Eisner Safety Consultants

The FDA issued a draft guidance document on ‘Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety & Effectiveness in Design’ for Industry and FDA Staff as of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.

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To submit comments follow these instructions: Submit written requests for single copies of the draft guidance document entitled “Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design” to the Division of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!

COCIR, the European industry association representing the radiological, electromedical and IT industries, issued (on 22 Nov 2010) a decision diagram to determine if software is considered a medical device per the Medical Device Directive (MDD) 93/42/EEC including the amendment.  The document includes a clear definition of what software includes, which is a wide range of items.  Refer to the footnotes for some details that refer back to the MDD.