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Medical Technology Safety aspects

Whilst we are in a monumental challenge / crisis for health care, medical safety is still a concern. There are clear regulations regarding medical devices (MDR). Most of the products for medical use or use by medical professionals would be classified as medical devices. In Sweden (and Europe) this would require CE-mark. Acquiring a CE-mark is a lengthy and complex process and also requires that a quality management system is in place. Thus this is not an option in this situation. For US the corresponding requirement is FDA approval (most cases 510(k) approval). FDA have a guidance document on modifications to ventilators / PAPR and similar devices. FDA also has a clearance path called Emergency Use Authorization (EUA) process.

In the text below I will for simplicity for the laymen referring to products where we really mean medical devices. Essentially all things that are not drugs with intention to be used to treat or in the treatment process a patient are classified as medical devices. This ranges from protective gloves, protective gears, needles, to ventilators, respirators…

So the general rule is that all medical devices (products) needs regulatory approval. However, for several products we are or will soon be in a situation were hospitals can not acquire required material or equipment commercially as there is a shortage in supply chains. It may likely be better to use something that is not regulatory approved than not using anything at all provided that proper risk analysis have been done.

For products used by Region of Scania

The following is the process and reasoning in Region of Scania. The principle should be valid for all health care providers in Europe, although each region may make other interpretations of the legal framework. There is an exception in the Medical Device Regulation (MDR) under Article 5, paragraph 5. The exemption is for health institutions to manufacture material on their own and under their quality system, if corresponding medical devices or quantities can not be met commercially.

For each product used by the Region of Scania (currently face shields and hand detergent) there is a document describing on the exact assembly and hygiene standard to be employed. As an example for the face shields, 3D Printing of parts are done by a larger number of contributors and final assembly are performed by LTH makerspace under supervision and instructions by Region of Scania, who acts as the formal manufacturer.

There is an additional complication in the terms that for instance face shields are not only classified as medical device, they are also classified as protective gear and from this legislation they also require CE-mark. The pragmatic approach by Region of Scania is to view them as medical products under current circumstances. This decision is also taken in light of that European Union have made an exception for usage of military masks for protection gear despite that they do not have formal CE-mark.

Since this process was adopted Inspektionen för vård och Omsorg (IVO) and Arbetsmiljöverket (AMV) have both made clarifications on their homepages. For details, see links below.

Situation in Sweden

There have been a few articles in Swedish media about usage of non CE-marked products for personal protection. Here are recent comments from Swedish authorities:

https://www.av.se/nyheter/2020/inga-sanktionsavgifter-pa-grund-av-skyddsutrustning/

https://www.ivo.se/publicerat-material/nyheter/2020/ivos-svar-pa-fraga-om-egentillverkade-visir-och-skyddsutrustning/. Please note that IVO as authority only deals with products that are to be classified as medical devices (and this definition may depend on intended use).

General Advice for all

For non approved products there are some key things that I would like you all to think on so please read and follow the advices below. If possible make the products according the principles of own manufacturing as a health provider if possible (see above for details).

Risk analysis

Risk analysis is mandatory for all products that some way or another deals with peoples health, Risk analysis should ideally be an integral part of the design process. Remember nothing is as safe so that it can not be made safer.

  • What risks are associated with the product for the user, and for the patient? What may possible go wrong? How can it be designed to avoid things go wrong.
  • How can a product be designed for inherent safety? Can we make it so it is completely obvious how to use it?
  • In corona times, how should the product be sterilized for initial use? Realistically, we must in the current situation assume that anyone that have handled the product may be infected.
  • In the risk analysis you need to account for use-errors (i.e the user is using the product incorrectly, due to stress, fatigue, or lack of knowledge).
  • Re-sterilization is a chapter on itself. Is this appropriate? What are the risks. Most of simple health care products are single use. Wasteful, yes, but less risky. In these times there will be a hard balance between risk and re-use of resources.

The risk analysis should be done together with a medical professional to get their opinion and expertise.

Documentation

Documentation in medical device design is key. It does not have to be complicated, just write down design iterations with date and version number. Technical platform is not critical, but best are platforms that contains version tracking. Ensure that the product contain version numbers (identification), if 3D printing place them in the product. Say you have made some improvements after user feedback. Suddenly you misplace some STL files and start to manufacture the wrong design iteration…

The documentation (can range from a page to no upper limit) should at least contain:

  • Who has been involved in the process
  • Design process and design iterations
  • Instructions for manufacture
  • Risk analysis process (what are the known risks, how were they mitigated, remaining risks). What was the input from medical professionals.
  • Initial sterilization (if applicable).
  • Re-sterilization (if this is possible / or not). In general be restrictive of this.
  • Testing (how was it tested). Depending on product it may range from inspection of blue prints, visual inspection, to very complex testing and even simple clinical tests. Include who took part of testing and date.
  • A note that the product is not regulatory approved and usage is on own risk and only in case of martial situations.

User instructions

Who will be the user of the product? Is it a highly trained expert or a more regular health care professional? Please note that in this situation many doctors will be stationed to do tasks that they are normally not doing. Decide if the product requires a user instruction. A user instruction may range from a complete booklet to a sticker or small notes with images on how to use it. Super simple instructions on how to use the product may be necessary, or at least make the product safer.

medicalsafety.txt · Last modified: 2020/03/31 09:25 by 213.89.112.97