Eisner Safety Consultants

Do you have EU transition period questions related to the MDD & AIMDD Harmonized Standard EN IEC 60601-1:2006 (or sometimes known as 3rd edition of EN IEC 60601-1), its’ collaterals (EN IEC60601-1-XX) and its’ particulars (EN IEC 60601-2-XX) standards?  If you do, you have until June 30th, 2011 to submit your questions to an expert team, at 60601Ed3.NBMED.issues@gmail.com, that will endeavor to answer these questions by September 30, 2011 for this 1st round of this new group.  Please read the below letter that have been sent to many different places around the world but note the only questions that will be answered are not the technical issues of how to apply 3rd ed. of EN IEC 60601-1 or even any transitional questions in regard to the FDA (ANSI/AAMI/ES 60601-1), Health Canada (CAN/CSA C22.2 No. 60601:08), MHLW (Japan), or SFDA (China) but only with respect to the implementation of EN IEC 60601-1, 3rd edition in regard to CE Marking under the MDD and AIMDD.  Several years ago there was a FAQ document issued that was on the older version of the CENELEC website when the site changed that link disappeared.  Only just before this letter (below) was issued about the submission of additional transitional questions with regard to 3rd edition of EN IEC 60601-1 did this FAQ document show up again on the CENELEC website in the Medical Equipment Technology Sector.  This FAQ document is an excellent primer for understanding some of the transitional issues for 3rd ed of EN IEC 60601-1 with respect to the MDD & AIMDD.  With this group hopefully collecting additional transition issues the FAQ document will grow and improve our overall understanding of some of the challenges with the transition of EN IEC 60601-1 3rd edition and its’ 60 or so related standards.

I would like to also thank Martin Schneeberg & Peter Linders for allowing me to share this with all my clients and website visitors.

Implementation of EN IEC 60601-1 3rd edition

Request for Issues

on the use of the standard for CE-conformity purposes

When the transition period was defined for EN IEC 60601-1:2006 (replacing the 1988 version with its two amendments), several questions arose. These questions were included in a FAQ document that was posted at the CENELEC web site (click here) to give all users the same interpretation[1]: (click here).

The transition period, after which only the 2006 edition will be giving presumption of conformity with the relevant Essential Requirements of the Medical Device Directive (93/42/EC), is now well underway. As an increasing number of manufacturers are implementing this version of the standard, more questions come up. In particular this is the case in conversations between manufacturers and involved authorities or Notified Bodies considering CE-conformity purposes.

In an attempt to support these discussions, and to harmonize responses, we are looking for specific matters that have arisen and that may have wider relevance. Together with regulatory experts, we will seek answers to those matters that reflect a consensus opinion of the Medical Notified Bodies. Clearly, this is not a request for technical matters, e.g., for required test conditions, but rather unclear situation. A few examples of such matters are given in the annex.

If you know of such matters, or even have experienced some yourselves, please share these. If you have reached agreement on these matters or you have proposals for the same, and wish to share: these are also very welcome. As indicated, the matters will be compiled and given to experts for sound advice, followed by scrutiny from NB-MED experts, resulting in the best available recommendations for the matters indicated. This advice will be made publicly available.

Please submit your contributions to: 60601Ed3.NBMED.issues@gmail.com. Note that not all contributions may receive individual responses. We will start work with material submitted by 30 June 2011, yet contributions after that date remain welcome. We expect first results by 30 September.

Thank you for your consideration and valuable contributions.

Martin Schneeberg (TÜV SÜD PRODUCT SERVICE, member of UK 811.1, IEC TC62A, WG14, MT28, A1PMT, IECEE RM TF)

Wolfgang Leetz (Siemens AG, Healthcare Sector, chair of DKE Division 8 (electro medical equipment, electro acoustic, ultrasound, laser), chair of COCIR Standardization Policy Focus Group)

Peter Linders (Philips Healthcare, chair of CENELEC TC 62, chair of COCIR Technical and Regulatory Affairs Committee, member of IEC/TC 62 CAG, A1PMT)

Annex – Examples of questions sought

Q1. Valid EC Design-Examination certificate period vs. DOCOPOCOSS: 2012-06-01:
Example: Suppose an MDD class IIB or III electrical medical equipment was placed on the EEA in 2009. It has a signed EC Design-Examination Certificate by a NB based on 2Ed EN 60601-1, valid until 2014-01-01 (five years).

