Hospital equipment provider does not meet essential requirements

PUTRAJAYA: Would Malaysians allow government hospitals to use critical life-saving equipment that have not met essential requirements?
Then, why does the Health Ministry continue to purchase equipment from a company that has not even met the basic provisions of the Medical Devices Act (MDA)?
These are questions being posed as medical equipment industry players continue to raise concerns over the ministry's decision to procure medical equipment from a company part-owned by its former deputy director-general.
Since July, they have been in the forefront to demand that patients' safety should not be jeopardised when it comes to critical-care equipment, and continue to do as they claim that the ministry has thrown caution to the wind.
The company is said to have been accorded "local assembly" status for four different types of medical equipment by the Trade and Industry Ministry (Miti), but yet had not completed formalities under the MDA as required by the Health Ministry.
The Miti letter states that the company ought to be given priority when purchasing the following equipment:
- patient monitor;
- defibrillator monitor;
- anaesthetic machine (GA); and
- hospital bed and furniture.
Citing product catalogues and literature from manufacturers, the companies noted that it would be impossible to assemble the "sensitive" and critical care equipment without precision tools and hi-tech equipment.
Miti has since Sept 1 declared that it would no longer issue such letters, although this particular letter continues to be used as a basis for procurement by the Health Ministry.
A search at the Companies Commission of Malaysia (CCM) showed that a former deputy director-general of health is a director and owns 50% of shares in the company while the other director has equal shareholding.
In a strongly worded letter to the Health Ministry's secretary-general, Datuk Farida Mohd Ali, signed by representatives of more than 70 companies, it is alleged that the quality of medical devices claimed to be manufactured by the company is "seriously questionable".
The letter noted that the company has not met the "Good Distribution Practice for Medical Devices and therefore in violation of the MDA".
theSun has independently verified with the chief executive of the Medical Devices Authority, Zamane Abdul Rahman that the company has yet to be certified, and hence is in contravention of the MDA. Particular references were made to two provisions in the Act:
- Section 5 (1): "No medical device shall be imported, exported or placed in the market unless the medical device is registered under the Act"; and
- Section 15(1): No establishment shall import, export or place in the market any registered device unless it holds an establishment licence granted under this Act"
The company's "assembly plant" is two units of shophouses at the Shah Alam Industrial Park. There was no activity there when a team from theSun visited the factory recently. At the rear was a lorry belonging to another medical supplies company.
The shutters were down, and on them were pasted all kinds of advertising material from loan providers and contractors.
The Malaysian Investment Development Authority (Mida) had in April 2012 approved an application from the company for a manufacturing licence for medical appliances and devices.
It was stipulated that the company should have a paid-up capital of at least RM2 million and employ at least 70 workers. In addition to these, the company was also required to obtain clearance from the Department of Environment.
However, checks done at the CCM on July 3 indicate that the company has a paid-up capital of only RM100,000. Subsequent checks by theSun showed that no manufacturing activities were being carried out at the premises.
The Malaysian Medical Association, meanwhile, says that the government should procure the best available products and provide the best medical care to Malaysians.