Indium Blog

RoHS Medical "Per Homogeneous" Conclusion


Let's see how Patty and Pete are doing with their Medical Device RoHS Crisis.....

Patty and Pete sat in a plane on the runway of the Manchester, NH airport.  Patty was just calming down after Jeff Sparkel  told her that Hal Lindsay had performed an analysis to show that the flagship medical device that Jeff’s factory assembled was RoHS-compliant using tin-lead solder.  Corporate RoHS compliance was under her responsibility and she was panicking that ACME’s St. Paul site would miss the July 22, 2014 compliance date for medical devices.   She literally drove straight to the airport after chatting with Sparkel on the phone.  Fortunately, she and Pete both had a three day suitcase in their offices for such emergencies.  Rob’s mom agreed to help with her twin boys.  What a blessing to have a mother-in-law like Rob’s mom.

To add to the stress, she and Pete almost missed the plane. He insisted that he needed to stop at a drug store, though he was secretive about the reason.

As the plane lifted off, Patty had to find out about this drug store mystery.

“OK, Pete. Why the drug store?” Patty asked.

“I’m afraid that, if I tell you, you’ll lecture me,” Pete said sheepishly.

“Out with it! Out with it,” Patty commanded.

“I bought Vick's VapoRub to put under my nose when we are with Mr. Lindsay.  Ain’t no way I’m gonna' be with that stink bomb unprepared,”  Pete responded.

Patty was going to say something but she started chuckling uncontrollably.

“You are welcome to share with me," Pete offered.

As Patty tried to catch her breath, she just shook her head no.

They arrived at their hotel room at 10PM, after a quick, late dinner.

Fortunately, the timing of events was favorable.  Lindsay had planned to give his final presentation the next day.  Sparkel was actually pleased that Patty asked to attend.

Patty met Pete for breakfast at 7AM.  By then she had run 5 miles, worked out with weights at the hotel gym, and showered.  They arrived at Sparkel’s office at 7:45AM and headed directly to the conference room where Lindsay was preparing to present.  Upon seeing Patty and Pete, Hal Lindsay seemed surprised and turned a little red in the face.  Pete checked the room for ventilation.  

 Patty and Pete agreed to listen to Lindsay’s complete presentation without interruption.

“I know everyone here except for that guy in the back. He looks like a lawyer,” Pete whispered into Patty’s ear.

“He looks like a lawyer because he is one,” Patty responded.  “He is my special guest,” she said.

Lindsay began his presentation sharply at 8AM. Patty had to admit that she was impressed with Lindsay’s experimental procedure.  He had taken three of ACME’s St. Paul site’s highest volume products and carefully performed teardown analyses.  He painstakingly extracted all of the solder from the PCBs.   One product weighed 10.2 kilograms and contained 11.2 grams of tin-lead eutectic solder.  Patty checked Lindsay’s calculations. The fraction of lead in the unit was 0.042%, less than 0.1% that RoHS requires.  All of the three products were below 0.05% by weight lead.

Lindsay then discussed his plan to analyze enough units to give the data statistical confidence.  His charge would be an additional $20K.  Jeff Sparkel then asked if there were any questions.

Patty raised her hand.

“Mr. Lindsay, what about RoHS’s requirement that all concentrations of substances of concern by ‘per homogeneous material?’” Patty asked. 

Lindsay looked confused.  His face turned a little red.  It appeared that he didn’t understand what she was asking. 

“Patty, please explain what ‘per homogeneous material' means?” Sparkel asked.

“It means that any part of the product that could be mechanically separated must be less than 0.1% lead.  As an example, a soldered joint can be cut out of a medical device with an X-Acto knife. Accordingly, the small piece of solder must be RoHS-compliant, so the solder itself must have less than 0.1% lead.” Patty explained.  

“Per hemorrhoidgenous material, don’t apply to no medical devices,” Lindsay grumbled.

Both Patty and Pete had trouble not chuckling at Lindsay’s mispronunciation of “homogenous.”

“I beg to differ.  Dr. Coleman’s explanation of ‘per homogenous material’ is spot on,” said Patty’s special guest.

Patty chuckled to herself when she realized that her guest thought she had a PhD.

“Who are you?” asked Jeff Sparkel.

“I’m Aaron Toynbee, Esq, our company’s general counsel.  My department has responsibility for interpreting corporate compliance with environmental laws like RoHS.  We have studied the RoHS law extensively and the requirement for medical device compliance. Almost all of the medical devices we manufacture must meet RoHS compliance by July 22, 2014.  I was alarmed when Dr. Coleman pointed out that there was some lack of understanding here about this.” Toynbee said.

After Toynbee spoke, it was agreed that the St. Paul team would work with Patty and Pete to resurrect the RoHS initiative that had been developed some time ago.  Patty let out a deep sigh of relief.

Just as it appeared that the meeting was over, one of the younger engineers asked, “Are we still going to have Mr. Lindsay perform the analysis he suggested.  It seems to me that there may be some benefit in getting this type of data.”

There appeared to be some murmuring of agreement.  Hal Lindsay brightened, as it appeared that his proposed work might still be accepted. 

Patty sat by watching this with incredulity.  She remembered the Professor telling her that sometimes people will be too polite and not say what needs to be said.  This was not going to be one of those times.

“You have got to be kidding me!” she shouted.  “There is no way we are going to continue any of this useless work!” she said even louder.

At this, Hal Lindsay’s  face turned beet red and he charged over to where Patty and Pete were.  Out of the corner of her eye, Patty could see the Vick’s VapoRub gleaming under Pete’s nose.

Patty was now standing up and Lindsay had advanced to within five feet of her.

All of the sudden Lindsay came up to within a foot of Patty.

“It’s tree huggers like you that that allowed this RoHS crap to happen in the first place,” he screamed into her face.

Patty was not prepared for this olfactory assault.  Worse yet, some of Lindsay’s spittle ended up on her face.  A natural gag reflex took over and she started having trouble breathing.  Those in the meeting were horrified as they watched Patty crumble and slump to the floor. 

Pete jumped up and instinctively and firmly pushed Lindsay back away from Patty.  His Vick’s VapoRub doing its job.  Sparkel’s  second-in-command, Jennifer Halliday, gently escorted Lindsay from the building, before any fisticuffs ensued.

Sparkel  and one of the female engineers helped Patty as she tried to get up.  Within a few moments Patty was herself again.  Everyone knew what happened, but when Patty said she probably should have eaten more for breakfast, everyone murmured in agreement.  Sparkel asked if just he, Patty, and Pete could wrap things up.  Patty agreed, but asked to go to the ladies room first.

When she returned, Patty again reiterated that medical devices have to obey the “per homogeneous material” requirement and that the only way this was possible was to change to a lead-free solder.  Patty and Pete confirmed their agreement to stay on for a few days to work with Sparkel’s team, to resurrect the plan to be RoHS-compliant by June 2014, a month early.

With two days of hard work, the plan was redeveloped, and Patty and Pete were confident the St. Paul team was on the right track.  Jeff Sparkel apologized to Patty about 10 times.

Within no time Patty and Pete were back on the plane, heading home.

“Hey kiddo! You should receive hazardous duty pay for this one,” Pete teased.

“No kidding,” Patty responded.

“When you said you needed to go to the ladies room, I was a little worried,”  Pete said. “I thought maybe some permanent damage was done,” he went on.

“It was worse than that. I had to wash Lindsay’s spit off my face,” Patty groaned.

“Definitely Purple Heart material,”  Pete teased.

They both chuckled.



Dr. Ron