Question: Is this product affected by the DOCOPOCOSS related to EN 60601-1:1990 (+ am1 + am2), June 1st 2012? Keep in mind that a valid EC certificate has been issued by a NB which is valid 5 years up to 2014.

Q2. Future totally new particular standards:
For a specific MEE does not exist a specific particular standard related to 2Ed EN 60601-1. However, for this specific MEE a totally new particular standard related to the 3Ed EN 60601-1:2006 is work in progress. This question is relevant at least for:
– 60601-2-63: for dental extra-oral x-ray equipment,
– 60601-2-64: light ion accelerators,
– 60601-2-65: for dental intra-oral x-ray equipment,
– 60601-2-66: hearing aids and hearing systems

Officially such MEE’s shall fulfil the complete 3Ed EN 60601-1:2006 plus the relevant particular standard 60601-2-XY at the date 2012-06-01, unless there is a specific transition period for the applicable particular standard. Usually no specific transition period for the totally new particular standards are defined in the OJ, therefore, 2012-06-01 will apply.

Is there any guidance beyond the general advice to discuss specific problems related to the application of these new standards with the NB and using Risk Management?

Can 3 years transition period for the EN 60601-2-XY be claimed starting from publishing the EN version of the particular standard?

Q3. Is ZLG paper 3.5 A1 legally binding for EU NB’s and MEE manufacturers:
The ZLG-paper 3.5 A1 addresses a valid concern extremely clear: “The missing new assessment by the manufacturer after the end of the “doc” or the missing knowledge about the existing of new harmonized standards or scientific knowhow are substantial NON-conformities. If these NON-conformities will not be adequate corrected, the certificates have to be suspended or withdrawn.”
Is this paper legally binding? Am I allowed to ignore it? In clear words: If the “doc” is over and I have not objective evidence about the new 3Ed EN 60601-1:2006 requirements in a point-by-point protocol format, is my NB forced to suspend or withdraw my CE-certificate?

[1] Collateral standards under the MDD & AIMD: CLC/TC 62 questions and answers on the EN 60601-series of standards in relation to the MDD and AIMD

The FDA issued a draft guidance document on ‘Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety & Effectiveness in Design’ for Industry and FDA Staff as of June 22, 2011.  A 90 day comment period is open and comments to be considered should be sent to FDA by September 19, 2011 per the Federal Register Notice.

In the Federal Register Notice the background information (the first few paragraphs of Section 3 [Overview] of the Guidance document) is interesting as follows:

“To understand use-related hazards, it is necessary to have an accurate and complete understanding of how a device will be used.  Understanding and optimizing how people interact with technology is the subject of human factors engineering (HFE) and usability engineering (UE). HFE/UE considerations that are important to the development of medical devices include three major components of the device-user system: (1) Device users, (2) device use environments, and (3) device user interfaces. This interaction and its possible results are depicted graphically in Figure 1.

Fig 1 From FDA Guidance Document - Interactions among HFE/UE considerations result in either safe & effective use or unsafe or ineffective use

For safety-critical technologies such as medical devices, the process of eliminating or reducing design-related use problems that contribute to or cause unsafe or ineffective medical treatment is part of a process for controlling overall risk. For devices where harm could result from “use errors,” the dynamics of user interaction are safety-related and should be components of risk analysis and risk management. By incorporating these considerations into the device development process, manufacturers can reduce the overall risk level posed by their devices, thus decreasing adverse events associated with the device, and avoid potential device recalls.

…”

To submit comments follow these instructions: Submit written requests for single copies of the draft guidance document entitled “Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

On LinkedIn there is a survey posted to find out what users of the standard ISO 13485 think about revising the standard.

“The purpose of this questionnaire is to determine the need for modification or updating of the ISO 13485:2003 requirements standard and the ISO/TR 14969:2004 guidance document.”

