-2 Electro Static Discharge—The shock you get in the winter when you touch something.
  • IEC 801-3 Radiated electric field 26 MHz to 1000 MHz—What you would see from a radio station or a walkie talkie.
  • IEC 801-4 Fast Electrical Transients—The energy seen on power lines when contacts are opened for an inductive load.

These were relatively simple but a big beginning.

I remember how amazed I was when the home appliance standard EN 55014 came out with its update and introduced 801-5 lightning on power lines, 801-6 RF on power lines, 801-8 magnetic field testing and 801-11 sag surge and dropout. This, for a while, was more stringent than the requirements for medical equipment!

Today, the 801s have been replaced by Standards IEC 1000-4-2, 3, 4, 5, 6, 8, and 11.

With the draft being proposed, which is trying to stay ahead of the wireless communication technology, there are new frequencies and levels being proposed. Many of the new requirements take into account the emissions from the following new technologies: TERA 400/800, GMS 460, GSM 800/900/1900, IDEN 820, CDMA 850/1900, DECT, UMTS, Bluetooth, WLAN 802.77 a/b/g/n, and RFID.

These are proposed to be tested to as much as 30 Volts/m.

This draft has had hundreds of comments so will most likely be revised, but there will eventually be changes made to the standard to prevent serious accidents from occurring. These will require additional design consideration when planning a new product. It is recommended that the design engineers make themselves knowledgeable by understanding EMC design or taking a class before new products are developed.