Blog in Bike Europe: What we can learn from the disastrous Philips recall

By Rutger Oldenhuis

“The health care turmoil in the US is only temporary,” Philips’ CEO said in an interview in 2017. Today, Philips itself seems to be in its worst turmoil ever. The company is recalling millions of medical devices due to the breakdown of foam (PE-PUR) used in the Philips Respironics ventilators and other medical devices, causing serious potential health risks.

And things only seem to get worse – the latest developments are that Philips enlarged the scope of the recall yet again, and their CEO announced he would step down. Typically, we read all of this in the newspapers, but interestingly, the US Food and Drug Administration (FDA) has published observations of their inspections carried out at Philips Respironics Inc., the US-based company that produces the affected medical devices.

Serious observations

The observations provide very detailed insight into the product design and safety processes that FDA claims Philips is not sufficiently in control of. Based on 21 company inspections, they made eight serious observations. Each observation is extensively substantiated with examples.

To mention just a few… According to the FDA, there was no documented investigation, risk analysis, or design failure mode effect analysis to support Philips’ rationale for which products were affected by the recall. Philips had not sufficiently demonstrated that other devices, also containing PE-PUR foam, should not be included in the ongoing recalls, as well.

A known problem

Furthermore, already in 2015, Philips was aware and knowledgeable of a preventative maintenance servicing procedure implemented by another Philips entity on affected products, but no further investigation, health hazard evaluation, risk analysis, or design review was performed or documented.

The FDA also claims that the analysis of quality data, such as complaints, was not adequately performed to identify or detect quality problems. No formal Corrective And Preventive Action (CAPA) was initiated or implemented, when appropriate, and no verification of effectiveness was performed. The FDA goes on to say that management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organisation.

Not addressing user needs

Finally, the intended patient population of affected ventilator devices are individuals requiring mechanical ventilation, that potentially lack typical and healthy lung and bodily functions. However, the FDA observed that Philips’ health hazard evaluation documented typical and healthy lung and bodily functions and did not conform to or address the user needs of the intended patient population of these ventilatory medical devices, including patients with a tracheostomy or that lack typical and healthy lung and bodily functions.

So, what can we learn from this?

Companies need to be in control of their product safety and recall processes, before and after market launch. For that purpose, the list of observations could easily be used as a (non-limitative) checklist. For example, ask yourself the following:

  • Do you have an adequate risk analysis procedure in place?
  • Do you have a CAPA procedure in place?
  • Do you have proper design validation procedures in place, considering the intended users and use?
  • Do you have a proper complaint system in place?
  • Does the executive management team take ownership of product compliance and safety within your company?
  • Do you have proper procurement procedures and supplier agreements in place?

I would like to add another observation. Respironics Inc. was acquired by Philips in 2008 for US$5 billon. The affected products were sold from 2009. We can only guess if the product design and safety processes of Respironics were assessed during due diligence. If only Philips could turn back time. However, they must still invent a machine for that…

Blog in Bike Europe: What we can learn from the disastrous Philips recall

By Rutger Oldenhuis

“The health care turmoil in the US is only temporary,” Philips’ CEO said in an interview in 2017. Today, Philips itself seems to be in its worst turmoil ever. The company is recalling millions of medical devices due to the breakdown of foam (PE-PUR) used in the Philips Respironics ventilators and other medical devices, causing serious potential health risks.

And things only seem to get worse – the latest developments are that Philips enlarged the scope of the recall yet again, and their CEO announced he would step down. Typically, we read all of this in the newspapers, but interestingly, the US Food and Drug Administration (FDA) has published observations of their inspections carried out at Philips Respironics Inc., the US-based company that produces the affected medical devices.

Serious observations

The observations provide very detailed insight into the product design and safety processes that FDA claims Philips is not sufficiently in control of. Based on 21 company inspections, they made eight serious observations. Each observation is extensively substantiated with examples.

To mention just a few… According to the FDA, there was no documented investigation, risk analysis, or design failure mode effect analysis to support Philips’ rationale for which products were affected by the recall. Philips had not sufficiently demonstrated that other devices, also containing PE-PUR foam, should not be included in the ongoing recalls, as well.

A known problem

Furthermore, already in 2015, Philips was aware and knowledgeable of a preventative maintenance servicing procedure implemented by another Philips entity on affected products, but no further investigation, health hazard evaluation, risk analysis, or design review was performed or documented.

The FDA also claims that the analysis of quality data, such as complaints, was not adequately performed to identify or detect quality problems. No formal Corrective And Preventive Action (CAPA) was initiated or implemented, when appropriate, and no verification of effectiveness was performed. The FDA goes on to say that management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organisation.

Not addressing user needs

Finally, the intended patient population of affected ventilator devices are individuals requiring mechanical ventilation, that potentially lack typical and healthy lung and bodily functions. However, the FDA observed that Philips’ health hazard evaluation documented typical and healthy lung and bodily functions and did not conform to or address the user needs of the intended patient population of these ventilatory medical devices, including patients with a tracheostomy or that lack typical and healthy lung and bodily functions.

So, what can we learn from this?

Companies need to be in control of their product safety and recall processes, before and after market launch. For that purpose, the list of observations could easily be used as a (non-limitative) checklist. For example, ask yourself the following:

  • Do you have an adequate risk analysis procedure in place?
  • Do you have a CAPA procedure in place?
  • Do you have proper design validation procedures in place, considering the intended users and use?
  • Do you have a proper complaint system in place?
  • Does the executive management team take ownership of product compliance and safety within your company?
  • Do you have proper procurement procedures and supplier agreements in place?

I would like to add another observation. Respironics Inc. was acquired by Philips in 2008 for US$5 billon. The affected products were sold from 2009. We can only guess if the product design and safety processes of Respironics were assessed during due diligence. If only Philips could turn back time. However, they must still invent a machine for that…