From what the full text on LinkedIn says ISO 13485 will be getting an update either way but this way you can provide feedback, to the authors of the standard, as to what you think and maybe that can have some impact on the development of the next edition of the standard.  If you are a medical device company and interested in responding to this survey you can access it by clicking here.  It asks some really good questions and hopefully your feedback will help the development  of the standard.

Thx Marcelo for posting this survey.

The latest release of the Manual on Boderline and Classification in the Community Regulatory Framework for Medical Devices Version 1.9 was updated March of 2011.

There are 4 new areas that have been incorporated into this version (1.9) of the manual.

They include: 1) Bio functional clothes or “therapeutic clothes” in section 1.7 of the manual, 2) System for the determination of bacterial contamination in blood products in section 1.8 of the manual, 3) Independent in-vivo dosimeters in section 1.9 of the manual, and 4) Eye drops regulated as medical devices in section 8.19 of the manual

Below is an excerpt of each of the four sections of its’ background to give you an idea of what each item is covering.

1.7 Bio functional clothes

Bio functional clothes or “therapeutic clothes” consist of clothes (e.g. socks, leggings, pyjamas, undershirts…) impregnated with silver and brown algae extract. These clothes are presented as having anti-bacterial, anti-microbial, breathable, thermal regulating and anti-odour properties. According to the manufacturer, the silver ions (positively charged) integrated into the fiber reduce the microbial growth in the fabric and inhibit microbial growth on the skin, and the brown algae extract protects against rash act by neutralization of neuromediators and vasodilatator agents responsible for flushing. The intended use of these clothes is to prevent inflammatory crisis of atopic dermatitis.

The main mode of action described by the manufacturer is the creation of a physical barrier that prevents the contact of sensitive skin with the outside and other tissues potentially sensitizing, creating an environment helping to the attenuation of skin conditions. The actions of silver and algae extract were presented as an ancillary action. The product was presented as a Class I medical device.

1.8 System for the determination of bacterial contamination in blood products

The bacterial contamination of blood components represents a high infectious risk in blood transfusion, particularly for platelets concentrate. In order to estimate the bacterial contamination, manufacturers have developed some bacterial detection systems near the time of blood collection. A new system has been developed based on the detection and identification of a wide spectrum of common pathogenic bacteria. Following the identification, a direct count is obtained by cytometry.

1.9 Independent in-vivo dosimeters

In vivo dosimetry systems are used in radiotherapy to monitor the radiation dose received by the patient during a radiotherapy treatment. The device consists in a semi-conductor detector placed on the patient’s skin and an electrometer placed in the control room where the physicians control the radiotherapy equipment. When performed early in treatment as an additional measure, the in vivo measurements of the radiation dose are an additional safeguard against setup, calculation or transcription errors. If the dose delivered to the patient is higher than the calculated dose, the system, independently of the radiotherapy equipment, can alert the physician, allowing him to act on the treatment.

8.19 Eye drops regulated as medical devices

The ocular surface is a physiological complex fundamental in the maintenance of a good visual function, so its integrity must be properly safeguarded irrespective of the use of contact lenses. The use of substances that increase the retention time of the lubricants, tend to increase the contact time between the lubricant and the ocular surface.

According to point 3.1.2.2 of MEDDEV 2.4/1 rev.9 on the Concept of continuous use, if it cannot be demonstrated that components of the device are totally eliminated in the interval between uses, this is also considered as an immediate replacement.

The continued use in situations where there is no lasting relief of symptoms as well as the continuation of aggressive conditions (environmental or not / or due to a number of medical conditions) can lead to the permanent and / or high frequency use (with products whose rate of elimination is unknown), setting the conditions for the continued use of these lubricants. Considering eye lubricants as examples of medical devices (in which there is no demonstration of their total elimination between applications) destined for continuous use.

Posted 12 May 2011 on the DeviceTalk blog of MD&DI, RoHS Directive and the Future of Medical Devices

Thx Heather Thompson, Editor in Chief of MD&DI, for your enlightening post!