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GRP-112 Medical Devices in Morocco: What Guarantees of Quality and Safety?
  1. MA El Wartiti1,
  2. W Enneffah1,
  3. A Benmoussa2,
  4. J Lamsaouri2,
  5. S Makram3,
  6. J Taoufik2
  1. 1Mohammed V Military Teaching Hospital – Faculty of Medicine and Pharmacy, Clinical Pharmacy – Therapeutic Chemistry, Rabat, Morocco
  2. 2Faculty of Medicine and Pharmacy – Mohammed V University Souissi, Clinical Pharmacy – Therapeutic Chemistry, Rabat, Morocco
  3. 3Mohammed V Military Teaching Hospital – Faculty of Medicine and Pharmacy, Pharmacy – Pharmacology, Rabat, Morocco

Abstract

Background Nowadays, all over the world, many medical devices, initially considered as non-risk or low risk, have been proved to be extremely dangerous to human health, as evidenced by the latest scandal of PIP implants.

Purpose To report the experience of Mohammed V Military Teaching Hospital of Rabat in evaluating the quality and safety of medical devices and to analyse elements that can compromise the quality of these products in our country.

Materials and Methods 30-month prospective study (January 2010–June 2012). We collected claims relating to the quality of medical devices at our hospital, in normal conditions of acquisition, dispensing and use. We also analysed the processes of placing on the market medical devices, the systems governing their use in hospitals and the main Moroccan rules regulating them.

Results 30 claims were collected. They concerned: catheters (40%), surgical drapes (20%), gloves (17%) and other medical devices (23%). 47% of their defects were discovered before they were used in patients, 13% presented a risk of incident and 40% caused an incident in patients.

The process of marketing a medical device, ensuring its quality and safety, must satisfy several cheques regarding the design, manufacture, import, sale purchase and use, before Ministry of Health certification can be obtained.

Conclusions Claims concerned several categories of medical devices. Abnormalities detected compromise the quality and the safety of our patient care. Checks must take place at all levels of the distribution chain to avoid these risks.

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Abstract GRP-112 Table 1

No conflict of interest.

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