FOI release

Freedom of Information requestfurther information on the toxins that these devices can pump out as well as any assessment of those toxins or how to treat the adverse impacts from the Philips Resperonics machine. (FOI 21/1236)

Published 31 May 2022

FOI 21/1236

15th December 2021

Dear,

Thank you for your information request, dated 18/11/21, where you asked for:

“In particular I’m looking for further information on the toxins that these devices can pump out as well as any assessment of those toxins or how to treat the adverse impacts from this machine.

I also want to know about the MHRA’s communication with the various stakeholders in relation to this matter such as documentation in relation to your ongoing meeting.

I’m also wondering when the MHRA were first notified by Philips about the issue and what actions were taken in response.”

I am pleased to provide you with some of the information requested, see below.

1. In particular I’m looking for further information on the toxins that these devices can pump out as well as any assessment of those toxins or how to treat the adverse impacts from this machine.

This information is available in our National Patient Safety Alert published on 23/06/21. The alert contains the following information:

Biological safety risk assessment (based on the currently available data)

The available evidence suggests:

• Volatile organic chemicals of concern (Dimethyl Diazine and Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl) are not detectable 24 hours after the first ‘out of box’ use of the device.
• Levels of diethylene glycol detected were within an acceptable margin of safety.
• The degradation by-products Toluene Diamine and Toluene Diisocyanate are classified by IARC as Group 2B carcinogens. This category is used for chemicals where there is limited evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals.
• Laboratory analysis found that as the foam degraded it tended to stick to nearby surfaces as well as itself. This reduces the risk of respirable particles entering the breathing circuit.
• Degradation of the polyurethane foam can be accelerated by off-label use of ozone decontamination or use in environments with high humidity and temperature, neither of which apply in the UK.
• Available evidence suggests that most degraded foam particles are too big to be inhaled.
• Diisocyanate is associated with isocyanate-induced asthma in a very small number of patients. For sensitised patients even low concentrations can cause adverse effects.

The available evidence suggests that the risks to patients of ceasing to use these devices significantly outweigh the biological safety risks if patients do not have ready access to an alternative

1. I also want to know about the MHRA’s communication with the various stakeholders in relation to this matter such as documentation in relation to your ongoing meeting.

Unfortunately, this information is exempt from release under Section 44 of Freedom of Information Act:

Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.

The MHRA is satisfied that the information you have requested:

• constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.

• relates to the affairs of Philips Resperonics, a business which continues to exist.

On that basis we are satisfied that section 44 of FOI Act applies and the information is exempt from release.

1. I’m also wondering when the MHRA were first notified by Philips about the issue and what actions were taken in response.

This question is also exempt under the above section. However, the MHRA publishes all manufacturers Field Safety Notices on our website the Monday after the manufacturer informs us that they are ready for publication. These notices can be found here.

The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email.

Yours sincerely

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 020 3080 6000