R. MEDICAL GROUP, INC Médico de Cabezera

Implementing a full regulatory programme can be very expensive and demanding on resources. The work of the GHTF and the trend to use international standards are, in effect, tackling this problem by steering manufacturers more and more toward producing medical devices with uniform standards. The methods and procedures relating to governmental regulations are also converging. These developments create opportunities for countries to establish low-cost programmes that promote the safety and performance of medical devices by taking full advantage of what others have already done in this field. Local adoption of harmonized recommendations will facilitate international exports of medical devices manufactured locally.

A good approach to setting a clear direction for all stakeholders is to establish a comprehensive national policy or guideline on medical device management. The government can subsequently bring in legislation and enforcement to suit the country’s conditions and needs. Five principal activities are identified:

1. Increasing the knowledge of the medical device sector 2. Establishing basic regulatory programmes

3. Drafting a comprehensive policy/guideline including the recognition and use of standards 4. Promoting compliance and cooperation

5. Setting priorities for regulatory programme development

6.1 Increasing knowledge of the medical device sector

1. Access the Internet for a great deal of freely available, relevant information. A list of web site addresses is provided in Annex 1.

2. Participate actively in the projects of the GHTF Task Forces in order to benefit from the experience of experts from other countries.

3. Form a partnership with a country that is a member of the GHTF and has a functioning regulatory programme on medical devices.

4. Make connections with national and international medical device problem coordinating centres.

5. Become an active member of a regional harmonization organization (e.g. Asian Harmonization Working Party (AHWP); the Latin American and Caribbean regional group (contact the GHTF for information on regional groups).

6.2 Establishing basic regulatory programmes

As discussed previously, medical device safety and performance is multi-phased and requires cooperation among all stakeholders. It is essential to identify the stakeholders in each country by maintaining a list of manufacturers, importers, distributors, retailers, institutional users (both public and private health care facilities), lay users (estimated from the number of home-use medical device vendors), and concerned citizens groups.

A basic regulatory programme should also include other important activities: holding education/consultation sessions with the stakeholders to discuss the issues; creating an atmosphere conducive to mutual trust and open discussions; and, inviting input from the stakeholders. The government should not overlook the willingness of stakeholders to help suggest solutions for issues that affect them. Such sessions will help to share understanding of issues affecting the safety and performance of medical devices, and should lead to the development of a policy/guideline that sets a direction for everyone (see Section 6.3). Apart from the rich source of practical suggestions that stakeholders can offer, they are more likely to comply with any requirements that they have participated in devising. If there are significant numbers of medical devices being sold or used in the country, then two basic programmes should be set up as soon as is possible: (1) Basic legislation; (2) Problem sharing.

6.2.1 Basic legislation

If the government has not already passed legislation, this should be done: a. To prohibit misleading or fraudulent advertising of medical devices,

Advertising has a powerful influence on people. A prohibition on the misleading or

fraudulent advertisement of health devices should be an essential legislation. This is particularly important since, as people are becoming more health conscious, the development of home-use medical devices is rapidly expanding.

Advertising control does not have to place demands on resources. For example, in Canada, even though the prohibition of misleading or fraudulent advertising is legislated, the Government does not routinely screen device advertising. The Government, however, will respond to inquiries or complaints made by the public or health care professionals. If the advertiser cannot convincingly prove their claims, the government can take action to prohibit the advertisement.

b. To empower the government to stop the sale of a device and issue alerts to the public under urgent hazardous conditions. Again, this is essential legislation in case the manufacturer or the vendor has not taken adequate action to ensure the safety of their product.

6.2.2 Sharing problem reports

The government should establish a national coordinating agency to receive and manage problem reports from all sources. This information can then be shared with other users in the country and in other countries as well. The objective is to improve the protection of the health and safety of patients, users and others by disseminating information, which can prevent repetition of adverse events.

If the government has no funding to set up such an agency, it should encourage the users, hospital technicians, clinical engineers and vendors to form a network. There is a high possibility that they will support such a programme, since it is in their own self- interest. Hospitals and universities are likely to have the resources and willingness to

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coordinate such activities. An advisory panel of experts and/or scientific testing laboratories in these institutions would be very useful for investigating problems. For example, they could confirm bacterial contamination, or investigate possible electrical hazards.

6.3 Drafting a comprehensive policy or guideline on